FAQs

Frequently Asked Questions Concerning Halyard Health Products and Services

Any product and other information above is provided solely for the general information of Australian and New Zealand healthcare professionals, and does not constitute medical advice. There are inherent risks in the use of all medical devices and products. Please see product packaging for full Directions for Use and our Legal Statement for further details.

TOPICS

General Information

Q: FAQs coming soon
A: Under construction
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About Halyard Health

Q: What is the company’s relationship with Ballard Medical Devices?
A: The company acquired Ballard Medical Devices in 1999. Ballard Medical Devices was a manufacturer in the medical device field with its lines of closed suction respiratory catheters and oral care systems, multifunction electrodes, enteral feeding tubes, diagnostic tests and a variety of endoscopy and pain management products.
Q: How is the company connected with Safeskin?
A: With the acquisition of Safeskin Corporation in 2000, Halyard added disposable gloves to its product portfolio and now offers head-to-toe protection for healthcare workers.
Q: Who is my Halyard Health Account Manager?
A: If you are unsure who your Halyard Health Account Manager is, call (AUS) 1800 101 021 OR (NZ) 0800 482 211 or email CustomerService_ANZ@hyh.com for their name and phone number. All we need is your hospital/facility name and geographic region (Post Code).
Q: How can I locate a Halyard Health distributor in my area?
A: Halyard Health utilizes distributors to get our products to you. To locate the distributor nearest you, call our Customer Care Line call (AUS) 1800 101 021 or (NZ) 0800 482 211 or email CustomerService_ANZ@hyh.com for more information.
Q: How can I get pricing information?
A: Please contact your local Halyard Health Account Manager or distributor to obtain pricing. Or call (AUS) 1800 101 021 or (NZ) 0800 482 211 or email CustomerService_ANZ@hyh.com
Q: What do I do if I have a quality complaint?
A: Halyard Health strives to produce the best quality products on the market today. There are times, however, when a product doesn't perform to a customer's satisfaction. Whenever that happens, Halyard Health would like to hear from you. Your questions and concerns should be directed to your local Account Manager or our Customer Care Line - call (AUS) 1800 101 021 or (NZ) 0800 482 211 or email CustomerService_ANZ@hyh.com
Q: How can I get a sample of your product?
A: To request samples, please contact your Halyard Health Account Manager or our Customer Care Line - call (AUS)1800 101 021 or (NZ) 0800 482 211 or email customerservice_ANZ@hyh.com
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Diagnostics

Q: Do I need to use a warming device with the CLOtest*?
A: No, use of a warming device may help speed the test reaction, but it is purely optional and will not affect the test accuracy.
Q: Can I read the CLOtest* after 24 hours?
A: Yes. If the color of the gel is yellow at 24 hours, the test is negative. However, if unavailable to be read at 24 hours, the test will remain valid for 72 hours after insertion of the biopsy into the gel medium.
Q: How fast is the CLOtest*?
A: The CLOtest* will diagnose 75% of H. pylori positive patients in 20 minutes. Within 1 hour, 85% of positive patients will be detected, and within 3 hours 90% are detected.
Q: How accurate is the CLOtest* Rapid Urease Test?
A: 98% sensitivity, 97% specificity
Q: Is the PYtest* 14C-Urea Breath Test reimbursable by Medicare?
A: Yes, and many other carriers also pay for the test.
Q: How much time is required to conduct the PYtest*?
A: The PYtest* test administration requires 10 minutes, and results can be in produced in less than 10 minutes.
Q: Does the PYtest* test for active H. pylori infection?
A: Yes, unlike serum and blood tests that detect antibodies, the PYtest* tests for active H. pylori infection.
Q: Can I perform the PYtest* in my office?
A: Yes, equipment to perform the analysis may be used in the physician office.
Q: Is the PYtest* regulated by CLIA?
A: No, CLIA does not consider breath a sample and, therefore, does not regulate the PYtest*.
Q: Does the PYtest* test require any special radioactive materials license?
A: No, other than Kansas and Maryland, no other states require a radioactive materials license to perform the PYtest*.
Q: How much radioactivity does the PYtest* capsule contain?
A: Each PYtest* capsule contains 1 micro curie of carbon 14. This is equivalent to 24 hours of normal background radiation.
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Enteral Feeding Tubes

Q: How should the external bolster of the MIC-KEY* tube fit?
A: The bottom of the bolster should rest just above the surface of the skin. A good fit is considered 2-3 mm above the skin, or about the thickness of a dime. Tight fitting tubes may lead to pressure necrosis and may be an indicator that the tube should be changed to a larger size.
Q: Should the MIC-KEY* feeding tube be rotated?
A: The MIC-KEY* Low-Profile Gastrostomy Feeding Tube should be rotated at least daily to prevent tissue from adhering to the tube, to relieve pressure on the skin and to allow for air circulation. However, the MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube should not be rotated as it extends into the jejunum and rotating may cause the tube to torque and retract into the stomach. This is also true for the MIC-KEY* Low-Profile Jejunal Feeding Tube as well as all other jejunal feeding tubes.
Q: Do the MIC-KEY* enteral feeding products contain DEHP?
A: MIC-KEY* feeding tubes are made of silicone and do not contain DEHP. MIC-KEY* Extension Sets, which are made of polyvinylchloride (PVC), were formerly available only in a DEHP-containing formulation. They are now available in a DEHP-free formulation and all MIC-KEY feeding tube kits are packaged with DEHP-free formulation extension sets. Extension sets containing DEHP may be purchased separately.
Q: How is the silicone retention balloon inflated and deflated?
A: The balloon is inflated and deflated by inserting a Luer slip syringe into the balloon valve. The valve should only be used to check the balloon volume or replace the tube. Be certain never to feed through the balloon valve.
Q: What maintenance is required for the silicone balloon?
A: We recommend that the balloon be filled with sterile or distilled water at the time of insertion. Use of saline or tap water may contain salt, mineral or other contaminants that can clog the balloon lumen or cause the balloon valve to stick. The balloon volume should be checked weekly and additional water added if indicated. The balloon should never be filled with air as silicone is porous to air and will cause the balloon to deflate.
Q: How is the extension set attached?
A: To attach the extension set, align the black line on the set with the black line on the feeding port. Insert the “nose” of the SECUR-LOK* connector into the feeding port, then rotate it clockwise until you feel a slight resistance (approximately three quarters turn). The extension set will swivel with movement, which allows the user to change position during feeding.
Q: How should the extension set be maintained?
A: The extension set should be washed after every feeding with warm, soapy water, then rinsed thoroughly. Prompt flushing and rinsing prevent the formula from drying and collecting. Extension sets should be changed periodically if they become cracked, discoloured, or otherwise non-functional.
Q: What is the purpose of the syringes?
A: A 6 ml Luer slip syringe is included with the feeding tube. It should be used only to fill and deflate the retention balloon when periodic volume checks are made, and when the feeding tube is replaced. A 35 ml catheter tip syringe should be used when priming and flushing the extension sets, and when checking for proper placement of the feeding tube.
Q: How often should the MIC-KEY* feeding tube be cleaned?
A: The tube should be cleaned daily and both the tube and the stoma should be kept clean and dry. Recommended cleaning supplies include soap and water, cotton tip applicators, tissues and a Luer-slip syringe.
Q: What are the steps for daily maintenance of the MIC-KEY* Low-Profile feeding tube?
A: 1. Wash hands with soapy water before touching the tube.

2. Inspect the skin around the stoma after feeding, making sure the skin is clean and dry and checking for any gastric leakage.

3. If a dressing is used, change it when it becomes wet or soiled.

4. Gently clean the skin around the stoma, rotate the feeding tube, then clean again using soap and warm water, and cotton-tip applicators or a soft cloth. Do not rotate jejunal feeding tubes.

5. Clean the feeding port with a cotton-tip applicator or soft cloth. When continuous feeding, flush the tube and extension set tubing at least three times a day.
Q: How long will the MIC-KEY* tube last?
A: Many factors can affect the life of feeding tubes including patient anatomy, gastric environment, feeding regimens, medications, and tube care. However, MIC-KEY* enteral feeding tubes can be expected to last between one and eight months. Your facility may elect to establish a routine changing protocol or to wait until the product requires replacement.
Q: How should the proper tube positioning be checked?
A: Before feeding, check the tube to be sure it is not clogged or displaced outside the stomach. Do this by connecting the extension set to the tube and attach a catheter tip syringe with 10 ml of water to the extension set feeding port. Pull back on the plunger. When stomach contents appear in the tube, flush the tube with water. Check for leaking around the stoma. Another way to do this is to draw 5-10 ml of air into a syringe. Place a stethoscope on the left side of the abdomen just above the waist. Inject the air into the extension set feeding port and listen for the stomach to “growl.” Try again if you do not hear the sound. If you still do not hear it, you should verify the tube’s position radiographically.
Q: When should the stomach residuals be checked?
A: The MIC-KEY* feeding tube permits the stomach residual to be checked without a decompression tube. Check for residual if the formula backs up in the extension tubing, or if the patient feels nauseated. Check the residual 30 minutes later and resume feeding if the amount is less than at the first check.
Q: How should medications be administered?
A: Medications should be given in liquid form. Thick medication can plug the feeding port. If a medication is only available in tablets or capsules, make sure it can be crushed and mixed with water. Normally, medication should not be mixed with formula. Small quantities of medication can be diluted with water in a luer slip syringe and injected directly into the feeding port. This eliminates the need for extension tubing. After giving medication, the port should be flushed with at least 10 mls of water.
Q: Can the patient or caregiver replace the tube at home?
A: If properly trained and permission is given by the physician, the patient or caregiver should be able to replace the tube at home. You may want to consider sending the patient home with a replacement device to be used in case of tube failure, especially for those patients who may live far from the facility or who may be traveling.
Q: How can we prevent tube occlusion?
A: One of the primary causes of tube failure is tube occlusion, especially with longer gastric-jejunal feeding tubes. In most instances this can be prevented with proper tube care. The tube should normally be flushed with 10-20 ml of warm water:
• Before and after each feeding.
• Before and after giving medications, which should be given 1 at a time with a 5-ml flushing between each. Medications should be administered only through the gastric port and not through the jejunal port.
• Every 4 to 6 hours if the patient receives continuous feedings.
• After checking for stomach content residuals.
Q: What steps should be taken if the feeding tube becomes occluded?
A: Fill a catheter tipped syringe with warm water. Connect the bolus extension set to the clogged port. Using a gentle in and out motion, try to dislodge the clog with the water. If the clog is visible above the skin surface, gently massage the tube between your fingers to break up the clog and proceed as above. Do not use force or pass foreign objects through the tube when trying to clear an occlusion as this may rupture the tube.
Q: What if the balloon will not deflate?
A: If water cannot be extracted from the balloon with the syringe, make sure the recess in the valve is clean and that the valve is not blocked by food. Clean inside the recess, then firmly seat the syringe into the valve, push and twist a quarter turn. Try pulling back on the plunger again. If the balloon will not deflate, use the end of a large paper clip to depress the valve and release the water. Make sure to have a replacement tube to insert into the stoma.
Q: What is the composition of MIC-KEY* feeding tubes and extension sets?
A: MIC-KEY* enteral feeding tubes are made of medical grade silicone. Extension sets are made of polyvinylchloride (PVC).
Q: Can the distal end of the MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube be trimmed?
A: Although we have no reason to believe that trimming the tube may affect tube performance, we have not conducted any studies demonstrating the safety or efficacy of using trimmed MIC-KEY Transgastric-Jejunal feeding tubes. The MIC-KEY* Jejunal Feeding Tube, which has access only to the Jejunum, may be trimmed to length.
Q: What does “KEY” in MIC-KEY* mean?
A: “KEY” refers to the unique lock and key mechanism used to connect the extension set to the MIC-KEY* tube. This connection allows the extension set to lock and rotate within the feeding tube without moving the tube itself.
Q: Are there any instructional materials available for our staff and patients?
A: Yes. A care guide entitled MIC-KEY* Low-Profile Gastrostomy Feeding Tube – Your Guide to Proper Care is provided with each MIC-KEY feeding tube and can be ordered separately in a variety of languages. A video entitled Life with MIC-KEY* Low-Profile Gastrostomy Feeding Tube is ideally suited for the patient and caregiver. An enteral feeding tube and stoma care program is also available for clinicians. Please contact Customer Service or your Account Manager for further information.
Q: How can I get product ordering information?
A: Call Customer Service at (AUS) 1800 101 021, (NZ) 0800 482 211 or contact your Account Manager. You can also visit the Enteral Feeding Tubes page on this website and refer to the product catalog.
Q: Should jejunal tubes be connected to suction or should residuals be checked through the jejunal portion of the tube?
A: No. The jejunum has a very small lumen. This could cause the mucosa to be suctioned into the tube and injure the patient or clog the tube.
Q: Should bolus or gravity feedings be administered through the jejunal portion of jejunal tubes?
A: No. Bolus feedings can create "dumping syndrome". Gravity feeding may go in too slowly and the tube can become clogged.
Q: What is the main advantage of the Halyard MIC-KEY* Low Profile Gastrostomy Feeding Tube?
A: The MIC-KEY* offers several advantages over conventional gastrostomy tubes, starting with its’ low-profile design. Conventional feeding tubes have a relatively long external portion that must be “secured” to the body. The low profile design of the MIC-KEY* means it is less cumbersome, unobtrusive, and easy to conceal.
Q: What makes the Halyard MIC* Transgastric-Jejunal Feeding Tube so appealing?
A: Available in a wide range of sizes and lengths, the MIC* Transgastric-Jejunal Feeding Tube allow simultaneous jejunal feeding while decompressing the stomach. Other unique advantages include a relatively large bore jejunal inner lumen and multiple exit ports to minimize clogging, and a tungsten-weighted jejunal portion to decrease the need for tube repositioning
Q: What are the advantages of the MIC* SECUR-LOK* External Retention Ring?
A: The SECUR-LOK* Ring, found on most MIC* Enteral Feeding Tubes, is designed to help prevent tube migration, but it has other significant benefits as well. It is also designed to help keep the stoma site healthy by allowing air to circulate and to reduce tube torque pressure 360° around the stoma site.
Q: What do I do if there is gastric leakage from the stoma site?
A: If you suspect gastric leakage:

• Gently clean and dry the site, then check the site after 30 minutes to see if there is any fresh leakage. This will indicate whether there is actual gastric leakage and not just spillage from a previous feeding or tube check. If there is actual gastric leakage and the skin is intact, you may ask your physician whether you should apply a skin protectant or moisture barrier such as zinc oxide ointment. Notify the physician if skin redness extends more than 1 cm from the stoma or is accompanied by pain, swelling or denuded skin.

• Check the amount of water in the balloon. The balloon may be leaking if it has lost the prescribed amount of fluid and the tube may need to be replaced. If the correct amount of water remains in the balloon, the device may be poorly sized or inadequately stabilized and you should have your clinician reevaluate the tube.

• Verify that the external bolster rests just above the abdomen by 2-3mm. Check for proper internal balloon placement by aspirating the stomach contents to assess for gastric residuals or by utilizing air auscultation.

• Verify that fluid will flow freely by flushing the tube with water.

Leaks can also be caused by improper patient positioning, by infusing the feeding formula too rapidly, or by feeding too large a volume. Keep the patient elevated at least 30 degrees during, and 1 hour after feeding. This will also help to prevent aspiration. If the feeding volume is too large, consult your clinician as to whether you should change to smaller, more frequent, or continuous volume feedings.
Q: How should the feeding port and anti-reflux valve be maintained?
A: The port and valve should be kept very clean. To prevent dried formula from lodging inside the recess and possibly holding the valve open, flush thoroughly with water and complete the cleaning with cotton-tipped applicators and water. Residual formula should not be left to pool and dry inside the valve opening.

Caution: Do not push cotton-tipped applicators or other foreign objects through the feeding port valve as this may cause the valve to tear and leak.

Q: How should medications be given?
A: Medications should be given in liquid form. Thick medication can plug the feeding port. If a medication is only available in tablets or capsules, make sure it can be crushed and mixed with water. Medication should not be mixed with formula as they may harden together and cause the tube to become occluded. Never crush enteric-coated medication. Before and after giving medication, the port should be flushed with water.
Q: What is the proper procedure for decompression or venting?
A: Decompression refers to releasing air or food from the stomach before or after feedings. To decompress the stomach, simply attach the extension set or bolus extension set to the MIC-KEY* feeding tube, then drain any contents into a collection cup or bag.
Q: How is the tube placement verified?
A: Before feeding, check the tube to be sure it is not clogged or displaced outside the stomach. You may do this by drawing 5-10 mls of air into a syringe. Place a stethoscope on the left side of the abdomen just above the waist. Inject the air into the extension set feeding port and listen for the stomach to “growl.” Try again if you do not hear the sound. If you still do not hear it, do not proceed to feed. Contact your specialist and report the problem. Another method is to connect the extension set to the feeding tube and attach a catheter tip syringe with 10 mls of water to the extension set feeding port. Pull back on the plunger. When stomach contents appear in the tube, flush the tube with water. Check for leaking around the stoma. If at any time you suspect the feeding tube has become dislodged, discontinue feeding and contact your specialist to report the problem.
Q: How is the silicone retention balloon filled and emptied?
A: The balloon, which holds the tube in place, is located inside the stomach. It is filled and emptied with water by inserting a slip tip syringe into the balloon valve. The valve should only be used to check the balloon volume or to replace the tube. Never feed through the balloon valve.
Q: How should the patient be positioned during feeding?
A: Correct feeding position is essential to avoid aspiration of stomach contents through the oesophagus and potentially into the lungs. The patient should be placed in an upright position or at least at a 30-degree angle during, and one hour after feeding.
Q: What maintenance is required for the silicone balloon?
A: The balloon should be filled with water at the time of insertion. We recommend the use of distilled or sterile water as saline may crystallize and clog the balloon valve or lumen and air may seep out and cause the balloon to collapse. Tap water may contain harmful contaminants that could shorten the life of the balloon. The balloon volume should be checked weekly and additional water added if the amount in the balloon is less than the amount prescribed by the physician. The balloon should never be filled with air as it may leak and the tube may fall out of the stomach.
Q: How should the extension set be maintained?
A: The extension set should be washed after every feeding with warm, soapy water, then rinsed thoroughly and allowed to air dry. Prompt flushing and rinsing prevent the formula from drying and collecting.
Q: What if the feeding administration set becomes disconnected?
A: If the feeding administration set becomes disconnected from the extension set tubing, stop the pump and estimate the amount of formula lost. Thoroughly wipe the tube connections with soap and water or alcohol. Clean inside the extension set feeding port with a cotton-tipped applicator and alcohol. Irrigate the tube with warm water. Dry the connections and firmly reconnect the tubes with a quarter turn. Resume feeding.
Q: What if the balloon will not deflate?
A: If water cannot be extracted from the balloon with the syringe, make sure the recess in the balloon valve is clean and that the valve is not blocked by food. Clean inside the recess, then firmly seat the syringe into the valve, push and twist a quarter turn. Try pulling back on the plunger again. If the balloon will not deflate, use the end of a large paper clip to depress the valve and release the water. Make sure to have a replacement tube to insert into the stoma.
Q: What is the purpose of the syringes?
A: A 6 ml slip tip syringe is included with the feeding tube. It should be used to fill and empty the retention balloon when periodic volume checks are made and when the feeding tube is replaced. The 35 ml catheter tip syringe should be used when priming and flushing the extension sets and when checking for proper placement of the feeding tube.
Q: What is the MIC-KEY* bolus extension set used for?
A: The MIC-KEY* kit includes a bolus extension set for feeding with a catheter tip syringe or feeding bag. Bolus feeding is comparable to a normal feeding pattern and normally takes 20 to 40 minutes. The bolus extension set is also attached by aligning the black line on the extension set with the black line on the feeding port and then rotating a quarter turn clockwise.

The bolus extension set is intended to be used for short term feeding when the person receives multiple feedings throughout the day. The straight connector and wide tubing facilitate quick feeds.

Q: How do I unclog a tube?
A: The short length of the MIC-KEY* Gastric Feeding Tubes make them quite clog resistant. The MIC-KEY* Jejunal Feeding Tubes must be monitored carefully to prevent clogging. If a tube does become clogged:

• Attach an extension set to the clogged port (gastric or jejunal) of the MIC-KEY* feeding tube. Place a catheter tip syringe filled with warm water into the extension set and gently pull back on then depress the plunger to dislodge the clog.

• If the clog remains, repeat the previous step. Gentle suction alternating with syringe pressure will relieve most obstructions.

• If this fails, consult your clinician and consider trying a solution of pancreatic enzymes and sodium bicarbonate instilled through a catheter tip syringe. We recommend you do not use cranberry juice, cola drinks, meat tenderizer or chrymotrypsin, as these can actually cause clogs or create adverse reactions in some cases. Diet sodas (non-cola) and carbonated or seltzer water may prove successful in removing some clogs.

• If the clog is stubborn and cannot be removed, the tube will have to be replaced.

Q: How does the MIC-KEY* feeding port work?
A: Nourishment and liquids are delivered through the tube and into the stomach through the feeding and medication port. When not in use, the port should be capped off with the attached cover. An anti-reflux valve located inside and toward the top of the feeding port helps prevent stomach contents from leaking out of the tube. The valve is opened with the extension set.
Q: How is the extension set attached?
A: To attach the right angle extension set, align the black line on the set with the black line on the feeding port. Insert the “nose” of the SECUR-LOK* connector into the feeding port, then rotate it a quarter turn clockwise. Next, open the extension set feeding port and attach the feeding bag connector to the extension set by firmly pushing and twisting. The extension set will swivel with movement, which allows the user to change position during feeding.
Q: How do I prevent the tube from becoming clogged?
A: Proper tube flushing is the best way to avoid clogging the MIC-KEY* feeding tube. Flush the tube with water every 4-6 hours during continuous feeding, before and after every intermittent or bolus feeding, or at least every 8 hours if the tube is not being used. The MIC-KEY* feeding tube should also be flushed before and after administration of medications and after checking for stomach residuals. Medications should be given in liquid form. If a medication is only available in tablets or capsules, make sure it can be crushed and mixed with water. Medication should not be mixed with formula. Never crush enteric-coated medication. Before and after giving medication, the port should be flushed with water. Medications should not be administered through the jejunal port of jejunal tubes as this may clog the tube lumen. When flushing a tube, use water and a 30cc-60cc catheter tip syringe. Do not use smaller sizes as this can increase pressure on the tube and potentially rupture the tube. The amount of water used to flush the tube will depend on the individual’s needs, clinical condition and type of tube, but the average volume ranges from 10-50 mls for adults, and 3-10 mls for children. Do not use excessive force to flush the tube as this can perforate the tube and can cause injury to the gastrointestinal tract.
Q: How should the external bolster fit?
A: The bottom of the bolster should rest just above the surface of the skin. A good fit is about an eighth-inch (2-3 mm) above the skin, or about the thickness of a dime.
Q: What types of skin and stoma problems can occur?
A:
  • Persistently red and sore stoma with a red area larger than 2.5 cm in diameter.
  • An odour coming from the stoma.
  • Swollen skin around the stoma.
  • Pus around the stoma.
  • Fever.
  • Granulation, which is the body´s attempt to repair the surgical incision.

If any of these conditions occur, contact your clinician for advice on how to treat the problem.

Q: What is the extension set used for?
A: The extension set connects the formula source to the MIC-KEY* feeding tube. The right angle SECUR-LOK* extension set is convenient to use for continuous pump feedings because it lies flat against the abdomen and swivels with the patient's movements. This makes it comfortable for continuous feeding. Detach the extension set when not in use and wash it between feedings.
Q: What if the balloon leaks or ruptures?
A: Silicone balloons may last several months, but the life span of the balloon can be affected by various factors such as medication, gastric pH, infection and tube care. We recommend that you have a replacement MIC-KEY* feeding tube available in case of inadvertent tube removal or failure. If the tube fails and you have been properly trained, you may replace the tube. If you have not been properly trained or your clinician prefers to replace the tube, you should contact your clinician as soon as possible as the stoma may begin to close within 2-4 hours.
Q: What is the procedure for replacing the MIC-KEY* feeding tube?
A: The specialist will decide when to replace the MIC-KEY* feeding tube. You may change the feeding tube yourself provided you have been properly trained and have been given permission to do so.

1. Cleanse the skin around the stoma site and allow to air dry.

2. Remove the new tube from the package. Using a slip tip syringe, fill the balloon with 5 ml of sterile or distilled water.

3. Remove the syringe and check the balloon for leaks. It should be symmetrical. Reinsert the syringe and remove the water from the balloon by pulling back on the plunger.

4. Attach the luer slip syringe to the balloon valve that is in the patient’s stomach. Pull back on the plunger until all of the water is out of the balloon.

5. Gently remove the tube from the patient. It may help to use a small amount of water-soluble lubricant around the stoma site and tube.

6. Lubricate the tip of the replacement feeding tube with a water-soluble lubricant. Do not use oil or petroleum jelly as these can damage the tube.

7. Gently guide the new tube into the stoma until it is flat against the skin.

8. Hold the tube in place and fill the balloon with amount of sterile or distilled water recommended by your physician. Do not use air or exceed the recommended volume.

9. Wipe away any fluid or lubricant from the tube and the stoma site.

10. Check the tube for correct placement by inserting an extension set into the MIC-KEY* feeding tube and listening for air or aspirating any residual stomach contents. If you cannot verify the tube placement, contact your clinician.

11. Flush the tube to confirm that fluid will flow freely and to also clean the tube.

Q: How does the MIC-KEY* Low-Profile feeding tube work?
A: The MIC-KEY* Low-Profile Feeding tube is used to provide a means of accessing the stomach to provide nourishment, liquids and medication. It may also be used as a means to release excess air or contents from the stomach. The MIC-KEY* Low-Profile Transgastric-Jejunal feeding tube extends through the stomach and into the jejunum for feeding into the small intestine. The MIC-KEY* feeding tube is made of medical grade silicone and is kept in place by an internal balloon that keeps the tube from falling out of the stomach and a fixed external base or bolster that keeps the tube from migrating into the stomach. The administration of feeding or medications is facilitated by the use of extension sets that connect to the feeding tube and to the feeding set.
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Facial Protection

Q: What face masks do you recommend for surgical procedures with a high incidence of fluid splash?
A: The FLUIDSHIELD* Face Mask with Wraparound SPLASHGUARD* Visor is an excellent choice for guarding against fluid splash. A one-piece system, this unique mask is designed to provide facial protection from high-impact body fluids and aerosolized particulate matter.
Q: What is SARS?
A: Severe Acute Respiratory Syndrome
Q: What age group will the Child's Mask fit?
A: A child's head size achieves 70-80% of adult size by age two. The mask is approximately 80% of the size of a standard face mask to fit children between the ages of 3 to 10.
Q: What products do you offer that address issues of fogging on glasses?
A: We offer several different styles of masks that address the issue of fogging. These masks include our fog-free masks, anti-fog masks and masks with Dermatouch® tape. Please contact your Halyard Health sales representative for more information.
Q: What age group will the Child's Mask fit?
A: A Child's head size achieves 70-80% of adult size by age two. The mask is approximately 80% of the size of a standard face mask to fit children between the ages of 3 to 10.
Q: Does Halyard offer support training for N95 respirators?
A: We offer a fit testing kit that contains training materials for your healthcare facility. Your Halyard Health sales representative can assist in training your trainers to do fit testing.
Q: What type of protection does the Child's Mask offer?
A: The Child's Face Mask (product code #47127) is made of premium materials and the same patented filtration media as used in other HALYARD* standard face masks. It offers the same protection level as a standard HALYARD* mask: • BFE of >96% • PFE of >97% • Delta P of <1.5
Q: What is the appropriate mask for surgical staff members when performing procedures for patients known to have TB or likely to have TB?
A: The only recommended mask to be worn when giving care to patients with suspected or known TB, regardless of the task involved, is a NIOSH Certified Respirator (NIOSH, CDC Respiratory Protection Guide, 1995). The Halyard PFR95* line of respirators fulfills this certification and provides appropriate choices.
Q: Should patients with TB wear respirator masks?
A: No. CDC recommends that patients suspected of having TB, or known to have TB, should wear Surgical Face Masks. According to a CDC report on preventing the transmission of TB, "Surgical masks are designed to prevent the respiratory secretions of the person wearing the mask from entering the air. When not in a TB isolation room, patients suspected of having TB should wear surgical masks to reduce the expulsion of droplet nuclei into the air. These patients do not need to wear respirators, which are designed to filter the air before it is inhaled by the person wearing the mask."
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Gastrointestinal Endoscopy and Biliary

Q: What products are available to the GI lab?
A: Halyard addresses the needs and demands of today's Gastroenterologist by providing innovative, efficient and cost effective diagnostic, therapeutic and palliative devices to access, diagnose and treat diseases of the GI tract. Halyard provides versatile systems of innovative biopsy forceps, polypectomy snares, cytology brushes, injection needles, aspiration catheters, Paracentesis kits / trays, sphincterotomes, guidewires, catheters, balloons, stent systems and endoscope maintenance products.
Q: What is different about the HALYARD* .025'' ERCP System and those currently on the market?
A: The .025" Micro Series System of ERCP products consists of catheters, guidewires, sphincterotomes, balloon stone extractors, and pre-assembled stent sets - all compatible with a .025" guidewire. This one-wire -system eliminates or minimizes multiple wire exchanges resulting in cost and procedural efficiency. The .025" System addresses the needs of ERCP procedures which may involve a stenotic papilla, minor papilla cannulation or distal stone impaction. The small, soft, pliable, radiused distal tip enhances ease of cannulation and facilitates smooth ductal access.
Q: What is different about the HALYARD* .035'' System and those currently on the market?
A: The .035" System of ERCP products consist of catheters, sphincterotomes, guidewires, balloon stone extractors and stent systems. This system provides the clinician with the largest variety of distal tip configurations, available in multi lumen, straight or precurved catheter construction, designed to address various anatomical and procedural demands.
Q: What are examples of endoscopy/biliary systems?
A: Researchers at Halyard have developed and designed products to meet multiple demands, including:
  • THERMAL OPTION* II biopsy forceps, the only disposable, dual purpose biopsy forceps capable of being utilized as either a hot or cold biopsy forceps.
  • The .025" and .035" biliary systems comprised of ERCP catheters, guidewires, papillotomes, balloon stone extractors and
  • Preassembled stents and endoscope maintnance systems comprised of single and dual ended cleaning brushes designed for maintenance of biopsy and umbilicus channels, valves, valve seats, lense and air/water nozzle.
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General Health Care Product FAQs

Q: Do HUGGIES* nappies contain natural rubber latex?
A: Halyard HUGGIES* nappies do not contain natural rubber latex.
Q: What studies are available regarding Halyard Health products and flammability?
A: Halyard takes the lead in the area of risk reduction, especially as it relates to the flammability characteristics of surgical drapes and gowns. These products are comprised of polypropylene (an inert polymer derived from petrochemicals) which is inherently "ignition resistant" in the OR setting. Contact your Halyard Health Account Manager for more information.
Q: Can Halyard Health's polypropylene-based products be safely incinerated?
A: Yes, Halyard polypropylene-based products can be safely incinerated. Polypropylene (an inert polymer derived from petrochemcials) is a long chain polyolefin and does not contain the elements of chlorine, which has become a concern in incineration. Complete combustion of Halyard polypropylene base fabric generates heat (approximately 19,000 BTUs per pound) and forms primarily water vapour and carbon dioxide, leaving a very small residue of ash (some Halyard Health products may also contain other components whose combustion characteristics are not included.) The ash formed contains trace amounts of inert minerals.
Q: How can I get informataion about OSHA requirements regarding bloodborne pathogens and respiratory protection standards?
A: Our PARTNERS IN QUALITY* Team can help you with any of your Halyard Health OSHA requirements regarding bloodborne pathogens and respiratory protection standards. Your questions and concerns should be directed to 1-844-HALYARD (425-9273).
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Halyard Health Customer Portal

Q: What is the Customer Portal?
A: More than just an online order status tool, the Customer Portal can help you effectively manage your business with 24/7 access and information at your fingertips. It's a user-friendly, yet comprehensive system that allows you to manage all of your transactions on a day-to-day basis. •A customizable homepage to meet your individual needs •User management to give you control of user access within your company •Ability to send Portal updates directly to your email •A Product Catalog equipped with a robust product search, detailed product information, and download capabilities •HYHHC Connection will be your link to the latest Halyard Health announcements •The Transaction Center provides you self-service access to the: •Order Management Center with real-time order statuses, invoice copies, and price discrepancy reports •Contracts Center for viewing, downloading, and printing your contracts in PDF or Excel format •Policy Center contains all current Halyard Health policy statements •Technical Center includes details regarding electronic communication including EDI
Q: How do I get access?
A: Fill out the quick online form located here: Access Request.
Q: Is this for North America only?
A: Currently, the Portal is for customers who order directly from North America. This includes all customers in North America as well as our international customers that order from North America.
Q: I purchase my Halyard products from a distributor. Can I still use the Customer Portal?
A: The Customer Portal is only available to customers who purchase directly from Halyard. However, the new and enhanced product catalog will be available at www.halyardhealth.com for all customers to access.
Q: Can I place orders via the Customer Portal?
A: With the initial launch of the Portal, you can check your order status but not actually place the order. Future plans for the Portal include capabilities to order online.
Q: How can I find out more about the Portal?
A: Contact Customer Care at 1-844-HALYARD or email HalyardCustomerPortal@hyh.com
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Medical Gloves - Barrier, Use and Preservation

Q: What qualities should I look for when selecting gloves?
A: Gloves should be comfortable, provide good barrier protection, sensitive to touch (tactile sensitivity) and not cause reactions to the wearer or patient. To reduce the risk of developing glove-associated sensitivities, select latex and synthetic gloves with reduced chemical and endotoxin levels. Additionally, select latex gloves with reduced latex protein levels. Individuals already diagnosed with Type I latex allergy should not use natural rubber latex gloves. If powder is inappropriate in an area, select powder-free gloves.
Q: What is natural rubber latex?
A: Natural rubber latex consists of small rubber particles primarily produced by the rubber tree Hevea brasiliensis. The milky fluid from this tree is harvested by a process called tapping. This milky sap-like substance oozes from the tree when the tree is scored or tapped. It is then collected and used in the manufacture of over 40,000 medical and consumer products.
Q: What is synthetic rubber?
A: Synthetic rubber is an alternative to natural rubber latex that is artificially created by chemical synthesis from an inorganic source rather than from an organic source.
Q: What is nitrile?
A: Nitrile (acrylonitrile butadiene) is a synthetic polymer formed by defined ratios of acrylonitrile, butadiene and carboxylic acid. Acrylonitrile provides permeation resistance characteristics. Butadiene contributes to glove softness and carboxylic acid contributes to physical characteristics such as strength and tear resistance. Other chemicals, typically used in most glove formulations are also added such as accelerators, antioxidants, colorants and preservatives.
Q: What is vinyl?
A: Vinyl, is a synthetic polymer. Vinyl, also called polyvinyl chloride or PVC, is used in many medical and industrial applications.
Q: What is Tactylon®?
A: Tactylon® is a synthetic polymer (styrene-ethylene-butylene-styrene [SEBS]) that mimics many natural rubber latex physical attributes. The material is soft, easily donned and well-suited for surgical procedures requiring a synthetic alternative to natural rubber latex. It contains neither natural rubber latex proteins nor rubber processing chemicals.
Q: Can storage of natural rubber latex, nitrile, neoprene or Elastryn® gloves near electrical sources affect glove barrier integrity?
A: Yes. When in use, electrical generators, X-ray machines and other energy generating sources can create ozone (O3) which can break down the chemical bonds in each of these glove materials. Storing latex, nitrile, neoprene, or Elastryn® glove boxes near this type of ozone-generating equipment can degrade the glove material.
Q: What are some typical signs of glove degradation?
A: If you observe any of the following symptoms during use, be aware that the glove material may be breaking down:
  • Hardening or embrittlement
  • Softening (may see extending of fingertips)
  • Tackiness (glove becomes sticky)
  • Cracking
  • Loss of strength
  • Loss of tear resistance
  • Loss of elasticity
  • Blistering of the surface
Q: What gloves should I use when handling specific chemicals?
A: Some glove materials are more resistant to specific chemicals than others. In order to determine which glove to use in which situation, chemical resistance guides are helpful. Ask your glove manufacturer for a general guideline or the manufacturer of the specific chemicals for recommendations.
Q: Should I double glove?
A: Double gloving has been documented to significantly reduce the penetration of contaminated sharps through to the skin surface and should be considered when the risk of exposure to highly pathogenic diseases is present or as dictated by facility policies.
Q: How does the STERLING* Nitrile Exam Glove remove the risk of patient/staff Type I allergic reactions to latex proteins?
A: The STERLING* Nitrile Exam Glove is made from a latex-free formulation removing the risk of Type I allergic reactions to latex proteins.
Q: Do all gloves provide the same in-use barrier protection?
A: Some gloves manufactured with different materials may have comparable barrier properties when removed directly from the box and tested. However, actual in-use, on-the-job barrier performance often differs. For example, the literature suggests natural rubber latex and nitrile gloves provide better barrier protection than vinyl in clinical studies or under laboratory conditions mimicking patient care. Latex and nitrile are flexible materials and allow for rigorous manipulation while maintaining barrier integrity. Vinyl (PVC or polyvinylchloride) is a more rigid material and exhibits decreased durability when challenged by hand manipulation if worn longer than a few minutes. Several factors should be considered when selecting a glove material for barrier protection. These factors should include the vulnerability of patient or wearer, rigorousness and duration of the procedure to be performed, in-use durability of the glove material, any potential risk of exposure to infectious microorganisms, the resistance to drugs or chemicals to be contacted and whether or not wearer or patient is allergic to the glove material.
Q: Where does natural rubber latex come from?
A: Natural rubber latex is harvested from rubber tree plantations in Southeast Asia, India, Sri Lanka and South America.
Q: What are some of the synthetic gloves that are available?
A: Some synthetic gloves currently available include, but are not limited to, nitrile (acrylonitirile-butadiene), vinyl (polyvinyl chloride), neoprene (chloroprene), Tactylon® (styrene-ethylene-butylene-styrene) viton (fluorocarbon rubber), and polyurethane.
Q: Why are some synthetic gloves like nitrile chlorinated?
A: Some nitrile gloves are chlorinated to remove calcium carbonate, added during the manufacturing process. Chlorination breaks down the calcium carbonate as well as other unbound chemicals on the glove. The chlorine is then neutralized and washed away with water, creating a donnable, powder-free glove low in surface residual chemicals.
Q: Are vinyl gloves as durable as latex?
A: According to published data: • Vinyl gloves have consistently had higher leakage rates during use than the natural rubber latex or nitrile gloves tested. • Vinyl, a synthetic, is not as flexible (and therefore as “forgiving” of snags and twists) as natural rubber latex and is not recommended for use in high-risk situations. • Vinyl is recommended for low-risk tasks of short duration where minimal stress is required. • Double gloving with vinyl may provide better protection. • Natural rubber latex is recommended for prolonged high-risk procedures involving contact with blood or body fluids. (Note, this analysis was performed prior to the introduction of nitrile in general medical use) • Natural rubber latex and nitrile provide better microbial barrier protection in hospital use than vinyl gloves. Glove material selection for any procedure should include the assessment of material durability during use, the amount of hand manipulation, the rigorousness and duration of the procedure and the potential exposure to pathogens and hazardous substances.
Q: What is the difference between Tactylon® and other gloves?
A: Tactylon® contains no natural rubber latex proteins. Tactylon® also does not contain the chemical accelerators found in natural rubber latex or nitrile.
Q: Why do some gloves turn brown when I put them on?
A: Several factors can affect glove discoloration.
  • Acidic perspiration may react with chemical additives in the glove resulting in discoloration
  • Chlorination can result in darker cuffs. This is not a problem unless there is a notable loss of strength as seen in over-chlorinated or over-heated gloves.
  • A chemical reaction between residual nicotine deposits (found between the index and middle finger where a smoker holds cigarettes) and manufacturing chemicals such as carbamates may stain the glove.
  • Metabolic copper or iron, or handling objects made of such metals, may also result in glove staining.
Q: Is there a way to determine what glove to use when handling a specific chemical?
A: Some chemicals can degrade gloves. They may become soft and tacky or hard and brittle. However, evidence of breakdown is not always this obvious. Therefore, permeation or penetration of a chemical through the glove to the wearer's hand may have no visible or tactile indication. There are several information sources that may be helpful:
  • Check with the chemical manufacturer and ask which glove to use with this specific chemical.
  • Refer to the available chemical resistance guides and/or on-line resources before you use a specific product.
  • Check with the safety office where you are employed and follow company guidelines.
  • Ask the glove manufacturer for chemical resistance glove studies to the more commonly contacted chemicals such as alcohol, glutaraldehyde and/or formalin.
Q: What makes this nitrile glove perform just as good or better then latex exam gloves?
A: Halyard researchers developed a new way to utilize synthetic nitrile polymers with an innovative proprietary compounding process. This process provides two key characteristics users want. 1. First, the new process increases the tensile strength of nitrile—the force required to break through the glove—to a very high degree. 2. Second, Halyard was able to reduce the glove thickness, which means that less force is required to stretch the material. The result is a latex-free exam glove that combines the dexterity and sensitivity of natural rubber latex with the strength and superior barrier protection qualities of nitrile.
Q: What are some factors that can affect glove barrier properties?
A: Glove formulation, manufacturing processes, storage conditions and wearer’s care can all affect the barrier properties of gloves. Glove degradation has been associated with heat, high humidity, oils, hand lotions, incompatible chemicals, UV light, sunlight, fluorescent lighting, X-ray machines and other ozone-generating sources such as electrical generators.
Q: Do all natural rubber latex gloves offer the same barrier protection?
A: Studies have demonstrated that glove durability may vary from one manufacturer to another. All latex and synthetic medical gloves are required by the FDA to comply with the minimal standard specifications described by the American Society for Testing and Materials (ASTM), although some manufacturers will choose to require higher specifications for their own gloves (e.g. A 1.5 AQL is more stringent – less holes – than the ASTM 2.5 AQL). Such specifications include, but are not limited to, physical properties including the ability to withstand pulling and tearing.
Q: How do I know which synthetic glove to choose as an alternative to latex?
A: Glove use (rigorousness and duration of the procedure to be performed) and possible exposure to toxic chemicals or pathogens should all be safety considerations when selecting a synthetic surgical or examination glove. Review the manufacturer’s data on durability and performance evaluations conducted by independent test laboratories before choosing an alternative.
Q: How long can I store nitrile gloves?
A: In general, gloves, including nitrile, have an average shelf life of from 3 to 5 years. This time frame can be adversely affected by general storage conditions including heat, humidity, exposure to direct sunlight or sources of ozone (e.g. x-ray machines, electrical generators).
Q: Is vinyl a synthetic?
A: Yes. Vinyl is a synthetic polymer. It is also called polyvinyl chloride or PVC.
Q: Is the Tactylon® glove resistant to methacrylate compounds (bone cement)?
A: Tactylon® gloves will rapidly break down when in contact with non-solidified methacrylates such as pre-cured bone cement. Once the cement solidifies, however, there is no adverse effect on the glove
Q: What is the typical shelf life of a box of gloves?
A: In general, gloves have an average shelf life of 3 to 5 years. This time frame can be affected by general storage conditions such as heat, humidity, exposure to direct sunlight or sources of ozone (e.g. x-ray machines and other electricity generating sources).
Q: What gloves should I use when handling chemotherapy drugs?
A: Gloves sold for chemotherapy use must pass chemical permeation challenges with numerous chemotherapeutic drugs. The test protocols and results must be accepted by the government and clearance issued allowing the manufacturer to market the gloves for chemotherapy use. It is important to note that chemotherapy glove clearance from the government is based only on the resistance to permeation. It is the responsibility of each facility to review guidelines published by professional associations to establish their own chemotherapy glove usage policy. Some published guidelines include, but are not limited to:
  • The Oncology Nursing Society (ONS) recommends using powder-free latex gloves at least .007 inches (7 mil) thick and long enough to extend over the cuff of a long sleeve, non-absorbent gown. Individuals with known or suspected natural rubber latex allergies should use an alternate material such as nitrile. (Note: the 7 mil minimum requirement is for natural rubber latex.)
  • OSHA recommends double gloving with a powder-free, thicker, longer glove that covers the gown cuff.
If the glove is not specified as a chemotherapy glove, ask the glove manufacturer for information on permeation and breakthrough time test data for the family of chemotherapeutic drugs you are using.
Q: Can artificial fingernails affect barrier protection?
A: Artificial fingernails present several problems. Of primary concern is the harboring of fungi and bacteria that cannot be effectively removed even with nailbrushes. Microorganisms can dwell and even thrive between the natural nail and artificial nail. This situation may be compounded by the fact that the moist, warm, occlusive environment under a glove supports microbial growth. Of somewhat less importance, but noteworthy nonetheless, artificial nails tend to cling to the glove surface (especially powder-free gloves) making donning more difficult.
Q: Are there any differences in the packaging of this glove compared to others in the market?
A: Yes. The glove comes packaged 1500 in a case (150 in a box) compared to almost every other exam glove in the market which contains 1000 in a case (100 in a box). The higher pack count reduces staff time in changing out empty glove boxes while also reducing packaging waste and storage space. The standard size of the glove box means it can fit within existing glove bracket holders.
Q: Is nitrile a better barrier than natural rubber latex?
A: Currently, there are only a few published studies addressing the barrier properties of nitrile. These studies indicate the nitrile and latex gloves evaluated were comparable in terms of barrier performance characteristics. Nitrile gloves are recommended for people with latex sensitivity and as an alternative to latex when handling chemotherapy drugs if the glove has FDA clearance for chemotherapy use. Nitrile gloves are also recommended for use with some chemicals such as glutaraldehyde, however, test data should always be requested from the manufacturer.
Q: Is Tactylon® stiffer than latex?
A: No. Tactylon® is a very supple, soft material that allows easy movement (low modulus).
Q: How should I store gloves?
A: Improper storage will promote glove degradation and shorten shelf life. Store gloves in their original packaging in a cool, dry environment away from X-ray machines and other energy generating sources that produce ozone. Keep boxes dust free and shielded from exposure to direct sunlight or intense artificial light. Continually rotate stock using the FIFO concept—first in, first out.
Q: What characteristics should I look for in a chemotherapy glove?
A: There are multiple issues to consider when choosing a glove for chemotherapy use. They include, but are not limited to:
  • Choose chemotherapy qualified gloves
  • Choose powder-free gloves to reduce the potential for powder absorption and aerosolization of cytotoxic drugs
  • Choose a glove that provides forearm protection*
  • If single gloving, tuck the clean glove over the cuff of the gown.
Note: If double gloves are worn, one glove is inserted under the cuff and one glove goes over the cuff.
Q: Can long fingernails affect glove barrier?
A: Long fingernails (whether natural or artificial) can tear and rip gloves. They put a tremendous amount of pressure in a tiny area at the fingertip. As the majority of microorganisms on the hand are found under and around the fingernails, short nails are advised to reduce the possibility of transferring potentially infectious microbes. There is less area for microorganisms to hide under and access for scrubbing is improved with short fingernails.
Q: How can the STERLING* Nitrile Exam Glove reduce costs throughout the healthcare facility?
A: The STERLING* Nitrile Exam Glove can reduce healthcare facility costs in 5 ways: 1. Removes costs associated with stocking large number of different manufacturer’s product codes. 2. Reduces inventory storage costs because of the larger quantity pack size which will result in buying and storing fewer cases. 3. Reduces the time (and therefore the cost) of changing out glove dispensers. 4. Reduces costs of treating latex exam glove-associated reactions among employees due to the latex-free formulation. 5. Reduces potential costs of treating patient complications stemming from latex exam glove-associated reactions due to the latex-free formulation.
Q: Can I use nitrile gloves when handling chemicals?
A: Good quality nitrile examination gloves provide an excellent biological barrier and general chemical splash protection, but they are not intended for applications involving prolonged, direct exposure to harsh, concentrated chemicals, where heavy duty or industrial gloves are required. Consult your company or healthcare facility safety protocols, the chemical manufacturer or permeability charts to ensure the appropriate glove material is used. In order to determine which glove material to use in which situation, chemical resistance guides are helpful. For an internet link to chemical permeation information, Click Here.
Q: Why do vinyl gloves fail more than latex gloves?
A: Multiple in-use studies document failure rates as high as 85% for vinyl gloves. Vinyl has a rigid, inflexible molecular structure that is easily disrupted creating structural breaks in the material. Also, the PVC is “floated” in large volumes of phthalates and other plasticizers that can separate from the PVC, potentially leaving gaps when the gloves are in use. Consequently, vinyl loses its barrier integrity rapidly when performing rigorous procedures or challenged by sharp implements. In contrast, latex has a coiled molecular structure2 chemically cross-linked with sulphur bridges, which allows the material to give or stretch rather than break. As soon as the challenge is released, the coils return to their original configuration. As a result, latex is more flexible, has greater resistance to fatigue and is far more resistant to breakthrough than vinyl. Nitrile has the same cross-linking structure as natural rubber latex. The elastic molecular portions that are bridged, however, are not as stretchy or “springy” as the natural rubber coils, resulting in a glove with slightly lower stretch (elongation) and resiliency (takes longer to return to its original shape).
Q: What are the recommendations for glove disposal?
A: Gloves contaminated with blood or body fluids, infectious agents or biological matter should be disposed of as clinical or potentially infectious waste. Non-contaminated gloves may be disposed of as domestic waste. Refer to and follow infection control guidelines and recommended practices for glove disposal.
Q: Can wearing jewelry affect glove barrier?
A: Yes, jewelry has the potential to affect glove barrier properties. Jewelry may snag, tear and puncture gloves. Microorganisms may collect under bracelets and rings to potentially jeopardize the health of wearer, patient, or family members. Jewelry may also trap soap, disinfectants and other substances that can contribute to irritation or a Type IV chemical allergy.
Q: Why does nitrile cost more than natural rubber latex gloves?
A: Nitrile gloves are manufactured from acrylonitrile butadiene, a chemical that is petroleum based, increasing the manufacturing costs. Natural rubber latex is produced by harvesting the rubber tree Hevea brasiliensis. Harvesting latex from this natural source is a less expensive process.
Q: Can vinyl cause glove-associated reactions?
A: Yes. Some manufacturing chemicals used for vinyl glove production have the potential to cause irritation and Type IV allergic dermatitis. In Japan, for example, where vinyl and latex gloves have been used equally for housework activities for a number of years, the literature suggests vinyl is responsible for greater than 50% of glove related irritant and allergic contact dermatitis. According to a recent survey in England and Wales, 44.4% of the general dental practitioners who routinely wear vinyl gloves experienced dermatitis. Plasticizers, resins, and surfactants appear to be the primary irritants and chemical contact sensitizers
Q: Can I use hand lotion under my natural rubber latex gloves?
A: Oils, petroleum based products, some lotions and cortisone creams underneath the glove can potentially weaken the glove material. Be sure to use lotions, compatible with the glove material and approved for use by your facility. Nitrile, vinyl, polyurethane and neoprene are not readily weakened by these products.
Q: Can I use steroid creams under my gloves?
A: Some steroid creams, such as cortisone creams, used to alleviate dermatitis symptoms, may be petroleum or oil-based and should not be used under latex gloves. Check the ingredients listed on the package and contact the manufacturer to determine glove material compatibility.
Q: Can I use hand sanitizers under my gloves?
A: Hand sanitizers may be used if proper technique is observed. Hand Sanitizers are frequently used in acute, long term and home healthcare situations and have been reported to improve hand hygiene compliance measures. To perform their function of killing microorganisms, hand sanitizers (usually alcohol based) must be allowed to dry on the hands before proceeding. This is not only critical to ensure efficacy of antimicrobial activity, it is also important in preventing glove barrier compromise. If the alcohol is still liquid when the glove is donned, most glove materials will be susceptible to rapid degradation.
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Medical Gloves - Barrier Selection, Use and Preservation Issues - Everyday Practices

Q: How can lotions affect glove barrier?
A: Petroleum and oil-based lotions act as plasticizers, chemical softeners speeding the breakdown of rubber. These lotions have the potential to break down the barrier integrity of a natural rubber latex glove within minutes. The ensuing glove deterioration may result in changes in physical characteristics, including, but not limited to, strength, elongation, tear resistance and dimensions. Nitrile, vinyl, polyurethane and neoprene are not readily weakened by these products.
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Pain Management

Q: Do Halyard Tuohy needles have metal or plastic stylets?
A: All Halyard Tuohy needles have metal stylets.
Q: Can I get a list of the available components in a tray?
A: Yes, by calling the Customer Care number at 1-800-742-1996.
Q: What is the color code for needle gauge size?
A: 16 Gauge = Light Blue 17 Gauge = White/Light Grey 18 Gauge = Pink 20 Gauge = Yellow 21 Gauge = Green 22 Gauge = Black 23 Gauge = Varies/Brown, Blue or Orange 24 Gauge = Purple 25 Gauge = Carolina Blue 26 Gauge = Brown 27 Gauge = Grey 29 Gauge = Red
Q: Does Halyard offer an Epidural Steroid Injection tray with CHG skin prep?
A: Yes, Halyard offers a variety of skin prep options, including CHG.
Q: Does Halyard have discography needle sets?
A: Yes, Halyard offers a variety of specialty needles, including Double Needle Sets for discography procedures.
Q: Does Halyard have continuous epidural trays?
A: Yes, Halyard offers a variety of catheters, needles, mini-kits and custom tray options for continuous epidural procedures
Q: Does Halyard have safety single shot epidural trays?
A: No, Halyard does not offer a SAFETY single shot epidural tray at this time.
Q: Does Halyard offer custom tray options for Epidural Steroid Injections and universal procedures?
A: Yes, Halyard does offer a wide variety of standard stock trays as well as the option to build a custom tray to meet your procedural needs.
Q: What are the shipping terms for procedural trays?
A: The customer pays freight and handling on orders below 75 units of sale. (Customer Terms and Conditions of Sale)
Q: What is Halyard’s policy for returned goods?
A: a. Returns must be requested within 90 days of invoice date with a minimum of 24 months of remaining shelf life. (Customer Terms and Conditions of Sale) b. Build to Order and drug containing products are NOT returnable. (Customer Terms and Conditions of Sale) c. A 25% restocking fee will be deducted from credit toward all returns. (Customer Terms and Conditions of Sale) d. Purchaser must obtain a Returned Goods Authorization in writing from Halyard. (Customer Terms and Conditions of Sale) e. Product containing drugs may not be returned.
Q: Is your radiofrequency lesioning system upgradeable?
A: Yes, the system is a software/hardware upgradeable platform.
Q: Is it possible to do bipolar radiofrequency lesioning with the generator?
A: Yes, the system is capable of performing bipolar lesioning with the usage of the bipolar adapter (product code: PMA-BP).
Q: Can the reusable probes be steam sterilized?
A: Yes, there are two types of steam sterilization methods that may be sued: pre-vacuum steam sterilization and gravity displacement steam sterilization. The Directions For Use should be referenced for specifics.
Q: Do the RF probes have a warranty?
A: Yes, they have a 90-day warranty from the date of purchase.
Q: Can I use curved cannulae with a straight RF probe?
A: No, curved cannulae should be used with curved probes. RF cannulae should be used with RF probes that match in gauge, length and style.
Q: How many RF probes can be used at the same time with the HYH generator?
A: Four probes may be used at the same time when using the Multi-RF cable (product code: PMS-BAY-MRF) with the HYH RF generator system (version 3.0 or higher).
Q: Do you have cannulae that show the active tip under fluoroscopy?
A: Yes, Halyard’s radiopaque radiofrequency cannulae have a radiopaque marker, which indicates the active tip margin.
Q: Can I buy an extended warranty for my RF generator?
A: Yes, extended warranties may be purchased in 1-year increments.
Q: Are the cooled RF probes reusable? (LumbarCool, SInergy, ThoraCool and TransDiscal)
A: No, all cooled RF probes and cooled RF kits are for single-use only.
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HALYARD MICROCUFF*

Q: Which patients should get a MICROCUFF* tube?
A: MICROCUFF* is targeted for those patients which have potential for ventilation longer than 24 hours. We recommend patients intubated in the critical care units, emergency department or EMS, and OR procedures where the patient is extubated in the critical care unit.
Q: Is the MICROCUFF* endotracheal tube DEHP free?
A: The endotracheal tube shaft is made of medical grade PVC which contains DEHP. The endotracheal tube cuff which has the vast majority of contact with tissues is DEHP free because it is polyurethane, not PVC (DEHP is a common softener for PVC).
Q: What cuff pressure do you recommend to inflate the cuff?
A: Whatever your current hospital protocol recommends. Inflate Microcuff using the same method that you use with your current ET tubes. Common cuff pressure to create a seal is typically between 25 and 35 cm H2O, however, MICROCUFF* has been found to seal at lower pressures in many cases.
Q: Do we use the Microcuff any differently than our current ET tube?
A: No – it will function the same as your current ET tubes.
Q: We have observed water accumulating in the cuff – what is this and what do you recommend?
A: This is condensation, which occur in most ET tube cuffs. Due to the microthin material, MICROCUFF* might accumulate more condensation than the standard ET tube. However, this does not affect product performance or patient safety. Just be sure to clear the pilot line of any condensation prior to measuring/adjusting cuff pressure as you do with any other ET tube.
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Medical Supplies

Q: What is nitrile?
A: Nitrile is an abbreviated term sometimes used for nitrile rubber, which is made from butadiene and acrylonitrile monomers. When intended for use in a latex form for dipping gloves, a third monomer, a carboxylic acid, is also included. These three monomers, in the correct proportions, produce a polymer that is excellent for use in manufacturing gloves. Butadiene provides soft, rubbery, resilient characteristics to the polymer. Inclusion of acrylonitrile into the polymer structure greatly increases chemical resistance to oils and many petroleum-based chemicals. Carboxylic acid greatly enhances physical properties, such as strength, elongation, and resistance to cut and puncture. Other chemicals are also often added to the nitrile in relatively small amounts, to make it even more appropriate for use in gloves. These typically include crosslinking agents, accelerators, stabilizers, and colorants
Q: Why do some gloves turn brown when I put them on?
A: Several factors can affect glove discoloration. • Acidic perspiration may react with chemical additives in the glove resulting in discoloration • Chlorination can result in darker cuffs. This is not a problem unless there is a notable loss of strength as seen in over-chlorinated or over-heated gloves. • A chemical reaction between residual nicotine deposits (found between the index and middle finger where a smoker holds cigarettes) and manufacturing chemicals such as carbamates may stain the glove. Metabolic copper or iron, or handling objects made of such metals, may also result in glove staining.
Q: Are the HALYARD* AAMI-level Isolation Gowns treated to prevent static buildup?
A: Yes, our Isolation Gowns are treated with an anti-stat to reduce the potential for static to build up in the gown.
Q: Does AORN make any recommendation about the length of time that a shoe cover can be worn?
A: AORN states: "If shoe covers are worn, they should be changed whenever they become torn, wet, or soiled, and they should be removed and discarded in a designated container before leaving the surgical area."
Q: What does AAMI stand for?
A: Association for the Advancement of Medical Instruments
Q: What are AAMI levels?
A: AAMI guidelines are a widely accepted system of classification for protective apparel based on liquid barrier performance, according to ANDI/AAMI PB70:2003(R)2009.
Q: What products do you offer that address issues of fogging on glasses?
A: We offer several different styles of masks that address the issue of fogging. These masks include our fog-free masks, anti-fog masks and masks with Dermatouch® tape. Please contact your Halyard Health sales representative for more information.
Q: Does Halyard offer support training for N95 respirators?
A: We offer a fit testing kit that contains training materials for your healthcare facility. Your Halyard Health sales representative can assist in training your trainers to do fit testing.
Q: Do HALYARD* Surgical gowns contain latex?
A: Halyard products are not manufactured with natural rubber latex.
Q: What do the different colors on the Halyard Surgical Gown neckbands signify?
A: Colour-coded gown neckbands, tie cards, and packaging are part of the HALYARD* Colour-Key. The HALYARD* Colour Key provides caregivers Instant Gown Recognition, to help minimize the risk of wearing the wrong gown. Now it’s easy to quickly select the gown you want for each and every procedure. The colours signify the following: Yellow – Non-reinforced surgical gowns Green – Fabric-reinforced surgical gowns Red – High Performance Type Surgical Gowns Packaging: The colour that corresponds to the neckband color is located on the top edge of the front of the gown package. Tie Card: The Colour-Key tie card accompanies each gown, to help users in the OR understand what their coloured neckbands represent.
Q: If a sterilizer cycle aborts or malfunctions before completion should wrapped packages be re-wrapped?
A: Yes, if a sterilizer malfunctions or a cycle is aborted before completion, packages wrapped with HALYARD* Sterilization Wrap should be re-wrapped prior to being placed in another sterilization cycle.
Q: Can HALYARD* Sterilization Wrap be re-used?
A: No. Halyard does not endorse the re-use (re-sterilization) of sterilization wrap and does not warrant performance of the product if it is re-used. It is cleared by the FDA as a single-use product.
Q: Does HALYARD* Sterilization Wrap contain natural rubber latex?
A: This product is not manufactured with natural rubber latex.
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Medical Gloves - Glove Manufacturing

Q: Natural rubber latex (NRL) products are produced when chemicals are added to raw NRL to increase elasticity and strength. This composition then undergoes multiple manufacturing processes to create a minimum of 40,000 commonly used products that may be used in hospitals, schools, workplaces and homes.
A: Natural rubber latex (NRL) products are produced when chemicals are added to raw NRL to increase elasticity and strength. This composition then undergoes multiple manufacturing processes to create a minimum of 40,000 commonly used products that may be used in hospitals, schools, workplaces and homes.
Q: Vulcanization or curing is the manufacturing step where chemical reactions cross-link (connect) the rubber particles into a network using heat and sulfur. After vulcanization, natural rubber becomes less sticky and exhibits added strength and elasticity.
A: Vulcanization or curing is the manufacturing step where chemical reactions cross-link (connect) the rubber particles into a network using heat and sulfur. After vulcanization, natural rubber becomes less sticky and exhibits added strength and elasticity.
Q: No. Because the government has not officially defined the phrase “Low Protein”, this claim can not be used on the package label.
A: No. Because the government has not officially defined the phrase “Low Protein”, this claim can not be used on the package label.
Q: Yes. Chlorination and the extensive washing that follows significantly reduce residual protein.
A: Yes. Chlorination and the extensive washing that follows significantly reduce residual protein.
Q: Some glove chemical additives may cause skin problems such as irritation (also known as irritant dermatitis) or allergic contact dermatitis, (also known as Type IV hypersensitivity). Both natural rubber latex and synthetic gloves can contain irritants and/or contact sensitizers. Commonly used chemicals associated with dermatitis, include, but are not limited to, accelerators, antioxidants and antiozonates, plasticizers and epoxies.
A: Some glove chemical additives may cause skin problems such as irritation (also known as irritant dermatitis) or allergic contact dermatitis, (also known as Type IV hypersensitivity). Both natural rubber latex and synthetic gloves can contain irritants and/or contact sensitizers. Commonly used chemicals associated with dermatitis, include, but are not limited to, accelerators, antioxidants and antiozonates, plasticizers and epoxies.
Q: Chlorination is a manufacturing process that must be tightly monitored and carefully controlled. Poor chlorination practices can result in gloves that are weak, tear easily, have pinholes, are discolored and can become brittle or gummy. Therefore, it is essential that all steps in the chlorination process be carefully regulated. Improper storage conditions can shorten the shelf life of chlorinated and non-chlorinated gloves. Check with the manufacturer for recommended storage conditions.
A: Chlorination is a manufacturing process that must be tightly monitored and carefully controlled. Poor chlorination practices can result in gloves that are weak, tear easily, have pinholes, are discolored and can become brittle or gummy. Therefore, it is essential that all steps in the chlorination process be carefully regulated. Improper storage conditions can shorten the shelf life of chlorinated and non-chlorinated gloves. Check with the manufacturer for recommended storage conditions.
Q: An accelerator is a chemical used to speed up the transition from a solution into a usable solid film such as a glove. Accelerators control cross-linking to properly align the rubber particles and are necessary for the manufacture of all natural rubber latex and most synthetic gloves.
A: An accelerator is a chemical used to speed up the transition from a solution into a usable solid film such as a glove. Accelerators control cross-linking to properly align the rubber particles and are necessary for the manufacture of all natural rubber latex and most synthetic gloves.
Q: Chlorination can potentially affect the shelf life of gloves. Poorly chlorinated gloves rapidly degrade. Discoloration, cracking, tearing and enhanced heat and light sensitivity may occur, thereby shortening the shelf life and reducing barrier effectiveness. Storage conditions including, but not limited to, temperature, humidity, sunlight and/or fluorescent light exposure may affect chlorinated gloves.
A: Chlorination can potentially affect the shelf life of gloves. Poorly chlorinated gloves rapidly degrade. Discoloration, cracking, tearing and enhanced heat and light sensitivity may occur, thereby shortening the shelf life and reducing barrier effectiveness. Storage conditions including, but not limited to, temperature, humidity, sunlight and/or fluorescent light exposure may affect chlorinated gloves.
Q: No. Accelerators are not used in the manufacture of vinyl (polyvinyl chloride), SBR (styrene butadiene rubber) or Tactylon® (styrene ethylene butylene styrene).
A: No. Accelerators are not used in the manufacture of vinyl (polyvinyl chloride), SBR (styrene butadiene rubber) or Tactylon® (styrene ethylene butylene styrene).
Q: Natural rubber latex, nitrile and neoprene use accelerators as do some of the newer glove materials being introduced.
A: Natural rubber latex, nitrile and neoprene use accelerators as do some of the newer glove materials being introduced.
Q: Accelerators are generally selected from the following three families of chemicals: thiurams, thiazoles and carbamates. All three of these accelerators may be used individually or in combination in the manufacture of natural rubber latex and most synthetic gloves. Thioureas are also used as accelerators by some manufacturers.
A: Accelerators are generally selected from the following three families of chemicals: thiurams, thiazoles and carbamates. All three of these accelerators may be used individually or in combination in the manufacture of natural rubber latex and most synthetic gloves. Thioureas are also used as accelerators by some manufacturers.
Q: The literature reports accelerators may cause Type IV delayed type hypersensitivity (allergic contact dermatitis).
A: The literature reports accelerators may cause Type IV delayed type hypersensitivity (allergic contact dermatitis).
Q: Antiozonates and antioxidants are added to protect the glove from drying and cracking caused by environmental oxygen or ozone exposure. These chemicals help to maintain the shelf life of stored gloves.
A: Antiozonates and antioxidants are added to protect the glove from drying and cracking caused by environmental oxygen or ozone exposure. These chemicals help to maintain the shelf life of stored gloves.
Q: Biocides are preservatives. Biocides are added to help prevent microbial growth associated with glove damage and potential endotoxin contamination. They may be added at several stages during the manufacturing process but are most commonly used in the glove powder liquid suspension tanks and in liquid lubricants.
A: Biocides are preservatives. Biocides are added to help prevent microbial growth associated with glove damage and potential endotoxin contamination. They may be added at several stages during the manufacturing process but are most commonly used in the glove powder liquid suspension tanks and in liquid lubricants.
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Medical Gloves - Glove Selection Guidance

Q: What gloves can be used for food handling?
A: Latex gloves are not recommended when handling food due to the potential for latex sensitized individuals reacting to a glove-handled food product (for example, salad ingredients). Non-latex, synthetic gloves should be used if gloves are needed for handling food in the home or food service establishments including, but not limited to, fast food and general restaurants, hospital cafeterias, grocery stores and delicatessens.
Q: If natural rubber latex reactions are a concern, why shouldn't we convert our facility to vinyl?
A: Care provider and patient protection should be of primary concern. The literature suggests vinyl gloves are adequate for low risk situations of short duration, but their use in high risk situations is not appropriate. Failure rates during use, rigorousness and duration of procedures to be performed and potential exposure to infectious agents or other hazardous substances must each be a consideration when choosing gloves. According to the Occupational Safety and Health Association (OSHA Technical Information Bulletin, April 12, 1999): “Since the reason for wearing gloves is to provide barrier protection from hazardous substances, substitute materials must maintain an adequate barrier protection and be appropriate for the hazard.”
Q: Are synthetic surgical gloves available?
A: Synthetic surgical gloves are available and include, but are not limited to, Tactylon® (SEBS, Styrene-ethylene-butylene-styrene), Elastryn® (SBR, Styrene-butadiene rubber) and neoprene® (CR, Polychloroprene), nitrile (NBR, Nitrile-butadiene rubber) and polyurethane (PU).
Q: Should my co-workers wear synthetic gloves if I am allergic to natural rubber latex?
A: Although individuals who have a confirmed Type I allergy to natural rubber latex (NRL) proteins MUST wear natural rubber latex-free gloves, it has been reported that co-workers can wear synthetic or low allergen, powder-free natural rubber latex gloves. Alternatively, synthetic gloves which provide adequate barrier protection can be worn by coworkers.
Q: Should patients be screened for natural rubber latex allergy?
A: The literature suggests all patient pre-admission histories contain a section on latex allergy. A patient profile indicating a potential for natural rubber latex allergy should be reviewed and forwarded as mandated by internal policy. An evaluation by an allergist may be appropriate in questionable cases.
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Medical Gloves - History of Gloves

Q: When were gloves introduced into the hospital?
A: Glove use can be traced back to the first published article dating 1758 when a surgical glove made from the cecum of a sheep was used during an obstetric procedure. In 1890, in an effort to protect the hands of his nurse from harsh chemicals used during surgery, Dr. William Halsted introduced the first rubber glove for clinical use. For many years, surgical gloves were washed, mended, powdered, sterilized and reused. It was not until the 1960s that the first disposable natural rubber latex gloves were available for general use.
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Medical Gloves - Manufacturing - Chlorination

Q: How does chlorination affect surface protein and chemical residuals?
A: Chlorination is a manufacturing process used to reduce the levels of extractable latex proteins (associated with Type I reactions) and chemicals (associated with irritant contact dermatitis and Type IV reactions). The extra washing steps performed as part of the chlorination process reduce levels of surface proteins found in natural rubber latex gloves and chemicals found in both latex and synthetic gloves. It is theorized the chemical interaction of chlorination also precipitates the natural rubber latex proteins, binding the molecules within the glove matrix, preventing migration to the surface over time.
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Medical Gloves - Powder-Associated Issues

Q: Why is glove powder an issue?
A: The literature indicates multiple issues regarding glove powder: These issues include, but are not limited to, the following:

General Issues
  • Powder is an irritant that can dry hands and macerate the skin.
  • Powder interferes with optimal wound healing and reduces resilience and strength of repaired tissue
  • Powder increases and prolongs inflammation by several mechanisms
  • Powder increases the risk of infection
  • Powder can irritate the respiratory mucosa and induce respiratory tract reactions.
  • Powder can reduce resistance to infection by interfering with the body’s local defenses.
  • Powder may act as a carrier, aerosolizing natural rubber latex proteins bound to its surface.
  • Aerosolized natural rubber latex protein bound to powder can be inhaled and cause reactions in latex allergic individuals.
  • Aerosolized glove powder may carry bacteria, viruses and fungi.
  • Natural rubber latex proteins can bind to powder, be aerosolized, and contaminate surgical tissues, instrument trays, drapes, sponges, suture material, needles, instruments and equipment.
  • Powder left behind in wound sites can cause inflammation, promote infection, increase scarring, induce adhesions, produce intestinal obstruction and cause pelvic pain and infertility.
  • Powder can cause glove starch peritonitis after cholecystectomy, appendectomy
  • Intraperitoneal dialysis procedures contaminated with glove powder can result in severe granulomatosis and dense adhesions.
  • Powder can cause foreign body reactions resulting in granulomas and adhesions after surgery.
  • Powder has been implicated in the misdiagnosis of carcinoma.
Cardiothoracic
  • Powder has been associated with peritonitis, pseudotumor formation and pericardial fibrosis in heart surgery.
  • Granulomatous endocarditis following cardiac catheterization
  • Post-surgical glove powder induced myocardial granulomas and mural thrombi
  • Granulomata of the pericardium
  • Contaminated blood vessels, potentially delaying wound-healing response, prolonging the period subacute thrombosis could occur
  • Blockage of pulmonary vessels with subsequent inflammatory response. Three autotransfusion deaths due to powder contamination
Facial Sinuses and Mastoiditis
  • Powder induced post-surgical unresolved cases of sinusitis, chronic inflammation with fibrous blockage requiring resurgery
  • Powder contamination of the surgical site during oral surgery can actually migrate along facial planes inducing powder complications away from the site of surgery
Gastro-Intestinal
  • Powder may increase post-operative scarring, inflammation, starch powder peritonitis syndrome and intractable adhesions.
Hernia and Testicular Complications
  • Granulomas with central necrosis after vasectomy
  • Severe inflammation and swelling of incision site, scrotum and entire right lower extremity
Laboratory
  • Powder has been associated with erroneous test results, including false-negative HIV tests and false-positive pregnancy tests.
  • Powder interferes with each of the three phases of Polymerase Chain Reaction (PCR) procedure
  • Powder interferes with x-ray diagnostics
  • Powder can absorb substances in test samples making them unavailable or giving erroneously low concentration levels (e.g. cyclosporin2).
Liposuction
  • Post liposuction starch granulomas seen as moveable nodules under the surface of the skin appearing months to years after surgery
Neurology
  • Powder has induced meningitis as a post-surgical complication.
  • Glove powder contamination of extradural catheters during anesthesia delivery thought to increase risk of infection and contribute to catheter occlusion.
  • Glove powder has created intracranial starch granulomas.
Ophthalmology
  • Powder can cause severe postoper
Q: Why do powdered gloves continue to be manufactured?
A: Manufacturers continue to produce powdered gloves to meet consumer demands and contractual requirements. Banning powdered gloves (as some have recommended) would require stopping glove production in order to install manufacturing changes. It was thought at one time that a ban on powdered gloves might lead to a glove shortage although this may no longer be the case.
Q: Can I have allergies to cornstarch?
A: Though rare, allergies to cornstarch have been reported. However, USP (United States Pharmacopeia) absorbable dusting powder (modified cornstarch) present in standard gloves can bind with the chemicals (latex and synthetic gloves) and proteins (latex gloves) to which individuals are much more likely to be allergic. Powder can also absorb and transport infectious organisms such as bacteria, virus and fungi with which it comes in contact. A genetically predisposed individual could have an allergic reaction to the powder-bound chemical or protein allergens.
Q: Is powder found only on the inside of powdered gloves?
A: No. Powder is added to facilitate glove donning and removal. The majority of powder in powdered gloves stays on the internal glove surface. However, some migrates to the outer surface during manufacturing, tumbling and packaging. Release of powder can also occur when gloves are torn or punctured and during donning, snapping in place and removal.
Q: Why do customers continue to demand powdered gloves?
A: Cost, education, wearer donning preference and budget concerns are factors affecting the demand for powdered gloves. As purchasing agents and staff workers understand the impact of powder more, healthcare organizations are taking steps to convert facilities to powder-free gloves. As consumers understand the impact of powder and realize the comparable cost of powder-free gloves and the cost avoidance of potential adverse outcomes, the demand for powdered gloves decreases. Through education, user demand is moving toward a powder-free environment whether the gloves are natural rubber latex or synthetic.
Q: What is aerosolization?
A: Aerosolization means airborne. Glove powder becomes airborne when removing gloves from the box, putting them on, snapping them in place, taking them off or tossing them into the disposal receptacle. These airborne powder particles may potentially contribute to inhalant allergies, rhinoconjunctivitis, inflammation of the nasal mucous membranes or asthma.
Q: What kind of powder is generally used on gloves?
A: The powder used for surgical gloves is USP (United States Pharmacopeia) absorbable dusting powder (modified cornstarch) with less than 2% magnesium oxide added. Calcium carbonate and other chemicals may be added, depending on the manufacturer. Non-USP absorbable dusting powder may be used on examination gloves (e.g. oat starch).
Q: Are powdered gloves easier to don than powder-free (PF) gloves?
A: Dry hands: If hands are dry, powder-free gloves may be equally or slightly more difficult to don than powdered gloves. Powder-free gloves are exposed to different manufacturing processes. One of these processes, chlorination, gives a “glazed” feel to the gloves. This process lowers the coefficient of friction (tackiness) of the glove, and facilitates donning. Damp hands: If hands are damp, powder-free gloves may be difficult to don. Surgeons may have difficulty donning in mid-surgery change-outs, however, there are significant differences in the donnability of the different surgical glove brands. It is important to trial double donning capability as well as dry and damp donning during glove evaluation trials.
Q: Is the government addressing the issue of powder-associated respiratory illness?
A: Yes. The government is addressing the issue of powder-associated respiratory illness. NIOSH (National Institute for Occupational Safety and Health): In April 1996, NIOSH listed asthma and occupationally-related airway diseases as a priority research area. Many cases of adult asthma may be associated with the work environment and, according to NIOSH, a significant number of employees have latex-related asthma. Investigation into the sensitization process as well as the substances that trigger asthma may result in methods to control or eliminate potential exposure methods. FDA Report: The government has received multiple requests to ban the use of powdered gloves. The Center for Devices and Radiological Health (CDCRH) Report on Medical Glove Powder (September 1997), suggests educating the consumer so they can “make an informed decision” and that consideration be given to banning the use of powdered medical gloves at some “predetermined time in the future.
Q: Is this cornstarch the same as I use at home for cooking?
A: No. The cornstarch used on gloves (USP absorbable dusting powder) is cross-linked with chemicals such as phosphorus oxychloride or epichlorhydrin. This alters the powder particles so they become more difficult to break down, enabling them to withstand steam sterilization and hand sweat without degrading. To this chemically cross-linked powder is added a maximum of 2% magnesium oxide to help prevent caking.
Q: How much powder do powdered gloves contain?
A: Historically, powdered medical gloves were found to contain powder levels ranging from 50 to over 400 mg (milligrams) of powder per glove. Currently, powdered medical gloves should comply with the newly established ASTM (American Society of Testing and Materials) limits on powder levels as specified in ASTM D3577 and ASTM D3578 for surgical and examination gloves respectively:
  • Surgical gloves should have no more than 15mg/dm2 (15 milligrams per square decimeter). An average surgical glove has a surface area of about 11dm2.
  • Examination gloves should have no more than 10 mg/dm2 (10 milligrams per square decimeter). An average examination glove has a surface area of about 8 dm.
Q: Why should I use powder-free gloves instead of powdered gloves?
A: Using powder-free gloves alleviates some of the concerns associated with glove powder. Advantages of using powder-free gloves include:
  • Powder-free gloves reduce the glove powder-associated transfer of natural rubber latex proteins, chemical contact sensitizers and endotoxins.
  • Powder-free gloves reduce the drying effect of glove powder on the skin.
  • Powder-free gloves reduce powder-induced irritation and abrasion to the skin.
  • Powder-free gloves reduce the risk of glove powder contamination of laboratory samples and assays.
  • Powder-free gloves reduce the aerosolization of glove powder, potentially reducing the level of environmental contaminants to be inhaled.
  • Powder-free gloves are generally lower in chemicals, endotoxin, and proteins (for natural rubber latex) than powdered gloves.
  • Powder-free gloves reduce glove powder-associated post-surgical complications.
  • Powder-free latex gloves reduce latex aeroallergen levels in medical environments.
Q: Is there a maximum amount of powder that is allowed on powder-free gloves?
A: The American Society for Testing and Materials (ASTM) standard for examination and surgical gloves, which has been accepted by the FDA, has set a maximum limit of 2mg of filter-retained extractable substances on the surface of a powder-free glove. Thus, whether there is residual cornstarch, calcium carbonate, non-filterable lubricants or anything else, there must be no more than 2 mg per glove.
Q: Why do powder-free gloves cost more than powdered gloves?
A: To produce a powder-free glove, manufacturers must incorporate extensive, time-consuming manufacturing processes to remove the powder. Alternatively, new coatings are being developed to take the place of powder and thus its removal. These methods add to the cost of the final product
Q: How does powder enter into the surgical wound?
A: The literature suggests powder may enter the surgical wound through several routes:
  • Direct tissue contact during surgery
  • Surgical instruments prepared by individuals wearing powdered gloves.
  • Falling into the wound from powder-contaminated air.
  • Through puncture or glove rupture, which may release inner surface donning powder into the wound.
Q: Does powder bind just chemicals, endotoxin and proteins?
A: No. The literature suggests powder may act as a microbial-laden fomite, an object that can carry infectious organisms such as bacteria, yeasts, viruses and fungi from one host to another through inhalation, direct or indirect contact. These glove powder fomites can potentially contact patients during procedures such as routine examinations, emergency treatments, respiratory care, surgery and wound dressings, potentially contributing to increased inflammation and infection, adversely affecting length of hospital stay and associated costs of treatment.
Q: What methods can a hospital employ to reduce its overall cost of glove purchases and still be able to acquire powder-free, low allergen gloves, known to be more expensive to produce than other gloves?
A: Standard NRL gloves must undergo additional processing to reduce allergen levels, increasing the cost of production. However, some hospitals have actually saved money when they moved to low allergen by a number of different strategies. For example, the Mayo Clinic in Rochester, Minnesota, was able to save generate a savings of over $200,000 annually by purchasing gloves from fewer vendors, reducing the complexity of their inventory control system. They accomplished this despite an increase in the number of gloves purchased.
Q: Does the government sanction powder in the surgical wound?
A: The Center for Devices and Radiological Health Report on Medical Glove Powder (September 1997) states “…the overall recommendation is to keep foreign bodies out of the operative area and this includes glove powder. Powder-free gloves are recommended….”
Q: Can powder have an adverse effect on laboratory test results?
A: Yes. The literature suggests powder can be a factor contributing to inaccurate drug level and blood chemistry determinations. In diagnostic laboratories powder interference has led to:
  • Cancer misdiagnosis
  • False negative HIV test results
  • False positive pregnancy test results
  • False readings in serologic tests for drug levels
  • Artifacts on processed dental film6
In research laboratories powder has:
  • Interfered with PCR procedures (polymerase chain reaction – a procedure used to replicate DNA or RNA in a sample)
  • Distorted X-ray films (auto-radiograph) readings
  • Interfered with enzyme assays
Q: Doesn’t the body absorb or remove foreign bodies such as powder?
A: The body slowly dissolves cornstarch powder particles deposited in a wound site. If the body cannot break down and remove the particles fast enough, the particles may be encapsulated to become a granuloma nodule. Powder granulomas have been found from several weeks to several years following surgery.
Q: Doesn’t wiping the gloves with a sterile wet sponge or towel remove the powder?
A: No. Even though the government requires a labeling statement on surgical gloves stating “Warning: Remove powder by wiping gloves thoroughly with a sterile wet sponge or other effective method”, this method does not effectively remove glove powder. The literature suggests such efforts lead to:
  • Added clumping, creating even less absorbable aggregates.
  • Reappearance of glove powder in 10 to 30 minutes even after careful rinsing. It is theorized that powder embedded in the glove is released after flexure of the glove material on the hands, and that the amount of powder increases with increased flexure.
  • It should also be emphasized that regardless of the amount of powder removed from gloves by wiping, the initial donning prior to wiping aerosolizes surface powder, and that punctures or tears can allow powder from the inside of the glove to flow into the open wound.
  • In one study, gloves that were washed twice before surgery still left up to 4 million powder particles inside the surgical wound.
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Medical Gloves - Standards and Regulations

Q: What does ASTM stand for?
A: ASTM stands for the American Society for Testing and Materials.
Q: What does ASTM do?
A: ASTM is a not-for-profit, non-governmental organization committed to the development of voluntary standards for materials, products, systems and services. ASTM standards for gloves describe minimum physical and dimensional properties of the finished glove.
Q: What is AAMI?
A: AAMI is the Association for the Advancement of Medical Instrumentation. AAMI’s objective is to develop standards and recommended practices that support its mission of the “advancement of medical instrumentation.” AAMI documents provide guidelines on such subjects as sterilization processing, methods of collecting data and other processing or evaluation techniques.
Q: What is ANSI?
A: ANSI or the American National Standards Institute, founded in 1918, is a private, non-profit organization that administers and coordinates voluntary consensus standards and conformity assessment systems. ANSI facilitates and adopts, but does not develop standards.
Q: What does AQL stand for?
A:

In health care today, it's more important than ever for clinicians to be equipped with the proper protective apparel. Used appropriately, the right gloves, gowns and masks help reduce the spread of Healthcare-Associated Infections (HAIs) among patients and visitors, as well as protecting healthcare workers from contamination and infections that can occur through patient contact, pandemic influenzas and other sources.

Q: What is the CDC?
A: CDC stands for the Centers for Disease Control. This is a public health service agency that leads efforts to control and prevent transmission of diseases. A responsibility of the CDC is to continue to educate the public on general infection control practices. Their guidelines are often modified and updated based on current information and are recommendations, not law. Their standards for infection control include safety precautions for patient care. Included are recommendations on the appropriate use of protective clothing including masks, gowns and gloves for the protection of both the patient and healthcare provider. More specific recommendations are identified in their “standard precautions” and “transmission based precautions.”
Q: Does the CDC have any control over gloves?
A: No. The Centers for Disease Control, established in 1946, is the Public Health Service agency that has led efforts to prevent diseases. CDC makes recommendations for glove use but does not approve or test gloves. CDC uses a panel of experts to set guidelines for the general safety of the population.
Q: What is the FDA?
A: The Food and Drug Administration (FDA) is an agency of the United States government. Among other responsibilities, the FDA regulates the medical device industry by ensuring marketed products are safe and effective. The FDA must review new medical devices (including medical gloves) before the manufacturer can market the product. The FDA also monitors medical device manufacturers to ensure quality standards are maintained and products meet specifications.
Q: What is a 510(k)?
A: A 510(k) is a term commonly used to refer to a premarket application sent to the FDA. The information in this application documents the safety and efficacy of the finished medical device. If the FDA deems the device to be substantially equivalent to a legally marketed medical device that is currently approved for marketing in the United States, clearance is granted to market the product.
Q: Is any testing required for a medical glove to receive a 510(k) clearance?
A: Medical gloves must be biologically compatible with human skin. To assess this, the FDA requires two biological tests: • Primary skin irritation (PSI), which assesses the glove’s potential to produce dermal irritation. • Dermal sensitization, which determines the potential of a device to elicit a delayed hypersensitivity (Type IV) reaction. Other data must also be submitted to confirm gloves meet or exceed minimum performance requirements described in the American Society for Testing and Materials (ASTM) standards. These include, but are not limited to, physical dimensions (length, width and finger, palm and cuff thickness), tensile strength and elongation (before and after aging), freedom from holes, powder levels and total protein content (for natural rubber latex gloves).
Q: What does IES stand for?
A: IES or the Institute for Environmental Sciences is now known as IEST, the Institute for Environmental Sciences and Technology. The Institute’s responsibilities include establishing recommended practices (RPs) for the evaluation of gloves and garments for use in clean rooms. RP-005 contains guidelines for the evaluation of particulates, extractables, non-volatile residues (NVRs), corrosion potential and a number of other factors that may be relevant to a glove user. These requirements are generally used by manufacturers who use gloves (e.g. semiconductor manufacturers) rather than healthcare facilities.
Q: What is ISO?
A: ISO is an acronym for the International Organization for Standardization headquartered in Geneva, Switzerland. ISO is a worldwide federation of national standards bodies charged with developing standards for industry much like the ASTM in the United States. One of the standards developed by ISO is for Quality Systems. This set of standards, referred to as ISO 9000 Quality Systems, is intended to provide a ‘generic core of quality system standards applicable to a broad range of industry and economic sectors’. ISO 9000 Quality Systems are divided into: • ISO 9000 – Concepts and Terminology • ISO 9001 – Requirements for Quality Assurance • ISO 9004 – Guidelines for Quality Management of Organizations • ISO 10011 – Guidelines for Auditing Quality Management Systems
Q: What is NIOSH?
A: The National Institute for Occupational Safety and Health (NIOSH) is a division of the CDC established by the Occupational Safety and Health Act of 1970. This group conducts research and makes recommendations for the prevention of work-related injuries. NIOSH is a research, rather than regulatory, agency. NIOSH identifies causes and potential hazards of work situations and practices. Their recommendations are provided to OSHA where they may be established as industry guidelines or enforceable regulations.
Q: What is the Occupational Safety and Health Act?
A: The Occupational Safety and Health Act was passed by congress in 1970 to assure every working man and woman in our nation has safe and healthful working conditions and to preserve our human resources as far as possible. Under this act, the Occupational Safety and Health Administration (OSHA) was created within the Department of Labor.
Q: What is OSHA?
A: OSHA, the Occupational Safety and Health Administration, is a division of the Department of Labor. OSHA was established as part of the Occupational Safety and Health Act of 1970 to maintain human resources. The authority of OSHA entails developing rules and regulations and enforcing the laws enacted to protect workers from injury.
Q: What is personal protective equipment or PPE?
A: OSHA defines personal protective equipment (PPE) as: “specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment.” Personal protective equipment will be considered “appropriate” only if it does not permit blood or other potentially infectious substances and contaminated materials to pass through to or reach an employee’s work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time the protective equipment is in use.
Q: Does OSHA have glove-related recommendations for dental practices?
A: OSHA recommends the use of personal protective equipment where there may be occupational exposure to bloodborne pathogens. This includes dental practices. According to OSHA: The employer shall ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the work site or is issued to employees.
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Medical Gloves - Testing

Q: What is the purpose of glove testing at the glove manufacturing facility?
A: The manufacturing facility assures the quality of gloves in several ways. First, it sets standards for the manufacturing processes and monitors the processes to assure consistent control. Secondly, it samples product at various stages throughout the manufacturing process and prior to final release to confirm that all product specifications have been met. Lastly, it monitors product complaints from the marketplace, and makes improvements to the product, manufacturing process and/or inspection techniques to address any quality issues.
Q: What are low levels of latex protein?
A: The government has not defined “low protein”. As a result, manufacturers cannot use the term “low protein” on their label.
Q: What is bioburden?
A: Bioburden is the total number of viable (live) microbes on a packaged item prior to sterilization. This includes bacteria, yeasts and fungi.
Q: What is the accepted method for natural rubber latex protein testing?
A: There are several test methods available to evaluate protein in natural rubber latex products. Currently, the FDA only accepts the Modified Lowry method developed by the American Society for Testing and Materials (ASTM). This method, referred to as ASTM D 5712, was approved in April 1995 and updated in August, 1999. It measures the total water extractable protein on a latex product including, but not limited to, any milk protein (used by some manufacturers), enzymes, natural rubber latex proteins and any other type of protein. This test, however, does have weaknesses. For example: „h Some chemical additives can interfere with accurate protein measurements. „h Because the assay detects all (total) proteins, the proteins may or may not be those to which an individual is allergic.
Q: What inspections or tests are performed by the FDA?
A: The FDA inspects registered medical device manufacturing facilities, both domestic and international, to assure that they are operating in conformance with FDA’s “Quality Systems” regulations. In addition, for imported medical gloves, the FDA conducts random customs inspections for barrier integrity testing (pinholes). If gloves are found not to meet applicable FDA requirements, they will be quarantined and not released for sale.
Q: What is a Sterilization Assurance Level or SAL?
A: SAL is the Sterilization Assurance Level. This is the expected probability of an item being non-sterile after exposure to a valid sterilization process. The normal SAL for medical devices is 10-3 (one in a thousand) for less critical devices and 10-6 (one in a million) for more critical and invasive devices. Surgical gloves are sterilized at 10-6 SAL.
Q: Is a protein claim or content statement mandatory?
A: No. The government does not mandate protein labeling. At the present time, this claim is optional.
Q: What is a Sterilization Assurance Level (SAL) dose?
A: The SAL dose is the level of radiation delivered to a product to achieve the required SAL (e.g. 10-6).
Q: What is the primary skin irritation test?
A: The government requires a primary skin irritation (PSI) test be performed prior to granting permission to market medical devices, such as gloves, in the United States. The test determines a material’s potential to induce or aggravate skin irritation. It is usually done according to the regulations of the Consumer Product Safety Commission, Title 16, Chapter II, Part 1500. The test article is applied to intact and abraded skin of six rabbits. Test article and skin contact is maintained for 24 hours. The sample site is usually occluded to mimic the occlusive nature of gloves on the hand. Contact sites are evaluated immediately and up to 72 hours for skin reactions.
Q: What is a kGy?
A: A kGy (or kiloGray) is the international unit for absorbed radiation dose. This was formerly expressed as Mrads. 1kGy = 10-1 Mrads, therefore 25 kGy = 2.5 Mrad.
Q: What is the 200 Person Modified Draize test?
A: The 200 Person Modified Draize test is a dermal sensitization test performed to demonstrate a product’s potential to elicit a Type IV delayed hypersensitivity response through skin contact. When testing gloves to submit to the government for reduced chemical claims, a series of small patches of the product are applied to human skin and replaced repeatedly over a 6-week time period. The results are determined based on the degree of skin reaction that is observed.
Q: What is dose setting?
A: Dose setting is the process undertaken to establish the level of radiation exposure (dose) required to destroy microorganisms (bioburden) on a product within a specified safety level (Sterilization Assurance Level—SAL). The process includes a determination of the number of organisms on the packaged, unsterilized product followed by irradiation at a dose calculated to kill 90% of that number of micro-organisms (sub-lethal dose). The sub-lethal dose takes into account the resistance of the microorganisms and the actual device.
Q: What is a patch test?
A: The patch test is an investigative procedure used to diagnose Type IV allergy. Diagnostic trays consist of test substances dissolved in petroleum, water or ethanol. For gloves, the standard diagnostic tray contains mixes of chemicals commonly used in manufacturing. These test chemicals, mixed in a petroleum base, are applied to the back or inside surface of the arms using paper discs or Finn Chambers®. Results are typically read within 24 to 48 hours after removal of the patch, then again 48 to 72 hours later. The presence of a skin rash, vesicles or papules underneath a disc indicates a positive response. A positive result is an indication of sensitivity to that specific chemical.
Q: What is Dmax?
A: Dmax is the maximum dose that can be delivered to a product before unacceptable damage to the product is incurred.
Q: What is a skin prick test (SPT)?
A: The skin prick test is an allergy test used to confirm the diagnosis of sensitivity to a substance including, but not limited to, foods, grasses, pollens, molds, and natural rubber latex proteins. In this test, a drop of diluted antigenic solution is placed on the skin. The skin is then gently pricked with a lancet. Any remaining solution is wiped away. The appearance of a wheal-and-flare response is observed up to 60 minutes. At this time, the wheal reaction is measured and compared to positive and negative controls. A positive test result is an indication of sensitivity. The individual tested may or may not have or develop any allergic symptoms.
Q: What is Dmin?
A: Dmin is the minimal dose required to assure sterilization to the desired SAL.
Q: What is the RAST test?
A: The RAST (radioallergosorbent test) is an in vitro or test tube assay used to identify and quantitate potential allergen specific IgE antibodies in patient serum or potential allergens from product extracts, depending on the way in which the test is conducted. If testing for the presence of latex specific IgE antibodies, the allergens used would be the proteins found in natural rubber latex. If latex specific IgE is detected, the individual is said to be sensitized. The individual tested may or may not have or develop any allergic symptoms.
Q: What is a dose audit?
A: A dose audit is a check to ensure the dose of radiation being used is still correct. The process for performing a dose audit is specified in the Association for the Advancement of Medical Instrumentation (AAMI) guidelines for irradiation.
Q: What is a dosimeter?
A: A dosimeter is a device that measures the dose of radiation delivered to the product at the position the dosimeter was placed in the batch of products.
Q: What is the LEAP assay?
A: The Latex ELISA for Antigenic Protein or the LEAP assay is a test for antigenic proteins in glove material specific to natural rubber latex. Test results are expressed as microgram of antigenic protein per gram of glove (µg/g). Currently, there is no regulatory requirement for antigenic protein testing. This assay method has basically been replaced by the ELISA Inhibition Assay (ASTM 6499).
Q: What is the difference between gamma sterilization and Electron beam (E-beam) sterilization?
A: Gamma sterilization employs the use of the radioactive isotope Cobalt 60. Interactions between the material and Cobalt 60 initiate biological damage to the micro-organisms on the product, resulting in sterilization. E-beam sterilization is a result of accelerated electrons focusing on and penetrating into a specific material killing the microorganisms. Both are highly effective methods of sterilization. There is no residual activity of either the radioactive isotope or the electrons on the product after the sterilization cycle is complete and the product is removed from the sterilization chamber.
Q: What foods and plants are cross-reactive with latex allergens?
A: A Type I reaction to latex gloves is caused by the naturally occurring protein allergens found in raw latex. Proteins that are very similar to latex allergens can be recognized by latex specific IgE antibodies. The literature suggests an allergy to the cross-reactive (similar) allergens in the items listed below may trigger an allergic reaction to latex proteins and vice versa. While an allergy to these foods and plants is a risk indicator for potential latex sensitization, having these allergies does not mean an individual is or will necessarily become latex allergic.
Almond Grapefruit Plum
Apple Hazelnut Potato
Apricot Kiwi Prawn
Q: What is the Modified Lowry assay?
A: The Modified Lowry assay (ASTM D5712) is an analytical test method used to determine the concentration of total water-extractable protein present in a sample. Currently, this is the only test recognized by the government for the determination of total extractable protein on natural rubber latex devices.
Q: What is an antigenic protein?
A: An antigenic protein is a protein capable of inducing a specific immune response (e.g. antibody production) and of reacting with the products of that response. All antigenic proteins will elicit the formation of antibodies (e.g. IgM, IgG, IgE, IgA, IgD), but not all antigens will elicit an allergic response. For example, the body produces antibodies to fight infection. This is not an allergic reaction. Specific types of antibodies, known as IgE antibodies, are produced in some individuals when exposed to antigenic proteins including, but not limited to, pollen, foods, grasses and animal dander. Once IgE antibodies are produced, this person is sensitized to that antigenic protein.2 The antigen that produces IgE antibodies is known as an allergen.1
Q: What is an allergenic protein?
A: An allergenic protein is a protein capable of inducing IgE antibody production in genetically predisposed individuals. Once IgE antibodies are produced, this person is sensitized to that allergenic protein. The person is said to be allergic after subsequent exposures to the allergen develop enough IgE antibodies to reach a threshold wherein allergic symptoms are experienced.
Q: Can test results for Modified Lowry and LEAP (or ELISA Inhibition assay) on natural rubber latex products be compared?
A: No. The LEAP (as well as ELISA Inhibition assay) is a method used to test for antigenic latex proteins - not natural rubber latex specific or antigen specific. The Modified Lowry assay is a method used to test for total water-extractable protein. Because each test method determines a different substance (total protein vs. antigenic protein) and employs different procedures, the end results cannot be compared.1
Q: Why is a reduced level of total allergenic protein important?
A: Scientific studies provide evidence that the greater the overall exposure to an allergy-causing substance, the greater the risk of sensitization in genetically predisposed individuals. Reduced exposure to natural rubber latex allergenic proteins has been reported in the literature to be associated with decreased allergenic response. Therefore, in the healthcare profession, it is important to select natural rubber latex gloves with reduced allergenic protein levels.
Q: Is there a specific natural rubber latex protein level that can cause an allergy?
A: As with most allergies, researchers have not been able to determine the exact level of natural rubber latex protein exposure, or how many exposures, will cause a genetically capable individual to become allergic and to begin expressing symptoms. There is scientific consensus that reduced allergenic protein levels will lower the potential for both sensitization of non-sensitized genetically susceptible individuals and allergic reactions in sensitized individuals.
Q: Should gloves be tested for pyrogens (endotoxins)?
A: Pyrogenic endotoxins are produced primarily by gram negative bacteria (endotoxins)1 but can also be found in some molds, viruses, yeasts and some other substances. Pharmaceuticals, intravenous solutions and medical devices such as gloves can become contaminated with pyrogens during the manufacturing process. Because pyrogen contamination has the potential to cause fever, inflammation, complement activation and even shock, testing may be used to ensure low contamination levels thereby reducing health hazards. The test method used for the detection of endotoxins is generally the Limulus Amebocyte Lysate assay (LAL).
Q: How are pyrogens (endotoxins) measured?
A: There are two accepted methods for measuring pyrogens. (1) The referee test has historically been the rabbit pyrogen test. This procedure, outlined in the United States Pharmacopeia (USP) XXIII <151> Pyrogen Test, involves injecting the extract fluid from a device or biomaterial intravenously into three rabbits. The animals are then monitored over a three-hour period for any increase in body temperature. (2) The Limulus Amebocyte Lysate (LAL) assay uses an aqueous extract obtained from the blood cells of the horseshoe crab to check for endotoxin quantitatively or semi-quantitatively. It is available in three major formats: gel-clot, turbidimetric and chromogenic. Despite its relative reliability, reproducibility, specificity and sensitivity, this test may be subject to a variety of interferences that can enhance or inhibit test results. Several methods may be employed to remove or dilute out interfering substances prior to testing.
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Medical Gloves - Glove-Associated Reactions

Q: What are the types of glove-associated reactions?
A: There are three known glove-associated reactions:
  • 1) Irritation (also known as dermatitis, irritant dermatitis or irritant contact dermatitis) can be caused by chemicals, endotoxin and/or powder potentially present in both latex and synthetic gloves. Irritation is a non-allergic reaction that can affect anyone.
  • 2) Type IV hypersensitivity (also known as delayed type hypersensitivity, allergic contact dermatitis or chemical allergy) is an allergic reaction associated with specific chemicals called chemical contact sensitizers, potentially present in both latex and synthetic gloves. This reaction is a delayed reaction that typically takes from 6 to 48 hours for maximum expression of physical symptoms.4 An individual must be genetically predisposed to have allergic reactions.
  • 3) Type I immediate type hypersensitivity is an allergic reaction associated with proteins found in natural rubber latex (NRL). This allergic response usually manifests from minutes to an hour after exposure and is associated only with genetically predisposed individuals.
Q: What precautions can I take to avoid developing Type IV glove allergies?
A: Because sensitization is thought to be dose and rate dependent, one should strongly consider wearing powder-free gloves with reduced chemical contact sensitizer levels (latex or synthetic gloves). However, individuals who have already acquired a natural rubber latex allergy (Type I) must NOT wear natural rubber latex gloves. Manufacturers offer a variety of synthetic alternatives. The use of powder-free gloves provides a greater assurance of reduced chemical residuals as the processes used to remove glove powder also wash away surface chemicals.
Q: Can UV light affect the barrier properties of natural rubber latex, nitrile, neoprene, Tactylon® or Elastryn® gloves?
A: Yes. Storage conditions, including unshielded, extended exposure to ultraviolet (UV) light, fluorescent lights or sunlight can compromise glove barrier integrity.
Q: What causes irritation?
A: Non-glove related irritation may be caused by soaps, detergents, disinfectants, solvents, degreasing agents, ethylene oxide, alcohol, cold, dry weather and hundreds of other irritants. Glove-associated irritation may be caused by glove powder, manufacturing chemicals and endotoxins found in both latex and synthetic gloves. Other irritation factors that are often overlooked are skin occlusion, sweat and friction experienced most often when gloves are worn too long.
Q: What is a Type IV delayed hypersensitivity?
A: Type IV hypersensitivity or allergic contact dermatitis is an allergic reaction involving the immune system including specific cells called T-lymphocytes. Genetically predisposed individuals may experience this allergic reaction after repeated contact with chemical contact sensitizers. The maximum expression of clinical symptoms usually occurs at the contact site within 12 to 24 hours but may vary from 6 to 48 hours. Allergic contact dermatitis has an appearance similar to poison ivy or poison oak. It is characterized by redness, itching, small blisters, thickened skin, papules and oozing lesions.
Q: Does latex paint contain latex proteins?
A: Latex paint is a water-based solution that does not contain natural rubber latex or its proteins. Latex paint derives its name from the definition of latex, which is ‘a suspension of particles in water’.
Q: What are the symptoms of glove associated reactions?
A: The symptoms of glove associated reactions vary depending on the type of reaction (irritation, Type IV or Type I). Some symptoms are listed in the following chart. For a more complete list of reaction associated symptoms, refer to the symptoms lists for irritation, Type IV and Type I reactions listed separately.
Q: How does friction cause irritation?
A: Friction occurs when tightly fitting gloves continuously rub against the skin. This constant chafing can rub layers of cells off causing damage to the upper layer of skin, resulting in irritation. The negative effects of friction are amplified if the skin is saturated with sweat or there is powder trapped in the areas of friction.
Q: What causes a Type IV reaction to gloves?
A: Type IV reactions to natural rubber latex or synthetic glove chemical additives can occur when chemical contact sensitizers come in contact with and penetrate the skin surface of genetically predisposed individuals. The genetically predisposed or capable individual develops sensitized T-cells each time he/she is exposed to the chemical. They are not yet allergic and no symptoms are visible while the body “develops” the allergy. After repeated contact over weeks, months or years, the body may reach a critical exposure level referred to as a symptom threshold level. Subsequent exposure after the threshold level is reached elicits clinical symptoms. The individual is then considered allergic to the chemical. On the other hand, if the level of chemical contact sensitizers is low enough, the threshold level may never be reached and thus even the genetically prone individual would never have symptoms.
Q: What precautions can I take to avoid developing Type I glove allergies?
A: Because sensitization is thought to be dose and rate dependent, one should strongly consider wearing powder-free gloves with reduced allergenic protein (if the glove is natural rubber latex). However, individuals who have already acquired a natural rubber latex allergy (Type I) must NOT wear natural rubber latex gloves. Manufacturers offer a variety of synthetic alternatives.
Q: How can the possibility of acquiring a glove-associated reaction be reduced?
A: In order to reduce the potential for glove associated reactions, wear gloves that are low in residual chemicals generally and chemical contact sensitizers specifically, and low in NRL allergens (if gloves are natural rubber latex). Select powder-free gloves to reduce reactions that can be associated with the powder such as irritant dermatitis. Some published reports have suggested that if NRL allergen laden powder comes into contact with a latex allergic individual, an allergic reaction might be initiated.
Q: What is skin occlusion?
A: Occlusion occurs when skin is blocked from air contact. Consequently, the skin is unable to breathe. Occlusion can become a problem when gloves are worn for extensive periods of time. Skin occlusion combined with excessive sweating, where perspiration collects under the glove, creates a soggy condition on the skin surface, leaving the cells more vulnerable to friction and abrasive irritation. Sweating under such occlusive conditions can lead to a more chronic manifestation of this type of skin breakdown termed dyshidrosis or dyshidrotic eczema. Clear fluid filled vesicles or tiny painful blisters often arise. In order to avoid occlusion, consider changing gloves frequently and/or wearing gloves that are half a size larger than you would normally wear. However, keep in mind that a glove that is too large may be a safety issue.
Q: What is a contact sensitizer?
A: Chemicals that have the potential to cause a Type IV allergic reaction in genetically susceptible individuals are called chemical contact sensitizers. Of the more than 85,000 chemicals in the world today, more than 2800 have been identified as contact sensitizers. In glove manufacturing, the primary contact sensitizers are most often accelerators. Additionally, glove preservatives, antioxidants and colorants have been identified as potential contact sensitizers.
Q: Are there any guidelines or recommendations for individuals with ongoing exposure to natural rubber latex?
A: Two organizations that have recommendations are NIOSH and OSHA. Excerpts from their recommendations follow. The National Institute for Occupational Safety and Health (NIOSH) Alert, issued June 1997, recommends the following steps for individuals with
  • Use non-latex gloves for activities that are not likely to involve contact with infectious materials (food preparation, routine housekeeping, maintenance, etc.).
  • Latex gloves should be powder-free, with reduced protein content.
  • Frequently clean work areas contaminated with latex "dust" (upholstery, carpets, ventilation ducts, and plenums).
  • Frequently change the ventilation filters and vacuum bags used in latex-contaminated areas.
  • Learn to recognize the symptoms of latex allergy: hives, flushing, itching, nasal, eye or sinus symptoms, asthma, and shock.
  • If you develop symptoms of latex allergy, avoid direct contact with latex gloves and products until you can see a physician experienced in treating latex allergy.
  • Individuals with an allergy to latex protein must wear synthetic gloves.
  • If you have latex allergy, consult your physician regarding the following precautions:
    • Avoid contact with latex gloves and products.
    • Avoid areas where you might inhale the powder from the latex gloves worn by others.
    • Tell your employers, physicians, nurses, and dentists that you have a latex allergy.
    • Wear a medical alert bracelet.
  • Take advantage of all latex allergy education and training provided by your employer.
Q: Can anyone have a reaction to gloves?
A: Yes and no. Since irritant contact dermatitis is a non-allergic response, anyone can have an irritant reaction to gloves. However, Type IV and Type I are allergic reactions. This means that an individual must be genetically predisposed (have the DNA instructions to make them capable of reacting) to the chemical contact sensitizers (Type IV) or natural rubber latex proteins (Type I) in order to have these glove-associated reactions.
Q: How does powder affect irritation?
A: Although many powdered glove users may not experience problems, the literature suggests irritation can be initiated or increased by wearing powdered synthetic or latex gloves. Powder may contribute to irritation by:
  • Drying the skin by absorbing protective oils and moisture, potentially leading to dryness, cracking and itching (hands appear chapped).
  • Macerating occluded hands causing mechanical irritation.
  • Abrading vulnerable cells after they are swollen from sweat absorption, potentially causing cell rupture and inflammation, reducing barrier properties and exposing vulnerability to infectious agents.
  • Depositing irritant chemicals and endotoxin through damaged skin.
Q: Can powdered gloves contribute to Type IV reactions?
A: Powder may contribute to the development of a Type IV allergy. Powder can act as a vehicle transporting bound chemicals from the glove to the wearer’s skin. Perspiration can dissolve or extract the chemicals, while the glove keeps them pressed against the skin.
Q: To minimize the possibility of latex allergy, do we need to go all synthetic?
A: First, it is important to understand that latex allergy is just that – an allergy. Allergies only affect a small portion of the population. The majority of us do not have the genetic capability (DNA instructions) to be able to react to latex allergens. We cannot produce the IgE antibodies specific to latex allergens (we may be able to develop other allergies) and thus never develop a latex allergy. Second, if latex allergen exposure level is sufficiently low, even individuals who are genetically capable of developing a latex allergy may fail to ever reach their symptom threshold level and thus never have a reaction. They may have a positive RAST or ELISA for IgE specific to latex (sensitized) but are not allergic (no symptoms). There are publications wherein it is reported that the use of low allergen powder-free latex for non-allergic individuals prevented new cases and allowed those who are latex allergic to return to work as long as they wear synthetic gloves.
Q: What does irritation look like?
A: Irritation can be divided into two phases: acute and chronic. In acute irritation the hands may: - be excessively dry. - become inflamed, red (erythema) or have a scalded appearance. - burn or have local itching. - swell (edema). After repeated or long-term exposure, acute symptoms may progress to a chronic state where symptoms include: - dry and thickened skin (hyperplasia). - evidence of cracks or horizontal fissures. - crusting, peeling skin. - surface lesions marked by skin over-growth (keratosis). - solid, circumspect elevation of the skin (papules). Symptoms of irritation related to glove use are confined to the area of glove contact and do not progress beyond the glove border.
Q: What are the symptoms of a Type IV glove-associated reaction?
A: Type IV allergic contact dermatitis, like irritation, can be divided into two phases: acute and chronic. Acute symptoms may include:
  • Localized redness or a scalded appearance (erythema)
  • Small blisters
  • Localized, itchy rash (pruritus)
After long-term exposure to chemical contact sensitizers, acute symptoms may progress to a chronic state. Chronic symptoms may include:
  • Localized redness and inflammation (erythema)
  • Swelling (edema)
  • Dry, thickened skin that can peel or crack
  • Small, circumscribed skin elevations containing fluid (vesicles)
  • Small, hard bumps (papules)
  • Open sores (lesions)
The maximum expression of symptoms of a Type IV allergic reaction typically appears 6 to 48 hours after exposure. In the chronic phase of a Type IV glove-associated reaction, the reaction can spread up the arm beyond the glove border. This is one way to differentiate a Type IV, allergic contact dermatitis from an irritant dermatitis (never advances beyond the cuff of the glove).
Q: Should my co-workers wear synthetic gloves if I am allergic to natural rubber latex?
A: Although individuals who have a confirmed Type I allergy to natural rubber latex (NRL) proteins MUST wear natural rubber latex-free gloves, it has been reported that co-workers may wear synthetic or low allergen, powder-free natural rubber latex gloves.
Q: Can you buy a glove that does not contain residues that will cause some sort of reaction?
A: There is no perfect glove. Latex proteins are inherent to natural rubber latex. Chemicals are necessary to manufacture both synthetic and natural rubber latex gloves. Latex proteins and glove manufacturing chemicals are removed during production steps that include, but are not limited to, multiple rinses, leaching and chlorination. While each of these steps, if used, remove substantial amounts, some protein and chemical residue may remain. Since natural rubber latex proteins cannot be completely removed, latex allergic individuals should not wear natural rubber latex gloves.
Q: What is irritation?
A: Irritation is a non-allergic inflammatory reaction that can be experienced by anyone. It is precipitated by contact with irritating substances such as soaps, detergents, glove powder, endotoxin, friction, and numerous chemicals that damage the skin.
Q: What does acute mean?
A: Acute means a condition or disease of short duration. With hand or dermal irritation, once the source of the condition is removed, the hands will heal. However, if contact with this same irritant is continued the condition may progress to a chronic state with more chronic appearing symptoms.
Q: How do I treat a Type IV reaction?
A: If a Type IV reaction is suspected:
  • Consult with your supervisor, employee health or occupational health professional
  • See a dermatologist to obtain a medical diagnosis
  • Switch to a glove documented to be low in chemical contact sensitizers
  • If there is a documented allergy to a specific chemical, switch to a glove manufactured without this chemical
  • Consider using cotton, nylon or other glove liners if permitted in the work environment. Replace liners every time the gloves are changed
  • Because the normal barrier protection of the skin is compromised, exercise extra caution when there is a potential for exposure to infectious substances
  • See a dermatologist for evaluation, diagnosis and identification of the chemical contact sensitizer
Q: Should patients be screened for natural rubber latex allergy?
A: The literature suggests all patient pre-admission histories contain a section on latex allergy. A patient profile indicating a potential for natural rubber latex allergy should be reviewed and forwarded as mandated by internal policy. An evaluation by an allergist may be appropriate in questionable cases.
Q: What does chronic mean?
A: Chronic means a condition or disease of long duration. With hand or dermal irritation, a chronic condition is a reflection of repeated contact over time. The symptoms of chronic irritation are different from those of short duration acute irritation.
Q: Can anyone have a Type IV reaction?
A: No. As with any allergy, an individual must be genetically predisposed to develop an allergy to a specific chemical. That means the DNA of the individual must have the instructions for making a receptor site on the specialized T-cell specific to the chemical contact sensitizer to which he/she is exposed.
Q: What is Type I hypersensitivity?
A: Type I or immediate type hypersensitivity is an allergy involving the immune system and the development of IgE antibodies specific to an allergen. The body continues to build up these IgE antibodies each time a genetically predisposed individual is exposed to the allergen. Examples of Type I hypersensitivity include but are not limited to, allergies to bee stings, penicillin, peanuts, seafood, plants, pollen and certain natural rubber latex proteins. As with any allergy, symptoms cannot manifest on first contact. While the body “develops” the allergy, no symptoms occur. As they develop IgE antibodies to the specific allergen, the individual is said to be sensitized. They are not “allergic” until symptoms occur. After repeated contact over weeks, months or years, the body may reach the critical exposure level referred to as a symptom threshold level. Subsequent exposure after the threshold level is reached elicits clinical symptoms in minutes to an hour.
Q: What is a natural rubber latex allergy?
A: A natural rubber latex allergy, also known as Type I immediate hypersensitivity and latex allergy, is the general terminology given to an IgE mediated allergic response to certain proteins found in natural rubber latex. This allergy can be associated with natural rubber latex gloves or with any of the 40,000 plus products containing natural rubber latex that can be found in household and medical environments. Certain foods contain allergens that may cross-react with latex allergens including, but not limited to, bananas, kiwis, avocados and chestnuts. Thus, an individual may be allergic to kiwis but have a reaction when in contact with latex or vise versa.
Q: How do I treat glove-associated irritation?
A: There are several actions that may help resolve the symptoms of glove-associated irritation. These include: Consult with your supervisor, employee health or occupational health professional. Choose a powder-free glove. Switch to gloves with reduced chemicals. Use cotton, nylon or other glove liners (under-gloves). Replace liners every time gloves are changed. They may be washed and reused. Follow facility policies. Use a larger size glove to allow for air circulation. Change gloves often. Exercise extra caution with infectious agents as the irritant dermatitis compromises the skin’s protective barrier. Consult a dermatologist if symptoms persist. Avoid gloves found to be irritating. Dermal anti-inflammatory lotions may be helpful, but make certain they do not degrade the glove.
Q: Can anyone have an irritant reaction?
A: Yes. Irritation is a non-allergic, non-genetic condition and can potentially affect anyone.
Q: What causes a Type I reaction to natural rubber latex gloves?
A: As with any allergy, individuals who develop an allergy to natural rubber latex proteins must have the genetic capability to do so. Their DNA must have the instructions for making IgE antibodies to the particular allergen to which they are exposed. Repeated contact with the latex allergen or allergens will generally build the individual’s level of sensitization until their symptom threshold is reached. This sensitization period may take days, months, or even years. Indeed, some individuals never reach their threshold. The individual will be asymptomatic throughout this period of sensitization. After the threshold level has been reached, subsequent exposure may result in symptoms. At this point the individual is considered “latex allergic”.
Q: Is glove exposure the only thing that will cause natural rubber latex sensitization?
A: No. Natural Rubber Latex proteins are found in over 40,000 products. These include, but are not limited to products commonly used in schools, at home, the athletic field, the workplace and healthcare facilities. The literature suggests approximately 50% of hospital products contain natural rubber latex. Repeated exposure to all natural rubber latex products and/or cross-reactive foods and plants increases the possibility that a genetically pre-disposed individual may become sensitized.
Q: How is a natural rubber latex allergy developed?
A: No one knows exactly how a latex allergy develops. We do know that an individual must be genetically capable to react to specific latex (or cross-reactive) allergenic proteins, and that this allergy, like other allergies, develops only after repeated exposure to the allergen.
Q: What is urticaria?
A: Urticaria is another word for hives.
Q: What is a wheal?
A: A wheal is the swelling of the skin appearing as a hive. Generally, it is slightly reddened, often blanched in the center, changing in size and shape, extending to adjacent areas and usually accompanied by intense itching. Wheals are often encircled by rays of swelling termed flares.
Q: What is anaphylaxis?
A: Anaphylaxis is a life-threatening antigen-specific immune reaction mediated primarily by IgE antibodies. This severe systemic Type I reaction results in blood vessel dilation (vasodilation) and smooth muscle constriction. A subsequent flow of fluid from the circulatory system, which, if localized, causes swelling in the immediate area. If excessive, fluid loss can cause a sudden drop in blood pressure and a rapid heart rate, which can progress to acute systemic shock and, rarely, death.
Q: Can natural rubber latex allergies be treated or cured?
A: There are no treatments commercially available to cure a latex allergy. Topical steroids and oral antihistamines may temporarily reduce some latex allergy symptoms. Bronchodilators or steroids may be prescribed to treat symptoms. Individuals who suspect they are allergic to natural rubber latex (Type I) need to be diagnosed and treated by their physician, and are usually referred to an allergist. In the most severe cases, such as anaphylactic shock, immediate emergency treatment is necessary. Medications include the use of an Epi pen (epinephrine), Benadryl, oxygen, etc.
Q: What should I do if I suspect I have a natural rubber latex allergy?
A: If a latex allergy is suspected, report the condition to your supervisor, employee health officer or appropriate individuals as stated in your employment personnel policies. An allergist experienced in diagnosing latex sensitivity is generally recommended for diagnosis.
Q: What should I do if a hospital patient has a natural rubber latex (NRL) allergy?
A: There are several steps that may be taken if a patient has a NRL allergy. These steps include, but are not limited to:
  • Document the allergy.
  • Provide a highly visible NRL allergy alert patient ID bracelet.
  • Immediately mark the patient’s chart.
  • Clearly label the patient’s room and bed with large natural rubber latex-allergy signs.
  • Communicate critical patient information across the continuum of care.
  • Initiate the appropriate protocol for latex-safe care.
  • Inform the patient if the allergy diagnosis is unknown to him/her.
Some steps to incorporate into latex-safe care include:
  • Provide a powder-free, latex-safe environment.
  • Use latex-safe crash carts and trauma carts.
  • Use only synthetic gloves.
  • Document compliance.
Q: Who is at risk for developing a Type I hypersensitivity to natural rubber latex?
A: Currently, there is no way to predict who will, or will not, develop an allergy to natural rubber latex. The literature suggests some population groups may have an increased risk for latex sensitization. These groups include, but are not limited to:
  • Atopic individuals.
  • Individuals with a family history of atopy.
  • Individuals with occupational exposure.
  • Individuals requiring repeated surgical interventions, especially those beginning such procedures as newborns (e.g. spina bifida, congenital abnormalities, multiple surgeries).
  • Individuals with frequent mucosal exposure to natural rubber latex products (e.g. urinary catheterization).
  • Individuals allergic to cross-reactive foods and plants
  • Presence of multiple risk factors.
Q: How will I know if I am becoming allergic to natural rubber latex?
A: As with any allergy, natural rubber latex allergy symptoms cannot manifest on first contact. While the genetically predisposed individual “develops” the allergy (becomes sensitized), no symptoms occur. After repeated contact over weeks, months or years, the body reaches a critical exposure level referred to as a symptom threshold level. Subsequent exposure after the threshold level is reached elicits clinical symptoms in minutes to an hour. After the first symptoms begin to appear, the person is said to be allergic. Threshold levels are very individual and depend on genetic makeup, susceptibility and environmental influences. (See question - What are the most common symptoms associated with a Type I reaction to natural rubber latex proteins? for Type I clinical symptoms).
Q: What does genetically predisposed to a particular allergy mean?
A: With regard to any particular allergy, a genetically predisposed individual is genetically capable of reacting to a specific allergen. The individual has the genetic code (or DNA) that allows their immune system to form a response (allergic reaction) to a specific allergen (e.g. poison ivy, poison oak, goldenrod, specific grasses [hay fever], peanuts, seafood and natural rubber latex proteins). Individuals without the genetic code for the specific allergen in question cannot have an allergic reaction to that specific allergen.
Q: What is an atopic person?
A: Those who have the genetic make up to develop many different allergies (e.g. allergies to ragweed, shell fish, grasses, peanuts, and penicillin) are referred to as atopic individuals. Because atopic individuals have a greater probability for developing any allergy, they are also at a higher risk for having the genetic make up for developing an allergy to natural rubber latex proteins.
Q: Can hospital patients be affected by natural rubber latex proteins?
A: Yes. Patients with a Type I allergy to natural rubber latex proteins can have an allergic reaction in a hospital or clinical setting. The literature suggests approximately 50% of hospital products contain natural rubber latex. Contact with any of these products through unbroken or broken skin, mucous membranes and/or airborne routes could trigger a Type I allergic response in a latex allergic individual.
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Medical Gloves - Endotoxin

Q: What is endotoxin?
A: Endotoxins are potent inflammatory agents produced by the cell walls of gram-negative bacteria. They are capable of causing multiple local and systemic reactions including irritation, fever, tissue inflammation, diarrhea, respiratory distress, and endotoxic shock. They are not destroyed by steam, ethylene oxide or irradiation sterilization. Endotoxins are also adjuvants, a term applied to substances that can increase or magnify a Type I or Type IV sensitization and/or allergic response. The presence of endotoxin with an allergen may speed up sensitization or amplify a reaction.
Q: Are endotoxins a concern in glove manufacturing?
A: Yes. Endotoxins are inflammatory agents produced by the cell walls of gram-negative bacteria. This type of bacteria readily grows in warm, moist or wet environments where basic nutrients are supplied such as in raw latex, stagnant leach tanks, untreated water and liquid powder mixtures (known as powder slurries). If bacterial growth is not controlled, the endotoxin level increases, potentially increasing endotoxin-associated responses in the glove user and/or patient. To control bacterial growth, manufacturers must maintain a clean, good manufacturing environment and may need to use small amounts of biocides at points during the manufacture of rubber latex and synthetic gloves to prevent microbial growth.
Q: What does pyrogenic mean?
A: Pyrogenic means producing a fever.
Q: What is a pyrogen?
A: A pyrogen is a fever producing substance. Endotoxins are pyrogens, although producing a fever is only one of the physiological consequences of endotoxin. Pyrogenicity, like the other consequences of endotoxin depends on the level and rate of introduction. Very low levels will not cause a fever. Higher levels increase the number and severity of potential adverse consequences.
Q: Does sterilization remove endotoxins?
A: No. The ethylene oxide, steam and radiation sterilization processes used for gloves do not destroy endotoxins. These forms of sterilization destroy microorganisms. Upon destruction, endotoxins, the pyrogenic lipopolysaccharides from the cell walls of dead gram negative bacteria, are released from the cell wall and remain capable of causing multiple local and systemic pathological conditions. It has been reported that sterilization may actually increase endotoxin levels due to the break-up of the bacterial wall into multiple pieces.
Q: I see “sterile, non-pyrogenic” on several products I use like fluid path in tubing, injection drugs, syringes, extradural catheters, and numerous other products. Doesn’t the government control the endotoxin (pyrogens) on surgical gloves as well?
A: No. The government has not set up any restrictions on endotoxin limits for surgical gloves. It is not something they have addressed. In fact, even if the manufacturer diligently controls endotoxins in the manufacturing process and tests every lot of surgical gloves to make certain the levels are very low before releasing the product (same requirements as the products listed in the question), they are not permitted to state “non-pyrogenic” or “low in endotoxin” or even “below X endotoxin units” on the glove packaging. So, unless the customer tests the gloves (not likely), they will not know if this glove or the next one will have high levels of endotoxin. You may require such information from the manufacturer or vendor.
Q: How can I find out about the level of endotoxin of my surgical gloves?
A: 1. Ask the manufacturers for evidence that they conduct lot-by-lot endotoxin release criteria for their gloves. 2. Ask for test results on a specific lot of gloves. Note: Pharmaceutical manufacturers are beginning to request that information from glove manufacturers to make certain that the gloves touching their products do not contaminate them with endotoxins.
Q: Are endotoxins found only on gloves?
A: No. Endotoxin may be present on medical equipment, infusion dialysis equipment, disinfection liquids, air cooler systems, water supplies, air filters, sterilized re-usable devices and generally in the hospital environment. Implants, medical devices utilized for invasive medical procedures and other medical instruments may be contaminated when in contact with sterile or clean medical fields contaminated with endotoxin.
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Protective Apparel

Q: How long can I wear my disposable Lab Coat/Jacket?
A: Our customers have informed us that you can expect to get multiple uses from the product depending on the type or style of Coat/Jacket being used and the environment in which it is used. However, if the Lab Coat or Jacket becomes contaminated, it should be removed immediately or as soon as feasible.
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Sterilization Packaging

Q: Is the HALYARD* Absorbent Tray Liner compatible with the Sterrad® sterilization system by Johnson & Johnson?
A: No, the Halyard Absorbent Tray Liner is made out of HYDROKNIT* material which may absorb the sterilant (hydrogen peroxide) and cause the Sterrad® system cycle to abort. The HALYARD* Absorbent Tray Liner is only intended for use in steam or ethylene oxide sterilization systems. Sterrad® is a registered trademark of Johnson & Johnson.
Q: Can HALYARD* Transport Trays be steam and/or ethylene oxide sterilized?
A: Yes, HALYARD* Transport Trays can be steam and/or ethylene oxide sterilized. Please contact your local sales representative for additional information regarding our Transport Trays.
Q: Is HALYARD* sterilization wrap compatible with dry heat sterilization?
A: No, Halyard sterilization wrap is not compatible with dry heat sterilization. The temperature for dry heat is 160C/320F, which could melt or soften Halyard sterilization wrap.
Q: Can I write directly on HALYARD* sterilization wrap with a permanent marker?
A: The American Society for Healthcare Central Service Professionals training manual for CS technician’s states “A method of labelling that will not damage the packaging materials should be selected. Generally, a felt tip, indelible-ink marker may be used to record the necessary information on the tape. Never write on the wrapper material – use the tape for this purpose.”
Q: Is HALYARD* Sterilization Wrap compatible with some of the new sterilization technologies like the Sterrad® Sterilization System?
A: The manufacturer of the Sterrad® System, Johnson & Johnson Advanced Sterilization Products, has tested the Sterrad® System for compatibily using some HALYARD* sterilization wraps. The wraps were found to be compatible with the Sterrad® System. Please contact Johnson & Johnson for the results of the compatibility testing. Sterrad® is a registered trademark of Johnson & Johnson.
Q: How can our hospital change from time-related expiration dating to event-related sterility maintenance?
A: An event-related sterility maintenance policy is based on the premise that events rather than time are the major cause of contamination of processed packages. Successful implementation of an event-related sterility maintenance policy depends upon factors such as the barrier quality of the packaging materials, internal storage conditions, conditions during transport, and handling practices. Halyard has designed a document with guidelines that assist customers should they choose to convert from a time-related to an event-related sterility maintenance policy. Your Halyard Health sales representative can provide you with the document and the tools necessary to proceed in your conversion.
Q: What is the shelf life of a package wrapped in HALYARD* Sterilization Wrap?
A: HALYARD* Sterilization Wrap has been tested to determine its ability to provide protection from contamination. Shelf-Life studies confirm that HYH wrap provides effective protection for 12 months.
Q: Can HALYARD* Sterilization Wrap be recycled?
A: We have determined that sterilization wrap can be safely and effectively recycled from hospitals for non-medical uses. Wrap is composed of polypropylene (an inert polymer derived from petrochemicals), which has a plastics recycling code of "5." Some hospital customers are presently recycling HALYARD* Sterilization Wrap that has been segregated prior to the beginning of the case. Segregation ensures that the wrap is "uncontaminated." This material can be transported to a plastics reprocessor who may use it to make such second-tier products as fence posts, park benches, flower pots and parking bumpers.

Please note: Some of our other products, such as surgical gowns and drapes, may, during the course of use, become soiled with enough blood and/or body fluids to meet the facility's definition of regulated medical waste. Most states and localities do not allow for the recycling of regulated medical waste. For this reason, these products are not recyclable at this time.

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Surgical Gowns

Q: What is the HALYARD* Colour-Key?
A: With colour-coded gown neckbands and packaging, the HALYARD* Colour-Key provides caregivers Instant Gown Recognition, to help minimize the risk of wearing the wrong gown. Now it’s easy to quickly select the gown you want for each and every procedure.
Q: What do the colours represent?
A: Yellow – Non-reinforced surgical gowns Green – Fabric-reinforced surgical gowns Red – Impervious Type Surgical Gowns
Q: Why are there different gown types?
A: Different gown types can be used for different procedures. While low fluid procedures normally require a non-reinforced gown, high fluid procedures require an impervious gown.
Q: Does a facility need to use all 3 gown types?
A: No. Based on the mix of procedures, each facility will have their own mix of gown types. Many facilities use a mix of non-reinforced and impervious gowns. This allows the facility to minimize the number of product codes while ensuring that they have an appropriate gown for every procedure.
Q: Do the colours represent the different levels of liquid barrier performance being introduced by the Association for the Advancement of Medical Instrumentation (AAMI)?
A: No. The AAMI standard is designed to help healthcare workers make selection decisions based on protection only. The HALYARD* Colour Key helps provide instant recognition of gown type. This is an important distinction in that you can have more than one gown type in a single AAMI level. For example, many manufacturers will have both non-reinforced and fabric-reinforced surgical gowns classified as Level III by the AAMI standard. These gowns are often used in completely different roles in the operating room.
Q: Do the different colours indicate gown size?
A: No. Sizes will still be indicated on the inside of the gown.
Q: What is the benefit of the tie card?
A: The Colour-Key tie card accompanies each gown, to help users in the OR understand what their colored neckbands represent.
Q: Is there a Colour-Key indicator on the package?
A: Yes, the colour that corresponds to the neckband colour is located on the top edge of the front of the gown package.
Q: What gown type are MICROCOOL* surgical gowns?
A: MICROCOOL* surgical gowns are breathable impervious gowns and have red neckbands.
Q: Has the gown changed in any way other than the coloured neckband?
A: No. All gowns remain the same, the only change is to the neckband and the tie card.
Q: Why did Halyard use a zoned impervious icon on the tie card to designate impervious gowns rather than a fully impervious icon?
A: The zoned impervious icon works for all impervious gowns since its reinforcements indicate the critical zones of the gown. By using the zoned impervious gown icon we could use one icon instead of two, eliminating potential confusion.
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Surgical Packs, Gowns and Drapes

Q: Do Halyard Surgical products contain latex?
A: Click here to see the Halyard latex free documentation, and educational information on Latex Allergies.
Q: What is the expiration date and shelf life of our surgical products?
A: Expiration Date: In North America, we do not have an expiration date on our surgical products. The concept of "event related sterility" is used, which appears on our packaging as the phrase: "CONTENTS STERILE: Unless this package is opened or damaged." On European packaging, the expiration date is posted on the packaging, which is 5 years from the manufacturing date.

Shelf Life: The shelf life of all sterile Halyard surgical products are all based on real time studies conducted according to the International Standard ANSI/AAMI/ISO 11607:2000, Packaging for terminally sterilized medical devices. These studies document that the packaging materials and the products packaged inside the package, maintain sterile integrity and package/product performance characteristics over at least a five (year) shelf life time period. All protocols and reports are on file at Halyard.
Q: Are there any recommendations for maximum temperatures and humidity for storing Halyard sterile surgical products?
A: There are no specific storage requirements for Halyard surgical products. Halyard recommends following AAMI guidelines which are between 68 and 73 degrees F with humidity between 30% and 60%. All Halyard products have been sterilized and released following the universally recognized standard: ISO 11135, "Medical devices- Validation and routine control of ethylene oxide sterilization, and each product is sterile unless opened or damaged.
Q: How does Halyard recommend that sterile surgical products be sterilized?
A: Halyard surgical drapes and gowns are constructed using a 3-layer polypropylene fabric. The recommendation for the Halyard surgical products is that they are sterilized using Ethylene Oxide. Gamma sterilization is not recommended for Halyard polypropylene drapes and gowns, as this method may break down the polypropylene fabric.
Q: What is the difference between the ASTM 1670 and ASTM 1671 tests?
A: ASTM 1670
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
This test method is based on Test Method F 903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing. Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials.

ASTM 1671
Test for Impervious Fabrics Standard Test Methods for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.

This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basis.
Q: Is it a requirement that the material used to wrap sterile surgical drapes and gowns is impervious?
A: The purpose of gown and drape overwrap is to maintain the sterility of the products during the procedure set up, which is stated as follows in “Berry and Kohn’s Operating Room Technique” 7th Edition, p 124-125.

“To ensure sterility, 1) Sterile packages are laid on dry surfaces. 2) The package is considered non-sterile if it comes in contact with moisture and 3) Drapes are placed on a dry field.”

The Halyard gown overwrap is constructed of a 3 layer SMS fabric. This is in compliance with these AORN Standards, Recommended Practices, and Guidelines 2004 Edition, which states that “a fused or bonded, double-layer, disposable, non-woven wrapper used according to manufacturer's recommendations may provide a bacterial barrier comparable to the sequential double wrap, allowing sage and easy presentation to the sterile field. (p. 330-331)
Q: Which of HYH Surgical Gowns pass the ASTM 1671 Standard?
A: All of the Halyard Impervious, Zoned-Impervious, MICROCOOL* and Specialty Gowns pass the ASTM 1671 standard. The ASTM standards are as follows:
    ASTM 1670
    Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
    This test method is based on Test Method F 903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing. Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials.
    ASTM 1671
    Standard Test Methods for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
    This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.

    This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basis.
Q: What do the different colours on the Halyard Surgical Gown neckbands signify?
A: Colour-coded gown neckbands, tie cards, and packaging are part of the HALYARD* Colour-Key. The HALYARD* Colour Key provides caregivers Instant Gown Recognition, to help minimize the risk of wearing the wrong gown. Now it’s easy to quickly select the gown you want for each and every procedure. The colours signify the following:
    Yellow – Non-reinforced surgical gowns
    Green – Fabric-reinforced surgical gowns
    Red – Impervious Type Surgical Gowns
Packaging: The colour that corresponds to the neckband color is located on the top edge of the front of the gown package.

Tie Card: The Colour-Key tie card accompanies each gown, to help users in the OR understand what their coloured neckbands represent.
Q: What are the differences between the various reinforcements offered on HALYARD* Surgical drapes?
A: CONTROL* Plus - Maximum Absorbency, CONTROL* - Absorbent, non-slip for instrument control, SURROUND Absorbent Reinforcement Fabric, Instrument Pad - non-slip pad.
Q: What tools are available to customers to help learn about Halyard Surgical products?
A: The Gown Selector Tool: a helpful tool for choosing the right gown for the right procedures.

The Draping Guide: this tool provides both a video and a print out poster to help in-service drapes. The guide gives step by step instructions on how to apply Halyard drapes, including a video module with audio instructions. This guide is available on the majority of the HYH Drape products, and can be found by clicking on a drape code in the Products section of the Halyard web site.

Click here to view the Gown Selector Tool and the Draping Guide.

The HALYARD* Color-Key Web Site: is a guide to the new gown recognition system on Halyard Surgical Gowns.

Click here to view the Color Key web site.
Q: Which of the HALYARD* Back Table Covers are the heaviest basis weight?
A: The Heavy Duty Back Table Covers (codes 89906, 79006, 89908, and 79008) are the heaviest basis weight of the 3 different Back Table Cover designs offered by Halyard. (Zone-Reinforced, Reinforced and Heavy-Duty Back Table Covers).
Q: What are the differences between the small and the large Tourniquet Cover - codes 53600 and 53605?
A: Small 53600 = the length is 21.5” x 15.5”
Large 53605 = the length is 31.5” x 15.5”
Q: Do all of the Halyard Surgical Drape Reinforcements (Control, Control Plus, Surround, and Instrument Pad) pass the NFPA Class I standards?
A: Yes, the reinforcements pass both the NFPA flammability standards for Class I.

Test Criteria: NFPA Standard: Class 1 = Flame spread time > 20 seconds
Q: What color is the Cysto Apron, 89741, and what is it made of?
A: It's blue and is made out of a polyethylene film material.
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Surgical Solutions

Q: Do you have clinical studies that demonstrate the effectiveness of INTEGUSEAL*?
A: Yes. We have in vitro and in vivo that demonstrate the effectiveness of INTEGUSEAL*. More information is available upon request.
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Temperature Management - Patient Warming

Q: What is the risk to the patient of inducing an electrosurgical thermal injury since the thermal pads have water circulating through them?
A: If electrosurgical grounding pads are properly placed on the patient as indicated by the manufacturer and a thermal pad is not placed over the grounding pad, there is no increase in risk to the patient. The thermal pad is not an alternative current path for the electrosurgical generator. However, the electrical current flowing through the grounding pad has the potential to increase the local temperature of the skin depending on the power settings and duration of use of the electrosurgical generator. Placement of a thermal pad over the grounding pad may cause the heat generated from both devices to exceed the safe thermal threshold of the skin.
Q: What is the recommendation for thermal pad placement related to EKG leads and defibrillation pads?
A: EKG leads and defibrillation pads may be placed between the patient’s skin and the thermal pads. EKG leads and defibrillation pads should NOT be placed between the thermal pads and the OR table.
Q: Do the thermal pads contain natural rubber latex?
A: The disposable thermal pads do NOT contain natural rubber latex.
Q: Are my patients at risk of thermal injury due to heat?
A: The threshold for thermal injury due to heat is reported as either 44ºC or 45ºC in much of the early literature. The data reported by Moritz and Henriques (1947) is the most comprehensive study performed on humans and has been cited by numerous authors in later works. The extrapolation of their data using the equation developed by Xu and Qian (1995) predicts the time threshold for a 1st degree burn to be16 hours at a skin temperature of 42ºC and 6.5 hours at a skin temperature of 43ºC. The Halyard Patient Warming System has redundant operating control limits to prevent the skin temperature from exceeding 41ºC.
Q: What do you recommend for use with RF ablation equipment?
A: The HALYARD* Patient Warming System can be used in conjunction with ablation procedures. Radio-frequency (“RF”)ablation pads can generate heat over a period of time. Therefore, the HALYARD* Patient Warming System should be placed in STOP mode during the period of use of RF ablation equipment. If RF ablation will be ongoing for a significant portion of the procedure, consider placing the ablation pad away from the thermal pad. If ablation pads are not between the patient and the thermal pads, you may follow normal warming protocol. If RF ablation is to be used intermittently during a procedure, the ablation pads can be placed between the patient and the thermal pads.
Q: Are the thermal pads radiolucent (can they be used with imaging equipment)?
A: Yes, the thermal pads are radiolucent and should have no impact to imaging quality or clarity.
Q: How do I manage an epidural line under the thermal pads?
A: There is a risk of pulling out the epidural line placed under the thermal pads during thermal pad removal. Any soft, non-adherent covering can be placed over the epidural line (under the thermal pad) to keep the epidural line from sticking to the Hydrogel. As always, the thermal pads should be removed slowly and carefully, especially when there is an epidural line underneath.
Q: How long can I leave the pads on a patient?
A: Our recommendation is not longer than 24 hours.
Q: How many thermal pads should I use?
A: We recommend that you use at least one set (2 pads) of torso pads for optimal performance. Additional pads will increase performance in both the time it takes to reach target temperature and temperature stability. Additionally, depending on the MAX water temperature setpoint, additional pads will compensate for lower temperatures.
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