Evidence, Experts' Campaigning May Convince FDA to Finally Ban Powdered Medical Gloves

Evidence, Experts' Campaigning May Convince FDA to Finally Ban Powdered Medical Gloves

The use of disposable gloves is integral to modern healthcare. Providing a protective barrier between patients and healthcare personnel, medical gloves discourage transmission of a wide variety of diseases. Currently, several types of examination and surgical gloves are available, falling into two main categories: traditional gloves manufactured with materials that provide optimal functionality but may cause health complications, or gloves that are made with newer materials and technologies but may have deficits in shelf life, strength and elasticity.

By Elizabeth Srejic

The use of disposable gloves is integral to modern healthcare. Providing a protective barrier between patients and healthcare personnel, medical gloves discourage transmission of a wide variety of diseases.(1) Currently, several types of examination and surgical gloves are available, falling into two main categories: traditional gloves manufactured with materials that provide optimal functionality but may cause health complications, or gloves that are made with newer materials and technologies but may have deficits in shelf life, strength and elasticity. 

Perhaps the most worrisome characteristic persisting in contemporary medical gloves is the use of powder lubricants commonly called “don-ning powders” or “dusting powders.” While the physical characteristics of these powders inhibit adhesion during manufacturing and reduce friction during donning and doffing, well-documented research indicates they may be hazardous to both patients and healthcare workers (HCWs).

Since numerous studies show that powdered gloves may be dangerous, various organizations and medical professionals have petitioned the Food and Drug Administration (FDA) to ban these devices. In response to this campaigning, which has spanned more than two decades, the FDA has repeatedly acknowledged the dangers of powdered gloves in reports and directives but done little more than alluding to banning them at some point in the future. However, in 2015, the FDA has finally begun to develop a rule to ban powdered gloves. The proposed rule will not take effect until it is published and passes through a period during which comments are accepted and reviewed. If the rule successfully survives this commentary period, it will then be published with an effective date.

Research shows that using cornstarch, the industry’s current powder of choice, on natural rubber latex (NRL) gloves, is associated with a number of adverse effects. These include latex hypersensitivity and allergies, contact and irritant dermatitis, granulomas, peritoneal adhesions, spread of infection, lowered resistance to infection, impaired wound healing, anaphylaxis, and respiratory problems such as asthma. Although the properties of NRL make for a flexible, durable medical glove, allergenic latex proteins shed continuously while the gloves are worn, accumulating on surfaces or aerosolizing (becoming airborne), which contaminates environments and tissues. And in conjunction with cornstarch, the effects of latex proteins are magnified; latex proteins bind to cornstarch particles which float and migrate readily, enhancing transmission. In fact, areas in which powdered gloves are used may contain hundreds of times more aerosolized latex protein than those where only powder-free, low-allergen latex gloves are used.(2)

“Latex can cause potentially severe allergic reactions in healthcare workers and patients, and thus should be avoided,” says Mary Cross, RN, MBA, CWCMS, senior consultant in clinical operations at Cardinal Health. “The potential risks of powder have been well documented for three decades. Powder can delay wound healing and contribute to such post-operative complications as adhesions, infections and granulomas. The potential risks of powder to clinicians are clear: It contributes to compromised skin health and irritant contact dermatitis (ICD), which causes dry, itchy and irritated skin; and powder heightens latex sensitivity, which affects an estimated 8 percent to 12 percent of healthcare workers.”

Given the potential dangers of cornstarch, a solution might appear to be identifying and using a dusting powder with more suitable properties. However, identifying a safer powder is unlikely as all powders are comprised of particles and, regardless of origin, particles elicit a biological response.(3) Another solution that has been considered is removing dusting powder from gloves before use. In fact, FDA requires that a caution label statement appear on powdered glove packaging which instructs the user to wipe off the powder with a sterile wet sponge or towel after donning. The most effective removal method is thought to be a one-minute wash with 10 mL of povidone-iodine followed by a 30-second rinse with sterile water; however, studies consistently show this and other washing procedures fail to remove all of the powder, which tends to stick to gloves in clumps; furthermore, powder removal may be time-consuming, costly and burdensome to staff.

Some alternatives to powdered NRL gloves include powder-free synthetic and isoprene substrates and chemically lubricated polymer coatings such as hydrogel, polyurethane, acrylic, silicone and nitrile. According to Cross, these kinds of gloves offer a number of benefits: “The grip, fit, feel and comfort that clinicians demand are all available in powder-free gloves. There are more choices in the powder-free portfolio than pow-dered. Even better, the performance of some powder-free surgical gloves is tailored to specific surgical needs. Powder-free is the choice of thought leaders such as the ACS, AORN, ANA, CDC and many others. In fact, AORN has changed their recommended practices to only reference powder-free gloves in the intraoperative setting. At Cardinal Health, we’ve been helping our customers move away from powdered surgical gloves for years, with the ultimate goal of removing powder from the operating room. Through our programs, and education, we’re trying to make the change easier for clinicians— with the goal of improving safety and health, without sacrificing comfort or performance.”

Although powder-free synthetic gloves offer a number of advantages over powdered NRL gloves, they do have their drawbacks. The evolving technologies, chemistry and manufacturing processes involved in producing these alternatives continue to improve but powder-free synthetics still may fall short of their powdered NRL counterparts in measures of functionality and durability. One reason for this is that synthetics must undergo vigorous post-forming steps such as chlorination, rinsing, extraction and drying, which reduce surface tackiness and strip the glove of residual powder from the manufacturing process but negatively affect certain mechanical and physical properties.(4) Likewise, currently available formulations of polymer coatings contribute some good characteristics to the finished products but fail to approximate the “unique mix of properties offered by NRL,” as the FDA describes it.(5) This characteristic suite of properties naturally present in rubber provides excellent tensile strength, puncture resistance and integrity after stretching, and is indeed proving difficult to duplicate in the laboratory.

Another drawback of synthetics is that they are more expensive than NRL gloves, thanks to the inevitable price tag associated with the re-search and development and specialized manufacturing processes required to produce these products. In contrast, the overwhelming majority of NRL gloves in the United States are imported (chiefly from Malaysia) where they are manufactured using cost-effective, well-established technologies. However, proponents of powder-free synthetic gloves argue that the higher cost of powder-free synthetics is eventually offset by fewer employee sick days, lower rates of patient health complications and higher patient satisfaction.

“From the standpoint of hospitals, changing to powder-free is a strategic decision to help a facility improve patient outcomes and lower total cost,” says Cross. “The decision to move to powder-free includes analyzing the broader impact of their glove selection – thinking of it as a part of their total cost and risk management strategy. In addition, the more reimbursements are tied to patient outcomes and satisfaction, the more hospitals need to focus on safety and quality. According to our research, switching to powder-free surgical gloves could cost as little as under a dollar more per clinician per surgery. Compare that to the potential risk of powder, which can delay wound healing, create post-operative com-plications enhance the growth of bacteria and cause longer hospital stays."

Realizing the well-documented dangers of cornstarch-powdered gloves, many hospitals and clinics in the United States are following the lead of countries such as Germany and the United Kingdom by banning the use of these devices, with encouraging results.(6) In spite of this, powdered gloves are still standard issue in some institutions in the U.S., in spite of almost two decades of impassioned campaigning by organizations and scientists for FDA to ban powdered gloves. Over this period, FDA has apparently repeatedly admitted to the potential dangers of powdered gloves but has largely avoided any decisive action. “The issue is education: while the potential risks of powdered gloves are well documented, they’re not often well communicated,” says Cross. “In fact, our research indicates that 9 in 10 HCWs would switch right now, if the risks of powder were more well-known in their facilities.”

The history of the medical glove began in 1758 when Julius Walbaum became the first surgeon to use gloves, which were made from sheep cecum and covered only the fingers.(9) Later, Joseph Bloodgood provided rubber gloves to his surgical team in 1893, and in the following year William Stewart, a surgeon at Johns Hopkins Hospital, introduced the first sterile reusable latex surgical glove.(10)

During the 20th century, manufacturers tackled the problem of glove friction during donning and doffing by adding dusting powders.(11) The first powder used, talc mixed with Lycopodium spore powder, was discontinued when suspicion arose that it might be poisonous. Gloves were then powdered with talc alone until talc was linked to surgical complications and impaired healing. Following its progenitors’ demise, cornstarch powder, valued for its purported absorbability and non-toxicity, became the next powder of choice.

Also during the 20th century, improved technology yielded thinner, stronger and more flexible gloves; in addition, disposable gloves became the industry standard and latex gloves were eventually associated with allergies.(12) Also around this time, research began to propose that dusting powder might be harmful and in 1971 the FDA required glove manufacturers to produce glove packaging with warning labels which advised users to remove powder after donning by wiping with wet towels or gauze. (13)

In the 1990s, manufacturers began to develop the technologies necessary to produce powder-free synthetic gloves.(14) In addition, FDA finally seemed to break its silence by publishing its first and only report on medical glove powder in 1997.(15) In the report, FDA admitted that research showed powdered gloves may be dangerous but concluded that banning them could dangerously disrupt the market: “Market availability must be factored into any policy regarding medical glove powder. The large majority of medical gloves used in the U.S. are imported [powdered NRL gloves], [and only] a small number of [domestic] manufacturers are using a process other than chlorination to produce powder-free gloves. A rapid increase in the demand for non-powdered gloves could result in products with poor barrier integrity and/or unacceptable shelf life entering the U.S. market. In addition to concerns about glove quality, most alternatives to glove powder currently would entail subsequently in-creased costs to the U.S. healthcare system.” The report then stated that FDA’s contribution to the powdered glove problem would be exer-cised in the form of consumer education including product labelling disclosing latex protein content and proposed that the United States rely on natural market forces to lower water-soluble protein and particulate levels in medical gloves. The report also considered possibly banning pow-dered medical gloves “at some predetermined time in the future.” It took nearly two decades for FDA to revisit this idea.

FDA’s 1997 report was immediately followed by the first citizen's petition to ban the use of powder in 1998.(16) The petition asked FDA to “ban the use of cornstarch powder on NRL and synthetic examination and surgical gloves because of the serious and widespread dangers that these powdered gloves present to medical personnel and patients.”

Another development in 1998 was a gradual and purposeful reduction in latex protein levels in NRL gloves.(17) The appearance of these low-allergen latex gloves provided another alternative to higher-protein gloves made with unaltered NRL. Also around this time, the availability of powder-free, synthetic, and other alternatives to powdered NRL gloves increased.(18)

In 1999, in response to the first citizen’s petition, FDA countered that banning all powdered medical gloves would not address the problem of exposure to NRL allergens in gloves with high levels of latex proteins and again expressed its concern that such a ban might compromise market availability of high-quality medical gloves and increase annual healthcare costs.(19) Puzzlingly, FDA also stated that due to limitations imposed by Congress it lacked the regulatory authority to impose such a ban(20) and then retreated, saying relatively nothing on the topic of powdered gloves for the next 10 years.

In 2008, the group Public Citizen sent a second petition to the FDA again requesting that the use of cornstarch powder on medical gloves be banned.(21) This second petition, comprised largely of the same arguments as its predecessor, also contended that FDA did in fact have the legal capability to impose a ban according to the Food and Drug Cosmetic Act, in spite of FDA’s prior plea that it lacked the authority to address the petitioners’ concerns.

Around the same time, a comprehensive review article on the second petition was published to discuss the contents of the 2008 petition in detail.(22) The authors, led by the late Richard Edlich, MD, a long-time activist for the banning of powdered gloves, wrote that the review was titled “Maltese cross birefringence” because individual cornstarch granules in contaminated tissue under polarized light microscopic observation resembled the Maltese cross, the symbol of an order of Christian warriors known as the Knights Hospitaller, or the Knights of Malta, to com-memorate the thousands of individuals seriously injured or dead as a result of powder-coated gloves.

In the review, the authors wrote: “We hereby petition the FDA to ban the use of cornstarch powder on NRL and synthetic surgical and ex-amination gloves because of the serious and widespread dangers that these powdered gloves present to medical personnel and patients. … [We] believe the scientific evidence supporting the need to ban the use of glove powder for the protection of all Americans is overwhelming and indisputable. We call upon the FDA to take immediate action to exercise its authority and end the menaces of cornstarch.”

Three years later, in 2011, Public Citizen sent its third petition to the FDA requesting an immediate ban of cornstarch powder in examination and surgical gloves; this time, the petitioners asked FDA to also ban NRL in conjunction with cornstarch “because of the widespread dangers these gloves cause to both medical personnel and to patients and the availability of a safer alternative.”(23) The petition also took FDA to task for its apparent inaction on the issue: "The FDA's prolonged failure to take action eliminating the dangers posed by powdered surgeon's and pa-tient examination gloves demonstrates an astonishingly reckless and inexcusable disregard for the health and safety of patients and healthcare workers. The available scientific evidence and market circumstances today provide overwhelming and irrefutable justification for granting our petition."

After the petition was submitted, FDA did not initiate the ban but published draft guidance requiring that powdered glove packaging be la-beled with a stronger, more detailed warning statement: "Powdered gloves may lead to foreign body reactions and the formation of granulo-mas in patients. In addition, the powder used on gloves may contribute to the development of irritant dermatitis and Type IV allergy, and on latex gloves may serve as a carrier for airborne natural latex leading to sensitization of glove users."(24)

In 2015, FDA finally published a proposed rule to ban powdered gloves. The proposal, entitled “Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves,” states: “FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present a substantial risk of illness that cannot be corrected by a change in labeling. These gloves are powdered natural rubber latex surgeon's gloves, powdered synthetic latex surgeon's gloves, powdered natural rubber latex patient examination gloves, powdered synthetic patient examination gloves, and absorbable powder for lubri-cating a surgeon's glove. Consequently, FDA is proposing to ban these devices.”(25) However, the document offers no timeframe and no apparent action has been taken since its publication.

“The proposed rule is on the Unified Agenda and is under development at the FDA,” says Angela Stark, public affairs specialist in the Office of Media Affairs for the Office of External Affairs at the FDA. “Once the proposed rule does publish, a 90-day comment period will follow. After the comment period has closed, all comments will be reviewed and final regulatory action will be determined. The proposed rule will include a proposed effective date for a ban. Any comments on the proposed effective date will also be considered in drafting the final rule. Because the proposed rule has not yet been published, that’s all we can say at this time.”

Elizabeth Srejic is a freelance writer.

References:

1. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
2. Edlich RF, Long WB 3rd, Gubler KD, Rodeheaver GT, Thacker JG, Borel L, Chase ME, Cross CL, Fisher AL, Lin KY, Cox MJ, Zura RB. Citizen's Petition to Food and Drug Administration to ban cornstarch powder on medical gloves: Maltese cross birefringence. Am J Emerg Med. 2009 Feb;27(2):227-35. doi: 10.1016/j.ajem.2008.10.009.
3. "Medical Glove Powder Report." September 1, 1997. Accessed October 15, 2015.
4. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
5. "Medical Glove Powder Report." September 1, 1997. Accessed October 15, 2015.
6. Ibid.
7. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
8. Edlich RF, Long WB 3rd, Gubler KD, Rodeheaver GT, Thacker JG, Borel L, Chase ME, Cross CL, Fisher AL, Lin KY, Cox MJ, Zura RB. Citizen's Petition to Food and Drug Administration to ban cornstarch powder on medical gloves: Maltese cross birefringence. Am J Emerg Med. 2009 Feb;27(2):227-35. doi: 10.1016/j.ajem.2008.10.009.
9. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
10. Ibid.
11. Ibid.
12. Ibid.
13. "Medical Glove Powder Report." September 1, 1997. Accessed October 15, 2015.
14. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
15. "Medical Glove Powder Report." September 1, 1997. Accessed October 15, 2015.
16. Public Citizen. April 25, 2011. Accessed October 15, 2015. http://www.citizen.org/documents/1945.pdf.
17. "Medical Glove Powder Report." September 1, 1997. Accessed October 15, 2015.
18. Ibid.
19. Public Citizen. April 25, 2011. Accessed October 15, 2015. http://www.citizen.org/documents/1945.pdf.
20. Edlich RF, Long WB 3rd, Gubler KD, Rodeheaver GT, Thacker JG, Borel L, Dahlstrom JJ, Clark JJ, Kasinger E, Lin KY, Cox MJ, Zura RD. A wakeup call to the Food and Drug Administration to ban cornstarch on medical gloves. J Emerg Med. 2012 Mar;42(3):314-6. doi: 10.1016/j.jemermed.2010.05.081. Epub 2010 Jul 24.
21. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
22. Edlich RF, Long WB 3rd, Gubler KD, Rodeheaver GT, Thacker JG, Borel L, Chase ME, Cross CL, Fisher AL, Lin KY, Cox MJ, Zura RB. Citizen's Petition to Food and Drug Administration to ban cornstarch powder on medical gloves: Maltese cross birefringence. Am J Emerg Med. 2009 Feb;27(2):227-35. doi: 10.1016/j.ajem.2008.10.009.
23. Public Citizen. April 25, 2011. Accessed October 15, 2015. http://www.citizen.org/documents/1945.pdf.
24. Deroian, Elizabeth, and Rose Moss. "Powdered Surgical Gloves: Is It Time for a Change?" March 1, 2015. Accessed October 15, 2015.
25. "Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon's and Patient Examination Gloves." Reginfo.gov. Office of Information and Regulatory Affairs.  Spring 2015. Accessed October 15, 2015.

Roundtable: Manufacturers Address Powdered Gloves 

ICT invited glove manufacturers to provide their perspectives on the powdered glove issue. Participating in this roundtable are:
- Lorraine Roley, clinical research consulting specialist for Halyard Health, and Laurie Clark, BS, MT (ASCP), senior manager, medical sciences and clinical education, Halyard Health
- Milt Hinsch, technical services and technology director of surgical products for Molnlycke Health Care
- Paul Bottcher, division president, surgical glove and orthopedics, Medline Industries
- Dr. Esah Yip, director of the Malaysian Rubber Export Promotion Council

ICT: Do you agree with the FDA's (as well as other organizations' and medical associations') concerns about powdered gloves? Why or why not?

Halyard Health: Yes, Halyard Health, formerly Kimberly-Clark Health Care, completely agrees with the FDA’s concerns about powdered gloves; this is the reason Halyard only offers powder-free exam gloves in its portfolio. Powder-free gloves are important due to the risks and dangers powdered gloves pose to both patients and healthcare workers.

Molnlycke Health Care: Absolutely. Mölnlycke has always been a staunch supporter of the FDA’s and other organizations’ concerns about powdered medical gloves. For more than 30 years, Biogel® gloves have been powder-free, and it has been our passion to educate customers about the dangers of powder and replace powdered medical gloves with powder-free medical gloves. So, why have we been so passionate about eliminating powdered medical gloves? Medical glove powder has been called “Medicine’s Deadly Dust,” with only one benefit – to facilitate glove donning. The harmful effects of medical glove powder to patients and healthcare workers have been widely known for decades and were called to the attention of the FDA in the 1990s. About 20 years ago AAAAI, ACAAI and NIOSH recommended using powder-free medical gloves due to the known harmful effects of glove powder. In 1997, the FDA published a Medical Glove Powder Report that outlined the ‘Adverse Health Effects’ of cornstarch on medical gloves.(2) Despite the evidence of the harmful effects of glove powder outlined in the report, the FDA rejected the 1998 Sydney Wolfe, MD, Citizen's Petition to the FDA to ban cornstarch on latex gloves petition.(6) As reasons, the FDA cited the following: powder-free gloves were more expensive and would increase hospital costs; the quality of powder-free gloves were often inferior to current powdered gloves and might increase risks; latex allergies were not addressed by the petition.(7) Despite that, Mölnlycke Health Care continued to support the elimination of powdered surgical gloves and, unlike other major U.S. surgical glove companies, manufactured and sold ONLY powder-free surgical gloves. The powder-free surgical glove market has changed dramatically during the past 17 years in the following ways: the overall quality of powder-free gloves by most glove manufacturers has improved; prices are lower due to increased sales volumes and price erosion; and supply of powder-free synthetic surgical gloves became readily available.(8) So, the three original FDA objections to the 1998 petition have been overcome by changes in the glove market. In fact, as of June 2015, only 16 percent of the surgical gloves sold in the U.S. are powdered and that segment of the market is declining at a rate of -6 percent while powder-free synthetic gloves are growing at a rate of 12 percent.(9) Customers have over the years begun to recognize the dangers and have begun converting to powder-free and latex-free surgical gloves on their own. In 2008 and 2009, new petitions were submitted to the FDA. Government agencies have since agreed with the language in the FDA’s proposed powdered glove ban.(10) Their next step is to publish the proposed ban in the Federal Register to obtain public comment and, then, hopefully, finally release the medical glove powder ban.
References:
 1. Medicine’s Deadly Dust: A Surgeon’s Wake-Up Call to Society. Richard E. Edlich, MD, PhD; 1997.
 2.  Food and Drug Administration Center for Devices and Radiological Health. Medical Glove Report. September 1997.
 3. American Academy of Allergy, Asthma and Immunology. Latex Allergy. 1999.
 4. Sussman G and Gold M. Guidelines for the Management of Latex Allergies and Safe Latex Use in Health Care Facilities. March 1996.
5. Department of Health and Human Services. Latex Allergy: A Prevention Guide. Publication No. 97-135; Third Printing August 1998.
6. Petition to Food and Drug Administration to ban cornstarch powder on latex (HRG Publication #1432) January 1998.
7. Baker C. A System in Need of Repair – Medical Device Regulation: The Example of Latex Medical Gloves. Synthesis Journal of Science, Technology, Ethics and Policy. 2013.
8. Edlich R. Letter to the Editor: The FDA agrees to Ban Powdered Medical and Surgical Gloves. J Emerg Med. Vol. 46, No. 3. Pp105-106, 2014.
9. GHX 2Q2015.
10. Proposal to Ban Powdered Natural Latex and Powdered Synthetic Gloves. http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201504&RIN=0910-AH02.

Malaysian Rubber Export Promotion Council: First of all, let me point out that the request for a consideration for a FDA ban on pow-dered gloves is not a new one. As far back as 2008, such a call was initiated by a citizen petition by Dr. Richard Edlich from the University of Virginia. As a response in 2011, the FDA proposed the use of a warning labeling about the presence of powder, but not a ban. This however, did not materialize. It is gathered that the FDA is once more under much pressure from Dr. Edlich to push again for a ban on powdered gloves; hence, the FDA’s move to publish a Proposed Rule on the ban. I believe that the consideration by FDA to publish a Proposed Rule does not neces-sarily mean that FDA has agreed to the ban. There were times that the Proposed Rule published never reached its Final Rule stage, if/when FDA finds that the action proposed is not justified.

ICT: What are the risks and dangers of powdered gloves?

Halyard Health: Powdered gloves increase the risk of post-surgical complications in patients. These complications can include adhesions, granulomas, aggravated inflammation, cytotoxic complications, clots, delayed healing and fever.(1) In addition, glove powder found in patient exam gloves may support microbial growth; being volatile, powder may also provide a vehicle for pathogenic microorganisms.(2-3) In addition to patient dangers, occupational risks associated with powdered medical gloves include asthma caused by inhaling glove powder and an increased risk of developing allergic reactions such as latex sensitivity.(4)
References:
1. Truscott W. Powdered Gloves Increase Surgical Complication Risk. AHC Media Continuing Medical Education Publishing RSS. AHC Media. May 1, 2004.
2. Comments by Sidney M. Wolfe, director, Public Citizen’s Health Research Group. FDA Docket No. 98N-0310 Proposed Regulation (7/30/99) on Powdered Latex Gloves. Feb. 1, 2000.
3. Hazards Associated with Glove Powder. Ansell Healthcare. Self-Study Guide. Ansell Healthcare. Self-Study Guide (2014):13.
4. Sjosten ACE, Ellics H, Edelstam GAB. Post-operative Consequences of Glove Powder Used Pre-Operatively in the Vagina in the Rabbit Model. Human Reproduction (2000):15(7):1573-1577.

Molnlycke Health Care: Exposure to powder from surgical gloves can cause unacceptable reactions to patients and staff. It has been well documented in literature that glove cornstarch powder induces adhesion formation while potentiating wound infections.(1) Latex proteins also bind with glove powder and become aerosolized when gloves are removed from the package, donned or removed from the hands. The aeroso-lized latex proteins can remain in the air, on clothing as well as surgical equipment for many hours after exposure to powdered gloves.(2) In 2008 Richard Edlich, MD, submitted a Citizen’s Petition to the FDA to ban powder on latex gloves,(3) followed in 2009 by another Citizen Petition by Wava Truscott, PhD, to ban cornstarch powder on latex gloves.(4) They outlined documented health problems related to medical glove powder:
- for patients: Increased risk of infection; Wound healing complications; Granulomas; adhesions; Peritonitis; Female reproductive complications; hernia and testicular complications; cardiovascular complications; CNS complications; ophthalmic complications; orthopedic complications; endotoxin reactions; organ procurement complications; and latex-allergic responses                               
- for healthcare personnel: Increased incidence of latex allergies; Type I – Immediate Systemic Allergic Reaction; Type IV – Delayed Local Skin Reaction; and occupational asthma.
References:
1. Edlich R, et. Al. Petition to Food and Drug Administration to Ban Powder on Latex Gloves. Sept. 1, 2008.
2. Duffield L. Latex Allergy: Everyone’s Concern. J Michigan Dental Association. June 1998.
3. Edlich R, et. Al. Petition to FDA to Ban Powder on Latex Gloves. Sept. 1, 2008.
4. Truscott W. Citizen's petition to FDA to ban cornstarch powder on medical gloves. Feb. 24, 2009. Available at http://1.usa.gov/jibyME

Malaysian Rubber Export Promotion Council: Two possible adverse reactions could be brought about by the gloves with high protein and high powder contents:
- Latex protein allergy risk: The contact with powder with high contact of allergenic proteins from high protein, high powdered gloves is known to cause sensitization and allergic reaction to sensitive individuals. Such gloves were commonly available in the 1980s and 1990s. Howev-er, this problem has been addressed by the improvement in glove manufacturing resulting production and use of gloves with minimum level of residual protein and reduced powder, and powder-free gloves. The use of these low–protein gloves particularly the powder-free variety, has been shown by many independent hospital studies reported in the U.S., Europe and Canada, to have significantly reduced sensitization and allergic reactions in work places.(1)
- Foreign micro-body reactions: The presence of foreign micro-bodies associated with surgeries is known to contribute to delay in wound healing, granulomas and adhesions. These foreign micro-bodies include particulate debris from gauze, sutures and glove powder that might be present. It may be mentioned that peritoneal adhesions in particular, is a world-wide problem related to post-surgical operations. According to a review by Kamel,(2) the presence of foreign micro-bodies during surgeries is only one of the many causes for the occurrence of peritoneal adhe-sions. Furthermore, in their study of the types of micro-bodies associated to human adhesions, Duron, et al.(3) reported that majority of the micro-bodies found were those from gauze lint and sutures (more than 80 percent). In light of these findings, I believe that eliminating the presence of glove powder during surgery may help to reduce the risk of adhesion formation to a limited extent, but it will not completely solve the problem of adhesion problem encountered. Therefore, banning the use of powdered NRL gloves is not warranted. This is notwithstanding the fact that today, the gloves available are no longer heavily powdered. The question is, has the FDA received many serious cases recently of adverse reac-tions caused by glove powder associated with improved low-protein lightly powdered or powder-free gloves today?
References:
1. www.latexgloves.info
2. Kamel RM. Prevention of postoperative peritoneal adhesions: Review. Eur J Obstetrics & Gynecology and Reproductive Biology. 150, 111-118. 2010.
3. Duron JJ, Eilian N and Oliver O. Post-operative Peritoneal Adhesions and Foreign Bodies. Eur. J. Surgery Suppl. 579 15-16. 1997.
   

ICT: What are the alternatives and why are they better for patients and healthcare personnel?

Halyard Health: Alternatives to powdered medical gloves include powder-free gloves made of nitrile, neoprene, latex, polyisoprene and vinyl. While vinyl offers a lower level of protection and natural latex can cause severe allergic reactions, these other powder-free glove choices provide excellent barrier protection, great strength and durability, and puncture and chemical resistance. These attributes, along with the reduced risk of complications and allergic sensitivities, make powder-free gloves a better and safer choice for patients and healthcare workers alike.

Medline Industries: Powder is in the glove to help aid in the donning of gloves. Medline offers 20 different powder-free glove options that have a synthetic polymer coating on the inside of the glove to aid in donning and double gloving. This eliminates the need for powder and the end user has an alternative without sacrificing performance.

Molnlycke Health Care: Germany is an example of a country that has successfully transitioned from powdered to powder-free gloves. In 1992, Germany passed new medical glove standards that precipitated the decline of powdered natural rubber latex gloves. At that time, only 1 percent of purchased natural rubber latex gloves in Germany were powder-free. By 2002, the use of powder-free surgical gloves in Germany had risen to 88 percent.(1)
German patients and healthcare staff have benefitted from the dramatic decline in the use of powdered gloves. With a combination of staff education about the risks of glove powder and natural rubber latex allergies and reduced latex protein levels in gloves, they saw a decline in the number of suspected and confirmed cases of occupational asthma and contact urticaria caused by natural rubber latex. Dr. Henning Allmers, a German allergist/immunologist, reported an 83.6 percent decrease in new skin allergy cases and an 87.8 percent reduction of reported new cases of occupational asthma in Germany by 2002.20 The German experience best documents the benefits of powder-free gloves to patients and to healthcare workers when government standards are in place. In addition, allergists and immunologists in the U.S. have seen proportion-ate declines of new glove-related allergy patients as the use of powder-free medical gloves has increased in this country.
Powder-free gloves provide multiple benefits because the powder elimination process removes the step of adding cornstarch powder used for glove donning.  The manufacturing process also removes the mold-release calcium carbonate powder and reduces extractable chemicals and extractable latex proteins through a number of additional rinsing steps. The resulting powder-free gloves are not only cornstarch powder-free, but also calcium-carbonate powder-free and contain lower levels of common glove allergens and irritants. Not all manufacturing processes are exactly the same and the final latex protein levels may vary.
Reference: 1. Allmers H, et al. Current State of the Art in Natural Rubber Latex Allergy Prevention. Hosp Engineering & Facilities Manage-ment. 2005.

Malaysian Rubber Export Promotion Council: To avoid possible powder problem, the healthcare personnel should be educated on the afore-mentioned information. While it is preferable to use powder-free gloves to minimize the occurrence of the micro-body reactions, I do not think a total ban of (lightly) powdered gloves is warranted. The powdered variety does facilitate relatively easier donning, and is generally less expensive. I believe users should be given a choice for selecting the type of gloves best suited for the task they do, especially in non-surgical pro-cedures.  

ICT: What should be done about educating healthcare workers?

Halyard Health: Continuing education about the risks and dangers of powdered medical gloves should be provided to healthcare workers. Educational options include onsite presentations, in-servicing, self-study programs, and continuing education courses like those offered by the Halyard Knowledge Network.

Medline Industries: Medline conducts “be free” days where we encourage the staff and surgeons to wear powder-free, latex-free gloves as an alternative. The goal is to educate healthcare workers on the potential issues of powder, and show them alternative options that are available.

Molnlycke Health Care: Although there are many hospitals today that still provide powdered surgical gloves, education is the key for prac-tice change. Providing continued education about SSI prevention as well as latex-associated allergies can go a long way to ensure that healthcare workers truly understand the risks associated with cornstarch glove powder. Glove powder increases the risk for post-operative wound infections, latex allergy sensitization potentially eliciting delayed hypersensitivity reactions and post-operative surgical site infections. Glove powder increases healthcare workers’ risk for developing latex sensitivities and occupational asthma. It has also been shown that washing powdered gloves is ineffective in removing powder, a step that is stated in the powdered glove directions for use as required by the FDA.
Clinicians should seek information in multiple ways to support the education of hospital staff:
• Understand current powdered latex guidelines for patients and surgical procedures
• Review alternative powder-free glove products and offer staff the opportunity to experience other glove choices
• Ask glove manufacturers to supply product technical information
• Engage the staff and surgeons through in-service or continuing education programs to share the latest clinical information
Knowledge is power, and with that knowledge comes ways to ensure better outcomes and the opportunity to make an impact on the fu-ture. 

ICT: What is your best advice for evaluating and purchasing powder-free gloves?

Halyard Health: When selecting medical gloves, it is important to choose gloves that fit the task at hand and have the appropriate physical characteristics.(1) Two key physical characteristics that should be considered are barrier integrity and desired attributes.(2) Data to evaluate with regard to barrier integrity include base material, tear resistance, durability and puncture resistance, and permeability and leakage rates. Some desired attributes to assess include ease of donning, fit comfort, dexterity, grip, tactile sensitivity, and limited risk of allergic reaction.
References:
1. Stoessel K and Smith S. The Clinical Issue: Does the Glove Fit? Critical Considerations for the Selection of Medical Gloves. Halyard Knowledge Network. Issue 4, 2015.
2. Ibid.
 
Medline Industries: If a facility is thinking about eliminating powder gloves, a committee should be established with staff and surgeons who champion the initiative to remove powder. From there, the manufacturer can work with the facility to educate and support trials of powder-free alternatives. This makes the process much easier.

Molnlycke Health Care: Switching from powdered to powder-free surgical gloves isn’t easy. A surgical glove conversion can be a smooth transition if there is a true partnership between the facility and the powder-free glove manufacturer. First, it is important to have facility com-mitment to the change. As mentioned earlier, providing education to the staff affords a stronger compliance to the practice change. Second, it is important to have full vendor support when evaluating and converting away from powdered gloves. For example, Mölnlycke Health Care provides pre-conversion, conversion and post conversion support which eliminates many of the challenges associated with a glove evaluation and conversion. We provide glove in-services, glove sizing days, education posters, etc. Clinical and technical support personnel are onsite during the evaluation and/or conversion and can continue to educate about the many reasons to eliminate powder. Finally, once a decision is made to evaluate powder-free surgical gloves, it is important to partner with a company such as Mölnlycke who will provide the resources to support a successful evaluation and make the conversion process much easier for everyone in the OR. Cornstarch powder is not benign. Wearing pow-dered surgical gloves promotes an unnecessary hazard for patients, staff and the environment and should be eliminated from hospital facilities.

Malaysian Rubber Export Promotion Council: It is important to note that the main function of medical gloves is to provide barrier protec-tion against infectious microorganisms. So the most critical feature to consider is the barrier capability of the gloves to considered, be that pow-dered or powder-free. Medical gloves of different materials may meet all their relevant standards as set out by the various Standards organiza-tions such as the ASTM, EN and the ISO, they may very well have different barrier capabilities.    

 

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