FDA balks at powdered-glove ban, warning label option blasted
'An excuse for manufacturers to continue to make money'
Latex gloves are back on the public agenda. The U.S. Food and Drug Administration has issued a proposed warning label for powdered gloves and is considering a ban on the use of powder in latex gloves and alternatives, even as hospitals greatly reduce their use of powdered gloves.
New cases of latex allergy among health care workers have dropped dramatically with the use of low-protein and powder-free gloves, as well as the increased popularity of latex alternatives. But three separate petitions cite risks to patients and health care workers and ask the FDA to ban powdered gloves. In fact, Public Citizen, a Washington, DC-based advocacy group, has asked the FDA to ban all latex gloves.1
Hospitals have successfully switched to alternates to protect patients and health care workers with latex allergies, says Michael A. Carome, MD, deputy director of the Health Research Group at Public Citizen. "When we see additional dangers from latex gloves, it's hard for us to be silent on that given our role as an advocate for public health," he says.
Cornstarch powder on surgical gloves in particular poses a risk to patients, Richard Edlich, MD, PhD, distinguished professor emeritus of plastic surgery, biomedical engineering and emergency medicine at the University of Virginia Health Systems in Charlottesville, asserted in his 2008 petition to the FDA requesting a ban. It was also signed by 11 other health professionals.2
Powder from the gloves can cause granuloma and adhesion formation and leave patients with abdominal pain and inflammation, according to studies cited by the petition. The powder also increases the risk of wound infection.
The FDA's proposed warning addresses those risks, as well as the continuing risk of latex allergy: "Warning: Powdered gloves may lead to foreign body reactions and the formation of granulomas in patients. In addition, the powder used on gloves may contribute to the development of irritant dermatitis and Type IV allergy, and latex gloves may serve as a carrier for airborne natural latex leading to sensitization of glove users."
"The warning label is waste of time," Edlich responded. "If you put all the dangers outlined [in the petition], it would take an 8 to 10 page warning on the label."
Concurring is Wava Truscott, PhD, director of Scientific Affairs and Clinical Education at Kimberly-Clark Health Care in Roswell, GA and author of a second petition submitted in 2009. She cites similar concerns and discusses cases of surgical complications triggered by cornstarch powder.3 Kimberly-Clark manufactures powder-free nitrile gloves.
"To me it's a non-action. It's not going to help at all," she says of the FDA proposed recommendation. "Surgeons don't see those labels at all."
Powder triggers occ asthma
Concerns about cornstarch powder on surgical gloves date as far back as the 1950s, but occupational health issues arose in the 1990s, when latex glove use became commonplace in the wake of HIV and the Bloodborne Pathogen Standard of the U.S. Occupational Safety and Health Administration. Health care workers became sensitized to the latex proteins, and cases of latex allergy soared. The powder became aerosolized and latex became a leading cause of occupational asthma among health care workers.
"In the early '90s, we had some very severe reactions. There was a point in time when you could find evidence of sensitization to latex in up to 10% of our worker population," says George L. Delclos, MD, MPH, PhD, professor in the Division of Epidemiology, Human Genetics and Environmental Sciences at the University of Texas School of Public Health in Houston, who was a leading researcher in latex allergy.
In 1995, Edlich petitioned the FDA to ban powdered latex gloves, and in 1997, the FDA responded by requiring a label on latex gloves, stating they "may cause an allergic reaction." Public Citizen, an advocacy group, petitioned the FDA again in 1998, arguing for a ban. "[A]nything short of a ban such as merely this label is a dangerous insult to the millions of patients and tens of thousands of health care workers whose lives and health are jeopardized by the continued use in health care settings of these powdered gloves," the petition stated.
In the new petition, Public Citizen calls the FDA's proposed label "grossly inadequate" and says it would be "laughable if the problem were not so serious for patients and healthcare providers alike."
Still considering a ban?
Under the current FDA proposal, even a warning label would be optional. The FDA would simply recommend that manufacturers caution consumers about the patient safety issues.
But in a separate Federal Register notice issued on Feb. 7, the FDA acknowledged the problems with powdered gloves.4 "FDA has considered this information and believes the petitions have raised legitimate concerns about the use of powdered gloves. However, FDA's regulatory approach to powdered gloves must consider the risks of these gloves in light of any benefits," the agency said.
The FDA specifically solicited comments about the benefits of powdered gloves. But the overwhelming number of comments submitted before the April 25 deadline were appeals to ban powdered gloves, many of them from nurses or physicians whose careers were impacted by latex allergy.
Truscott also notes the risk to the surgical patient, who has no choice between powdered and powder-free gloves. The powder is particularly problematic because it is designed not to dissolve so it will survive the sterilization process, she says.
So what are the benefits of powdered gloves? They are easier to don, absorb perspiration from surgeons' hands, and are less expensive to produce, she says.
Regardless, most hospitals have already abandoned powdered gloves. A report by Global Industry Analysts of San Jose on the disposable glove market in 2010 found that only 7% of gloves in the U.S. market were powdered. Some 92% of exam gloves were powder-free and 94% of surgical gloves were powder-free, despite the increased cost of powder-free gloves, the report says. Global Industry Analysts predicts further reduction in the use of powdered gloves by 2015.5
"The unequivocal role played by powdered gloves in eliciting post-surgical complications is beginning to lead to a major product shift from traditional powdered latex gloves to powder-free synthetic gloves," the report says.
A personal appeal
For Edlich, the effort to ban powdered gloves is a personal one. When he was a child, his mother's health declined due to recurrent benign abdominal tumors and acute intestinal obstructions, which he says were linked to powder on surgical gloves. Her medical problems influenced his decision to become a physician and led him to research the impact of cornstarch glove powder.
While Edlich was at the University of Virginia, the health system switched to powder-free gloves. Many other hospitals and health systems have taken similar action, he notes. Powdered gloves are banned in the United Kingdom and Germany.
"Warning labels are just an excuse for manufacturers to continue to make powdered gloves to make money," he says. "There's not one article on PubMed [the National Library of Medicine's database of scientific literature] that says it's safe."
The switch to powder-free gloves has greatly reduced the occupational risk to health care workers. "The frequency of allergic reactions to latex in health care personnel has gone down dramatically," says Delclos. "We still ask new hires a series of questions regarding latex allergy. I haven't seen [a case] in a long time."
References
1. Carome MA and Wolfe SM. Petition to FDA to ban powdered and latex surgeon's and patient examination gloves. April 26, 2011. Available at http://bit.ly/lYK37s
2. Edlich RF, Long WB, Gubler KD, et al. Citizen's petition to Food and Drug Administration to ban cornstarch powder on medical gloves. September 24, 2008. Available at http://1.usa.gov/j2eIqG
3. Truscott W. Citizen's petition to Food and Drug Administration to ban cornstarch powder on medical gloves. February 24, 2009. Available at http://1.usa.gov/jibyME
4. Food and Drug Administration. Information related to risks and benefits of powdered gloves; Request for comments. Federal Register February 7, 2011. Available at http://bit.ly/kopAPH
5. Global Industry Analysts. Disposable Medical Gloves. January 2011, San Jose, CA.
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