APIC joins calls for powdered glove ban

FDA label alternative widely blasted

Though conceding that powdered latex gloves pose little risk of causing patient infections, the nation's largest infection prevention group is joining the chorus of those urging the Food and Drug Administration to ban the gloves in favor of safer alternatives.

In comments submitted to the FDA, the Association for Professionals in Infection Control and Epidemiology (APIC) "finds very limited scientific evidence that powder on medical gloves, specifically surgeon's gloves, may act to promote infection. However, APIC cannot cite any instance in which powdered gloves offer a unique benefit over powder-free gloves...Indeed, the elimination of powdered gloves will significantly lower the risk of allergic reactions."

By making powder-free gloves the standard, the FDA will reduce the incidence of allergic reactions from airborne protein particles carried to the medical staff using them and to the patient. Further, because the protein level in powder-free gloves is much lower, the gloves are less subject to hydration and, hence, retain their barrier qualities, APIC noted.

The generally cited merits of powdered gloves include that they are easier to don, absorb perspiration from surgeons' hands, and are less expensive. However, new cases of latex allergy among healthcare workers have dropped dramatically with the use of low-protein and powder-free gloves, as well as the increased popularity of latex alternatives. Thus, three separate petitions have been filed, citing the risks to patients and healthcare workers in calling for an FDA ban on powdered gloves. Going further, Public Citizen — a Washington, DC-based advocacy group — has issued a petition calling for a ban on all latex gloves.1

Some of the petitions raise the issue of patient safety and powdered gloves, primarily allergic reactions but also a possible risk of wound infections. Balking at an outright ban, the FDA has instead proposed a warning label that would read: "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 on latex gloves may serve as a carrier for airborne natural latex leading to sensitization of glove users."

The FDA's proposed warning has been widely criticized by the petitioners as an insufficient intervention. For its part, APIC advised the FDA to put the warning in "plain language," noting that healthcare workers may benefit from more "plainly-stated guidance."

Many have made the move

Many hospitals have successfully switched to alternatives to protect patients and healthcare 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 warning label is a 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."

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."

References

  1. Carome MA and Wolfe SM. Petition to FDA to ban powdered and latex surgeon's and patient examination gloves. April 26, 2011.
  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.