APIC to FDA: Put glove warning in ‘plain language’

January 12th, 2015

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 i

n 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 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. Thus, three separate petitions have been filed, citing the risks to patients and health care workers in calling for an FDA ban on powdered gloves. Going farther, Public Citizen -- a Washington, DC-based advocacy group -- has issued a petition calling for a ban on all latex gloves.

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 health care workers may benefit from more “plainly-stated guidance.”