Image: The FDA has banned all use of powdered gloves (Photo courtesy of 123rf.com).
The U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) have banned the use of powdered gloves by medical professionals, as they present an unreasonable and substantial risk of illness or injury.
The FDA’s final rule bans powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove. Because FDA classification regulations do not distinguish between powdered and non-powdered versions, the agency will amend the descriptions of these gloves to specify that the regulations for patient examination and surgeon's gloves will apply only to non-powdered gloves, while the powdered version of each type of glove will be added to the listing of banned devices in the regulations.
The FDA first identified powdered gloves as a potential risk to patients in 1997, determining at the time that airborne glove powder represents a threat to individuals allergic to natural rubber latex and could represent an important agent for sensitizing non-allergic individuals. At the time, however, the FDA refrained from issuing a full-scale ban, in part because they believed there were not enough adequate alternatives to powdered gloves in the marketplace.
In the intervening years, additional evidence has accumulated, suggesting the risks that come with using powdered gloves are far more wide-ranging. By the time the FDA actually proposed the ban, the agency was able to draw attention to reports that potential adverse effects included severe airway inflammation, wound inflammation, and post-surgical adhesions. In studying the likelihood of these side effects emerging, the FDA saw no significant differentiation between latex gloves and synthetic gloves.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health (CDRH). “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients. Various types of powder have been used to lubricate gloves so that wearers could don the gloves more easily. However, the use of powder on medical gloves presents numerous risks to patients and health care workers, including inflammation, granulomas, and respiratory allergic reactions.
U.S. Food and Drug Administration