For only the second time in its history, FDA is recommending an already-approved medical device be taken off the market: powdered medical gloves.
The powder in the gloves makes it easier for providers to slip the gloves on and off their hands. But FDA says the powder can cause health problems, including sparking allergic reactions, inflaming the airway, and causing scars to form after surgery. Powdered gloves, the agency says, pose an "unreasonable and substantial risk of illness and injury" to both patients and medical professionals.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," says Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. "We take bans very seriously and only take this action when we feel it's necessary to protect the public health."
FDA issues medical device guidance
The proposal is open to a 90-day public comment period. If the ban takes effect, powdered gloves would become the second already-approved medical device to be banned by FDA: The agency banned prosthetic hair fibers, which caused infections, in the 1980s.
FDA released a report in 1997 that detailed potential health risks of powdered gloves.
At the time, the agency was hesitant to remove powdered gloves from the market out of a concern the move cause shortages and negatively affect care. About 75 percent of surgical gloves used in America contained powder in the late 1990s. However, most of the gloves have now been phased out, FDA says.
"As better alternatives have come out," says FDA spokesperson Eric Pahon, the agency is now able to ban the gloves without worrying about causing shortages.
But advocacy group Public Citizen, which petitioned FDA in 1998 to ban the gloves, says FDA's decision to wait was irresponsible.
"There is absolutely no new scientific information today that we didn't have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves," says co-founder Sidney Wolfe. "The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is" (McGinley, "To Your Health," Washington Post, 3/21; Devaney, The Hill, 3/21; Tavernise, New York Times, 3/21; Perrone, AP/Sacramento Bee, 3/21).
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