FDA Ban Medical Gloves

March 22, 2016 by  

FDA Ban Medical Gloves, The Food and Drug Administration has announced a proposal to ban most powdered medical gloves, saying they pose “an unreasonable risk” to health care workers, patients, and others exposed to them.

An FDA news release on Monday said the ban would apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. The statement said that powder is sometimes added to the gloves so they are easier to put on and take off.

“… However, powdered gloves are dangerous for a variety of reasons,” the FDA said. “In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions.”

“Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues.”

Powdered medical gloves have been under scrutiny since 1998 when the consumer watchdog group Public Citizen first petitioned the FDA to ban them, said ABC News. The group said about 75 percent of surgical gloves used in the U.S. contained the powder at that time.

“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,” said Sidney Wolfe, founder and senior adviser to Public Citizen’s health research group, in a news release.

“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. Alternatives to powdered medical gloves have existed for decades,” he said.

Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said the ban is meant to protect patients and healthcare professionals from unknown dangers.

“We take bans very seriously and only take this action when we feel it’s necessary to protect the public health,” Shuren said.

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