Practice Economics

FDA proposes ban on powdered gloves


 

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The Food and Drug Administration has proposed a ban on most powdered gloves used during surgery and for patient examination, and on absorbable powder used for lubricating surgeons’ gloves.

Aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and while powdered synthetic gloves don’t present the risk of allergic reactions, all powdered gloves have been associated with numerous potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions, according to an FDA statement.

The proposed ban would not apply to powdered radiographic protection gloves; the agency is not aware of any such gloves that are currently on the market. The ban also would not affect non-powdered gloves.

The decision to move forward with the proposed ban was based on a determination that the affected products “are dangerous and present an unreasonable and substantial risk,” according to the statement.

In making this determination, the FDA considered the available evidence, including a literature review and the 285 comments received on a February 2011 Federal Register Notice.

That notice announced the establishment of a public docket to receive comments related to powdered gloves and followed the FDA’s receipt of two citizen petitions requesting a ban on such gloves because of the adverse health effects associated with use of the gloves. The comments overwhelmingly supported a warning or ban.

The FDA determined that the risks associated with powdered gloves cannot be corrected through new or updated labeling, and thus moved forward with the proposed ban.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health said in the statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

In fact, should this ban be put into place, it would be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit. The benefits cited for powdered gloves were almost entirely related to greater ease of putting the gloves on and taking them off, Eric Pahon of the FDA said in an interview.

A ban on the gloves was not proposed sooner in part because when concerns were first raised about the risks associated with powdered gloves, a ban would have created a shortage, and the risks of a glove shortage outweighed the benefits of banning the gloves, Mr. Pahon said.

However, a recent economic analysis conducted by the FDA because of the critical role medical gloves play in protecting patients and health care providers showed that a powdered glove ban would not cause a glove shortage or have a significant economic impact, and that a ban would not be likely to affect medical practice since numerous non-powdered gloves options are now available, the agency noted.

The proposed rule will be available online March 22 at the Federal Register, and is open for public comment for 90 days.

If finalized, the powdered gloves and absorbable powder used for lubricating surgeons’ gloves would be removed from the marketplace.

sworcester@frontlinemedcom.com

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