FDA to ban most surgical gloves with powder

news
22 March 2016

US federal health officials plan to ban most surgical gloves made with powder, a feature designed to make them easier to wear, but which actually posed health risks to patients and health professionals.

The agency proposed the ban yesterday in a federal filing.

The Food and Drug Administration (FDA) said yesterday that the powder added to some latex gloves could lead to breathing problems, wound inflammation, and scar tissue on internal organs when used during surgery.

According to government research, the action was not expected to have much impact on glove supplies, as most powdered gloves had already been phased out, and only six manufacturers were still registered to make them in the US, according to the agency.

"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Dr Jeffrey Shuren, head of the FDA's medical device centre.

The move comes 18 years after, Public Citizen, a consumer watchdog group, petitioned the FDA to ban powdered gloves in 1998. The group cited allergic reactions caused by cornstarch powder used in most brands to call for the ban.

According to the group's estimates at the time, around 75 per cent of surgical gloves used in the US contained the powder.

The proposed ban would apply to all powdered surgeon's gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeon's gloves, though it would exclude powdered radiographic protection gloves.

Sidney Wolfe, director of the group called the agency "recklessly negligent" for the tardy action in the matter, adding that "there is absolutely no new scientific information today that we didn't have in 1998."

The FDA said the gloves need to be banned in light of evidence tying powdered gloves to "an extensive list" of potential risks, including airway and wound inflammation, as well as post-surgical adhesions. The agency further warned that powder from natural latex gloves could cause allergic reactions when it entered the air.





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