Drugs/Therapy
Powdered surgical gloves found to pose health risks in patients
Most surgical gloves made with powder were found to pose health risks to patients, the Food and Drug Administration (FDA) revealed.
The agency, which proposed the ban in a federal filing, noted that the powder added to some latex gloves can cause breathing problems, wound inflammation, and scar tissue on internal organs when used during surgery, NBC News reported.
Many people are allergic to latex, and powder on these gloves can disperse allergens into the air. However, powder from surgical gloves doesn't carry these allergens.
The proposed ban is based on extensive review of scientific literature and public comments, which it the FDA began collecting in 2011.
Most powdered gloves have already been phased out, and only six manufacturers are still registered to make them in the U.S., according to the agency.
Dr. Jeffrey Shuren, head of the FDA's medical device centre, said that the ban is about protecting patients and health care professionals from a danger they might not even be aware of.
While the FDA typically addresses safety issues with medical products by adding warning labeling or modifying instructions for use, it found that safety issues with powdered gloves could only be addressed through removal from the market.
The FDA said will consider comments and advice regarding the proposed ban.
Meanwhile, a doctor lambasted the U.S. Food and Drug Administration (FDA)for taking 18 years to propose banning powdered surgical gloves from the market, ABC News reported.
"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
Dr. Sidney Wolfe of Public Citizen called the FDA recklessly negligent for taking so long to make the move, noting that "there is absolutely no new scientific information today that we didn't have in 1998."
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