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FDA: Hospitals banned from using powdered medical gloves

Accreditation Insider, January 17, 2017

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The Food and Drug Administration’s (FDA) ban on powdered medical gloves goes into effect tomorrow. The use, advertising, and marketing of powdered surgeon's gloves, patient examination gloves, and absorbable powder for surgeon's gloves at medical clinics and hospitals will be strictly forbidden.

Powders have been used to lubricate gloves for easy removal for more than 100 years. However, the powder currently used in medical gloves has been shown to cause severe airway and wound inflammation, granulomas, and post-surgical adhesions in the tissue between internal organs. In addition, powdered latex gloves carry the risk of allergic reaction in patients.

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

The agency’s most recent push to get rid of powdered gloves came after receiving three citizen petitions between 2008 and 2011. The proposed rule was published last March; the FDA estimates the reduction in patient harm and the rise of affordable powdered glove alternatives will save the health industry between $26.6 million and $29.3 million annually. 

“We need to take every measure to ensure patient well-being, complete healing and satisfaction with their surgery,” wrote Linda Gylland, QLS, MLS (ASCP), lab safety officer at Sanford Health, N.D., in an email. “I am surprised it has taken this long (since 1997 when the FDA was aware of this) to reach this decision. We have more good glove alternatives than we had 10 years ago, so in my opinion, this shouldn’t be a factor. We need to be proactive and prevent possible problems to patients with powder.”

 



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