Jan 18, 2017

Ban on powdered gloves coming Jan. 18 FDA cites numerous health dangers

REGULATION SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.

Full Regulation:

Powdered medical gloves are going the way of powdered wigs.

A once ubiquitous staple of doctors, powdered gloves are being thrown out of exam and operating rooms by the U.S. Food and Drug Administration as of Jan. 18. The reason: The powder poses a variety of risks to wearers, patients and even bystanders.

The dangers include severe airway inflammation from inhaling the powder; wound inflammation and post-surgical adhesions from contact with the powder; and respiratory allergic reactions from breathing powder that carries proteins from natural rubber latex gloves. The most common type of powder used in gloves is cornstarch, according to the FDA.

The coming ban is absolute — there's no grace period for using up existing supplies. "[T]he risks of illness or injury to individuals who are currently exposed to these devices is [as] equally unreasonable and substantial as it would be for future individuals that might be exposed to powdered gloves," the FDA stated in a March 22, 2016, Federal Register notice proposing the ban. The ban was made final on Dec. 19.

Although glove use in veterinary medicine is not explicitly mentioned in the FDA rule, the prohibition applies in the veterinary sphere, too, an agency spokeswoman confirmed.

"The ban applies to powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove that are already in commercial distribution and for these devices that are already sold to the ultimate user, such as small medical practices and hospitals. As such, it applies to ... gloves that are in use at veterinary practices," the spokeswoman, Deborah Kotz, said by email.

Asked how the ban will be enforced, Kotz replied: "The FDA can take various enforcement actions, if necessary, to remove banned devices from the market, including seizure of the product, civil money penalties or criminal prosecution."

She declined to say what criminal charges could be brought, or the potential size of fines.

The FDA recommends unused inventories of gloves be disposed of like any community solid waste, which usually is by burial in a landfill or by incineration.

Read full: http://news.vin.com/VINNews.aspx?articleId=43448