FDA Bans its 2nd Medical Device Ever

This article was originally published here

By Dana A. Elfin

The FDA is waving goodbye to powdered medical gloves, banning them starting Jan. 18, 2017, because of risks to patients and health-care providers.

The Food and Drug Administration rarely uses its authority to ban devices. The agency’s ban on powdered medical gloves is only the second time it has banned a medical device. The first time was more than 33 years ago, when it banned prosthetic hair fibers.

Exposure to powdered latex gloves can cause unreasonable and substantial risk of illness or injury to patients and health-care providers, the final rule containing the ban, published Dec. 19 (81 Fed. Reg. 91,722), says.

A medical device ban completely prohibits current and future sales, distribution and manufacturing of a medical device. The FDA is authorized to ban a medical device intended for human use if it finds the device presents an unreasonable and substantial risk of illness or injury that can’t be corrected by changing the device’s labeling.

“Banning powdered glove products is not expected to impose any costs to society, but is expected to reduce the number of adverse events associated with using powdered gloves,” the agency said. “The primary public health benefit from adoption of the rule would be the value of the reduction in adverse events associated with using powdered gloves.”

Ban Called Overdue

Public Citizen, a public health advocacy organization, welcomed the final rule but criticized the agency for not acting to ban the gloves in 1998, when the group first called for a ban.

“The agency’s 18-year delay in acting to remove these dangerous products from the market represents reckless negligence,” Michael A. Carome, director of Public Citizen’s Health Research Group, told Bloomberg BNA Dec. 19.

“There is absolutely no new scientific information today that we didn’t have in 1998 about the dangers posed by cornstarch powder and by latex when used in surgical and patient examination gloves. And alternatives to powdered medical gloves have existed for decades,” Carome said.

“The FDA had the legal authority to ban powdered gloves in 1998. The agency should have used that authority to protect hundreds of thousands of hospital workers and patients who have been exposed to the powder. Had the FDA initiated the process of banning powdered medical gloves in 1998 instead of 18 years later, hundreds of thousands of health workers and patients would have been spared preventable, often life-threatening adverse reactions,” Carome said.

Bloomberg BNA also contacted the American Latex Allergy Association (ALAA), a group representing people with latex allergies, which supported the ban, for comment on the rule, but didn’t receive a response.

Malaysia Has Economic Interests

The Malaysian Rubber Export Promotion Council and the Trade Section of the Embassy of Malaysia in New York didn’t respond to Bloomberg BNA’s request for comment.Malaysia is the largest surgical and medical gloves supplier to the U.S. In fact, the value of glove exports reached $1.6 billion in 2015, according to the Malaysian embassy.

Banning powdered medical gloves “could eventually impair the competitiveness of our local players in the global rubber industry,” the embassy told the FDA in comments on the proposed rule earlier this year.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.

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