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The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017.
FDA proposed the ban in March, citing mounting evidence that such gloves posed serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions.
This is only the second time FDA has banned a medical device since banning prosthetic hair fibers in 1983. In April, FDA proposed banning a third type of device, electrical stimulation devices when used to treat self-injurious or aggressive behavior, though a final ban is still pending.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Jeffrey Shuren, director of the Center for Devices and Radiological Health, after the ban was proposed.
However, Michael Carome, director of Public Citzien's Health Research Group, criticized the agency for how long it took to issue the ban. Public Citizen has twice called for FDA to ban powdered gloves, first in 1998 and again in 2011.
"While we are pleased to see the FDA issue this final rule, the agency's 18 year delay in acting to remove these dangerous products from the market represents reckless negligence. 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," Carome told Focus.
Specifically, FDA says it will ban the sale, distribution and manufacturing of all powdered surgeon's gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeon's gloves, though it notes the ban will not apply to powdered radiographic protection gloves.
Additionally, the ban will not apply to powder used during the manufacturing process for non-powdered gloves, so long as only trace amounts (no more than 2mg of powder per glove) make it into the finished product.
"Based on a careful evaluation of the risks and benefits of powdered gloves and the risks and benefits of the current state of the art, which includes readily available alternatives that carry none of the risks posed by powdered gloves, FDA has determined that the standard to ban powdered gloves has been met," the agency writes.
According to FDA, the majority of the roughly 100 comments submitted to the proposed rule favored banning powdered gloves.
Most of the comments that opposed banning powdered gloves claimed that non-powdered gloves were more difficult to put on and are less comfortable. However, FDA rejected these claims, citing studies supporting the performance characteristics and ease of donning non-powdered gloves.
FDA also rejected claims that powdered gloves should not be banned as newer reduced-powder gloves are safer than gloves with a higher powder content. "Several studies indicate that gloves with reduced powder levels continue to present unreasonable and substantial risks to patients and health care workers," the agency writes.
To facilitate the ban, FDA says it is also amending the classification regulations for medical gloves in order to distinguish between powdered and non-powdered gloves, as the current classifications do not differentiate between the two.
Final Rule, FDA
Tags: Powdered Gloves, Medical Device Ban