(AHC Media, publisher of Same-Day Surgery, first published this news on March 21. To keep up with breaking news, go to reliasmedia.com and follow us on Twitter @SameDaySurgery.)
The Food and Drug Administration (FDA) has announced a proposal to ban powdered gloves, and it cites the ongoing “dangerous” risk of allergic reactions to healthcare workers and patients.
While use of these gloves is decreasing, the FDA decided they “pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling.”
The ban, which is open for comment for 90 days from March 22, 2016, applies to powdered surgeon’s gloves, absorbable powder for lubricating surgical gloves, and powdered patient examination gloves. Non-powdered surgeon gloves and non-powdered patient examination gloves won’t be included in the ban.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health said in a statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
Powder can spread latex allergens if aerosolized and inhaled. Reported allergic reactions have included severe respiratory problems in healthcare workers and others with latex allergies.
Although powdered synthetic gloves don’t present the risk of latex allergic reactions, the FDA noted, these gloves “are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.”
Deciding the risk cannot be mitigated through new or updated labeling, the FDA is moving forward with the proposal to ban powdered gloves. The agency cited information gathered in a 2011 review of the literature and request for comment on the issue in determining the gloves “are dangerous and present an unreasonable and substantial risk.”
In addition, given the critical role medical gloves play in protecting patients and healthcare providers, the FDA also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant. The ban also is not likely to impact medical practice, because many non-powdered protective glove options are available.
The FDA has determined that the banning standard would not apply to powdered radiographic protection gloves. The agency is not aware of any powdered radiographic protection gloves that are on the market. (To see the proposal, go to 1.usa.gov/1UBPRau.)
