After signaling its intentions for years, the US Food and Drug Administration (FDA) today unveiled a proposal to ban most powdered medical gloves to guard against multiple health threats to clinicians and patients alike.
The proposed ban applies to powdered surgeons' gloves and the absorbable powder for lubricating them, as well as powdered gloves for patient examinations. Both synthetic gloves and those manufactured from natural rubber latex (NRL) are covered.
If made final, the ban would hasten a phase-out of powdered gloves already occurring in the healthcare industry. Major health systems such as the Cleveland Clinic and Johns Hopkins Medicine have either restricted or forbidden the use of these gloves, a move affirmed by several medical societies, according to the FDA. An estimated 93% of clinicians are putting on powder-free versions.
"This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "We take bans very seriously and only take this action when we feel it's necessary to protect the public health."
A ban was the FDA's only choice because "no change in labeling could correct the risk of illness or injury" posed by powdered gloves, according to the agency's proposal.
Surgical gloves debuted in operating rooms in 1889, and from the start, all sorts of lubricants were used to make them easier to don. The first one was a powder made from the spores of plants called ground pines or club moss. Found to be toxic, this material gave way to talcum powder, which turned out to cause postoperative complications such as granulomas and scar tissue adhesions connecting internal organs and tissues.
The healthcare industry gradually switched from talcum powder to cornstarch. Research showed it to be just as problematic, if not more so. With NRL gloves, aerosolized cornstarch can transport latex proteins capable of triggering respiratory allergic reactions, according to the FDA. Other adverse events include severe airway inflammation, wound inflammation, granulomas, and postoperative adhesions, all of which occur with synthetic as well as NRL gloves dusted with cornstarch.
A Growing Consensus to Go Powderless
The FDA described the shortcomings of powdered medical gloves in a 1997 report, but said that a ban "would cause a market shortage that could result in inferior products and increased costs." In 2011, the agency proposed adding a label warning for the gloves, but the proposal never was implemented.
In the meantime, professional groups such as the American College of Surgeons, the American Academy of Allergy, Asthma and Immunology, and the American Nurses Association were taking stands against powdered gloves. Government agencies such as the Centers for Disease Control and Prevention joined the chorus, as did the healthcare systems of Germany and the United Kingdom.
The FDA also received several citizen petitions, including two from the consumer watchdog group Public Citizen, demanding a ban of powdered medical gloves. It wasn't that the agency was ignoring this growing consensus, though. It put the matter of a ban on its regulatory to-do list in 2013, 2014, and 2015.
In today's announcement, the agency said that the ban would not cause a glove shortage or have significant economic fallout. Also, the ban would not likely affect medical practice, given that many nonpowdered glove options are available, according to the FDA.
The proposal to ban most powdered medical gloves will be officially published on the Federal Register tomorrow. The FDA will accept comments for the following 90 days. The proposal, already posted online, explains how to submit comments.
More information on today's announcement is available on the FDA website.
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Cite this: FDA Proposes Ban of Powdered Medical Gloves - Medscape - Mar 21, 2016.