FDA has issued a ban on the sale, manufacture, and use of powdered surgical and examination gloves — as well as associated absorbable powders — that will begin on January 19, 2017. The agency first proposed the ban in March, citing evidence of wound inflammation, allergies, and post-surgical adhesions and complications.
Surgical and examination gloves are the most common form of personal protection equipment (PPE) used in the healthcare setting, and the recent emergence of drug-resistant microorganisms and pathogens have only increased their use among healthcare workers, according to a 2015 report. Though powders like cornstarch are applied to certain kinds of gloves to facilitate easy and comfortable wearing, recent studies have found these powders pose significant dangers to both clinician and patient.
In their proposed ruling in March, FDA cited studies that demonstrated increased risk of respiratory allergic reactions, airway and wound inflammation, and the formation of fibrous car tissue between internal organs and tissue when the powder is introduced to surgical sites, which correlates with the use of powdered gloves. Additionally, FDA found that a ban on the gloves would not pose a significant economic burden or device shortage.
FDA collected comments for 90 days, and in their final ruling stated that over 100 responses had indicated enthusiastic support of the ban. Those arguing against the ban cited the difficulty using non-powdered gloves and studies that demonstrated reduced risk with gloves using less powder. In their ruling, FDA stated that these arguments against the ban did not outweigh the potential risks associated with powdered gloves.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, director for the Center for Devices and Radiological Health (CDRH), in a statement in March.
Consumer watchdog group Public Citizen has argued for the ban of powdered gloves for 18 years, writing first in 1997 and then again in 2011 in support of a ban. Their most recent letter criticized the agency’s unnecessary delay in banning the gloves, noting that “available scientific evidence” in support of the ban was “overwhelming.”
FDA responded to criticisms by saying that the agency wanted to ensure that the market contained a sufficient supply of alternative powder-free gloves before issuing the ban.
“Based on the 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 wrote.
The FDA ban does not extend to powders used in glove manufacturing or powdered gloves used by radiographic technicians. Residual powder applied to other medical devices does not pose similar health risks, according to the agency, and would not be affected by the ban.
FDA has only banned medical technology once before, according to the Regulatory Affairs Professionals Society. In 1983, the agency issued a ban on prosthetic hair fibers and is currently considering a ban on electrical stimulation devices for patients who pose a danger to themselves and others.