FDA warns veterinarians that some imported medical gloves aren’t safe
The FDA announced last week that it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.”
It’s not just a case of a couple of bad actors, either: The agency listed the names of 270 different firms on an import alert list and declared that any gloves manufactured by those firms and imported to the US are subject to seizure without physical examination.
Companies suspected of selling fraudulent products are listed on an import alert when the agency has enough evidence of malfeasance to order the products to be seized at the point of import without requiring a physical examination. This occurs when the imported items appear to be in violation of the FDA's laws and regulations, and pose a potential risk to healthcare professionals, patients, and users.
Steven Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine (CVM) told NEWStat that the FDA wants to make sure that veterinary hospitals are aware of the issue.
“We’re highlighting this safety information about certain imported medical gloves for the veterinary community because we know that use of medical gloves isn't limited to human healthcare,” Solomon said.
Unlike in human healthcare settings, veterinary practices must be concerned not only with the potential spread of COVID-19 among hospital staff and clients, but also between humans and animals, Solomon noted.
The suspect gloves are sourced from countries all over the world, from Asia to Mexico to Canada.
To make sure any medical gloves you’ve purchased have been cleared by the FDA, check the product codes against the FDA’s 510(k) Premarket Notification database.
To expand the availability of medical gloves during COVID-19, the FDA is being flexible on some of its regulatory requirements under certain circumstances, as described in the agency’s enforcement policy for gloves during the COVID-19 public health emergency.
How to report a problem
The FDA asks that you please report any medical gloves purchased by your practice that are visibly soiled, are a different color, appear to have been used, or otherwise seem to be fraudulent to [email protected].
“Veterinarians and staff use gloves on a daily basis and we want everyone to be aware of the potential health risk to both the people wearing the gloves and the animals being cared for,” Solomon added.
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