FDA adds surgical sponges, strips to list of shortages after Medline recall
The U.S. Food and Drug Administration sent healthcare providers a letter on Wednesday, alerting them to a shortage caused by “recent supplier issues.”
Added to the Medical Devices Shortages list that the agency keeps to improve public transparency are neurosurgical patties, sponges and strip devices, used during surgeries to soak up fluids, control bleeding and protect delicate tissue during invasive procedures.
In part, the supply issue is because of a recent recall by manufacturer Medline Industries. The company recalled its neurosurgical patties due to an issue with out-of-specification endotoxin levels being present on the products. This has since extended to related products, namely the sponges and strips.
Medline announced the recall in a letter sent to providers on March 13.
A pause in the market
The issue has not been fully resolved, and shortages are likely to extend until the end of the year, the FDA said. Medline said on its website that it’s exploring alternatives to avoid the toxicity issue, but a market reentry date remains uncertain.
“Use of the product may result in health hazards that may necessitate medical or surgical intervention, such as febrile response and/or local transient inflammation, hypotension, or nausea,” the FDA wrote.
The neurosponge product page from the company shows the SKUs of the recalled products.
For now, the FDA is asking providers to ration supplies of patties, sponges and strips, and to seek alternatives when possible. The agency said “essential clinical use” should be prioritized—meaning, best practices should be adhered to to ensure the devices are being used “only when necessary” and not when convenient.
They’re also asking hospitals, doctors and surgery centers to keep a close eye on supplies. Daily usage should be monitored to ensure staff is adhering to conservation principles.
The FDA added that it is working to ensure that necessary neurosurgical patties, sponges and strips remain available for patients for those cases of medical necessity.
The agency’s full notice is available by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.