Dive Brief:
- The Food and Drug Administration added neurosurgical supplies to its medical device shortages list on Wednesday.
- The regulator sent a letter to healthcare providers warning about disruptions in availability of neurosurgical patties, sponges and strip devices, which are used to absorb fluids and protect tissue during surgery.
- The FDA attributed the problem to recent supplier issues, noting that Medline Industries recently recalled its neuro sponge products. The agency expects the shortage to continue through the end of the year.
Dive Insight:
In March, Medline sent a letter to alert customers that higher-than-expected endotoxin levels had been identified on the company’s neurosurgical patties. The company began a recall of its neuro sponges that month, telling customers to identify, quarantine and destroy the affected devices. The FDA categorized the recall as Class 2.
On Medline’s website, the company said it has recalled all SKUs of its branded neurosponges. “While we continue to explore alternatives, there is no definite market re-entry date at this time,” the company’s website stated.
The FDA recommended that healthcare providers consider ways to conserve the use of neurosurgical patties, sponges and strips when possible, reserving the products for intracranial operations and cases where alternatives are unsuitable. The regulator also advised opening packages only when needed and diversifying supply sources.
The agency said it plans to work with manufacturers to ensure supplies remain available when medically necessary and to evaluate ways to mitigate patient impact. The FDA asked healthcare providers to report any supply chain challenges or suspected adverse events related to the devices.
