Supply disruptions of neurosurgical patties, sponges and strip devices could affect patient care and neurosurgical procedures through the end of 2026, according to a May 6 letter by the FDA.
The shortage stems in part from supplier issues involving Medline Industries. On March 13, Medline notified customers that higher-than-expected endotoxin levels had been identified in its branded neurosurgical pattie products, raising concerns that out-of-specification endotoxin levels may be present in products already on the market, according to the agency.
Use of the affected products may lead to complications requiring medical or surgical intervention, including fever, inflammation, hypotension and nausea. Medline also initiated a recall of all SKUs in its branded neuro sponge category and said there is no definite timeline for market re-entry.
The FDA updated its medical device shortages list to include the affected products and urged healthcare providers to conserve supply for intracranial neurosurgical procedures and cases requiring delicate neural tissue protection.
The agency also recommended that hospitals centralize inventory management, avoid stockpiling, diversify supply sources and limit use of the products to essential clinical cases while the shortage continues, according to the release.
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