The U.S. Food and Drug Administration on Wednesday acknowledged ongoing supply disruptions of certain sterile pads, sponges and strips used in neurosurgery, warning the shortage could last through the end of 2026.
Here are some details:
The agency said it has added neurosurgical patties, sponges and strips — used during neurosurgery and microsurgery to absorb fluid and protect delicate tissue — to its medical device shortages list.
In March, one of the manufacturers, Medline Industries (MDLN.O), opens new tab, recalled neurosurgical patties in its neuro sponge line over elevated endotoxin levels, with no return date set, the FDA said.
Use of affected products could lead to health problems requiring medical or surgical treatment, including fever, inflammation, low blood pressure or nausea, the FDA said.
The agency said it is working with other manufacturers and healthcare providers to monitor supplies and evaluate ways to reduce the impact on patients.
The agency has instructed healthcare providers to conserve the products whenever possible and reserve them for the most critical cases, including brain surgery and procedures where alternatives are not suitable.
Healthcare service provider Premier said the recalled products are highly specialized for brain and spine surgeries. “This is a high-risk low-frequency product,” said Karen Niven, senior director of clinical value analysis at Premier. “We have advised our members to first look at conservation.”
