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Provided by AGPThe Food and Drug Administration announced May 6 that it is aware of a shortage of neurosurgical patties, sponges and strip devices across the U.S. due to supplier issues, and expects the issue to continue through the end of the year. The agency said a manufacturing disruption in supplying the products is expected to impact patient care and could require adjustments to clinical management of patients receiving neurosurgery or microsurgery. The FDA recommended a list of strategies for health care providers to consider which would conserve the use of neurosurgical patties, sponges and strips when possible.
The FDA said that Medline Industries sent a customer letter March 13, saying that higher-than-expected endotoxin levels were identified on Medline-branded neurosurgical pattie products, suggesting that out-of-specification endotoxin levels may be present in on-market products. Using the product may result in health hazards that could necessitate medical or surgical intervention, such as febrile response and/or local transient inflammation, hypotension or nausea, the FDA said.
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