The FDA said it's aware that the U.S. is experiencing interruptions in the supply of neurosurgical patties, sponges and strip devices because of recent supplier issues. It's recommending healthcare providers "consider strategies to conserve the use of neurosurgical patties, sponges and strips when possible."
The agency traced the shortage back to Medline Industries, which earlier this year issued a customer letter stating 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.
The company warned that 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 manufacturing disruption in supply of these devices is expected to impact patient care and may require adjustments to the clinical management of patients receiving neurosurgery or microsurgery. The FDA currently expects the duration of this shortage to extend through the end of 2026. The FDA recommends:
- Prioritize essential clinical use: Reserve neurosurgical patties, sponges and strips, as well as the procedural convenience packs, trays, and kits (kits) containing them for intracranial neurosurgical operations, delicate neural tissue protection where alternatives are unsuitable, and cases requiring high absorbency with minimal linting.
- Implement conservation best practices: Use neurosurgical patties, sponges and strips, and kits containing them, only when necessary, avoid routine or convenience use, open packages only as needed since unused devices cannot be used later, coordinate to minimize redundant use, and consider FDA-authorized alternatives appropriate to the specific surgical application when possible.
- Manage inventory and communication: Monitor daily usage and centralize storage and distribution of bulk and kitted devices, requisition inventory only for essential clinical use, diversify sources of supply for alternatives that are clinically appropriate for specific surgical applications, prioritize neurosurgical cases, avoid stockpiling, and escalate availability or safety concerns to leadership and supply chain teams.
