Avoiding TSE in surgery?
This article was originally published in The Gray Sheet
A claim for "complete elimination" of transmissible spongiform encephalopathy (TSE) in surgical instruments is not currently possible, but a sponsor could reasonably validate a claim for "reducing TSE infectivity" using animal model studies, the FDA's General Hospital & Personal Use Devices Panel concluded Sept. 27 at a meeting in Gaithersburg, Md. TSE is the source of "mad cow disease" in bovine and the rare but deadly Creutzfeldt-Jakob disease in humans. The device center is anticipating marketing approval applications for products or processes intended to decontaminate surgical tools, although it has not received any such submissions yet...
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