Are there special considerations for cleaning and sanitizing equipment at risk for Transmissible Spongiform Encephalopathy contamination?
While prion contamination is a significant concern, existing technology and current scientific information is limited regarding reducing the risk of transmissible spongiform encephalopathy (TSE) in surgical instruments used for HCT/P recovery and/or processing. There are no definitive recommendations for how to reliably perform TSE decontamination, nor procedures for rapidly identifying the presence of prions on instruments. However, we recommend that you use heightened screening and stringent recovery procedures. For example, where possible, consider using disposable instruments for recovery of HCT/Ps at high-risk for prion contamination, such as cornea and dura mater. You should consider establishing procedures to track instruments that were used on particular donors as well as instruments that are cleaned and sanitized together. FDA’s Transmissible Spongiform Encephalopathy Advisory Committee advised on July 18, 2003, that instruments need not routinely undergo special cleaning proc
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