Controlling the process: legislation and guidance regulating the decontamination of medical devices.
The reprocessing of medical devices, in particular surgical instruments, is an extremely technical and highly regulated industry. There are many guidance documents, and European and international standards that cover different aspects of decontamination. This article provides an outline of the main documents covering the critical elements of reprocessing which aim to ensure that reusable medical devices are provided which are fit for purpose and safe for patient use.
O'Brien
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Theatres, Worcester Royal Hospital, Charles Hastings Way, Worcester, WR5 1DD.
D003666:Decontamination / Q000331:legislation & jurisprudence* / Q000592:standards; D004866:Equipment Contamination; D017743:Equipment Reuse; D006801:Humans; D013222:State Medicine; D013242:Sterilization / Q000331:legislation & jurisprudence / Q000592:standards; D006113:United Kingdom