Controlling the Process: Legislation and Guidance Regulating the Decontamination of Medical Devices

Abstract

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.

Keywords

Decontamination Legislation Medical devices

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References

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