Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Advisory Committee to Department of Health
This publication, also known as the MAC Manual, has been prepared and endorsed by the MHRA`s Microbiology Advisory Committee to provide advice on all aspects of decontamination.
The MHRA will be considering the need for a full review of this publication once the Department of Health has published its revised Health Technical Memorandum 01-01 `Decontamination of reusable medical devices` later in 2010. In the meantime, please be aware that some information in Parts 2 and 3 of the document may be out of date.
Part 1 Principles (revised 2010)
This part provides the general principles of decontamination, illustrated by some examples of basic decontamination equipment.
Part 2 Protocols (revised 2005)
This part contains the protocols for decontamination using cleaning, disinfection and sterilization processes. The introduction provides general guidance on the need for systems of work for the decontamination of medical devices and equipment both prior to clinical use and before inspection, service or repair. A general protocol for handling items to be maintained or repaired is then provided, and detailed protocols for cleaning, disinfection and sterilization follow this.
Part 3 Procedures (revised 2006)
Section 1 provides an overview of what the European Directives for medical devices mean for users. In particular, the implications of the Medical Devices Directive for those carrying out reprocessing activities will be reviewed, in terms of both self-declaration of compliance with the Regulations, and the information that reprocessors may expect to be provided with by manufacturers of CE-marked reusable devices.
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