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.
British Standards Institute2000BS EN ISO 9001 Quality Management Systems Standards: RequirementsLondon, BSI
2.
British Standards Institute2003 ISO 13485 Quality Management Systems for Medical DevicesLondon, BSI
3.
British Standards Institute2004BS EN ISO 17664 Sterilization of Medical Devices. Information to be provided by the manufacturer for the processing of resterilizable medical devicesLondon, BSI
4.
British Standards Institute, 2006BS EN ISO 17665–1 Sterilization of Health Care Products – Moist Heat. Requirements for the development, validation, and routine control of a sterilization process for medical devicesLondon, BSI
5.
British Standards Institute2008BS EN 980 Symbols for Use in Labelling Medical DevicesLondon, BSI
6.
Department of Health2004Core Standards for Better HealthLondon, DH
7.
Department of Health2007a HTM 01-01A Decontamination of Reusable Medical Devices Part A: Management and EnvironmentLondon, The Stationery Office
8.
Department of Health2007b Decontamination of Re-usable Medical Devices in the Primary, Secondary and Tertiary Care Sectors (NHS and Independent providers)London, DH
9.
Department of Health2008The Health and Social Care Act: Code of Practice for the NHS on the prevention and control of healthcare associated infections and related guidanceLondon, DH
10.
Department of Health2009HTM 01–05 Decontamination in Primary Care Dental PracticesLondon, DH
11.
HMSO2003The Medical Devices (Amendment) Regulations 2003Norwich, The Stationery Office
12.
Medicines and Healthcare products Regulatory Agency1990The Active Implantable Medical Devices Directive 90/385/EEC (AIMD)London, MHRA
Medicines and Healthcare products Regulatory Agency1998In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)London, MHRA
15.
National Institute for Health and Clinical Excellence2008Decontamination of Surgical Instruments: Patient safety and reduction of risk of transmission of Creutzfeldt - Jakob disease (CJD) via interventional procedures PL CMO Part 2 London, NICE
