Decontamination of re-usable medical devices in the primary, secondary and tertiary care sectors: 2007 clarification and policy summary

This document confirms the importance of effective decontamination of re-usable medical devices in the strategy to reduce health care associated infection.  It underlines the duty of care to patients wherever treatment is undertaken, in that decontamination processes should be of consistently high quality irrespective of location. Reprocessing units in healthcare establishments, responsible for decontamination of medical devices fall into two distinct catagories when considering compliance with EEC medical devices directive (MDD): - 1. devices transferred between two legal entities 2. devices remaining within one legal entity The four options or combination of options for achieving a compliant service are listed, including the national decontamination programme option, and each one is explained but it is also noted that local needs and facilities will determine the way in which the service is provided. The decontamination service must comply with DH policy and MDR 'essential requirements' A key consideration in the selection of an appropriate strategy is Risk Management