Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care

This guidance has been developed to support health organisations in delivering the required standard of decontamination of surgical instruments and builds on existing good practice to ensure that high standards of infection prevention and control are developed and maintained. The guidance in this Health Technical Memorandum should inform your local continuous improvement programme on decontamination performance. The major change in this latest revision is taking account of recent changes to the Advisory Committee on Dangerous Pathogens Transmissible Spongiform Encephalopathy (ACDP-TSE) Subgroup’s general principles of decontamination (see ACDP-TSE’s Annex C). This establishes a move towards in situ testing for residual proteins on instruments. Residual protein is important because of the continuing risks of transmission of prions (the causative agent of transmissible spongiform encephalopathies such as variant Creutzfeldt-Jakob disease (vCJD)). This guidance provides information on how sterile services departments (SSDs) can mitigate the patient safety risk from residual protein with a move towards first achieving this ≤5 μg level and subsequently producing further reductions in protein contamination levels through the optimisation of decontamination processes. The ambition is that all healthcare providers engaged in the management and decontamination of surgical instruments used in acute care will be expected to have implemented this guidance by 1 July 2018. However, providers whose instruments are likely to come into contact with higher risk tissues, for example neurological tissue, are expected to give