A detailed look at the background to the Department of Health’s updating, in 2016, of its guidance for surgical instruments, HTM 01-01, Management and decontamination of surgical instruments (medical devices) used in acute care. As the authors, Jimmy Walker et al explain, the changes were based on evidence from DHcommissioned research to understand the epidemiology of variant Creutzfeldt-Jacob Disease and the transmission of prion protein.
Independent, objective assessment of DH research
Over the last two decades the DH commissioned research on the transmission of vCJD2–10 In 2014 ACDP convened a specialised committee, ‘ACDP Transmissible Spongiform Encephalopathies Subgroup: Protein Detection and Decontamination Working Group 2014’, chaired by Dr Geoff Ridgway to assess the output from the research teams and the implications for future guidance documents (for membership see Table 1). The working group consisted of members representing ACDP, DH England, the Medicines and Healthcare products Regulatory Agency (MHRA), the Infection Prevention Society (IPS), the Association for Perioperative Practice (AfPP), the Institute of Decontamination Science (IDSc), the Central Sterilising Club (CSC), the Devolved Nations, and Public Health England (PHE). These studies assessed research from a number of university departments that had investigated i) the presence of protein on surgical instruments and the development of technologies to detect low protein concentrations,4,11–13 ii) the efficacy of detection technologies currently used in sterile services departments (SSDs) for proteins associated with transmissible spongiform encephalopathies – including ninhydrin and other commonly used methods which were found to be insensitive with inefficient elution of protein from instrument surfaces,2–6 and iii) that moisture retention aided removal of the protein from surgical instruments.5,14
Sub-group recommendations
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