This document includes a description of the overall structure of the guidance and the rationale behind the structure, the regulatory framework, roles of key personnel, procedures for the reporting of adverse incidents and defective equipment, local reprocessing (decontamination in primary care and local decontamination) and the management of instruments potentially contaminated with transmissible spongiform encephalopathy (TSE) infectivity. "HTM 01" supersedes "HTM 2010", 2030 and 2031.