The Principles of Medical Device Decontamination

The line of responsibility shown in this document covers all areas concerned with decontamination e.g. Endoscopy, ultrasound probes etc. and how concerns are passed to the organisations board. The bulletin highlights the present lack of training within decontamination re-enforcing the need for competency for staff at all levels.

Health Technical Memorandum

The HTM’s (all countries within the UK) define roles within the decontamination hierarchy giving a responsibility route to the CEO of the organisation, this can be different from the managerial reporting route. In addition, the following statements are in the HTM 01-01 (England) 12 Roles and Responsibilities:

“ The ACDP-TSE Subgroup therefore recommends that decontamination staff should undertake appropriate formal training: for example, the training package offered by the Institute of Decontamination Sciences (IDSc) ……….such as the training programmes being developed under the Modernising Scientific Careers initiative. “…………….”It also suggests that, although there are no current professional registration of decontamination personnel, it would be best practice for senior SSD staff (for example the User) to be members of a relevant professional body such as the IDSC.”

In HTM 01-01, section 4.29, page 16 states, “staff are trained in cleaning and decontamination processes and hold appropriate competences for their role:”

ISO 13485:2016 also includes the need for staff to be trained but for the first time added the requirement for staff to be competent i in their roles and that this must be reassessed on a regular basis.

i Competency is defined in the Cambridge dictionary ‘as an important skill that is needed to do a job’ https://dictionary.cambridge.org/dictionary/english/competency

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