The Principles of Medical Device Decontamination

Auditing should also cover any area carrying out medical device decontamination by technically competent individuals, and those reports should form part of the Decontamination Committee agenda. Any serious concerns/risk issues should be escalated to the executive lead for decontamination. Information from auditing practices provides written evidence of adherence to extant guidance and standards, and demonstrates continuous improvement within the organisation. This evidence of compliance is useful should it be required by the Care Quality Commission.

Reporting Adverse Incidents

The definition of an adverse incident is “an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of patients, users or other persons”. Every healthcare organisation should have a Medical Devices Safety Officer (MDSO) or equivalent and their details should be available to staff to which adverse incidents are reported. This person will also be in receipt of medical device information from the MHRA for dissemination to all relevant wards and departments as required. Sharing adverse incident information allows lessons learned to be shared across the healthcare sector and help prevent similar incidents. Adverse incidents can be reported through the Yellow Card scheme 8 run by the MHRA in England and other Competent Authorities in Wales, Scotland and Northern Ireland.

Basic Recommendations for Managing Medical Devices should include the following:

1. a systematic approach to managing risks described in a policy; 2. a multi-disciplinary medical devices group;

3. a comprehensive organisation-wide policy on the management of medical devices to include acquisition, deployment, use, monitoring, maintenance, decontamination and disposal; 4. an asset register to include device information (manufacturer, date of acquisition, including loans etc) 5. a tracking system to record current and past locations of medical devices and a nominated point of contact for dissemination of information (internally and external organisations)

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