The Principles of Medical Device Decontamination

Documentation

Good record keeping is essential for the safe management of medical devices. Documentation is key to maintaining evidence of activities and to demonstrate who has done ‘what’, ‘when’ and ‘how’. A good reminder of why documentation is essential is the principle that “if its not written down, it did not happen”. Records must be protected to ensure accessibility over a period of time. Statute of limitations on legal actions require records to be kept for a defined period of time depending upon regional legislation. Increasing dependency is put upon electronic records which require regular back up 1 . NHS Digital provides guidance on electronic record retention 2 .

Monitoring and Audit

Monitoring the organisation’s performance and activities around medical device management is vital to minimise or eliminate risks to patients and staff. This can be performed by internally competent personnel as part of the organisation’s governance arrangements. This should be controlled and monitored by the Medical Device Management Group and reported to the Executive Board. In England external monitoring will be carried out by the Care Quality Commission (CQC) essential standards of quality and safety 3 . Scotland established Healthcare Improvement Scotland 4 , Northern Ireland established the Regulation and Quality Improvement Authority 5 and Wales the Healthcare Inspectorate Wales 6 . ISO 13485 7 is a standard that is designed for organisations involved in medical device design, production, installation and servicing and can be used to demonstrate compliance to specified standards applied in medical device manufacturing. This standard is used in sterile services units and endoscopy units where central processing takes place. It is not applicable to decontamination which takes place at the point of use. Organisations who wish to be formally certified to ISO 13485 must employ a notified body or certification business, to undertake external audit of their practices and monitor performance. For those who do not need or who do not wish to pursue formal certification, internal auditors can undertake annual reviews and produce reports with recommendations.

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