Report 110 Quality in Clinical Engineering
Published Institute of Physics & Engineering In Medicine: 2015: IPEM Report Series
This report examines the response of clinical engineering departments providing equipment management services within the context of the requirements of regulatory bodies such as the Care Quality Commission. Reference is made to the emergence of accreditation systems likely to impact on clinical engineering departments and the standardisation of nomenclature/device identification and a framework for assessment of the relevance of RFID technologies. A review is included on the implementation and value of measures of performance which can, for example, have relevance as evidence for meeting regulatory requirements. The report includes a review of the framework of systems for calibrating equipment typically used in the clinical engineering department. A further chapter focusses on ‘patient related’ risk associated with medical devices using fuzzy logic and where this risk is identified as a series of up to five independent elements. A detailed strategy for device evaluation and procurement provides a useful framework for local policy development. A description of a framework for medical device design and manufacturing within the medical device directive is also included. The Report will be of interest of those with involvement in the life cycle management of medical equipment and also with involvement in device design and development.