The majority of adverse incidents involving medical devices are user-related, yet the equipment is usually blamed. The “Completing the Picture” event, attended by clinical and biomedical engineers, examined how to minimise risk and the clinical issues that must be addressed to improve the quality and safety of patient care. LOUISE FRAMPTON reports.
The Medicines and Healthcare products Regulatory Agency (MHRA) says that there is “no such thing as a risk-free product”. Nevertheless, risk – in the event of an adverse incident – is usually found to be culturally specific. A lack of standardisation on technologies, gaps in user knowledge and misuse of equipment are all challenges to the delivery of quality, cost-effective care, which clinical engineers are striving to overcome. The “Completing the Picture” conference considered the impact that improved medical device management has on clinical care and the key role clinical engineering departments have in delivering change. Examining the issue of medical devices risk, Scott Brown, Royal Cornwall Hospitals NHS Trust, addressed the question: “Are medical devices intrinsically safe?” He pointed out that there are three EU directives, concerned with medical devices, aimed at protecting patients and staff. These include:
• Active Implantable Medical Devices Directive (90/385/EEC).
• Medical Devices Directive (93/42/EEC).
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