The thorough and structured investigation of all medical device-related incidents is and, has remained, an essential HTM function. As the interface experts between healthcare technology, clinicians, and their patients, clinical engineers and BMETs are the best ones to be involved in such investigations. However, that they may not be particularly well trained to do the investigations. The focus of this session – using actual case study examples – will be on how to bring a thorough and structured approach to device-related investigations from the scientific, ethical, moral, regulatory and legal perspectives. While these viewpoints are all interrelated, they can have opposing objectives. The accidental risk of damaging or destroying potential evidence will be also emphasized.
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