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Finding the hidden risks with medical devices: a risk profile tool

Anthony Scott Brown

There is an increasing interest in the risk management of medical devices in the UK to comply with Controls Assurance standards. Controls assurance and clinical governance share a common thread with risk pooling in risk management. This paper gives a brief outline describing the development and thought processes for designing a risk register tool.It illustrates one method of determining the risk rating number based on the New Zealand model for calculating risk. The tool is universal in that it can be used across any medical device; we have chosen to assess risk using generic device types such as defibrillators, infusion pumps, or a pair of crutches,but it could be used for a specific model equally well. This tool will work across the healthcare sector and it is envisaged that, with some modification, it can be used to inform procurement decisions.