Safety Cases for Medical Devices and Health IT:

In the UK, there are more than 9,000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the US have been challenged as to their ability to protect patients effectively from unreasonable risk and harm. Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present there is little awareness of this concept in healthcare. Safety cases have the potential to provide greater transparency and confidence in safety certification, and to act as a communication tool between manufacturers, service providers, regulators and patients. Appeared in: Health Informatics Journal, 2013;19(3):165-182