Safety cases for medical devices and health information technology: Involving health-care organisations in the assurance of safety

Mark A Sujan, Floor Koornneef, Nick Chozos, Simone Pozzi, Tim Kelly
2013 Health Informatics Journal  
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,
more » ... 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.
doi:10.1177/1460458212462079 pmid:23981393 fatcat:3qpvtee2wfdznndxwcydyktuly