title: Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.
abstract: In the United Kingdom, there are more than 9000 reports of adverse events involving medical devices annually. The regulatory processes in Europe and in the United States 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 health care. 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.
authors: Warwick Medical School, University of Warwick, Coventry, UK. m-a.sujan@warwick.ac.uk
authors: Mark A
authors: MA
authors: Sujan
authors: Floor
authors: F
authors: Koornneef
authors: Nick
authors: N
authors: Chozos
authors: Simone
authors: S
authors: Pozzi
authors: Tim
authors: T
authors: Kelly
mesh_terms: D003142:Communication; D004867:Equipment Design; D004868:Equipment Failure; D004864:Equipment and Supplies; D033161:Government Regulation; D006801:Humans; D007256:Information Systems / Q000331:legislation & jurisprudence / Q000458:organization & administration* / Q000592:standards; D061214:Patient Safety / Q000331:legislation & jurisprudence / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D018570:Risk Assessment; D017751:Safety Management / Q000331:legislation & jurisprudence / Q000458:organization & administration*
keywords: Medical devices; patient safety; regulation