Safety cases for medical devices and health information technology: involving health-care organisations in the assurance of safety.
Health Informatics J
; 19(3): 165-82, 2013 Sep.
Article
en En
| MEDLINE
| ID: mdl-23981393
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.
Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Sistemas de Información
/
Administración de la Seguridad
/
Equipos y Suministros
/
Seguridad del Paciente
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
Health Informatics J
Año:
2013
Tipo del documento:
Article