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Safety cases for medical devices and health IT : involving healthcare organisations in the assurance of safety
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Sujan, Mark-Alexander, Koornneef, Floor, Chozos, Nick, Pozzi, Simone and Kelly, Tim (2013) Safety cases for medical devices and health IT : involving healthcare organisations in the assurance of safety. Health Informatics Journal, 19 (3). pp. 165-182. doi:10.1177/1460458212462079 ISSN 1741-2811.
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Official URL: http://dx.doi.org/10.1177/1460458212462079
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.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > R Medicine (General) | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Social Science & Systems in Health (SSSH) | ||||||
Library of Congress Subject Headings (LCSH): | Medical instruments and apparatus -- Safety regulations, Medical instruments and apparatus -- Standards | ||||||
Journal or Publication Title: | Health Informatics Journal | ||||||
Publisher: | Sage Publications Ltd. | ||||||
ISSN: | 1741-2811 | ||||||
Official Date: | September 2013 | ||||||
Dates: |
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Volume: | 19 | ||||||
Number: | 3 | ||||||
Page Range: | pp. 165-182 | ||||||
DOI: | 10.1177/1460458212462079 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||
Date of first compliant deposit: | 5 July 2016 | ||||||
Date of first compliant Open Access: | 5 July 2016 | ||||||
RIOXX Funder/Project Grant: |
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