The development of safety cases for healthcare services: Practical experiences, opportunities and challenges

Reliability Engineering and System Safety

Volumn 140, Issue , 2015, Pages 200-207

  Sujan, Mark ^a   Spurgeon, Peter ^a   Cooke, Matthew ^a   Weale, Andy ^b   Debenham, Philip ^c   Cross, Steve ^d  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b NORTH BRISTOL NHS TRUST   (United Kingdom)

^c BIRMINGHAM CHILDREN S HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^d UNITED LINCOLNSHIRE HOSPITALS NHS TRUST   (United Kingdom)

Author keywords

Healthcare; Patient safety; Risk management; Safety assurance; Safety case; Safety regulation

Indexed keywords

HEALTH CARE; RISK MANAGEMENT;

HEALTH INFORMATION TECHNOLOGIES; HEALTHCARE ORGANISATIONS; PATIENT SAFETY; PRACTICAL EXPERIENCE; REGULATORY OVERSIGHT; SAFETY ASSURANCE; SAFETY CASE; SAFETY REGULATIONS;

SAFETY ENGINEERING;

EID: 84929104277     PISSN: 09518320     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ress.2015.03.033     Document Type: Article

References (30)

1. Department of Health An organisation with a memory 2000 The Stationery Office London
2. LT Kohn, JM Corrigan, and MS Donaldson To err is human: building a safer health system 2000 The National Academies Press Washington
3. EN de Vries, MA Ramrattan, SM Smorenburg, DJ Gouma, and MA Boermeester The incidence and nature of in-hospital adverse events: a systematic review Qual Saf Health Care 17 2008 216 223
4. J Ovretveit Does improving quality save money? 2009 Health Foundation London
5. C Vincent, G Neale, and M Woloshynowych Adverse events in British hospitals: preliminary retrospective record review BMJ 322 2001 517 519
6. DM Steinberger, SV Douglas, and MS. Kirschbaum Use of failure mode and effects analysis for proactive identification of communication and handoff failures from organ procurement to transplantation Prog Transpl 19 2009 208 214
7. M Apkon, J Leonard, L Probst, L DeLizio, and R Vitale Design of a safer approach to intravenous drug infusions: failure mode effects analysis Qual Saf Health Care 13 2004 265 271
8. M Sujan, P Spurgeon, M Inada-kim, M Rudd, L Fitton, and S Horniblow Clinical handover within the emergency care pathway and the potential risks of clinical handover failure (ECHO): primary research Health Serv Deliv Res 2014 2
9. R Bloomfield, N Chozos, D Embrey, J Henderson, T Kelly, and F Koornneef Using safety cases in industry and healthcare 2012 Health Foundation London
10. P Bishop, R Bloomfield, and S. Guerra The future of goal-based assurance cases Proc Workshop Assur Cases 2004 390 395
11. I Habli, and T Kelly Process and product certification arguments: getting the balance right ACM SIGBED Rev 3 2006 1 8
12. R Hawkins, I Habli, T Kelly, and J McDermid Assurance cases and prescriptive software safety certification: a comparative study Saf Sci 59 2013 55 71
13. R. Maguire Safety cases and safety reports 2006 Ashgate Aldershot
14. Dependability Research Group University of Virginia. Safety Cases: Repository.
15. C Haddon-Cave The Nimrod review: an independent review into the broader issues surrounding the loss of the RAF Nimrod MR2 aircraft XV230 in Afghanistan in 2006 2009 The Stationery Office London
16. N. Leveson The use of safety cases in certification and regulation J Syst Saf 2011 47
17. R. Steinzor Lessons from the North Sea: should "Safety Cases" come to America? Boston Coll Environ Aff Law Rev 38 2011 417 444
18. Health Foundation Exploring the potential use of safety cases in health care 2014 Health Foundation London
19. MA Sujan, F Koornneef, N Chozos, S Pozzi, and T Kelly Safety cases for medical devices and health IT: involving healthcare organisations in the assurance of safety Health Inform J 19 2013 165 182
20. MA Sujan, F Koornneef, and U Voges Goal-based safety cases for medical devices: opportunities and challenges Comput Saf Reliab Secur 2007 14 27
21. FDA. Total Product Life Cycle: Infusion Pump Premarket Notification 510(k) Submissions. 2010.
22. Health & Social Care Information Centre. Clinical Risk Management: Its Application in the Manufacture of Health IT Systems - Implementation Guidance. 2013.
23. Health & Social Care Information Centre. Clinical Risk Management: Its Application in the Deployment and Use of Health IT Systems - Implementation Guidance. 2013.
24. M Sujan, M Harrison, A Steven, P Pearson, and S Vernon Demonstration of safety in healthcare organisations Comput Saf Reliab Secur 2006 219 232
25. International Civil Aviation Authority Safety management manual 2013 ICAO Montreal, Canada
26. UK Ministry of Defence Defence standard 00-56: safety management requirements for defence systems 2007 The Stationery Office London
27. Health and Safety Executive. Reducing Risk: Protecting People. 2001.
28. International Organization for Standardization ISO 14971:2012 medical devices: application of risk management to medical devices 2012 ISO Geneva
29. Department of Health The never events policy framework 2012 The Stationery Office London
30. Health Foundation Are clinicians engaged in quality improvement? A review of the literature on health professionals' views on quality improvement 2010 Health Foundation London