An essential 'health check' for all medical devices

Clinical Medicine

Volumn 3, Issue 6, 2003, Pages 543-545

  Spencer, S A ^a,b   Nicklin, S E ^b   Wickramasinghe, Y A ^b   Nevill, A ^b   Ellis, S J ^b  

^a KEELE UNIVERSITY   (United Kingdom)

^b UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE   (United Kingdom)

Author keywords

CE mark; Clinical governance; Medical device; Research governance; Risk assessment

Indexed keywords

CLINICAL PRACTICE; DEVICE; GOOD CLINICAL PRACTICE; HEALTH CARE QUALITY; HUMAN; MEDICAL INSTRUMENTATION; MEDICAL RESEARCH; PATIENT CARE; PERFORMANCE; REVIEW; RISK MANAGEMENT; RISK REDUCTION; SAFETY; STANDARDIZATION; TOTAL QUALITY MANAGEMENT;

EID: 0346251179     PISSN: 14702118     EISSN: None     Source Type: Journal    
DOI: 10.7861/clinmedicine.3-6-543     Document Type: Review

References (12)

1. Amoore J, Ingram P. Quality improvement report: Learning from adverse incidents involving medical devices. BMJ 2002;325:272-5.
2. Her Majesty's Stationery Office. The Medical Devices Regulations 2002: Statutory Instrument 2002 No 618. www.hmso.gov.uk/
3. Medical Devices Agency. Information about the EC Medical Devices Directives: Bulletin No 8. 1998. www.medical-devices.gov.uk
4. Medical Devices Agency. Medical Devices Directive 93/42/EEC, 1993. www.medical-devices.gov.uk
5. Joint report of the British Paediatric Society and the Association of the British Pharmaceutical Industry. Licensing medicines for children. London: British Paediatric Association, 1996.
6. Medical Devices Agency. The CE mark: Bulletin No 2, 1999. www. medical-devices.gov.uk
7. Wickramasinghe YABD. Risk analysis of medical devices - Risk analysis form. Department of Clinical Technology, North Staffordshire Hospital NHS Trust, 2002. (PDF available from www.partnersinpaediatrics. org.uk, see papers and reports/other reports.)
8. British Standards Institution. BS EN ISO 14971: Medical devices - Application of risk management to medical devices. Geneva: ISO, 2001.
9. Department of Health. Governance in the new NHS: Controls Assurance Statements 1999/2000: Risk management and organisational controls. London: DH, 1999.
10. Department of Health. Controls Assurance Standard for Medical Devices Management. www.doh.gov.uk
11. Department of Health. Research governance framework for health and social care. London, DH, 2001.
12. Department of Health. Governance arrangements for NHS research ethics committees. London, DH, 2001.