Graham
These are all the references that our Medical Device Management Committee have used for their policy on purchase and regulation of Medical Devices.
Hope they help.
References
1. Department of Health (2002) Medical Devices Management Controls Assurance October 2002 Rev:03
2. General Medical Council Ethical guidance - Good clinical care
http://www.gmc-uk.org/standards 3. Medical Devices Agency (1998) Medical Device and Equipment Management for Hospital and Community-based Organisations January 1998 DB 9801
4. Medical Devices Agency (2000) Medical Devices and Equipment: Repair and Maintenance Provision June 2000 DB 2000(02)
5. Medical Devices Agency (2001) Devices in Practice ISBN 1 84182 359 7
6. Medical Devices Agency (2001) Equipped to Care The safe use of medical devices in the 21st century October 2001
7. Medical Devices Agency (2002) Management of loaned medical devices, equipment or accessories from manufacturers or other hospitals SN 2002(17)
8. Medical Devices Agency (2001)- Medical Devices - Reporting Adverse Incidents and Disseminating Safety Warnings SN 2001(01)
9. Medical Devices Agency (2003) Reporting Adverse Incidents & Disseminating Medical Device Alerts MDA/2003/001
10. MHRA (2003) Management of Medical Devices Prior to Repair Service or Investigation DB2003(05)
11. National Audit Office (1999) Management of Medical Equipment in HNS Acute Trusts in England June 1999
12. NHS Litigation Authority (2002) CNST Clinical Risk Management Standards June 2002.
13. Nursing and Midwifery Council (2002) Code of Professional Conduct June 2002
14. PASA Trust Operating Purchasing Procedures Manual (TOPPM)
http://nww.pasa.nhs.uk/purchasing/shared/toppm//toppm.stm 15. Not used.
16. Medical Devices Agency (2001) Guidance on the Sale, Transfer of Ownership and Disposal of Used Medical Devices MDA DB9801 Supplement 2 Oct 2001
17. EN 14971:2000 Standard: The Application of Risk Management to Medical Devices
18. The Ionising Radiation Regulations 1994
19. Department of Health (2004) Standards for Better Health July 2004