Implementing Medical Device Regulation and Maintaining Patient Safety

1. Implementing Medical Device Regulationand Maintaining Patient Safety Name Nicola Lennard Date October 2011

2. EU Regulatory System investigation action accredit audit compliance ERs safety, performance • Notified Body • quality systems • design dossier • clinical data (literature, C/I) Competent Authority post market surveillance serious adverse events European market

3. Essential Requirements • devices must be designed in such • a way that…. “the they will not compromise • the clinical condition or SAFETY of • patients…..provided that any RISKS • which may be associated with their • use constitute acceptable RISKS • when weighed against the benefits….” • …..devices must achieve the performances • intended by the manufacturer….. • MDD: Annex 1

4. EU Regulatory System investigation action accredit audit compliance ERs safety, performance • Notified Body • quality systems • design dossier • clinical data (literature, C/I) Competent Authority post market surveillance serious adverse events European market

5. Adverse Incident Investigation • Investigation of 10,280 reports received in 2010 resulted in the following actions:- • 100 medical device alerts issued • 129 notifications to authorities in EU member states • 403 manufacturer field safety corrective actions • 293 other manufacturer field actions • 294cases requiring the provision of advice on safer device use or improved staff training • 730 manufacturer undertakings to improve designs, manufacturing processes and quality systems

7. Specific Safety Initiatives • Surgical Diathermy • Endometrial Ablation • Endovascular Aneurysm Repair • Vaginal Tapes • MOM Hip Replacements

8. Causes of adverse incidents

9. Device Education

10. Specialist Webpages