MEDICAL DEVICES REGULATORY ISSUES: RESPONSIBILITIES OF A CLINICIAN

Transcription

1 Safeguarding public health MEDICAL DEVICES REGULATORY ISSUES: RESPONSIBILITIES OF A CLINICIAN DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory Agency, UK q Name q Date

2 COSTS TO NHS q over 90,000 devices q 11.2 billion annually q 300 million maintenance q drug bill: 11.6 billion Slide 2

3 COSTS: ADVERSE EVENTS q 2 billion annually hospital stay q 20% device related q 50% preventable 60,000 50,000 40,000 30,000 20,000 10, Indemnity Costs '000 Defence Costs '000 Slide 3

4 ..devices regulations regulate manufacturers NOT clinicians Slide 4

5 EU REGULATORY SYSTEM compliance ERs safety, performance provide ifu Notified Body quality systems design dossier clinical data ifu pmcf plan pms plan clinical investigation training humanitarian use accredit audit investigation action, including recall, safeguard Competent Authority European market pmcf post market surveillance vigilance (off-label use) Slide 5

6 CLINICAL DATA....as a general rule, confirmation of conformity...under normal conditions of use and the evaluation of SIDE EFFECTS and the acceptability of the BENEFIT/RISK ratio must be based on clinical data... MDD: annex X Slide 6

7 CLINICAL DATA..clinical data must be based on either a compilation of the relevant scientific literature..or the results of all the clinical investigations.. MDD: Annex X Slide 7

8 BY EQUIVALENCE q atrial appendage plug q importance q claims identical other cardiac defect devices q differences q consequences q pms Slide 8

9 CLINICAL INVESTIGATIONS q end points to demonstrate safety, performance q NOT randomised controlled q think numbers q think timescales q think investigating centres q think claims q ensure adequate training design biocompatibility toxicology tissue safety sterilisation materials pre-market testing animal testing Slide 9

10 HUMANITARIAN USE Slide 10

11 POST-MARKET an undertaking by the manufacturer to institute and keep up-dated a POST MARKET SURVEILLANCE SYSTEM MDD: annex 2 Slide 11

12 WHAT IS PMS? q collection q investigation q evaluation q and reaction to.. data on device performance after full market approval.. Slide 12

13 PMS a late unexpected result! Slide 13

14 PMS STRATEGIES q classification q innovation q high risk anatomical situation q customer complaints, literature, media, sales feedback q long term safety/performance studies trial continuation cohort studies sub-population studies registers Slide 14

15 PROBLEMS q high cost per patient q pronged duration q lack of funding q physician decreased interest q patient decreased interest q difficulties with interpretation Slide 15

16 VIGILANCE..any deterioration in characteristics or performances, and any inaccuracies in the instruction leaflet which might have lead to death or to a serious deterioration in state of health.. any technical or medical reason resulting in withdrawal of a device.. Slide 16

17 PROBLEMS q differences in EU/ USA requirements q receiving manufacturer reports/time delay q obtaining manufacturer facts q difficulties interpretation q obtaining numerators/denominators q obtaining comparative data q obtaining device q determining action thresholds/ trend analysis q determining explantation morbidity..persuading clinicians to report!! Slide 17

18 REPORTING SOURCES Incident report sources as a % of total NHS Other government bodies Non-government organisations Manufacturers Overseas reporting organisations Private healthcare organisations Slide 18

19 CLINICAL EXAMPLE q uncoated model good results q reduction endocarditis q coating on valve (previous experience) q thrombosis, embolisation q removed from market Slide 19

20 OUTCOMES 2009: >12,000 adverse events reported q 100 Medical Device Alerts q 571 improve design, quality systems, processes q 844 field safety corrective actions q 470 advice on safer use, training Slide 20

21 Daily Mirror July 2007 Slide 21

22 CLINICIAN RESPONSIBILITY q demand clinical data to support claims q ensure trial design demonstrates end points q ensure adequate training q consider carefully before off-label use q consider humanitarian use q demand/collect pms data q report adverse events including problems ifu q read advice from regulatory/other organisations Slide 22