ADVISING THE PROFESSIONALS: THE ROLE OF MHRA
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1 Safeguarding public health ADVISING THE PROFESSIONALS: THE ROLE OF DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory Agency, UK Name Date
2 WHAT IS? Medicines and Healthcare Products Regulatory Agency Executive Agency of Dept of Health responsible for ensuring that medicines and medical devices work and are acceptably safe Slide 2
3 PERSPECTIVE needle pacemaker pregnancy test thermometer diathermy machine hip implant coronary stent ICD condom blood glucose meter MRI scanner specimen collection tube urinary catheter contact lens cholesterol test blood bag intra-uterine device anaesthetic machine 90,000 devices on market 1/25 has an implant billion UK 200 million maintenance Slide 3
4 GUIDING PRINCIPLES apply legal requirements ensure compliance but also help manufacturers SUPPORT, ADVISE CLINICIANS Slide 4
5 ADVISING CLINICIANS performance not as claimed field actions taken serious adverse events indicative trends changes/limitations in criteria for use problems instructions for use user/training issues problems Slide 5
6 EU REGULATORY SYSTEM investigation action/recall compliance ERs safety, performance Notified Body quality systems design dossier clinical data (literature, C/I) accredit audit Competent Authority European market post market surveillance vigilance Slide 6
7 LIMITATIONS VIGILANCE failure recognition non-promotion requirements difficulties professional communication differences aetiology difficulties interpretation differences EU/USA systems failure undertake trend analysis failure define corrective action trigger points Slide 7
8 REPORTING SOURCES Incident report sources as a % of total NHS Other government bodies Non-government organisations Manufacturers Overseas reporting organisations Private healthcare organisations Slide 8
9 ACTIONS investigate discuss with healthcare workers discuss with manufacturer test device advice to health service (CAS) advice on website promote field action recall (safeguard) Slide 9
10 OUTCOMES 2008: >9000 adverse events reported 100 Medical Device Alerts 571 improve design, quality systems, processes 844 field safety corrective actions 470 advice on safer use, training Slide 10
11 SPRINT FIDELIS ICD new type of lead flexibility lead conductor fracture inappropriate shocks removal from market advice to clinicians Slide 11
12 LABCOR HEART VALVES friable annular tissue endocarditis-type changes early valve failure deaths Slide 12
13 but advising satisfactorily and scientifically can be a problem.. Slide 13
14 INFORMATION TO REGULATOR launched April ,000 worldwide report September 2003 (2 further) analysis early 2004 meeting with manufacturer battery problems 2002 damage during assembly, manufacturing improved manufacturing techniques improved quality control risk 1/10,000 Slide 14
15 HOWEVER IN further premature battery depletions (87,000) further analysis by manufacturer further meeting with manufacturer weakness in battery design short circuit between internal battery components time indeterminate shorter time where substantial power consumption Slide 15
16 identify, return follow up max 3 months re-programme handheld magnet test patient education immediate follow up alternating tone lack steady tone persistent arrhythmia warm sensation, pain elective replacement (20,000 explanted 6 months) Slide 16
17 OTHER EXAMPLES Slide 17
18 ACTIONS FOR REGULATOR?random failure (1/10,000), root cause analysis consult manufacturer true facts, figures any interim actions taken consult clinician appropriate advice to clinicians/uniformity advice to patients risk/benefit analysis Slide 18
19 RISK/BENEFIT ANALYSIS failure rates (real and estimated) explant effects on mortality, morbidity, quality of life infection to re-op 2% haematomas to re-op 2.5% death 0.5-1% subgroup identification (avoid inappropriate action) costs to health service Slide 19
20 PROBLEMS no common reporting strategy determining action thresholds determining timing of action do not report/time delays time delays with analysis results obtaining numerators/denominators obtaining comparative data persuading clinicians to report/inadequate reports obtaining device for analysis determining explantation morbidity obtaining UK/ European/global consensus Slide 20
21 EVENTUAL OUTCOMES 95 confirmed failures (0.09%) 37,000 explanted worldwide only patient injury/death from explants Slide 21
22 advising clinicians and ensuring patient safety involves co-operation and communication... adverse events trends results post market studies registry information Slide 22
23 Slide 23
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