1. MHRA - November 2006 Medical Device Management Are single-use devices a special case? Alun Tomkinson Consultant Otolaryngologist, University Hospital Wales, Cardiff. Project Lead, Single-use Instrument Surveillance Programme (SISP ) SISP SMTL WORLA

2. MHRA - November 2006 Single-use experience Instrument Analysis 2 detailed laboratory examinations (tonsil instruments) Company Audits 2 site audits of suppliers Instrument Surveillance Near 4 years of continuous surveillance

3. MHRA - November 2006 Background

4. MHRA - November 2006 Single-use or Reusable? 2001 SEAC Reusable - Possible Prion transmission risk Evidence - theoretical but significant DoH Single-use - Instruments failure risk Evidence - conflicting but serious concern Background

5. MHRA - November 2006 Crude Pedw (HES) Analysis Early 2002 YearNn% 95% Confidence Interval 19964090531.3 1.01.7 19973653551.5 1.22.0 19983318471.4 1.11.9 19993056662.2 1.72.7 20003045591.9 1.52.5 2001948*424.4 3.35.9 *Partial Year as PEDW Dataset incomplete Background

6. MHRA - November 2006 Prospective Audit - Nov 01 - Apr 02 Procedures190 Malfunctions37 Patients injured by malfunction2 Reported failure of 20% or 1 in 5 Background Cause (SMTL) : Design Failure

7. MHRA - November 2006 Instrument Analysis

8. MHRA - November 2006 Single-use instruments Fundamentals Surgeons & Instruments Innate familiarity and confidence Single-use Instruments Any one instrument must function exactly as expected must be: precise replica of original Every instrument is identical must have: good design control must have: good quality control

9. MHRA - November 2006 Instrument Companies Two Examinations 2002 invitations 5 companies 2004 OJEC specific advert 6 responded

10. MHRA - November 2006 Instrument Analysis Baseline standard Reusable instruments studied in detail

11. MHRA - November 2006 Instrument Companies Requested Complete Tonsillectomy Sets Instruments packaged as for sale & use Multiple samples of each instrument

12. MHRA - November 2006 Instruments 2004 Company Reusable lmnopq % unacceptable002720134033 5/6 had defective instruments

13. MHRA - November 2006 Instrument Analysis 2 Problems Poor Design Did not know what made instruments fit for purpose Poor Consistency Could not make two instruments the same

14. MHRA - November 2006 Instrument Analysis - Laboratory Original Single-use Deep curve to lock onto teeth No curve, instrument will slip Design Defects

15. MHRA - November 2006 Instrument Analysis - Laboratory Reusable Never Changes Poor consistency Single-use Variability in key dimensions

16. MHRA - November 2006 Lessons Lesson 1. Compare prospective single-use to the original. Specification to procure against Standard to judge against if problems occur

17. MHRA - November 2006 Company Audits

18. MHRA - November 2006 Company Audits Examined Company Structure Design & Construction Process Design & Quality Control Processes Documentation + others

19. MHRA - November 2006 Company Structure LMNOPQ XYZ

20. MHRA - November 2006 Company Audit 2004 Problems Technical drawings in design / quality process (5/6) Ignored detailed specification in OJEC (3/6) No functional testing (3/6) Poor Change control & Risk analysis (removed/added) (4/6) CE mark (avoid 3rd party inspection) (4/6) No changes from 2002 despite serious defects (2/6) Misleading information (3/6)

21. MHRA - November 2006 Technical drawings

22. MHRA - November 2006 Lessons Lesson 1. Compare prospective single-use to the original. Lesson 2. Understand the suppliers processes Effective design & quality control will correlate with reliability of instruments

23. MHRA - November 2006 Company Surveillance

24. MHRA - November 2006 Single-use Instrument Surveillance Programme (SISP) Selection Quality (not cost) based - Reusable Procurement Best Instruments (Design & Consistency) Best Design & Quality Control Systems Agreed & Locked the Standard

25. MHRA - November 2006 Single-use Instrument Surveillance Programme Procedures All Tonsil & Adenoid Surgery in Wales Single-use Instruments Function rated by surgeon Defective instruments returned to SMTL compared to agreed spec. Complication rates SISP (2003 - 06)

26. MHRA - November 2006 Single-use Instrument Surveillance Programme Instrument Complaints SISP 2003 - 04

27. MHRA - November 2006 Single-use Instrument Surveillance Programme Problems Instrument failure Unforeseen problems Eg. Gag & Blade Change of specification by supplier SISP (2003 - 06)

28. MHRA - November 2006 Instrument Failure Gag & Blade

29. MHRA - November 2006 Lessons Lesson 1. Compare prospective single-use to the original. Lesson 2. Understand the suppliers processes Lesson 3. Monitoring or reporting system essential 1 & 2 alone won’t identify all problems

30. MHRA - November 2006 Medical Device Management Are single-use devices a special case?

31. MHRA - November 2006 Re usable Reusable Instrument SUPPLIERSUPPLIER Purchase Problem Use

32. MHRA - November 2006 Re usable Manufacture Manufacturer Hospital Sterilised & Packaged Surgeon Patient Theatre personnel Surgeon/Sister Non sterile Finished Product Factory Checks Finished Product Packaged Design Supplier Theatre personnel

33. MHRA - November 2006 Single-use Manufacture Manufacturer Hospital Theatre personnel Sterilised & Packaged Surgeon Patient Surgeon/Sister Non sterile Finished Product Factory Checks Finished Product Packaged Design Supplier Theatre personnel

34. MHRA - November 2006 Single-use Sample Instrument SUPPLIERSUPPLIER

35. MHRA - November 2006 Single-use Instruments No Problem

36. MHRA - November 2006 Single-use Instruments Poor Consistency

37. MHRA - November 2006 Single-use Instruments Design Change or Failure / Change of Manufacturer

38. MHRA - November 2006 Single-use Selection Procurement Evaluation

39. MHRA - November 2006 Single-use Selection Understand the reusable instrument Use the reusable as the standard Get expert advice (supplier may know little) Create a detailed and explicit advert

40. MHRA - November 2006 Single-use Procurement Procure to the set standard Request documentation (or visit) Agree a standard and lock it Get good legal advice Consider penalties for breech

41. MHRA - November 2006 Single-use Evaluation Period Advise users to: Report ALL suspect failures to company & MHRA Compare to standard Collect evidence: Take photographs DO NOT return product to the company Keep physical evidence or Send to MHRA

42. MHRA - November 2006 Conclusions