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Medical Device Management Are single-use devices a special case?

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 ). WORLA. SISP. SMTL. Single-use experience. Instrument Analysis

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Medical Device Management Are single-use devices a special case?

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  1. Medical Device ManagementAre single-use devices a special case? Alun TomkinsonConsultant Otolaryngologist, University Hospital Wales, Cardiff.Project Lead, Single-use Instrument Surveillance Programme (SISP) WORLA SISP SMTL

  2. 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. Background

  4. 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. Crude Pedw(HES) Analysis Early 2002 *Partial Year as PEDW Dataset incomplete Background

  6. Prospective Audit - Nov 01 - Apr 02 Reported failure of 20% or 1 in 5 Cause (SMTL): Design Failure Background

  7. Instrument Analysis

  8. 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. Instrument Companies • Two Examinations • 2002 • invitations • 5 companies • 2004 • OJEC specific advert • 6 responded

  10. Instrument Analysis • Baseline standard • Reusable instruments studied in detail

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

  12. Instruments 2004 5/6 had defective instruments

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

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

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

  17. Company Audits

  18. Company Audits • Examined • Company Structure • Design & Construction Process • Design & Quality Control Processes • Documentation • + others

  19. X Y Z Company Structure L M N Q O P

  20. 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. Technical drawings

  22. 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. Company Surveillance

  24. 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. 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. Instrument Complaints Single-use Instrument Surveillance Programme SISP 2003 - 04

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

  28. Instrument Failure Gag & Blade

  29. 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. Medical Device ManagementAre single-use devices a special case?

  31. Re usable Purchase SUPPLIER Reusable Instrument Use Problem Reusable Instrument

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

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

  34. Single-use SUPPLIER Sample Instrument

  35. Single-use Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments No Problem

  36. Single-use Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Instruments Poor Consistency

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

  38. Single-use • Selection • Procurement • Evaluation

  39. 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. 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. 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. Conclusions

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