mhra - november 2006 medical device management are single-use devices a special case? alun tomkinson...
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MHRA - November 2006
Medical Device ManagementAre single-use devices a special case?
Alun TomkinsonConsultant Otolaryngologist, University Hospital Wales, Cardiff.
Project Lead, Single-use Instrument Surveillance Programme (SISP)
SISPSMTLSMTLWORLA
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
MHRA - November 2006
Background
MHRA - November 2006
Single-use or Reusable?
2001
SEACReusable - Possible Prion transmission
riskEvidence - theoretical but significant
DoHSingle-use - Instruments failure risk
Evidence - conflicting but serious concern
Background
MHRA - November 2006
Crude Pedw(HES) Analysis Early 2002
Year N n %95%
Confidence Interval
1996 4090 53 1.3 1.0 1.7
1997 3653 55 1.5 1.2 2.0
1998 3318 47 1.4 1.1 1.9
1999 3056 66 2.2 1.7 2.7
2000 3045 59 1.9 1.5 2.5
2001 948* 42 4.4 3.3 5.90
1
2
3
4
5
1996 1997 1998 1999 2000 2001
Return to Theatre
*Partial Year as PEDW Dataset incomplete
Background
MHRA - November 2006
Prospective Audit - Nov 01 - Apr 02
Procedures 190Malfunctions 37
Patients injured by malfunction 2
Reported failure of 20% or 1 in 5
Background
Cause (SMTL): Design Failure
MHRA - November 2006
Instrument Analysis
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
MHRA - November 2006
Instrument Companies
Two Examinations
2002
invitations
5 companies
2004
OJEC specific advert
6 responded
MHRA - November 2006
Instrument Analysis
Baseline standard
Reusable instruments studied in detail
MHRA - November 2006
Instrument Companies
Requested
Complete Tonsillectomy SetsInstruments packaged as for sale & use
Multiple samples of each instrument
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Instruments 2004
Company Reusable l m n o p q
% unacceptable 0 0 27 20 13 40 33
5/6 had defective instruments
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
MHRA - November 2006
Instrument Analysis - Laboratory
Original
Single-use
Deep curve to lock onto teeth
No curve, instrument will slip
Design Defects
MHRA - November 2006
Instrument Analysis - Laboratory
ReusableNever Changes
Poor consistency
a
Single-useVariability in key dimensions
MHRA - November 2006
Lessons
Lesson 1.
Compare prospective single-use to the
original.
Specification to procure against
Standard to judge against if problems
occur
MHRA - November 2006
Company Audits
MHRA - November 2006
Company Audits
Examined
Company Structure
Design & Construction Process
Design & Quality Control Processes
Documentation+ others
MHRA - November 2006
Company Structure
L M N O PQ
X Y Z
MHRA - November 2006
Company Audit 2004
ProblemsTechnical 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)
MHRA - November 2006
Technical drawings
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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
MHRA - November 2006
Company Surveillance
MHRA - November 2006
Single-use Instrument Surveillance Programme (SISP)
SelectionQuality (not cost) based - Reusable
ProcurementBest Instruments (Design & Consistency)
Best Design & Quality Control Systems
Agreed & Locked the Standard
MHRA - November 2006
Single-use Instrument Surveillance Programme
ProceduresAll Tonsil & Adenoid Surgery in Wales
Single-use InstrumentsFunction rated by surgeon
Defective instruments returned to SMTL compared to agreed spec.
Complication rates
SISP (2003 - 06)
MHRA - November 2006
Single-use Instrument Surveillance Programme
Instrument Complaints
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
40.0%
45.0%
50.0%
Feb-03 Mar-03 Apr-03 May-03
Jun-03 Jul-03 Aug-03
Sep-03 Oct-03 Nov-03 Dec-03 Jan-04 Feb-04 Mar-04
Date of Procedure
Num
ber
of
Pro
ble
ms (
% o
f pro
cedure
s)
Gag & Blade
Draffin rods
Yankauer
Eves Snare
Lucs
Den. Browne
Birkett
Gwynne Evans
Negus
Knot pusher
Currette
Diathermy
SISP 2003 - 04
MHRA - November 2006
Single-use Instrument Surveillance Programme
Problems
Instrument failure
Unforeseen problems
Eg. Gag & Blade
Change of specification by supplier
SISP (2003 - 06)
MHRA - November 2006
Instrument Failure
Gag & Blade
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
MHRA - November 2006
Medical Device ManagementAre single-use devices a special case?
MHRA - November 2006
Re usable
Reusable InstrumentSUPPLIER Reusable Instrument
Purchase
Problem
Use
MHRA - November 2006
Re usable
Manufacture
Manufacturer Hospital
Sterilised & Packaged
Surgeon
Patient
Theatre personnel
Surgeon/SisterNon sterile
Finished Product
Factory Checks
Finished Product
Packaged
Design
Supplier Theatre personnel
MHRA - November 2006
Single-use
Manufacture
Manufacturer Hospital
Theatre personnel
Sterilised & Packaged
Surgeon
Patient
Surgeon/SisterNon sterile
Finished Product
Factory Checks
Finished Product
Packaged
Design
Supplier Theatre personnel
MHRA - November 2006
Single-use
Sample Instrument
SUPPLIER
MHRA - November 2006
Single-use
Instruments
Instruments
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No Problem
MHRA - November 2006
Single-use
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Poor Consistency
MHRA - November 2006
Single-use
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Design Change or Failure / Change of Manufacturer
MHRA - November 2006
Single-use
Selection
Procurement
Evaluation
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
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
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
MHRA - November 2006Conclusions