mhra - november 2006 medical device management are single-use devices a special case? alun tomkinson...

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


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


Background


Single-use or Reusable?

2001

SEACReusable - Possible Prion transmission

riskEvidence - theoretical but significant

DoHSingle-use - Instruments failure risk

Evidence - conflicting but serious concern

Background


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


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


Instrument Analysis


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


Instrument Companies

Two Examinations

2002

invitations

5 companies

2004

OJEC specific advert

6 responded


Instrument Analysis

Baseline standard

Reusable instruments studied in detail


Instrument Companies

Requested

Complete Tonsillectomy SetsInstruments packaged as for sale & use

Multiple samples of each instrument


Instruments 2004

Company Reusable l m n o p q

% unacceptable 0 0 27 20 13 40 33

5/6 had defective instruments


Instrument Analysis

2 Problems

Poor Design

Did not know what made instruments fit

for purpose

Poor Consistency

Could not make two instruments the

same


Instrument Analysis - Laboratory

Original

Single-use

Deep curve to lock onto teeth

No curve, instrument will slip

Design Defects


Instrument Analysis - Laboratory

ReusableNever Changes

Poor consistency

a

Single-useVariability in key dimensions


Lessons

Lesson 1.

Compare prospective single-use to the

original.

Specification to procure against

Standard to judge against if problems

occur


Company Audits


Company Audits

Examined

Company Structure

Design & Construction Process

Design & Quality Control Processes

Documentation+ others


Company Structure

L M N O PQ

X Y Z


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)


Technical drawings


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


Company Surveillance


Single-use Instrument Surveillance Programme (SISP)

SelectionQuality (not cost) based - Reusable

ProcurementBest Instruments (Design & Consistency)

Best Design & Quality Control Systems

Agreed & Locked the Standard


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)



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



Problems

Instrument failure

Unforeseen problems

Eg. Gag & Blade

Change of specification by supplier

SISP (2003 - 06)


Instrument Failure

Gag & Blade


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


Medical Device ManagementAre single-use devices a special case?


Re usable

Reusable InstrumentSUPPLIER Reusable Instrument

Purchase

Problem

Use


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


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


Single-use

Sample Instrument

SUPPLIER


Single-use

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

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Instruments

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Instruments

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Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

No Problem


Single-use

Instruments

Instruments

Instruments

Instruments

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Instruments

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Instruments

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Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Instruments

Poor Consistency


Single-use

Instruments

Instruments

Instruments

Instruments

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Instruments

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Instruments

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Instruments

Instruments

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Instruments

Instruments

Instruments

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Instruments

Instruments

Design Change or Failure / Change of Manufacturer


Single-use

Selection

Procurement

Evaluation


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


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


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

mhra - november 2006 medical device management are single-use devices a special case? alun tomkinson...

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