BEYOND COMPLIANCE & ODEP

KEITH TUCKER

PHIL LEWIS

RICHARD ARMSTRONG

RICHARD PARKINSON

OUR DISTINGUISHED PANEL AND

YOU!

New Orleans 2014

AIM OF MEETING FOR MANUFACTURERS

• TO PRESENT BEYOND COMPLIANCE

• TO PRESENT OUR UP GRADED ODEP HIP GUIDELEINES

• TO DISCUSS NICE FOR HIPS

• TO DISCUSS ODEP FOR KNEES

• ANYTHING YOU WOULD LIKE TO DISCUSS

• TO ARRANGE ONE ON ONE MEETINGS

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BEYOND COMPLIANCE

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WHY HAVE WE DEVELOPED “BEYOND COMPLIANCE”?

• IN SPITE OF ALL THE REGISTRY AND OTHER SYSTEMS THERE ARE STILL EXAMPLES OF UNDERPERFORMING IMPLANTS GETTING INTO THE MARKET

• WE FEEL A MORE PROACTIVE SYSTEM OF SURVEILLANCE MIGHT HAVE ADVANTAGES

New Orleans 2014

MoM Conventional Hip replacement

New Orleans 2014

REJUVENATE HIP (STRYKER) WITHDRAWN

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Novel implant

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WHY “BEYOND COMPLIANCE”?

• IF THE CE MARK IS “COMPLIANCE”

• BOA, ABHI, MHRA HAVE ALL SUGGESTED IT IS SOMETIMES APPROPRIATE FOR MANUFACTURERS TO GO

“BEYOND COMPLIANCE”

• AND SUBMIT THEIR NEW IMPLANT TO A MORE RIGOROROUS ASSESSMENT AND SURVEILLANCE

• IS NOT A RE-RUN OF THE CE MARK ASSESSMENT

New Orleans 2014

STEERING COMMITTEE CHAIR STAKEHOLDERS PETER KAY

• INDUSTRY 3 MEMBERS

• NOTIFIED BODIES

• MHRA

• PROMS

• DEPARTMENT OF HEALTH

• BASK

• BHS

• BOA

• CHAIRMAN ADVISORY GROUP

• NHS SUPPLY CHAIN

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IMPORTANT LEGAL NOTE FOR BEYOND COMPLIANCE (AND ODEP)

• NO BARRIER TO TRADE

• CANNOT BE USED IN TENDERING PROCESS

• ILLEGAL FOR A GROUP SUCH AS BOA, ABHI, ODEP ETC TO INSIST THAT BEYOND COMPLIANCE HAS TO BE USED

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WE SEE 3 FUNCTIONS FOR BC

• ADVISORY

• DATA COLLECTION

• DATA ANALYSIS AND REPORT

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THE ADVISORY GROUP AND THEIR ROLE

• INITIALLY MEMBERS OF ODEP, PLUS OTHER EXPERTS

• ADVISES MANUFACTURER AND CHAMPION SURGEONS

• SUPERVISE DATA COLLECTION

• ORGANISES DATA ANALYSIS AND REPORTING

New Orleans 2014

ADVISORY GROUP (ODEP PLUS OTHERS)

• *Colin Esler, FRCS • * Peter Kay FRCS • *Richard Parkinson FRCS • * Martin Pickford PhD ODEP

Northgate *Andrew Porteous FRCS

• Andy Smallwood NJR Founder ODEP

• *Evert Smith. BSc. FRCS • *Ian Stockley MD FRCS • *Andrew Toms MSc FRCS • *Timothy Wilton MA FRCS • *Keith Tucker FRCS (Chairman) • Phil Lewis PhD NHS supply chain,

Orthopaedic Project Manager ODEP

• Ben Bolland • *Tim Board • *Malcolm Glasgow • George McLauchlan • Ian Mcnamara • Michael Rigby • Tim Harrison

• * Denotes involvement (Past or present) with the design and introduction of a joint replacement

New Orleans 2014

BIO-ENGINEERS... HAVE AGREED TO BE AVAILABLE

GORDON BLUN RICHIE GILL JULIA SHELTON TONY MILES CHRISTINA DOYLE TOM JOYCE JOHN FISHER ANNE NEVILLE ANDREW AMIES TONY UNSWORTH

New Orleans 2014

THE ADVISORY GROUP (WORKING WITH THE MANUFACTURER AND THE SURGEONS)

• ASSESSES LEVEL OF RISK

• TAKE ADVICE WHERE REQUIRED

• ADVISE RATE OF RELEASE INTO THE MARKET

• MAINTAIN SURVEILLANCE WITH REGULAR MEETINGS

• AIM AT LINKING WITH ODEP LEVEL 3

• (ALL UNPAID)

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RISK STRATIFICATION

LEVEL 1 RISK NO MAJOR CHANGE FROM BENCHMARK PREDICATE (Eg. Line extension) Rate of introduction:- No restriction Monitoring:- Through BC process. LEVEL 2 RISK ONE CHANGE FROM BENCHMARK PREDICATE Rate of introduction:- To be decided along the tripartite lines Monitoring:- Through BC process, initially 3 monthly with tripartite meetings LEVEL 3 RISK 2 SIGNIFICANT CHANGES FROM BENCHMARK Rate of introduction:- Limited Monitoring:- Full BC programme LEVEL 4 RISK PAUCITY OF BENCHMARK DATA, > 3 MAJOR CHANGES FROM THE PREDICATE Rate of Introduction:- Limited Monitoring:- Close monitoring

New Orleans 2014

THE ADVISORY GROUP RATE OF INTRODUCTION

OPTION 1:-

STEP BY STEP OPTION 2:-

BIGGER NUMBERS, STOP AND WAIT

• MUST BE BACKED BY SURGICAL TRAINING

• APPROACH DIFFERENT FOR DIFFERENT CIRCUMSTANCES

• ADVISE REVIEWED AT JOINT MEETINGS

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THE BC PROCESS

• MAKE CONTACT

• STAGE 1 MEETING

• PREPARATION OF DATA BY MANUFACTURER

• STAGE 2 MEETING

• REPORT BY RAPPORTEURS

• CONTRACT

• UPLOAD

• RECEIVE REPORTS New Orleans 2014

CONFLICTS

• SURGEONS AND OTHER EXPERTS ALL COMPLETE A COI FORM

• MOST OF OUR EXPERTS HAVE OR HAVE HAD THEIR NAMES ASSOCIATED WITH ONE OR MORE IMPLANT

• WE NEED INTEREST! WE DISCLOSE CONFLICTS!

• MANUFACTURERS ALL HAVE THE FINAL SAY AS TO WHO BECOMES RAPPORTEUR FOR THEIR PRODUCT

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CONFLICTS NHS SUPPLY CHAIN (OWNED BY DHL)

• NHS SUPPLY CHAIN HAVE BEEN RUNNING ODEP AND THERE HAS NEVER BEEN AN ISSUE

• NHS SC DO NOT SEE ANY OF THE PRE STAGE 2 DATA SETS

• NHS SC DO NOT SEE THE ASSESSMENT FOLLOWING THE LEVEL 2 MEETING

• MOST OFTEN THE COMPANY WHO HAS COME TO SUBMIT PREFERS TO HAVE THE BENEFIT OF THE EXPERIENCE AND KNOWLEDGE OF OUR NHS SC AND NHS WALES IN THE ROOM

• IMMUNE FROM FOIs

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POTENTIAL CONFLICTS

• THE ADVISORY GROUP DO NOT RECEIVE A SALARY. THEY ARE ALL VOLUNTEERS

• THE ADVISORY GROUP ARE PAID EXPENSES BY NHS SC

• NHS SC ARE RESPONSIBLE FOR THE INDEMNITY OF THE GROUP

• THE ADVISORY GROUP WILL NOT BE PAID OR RECEIVE EXPENSES FROM INDUSTRY

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CONSENT

• OUR AMBITION TO PRODUCE A ONE SIDE CONSENT FORM FOR BC HAS BEEN REALISED

• BC IS A ‘SERVICE EVALUATION’ (NHS RESEARCH AUTHORITY)

• WE HAVE APPROVAL FOR THE USE OF PROMS

• THE PATIENTS WILL SIGN 3 FORMS AS LONG AS WE HAVE ONE CONTRACT PER IMPLANT

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DATA COLLECTION

• UNIQUE DATA COLLECTION SYSTEM

• USING NJR

• CHEAP

• A` LA CARTE DATA ADD IN

• COLLATED BY NORTHGATE

• AVAILABLE TO RAPPORTEUR MANUFACTURER AND SURGEONS

DATA COLLECTION

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DATA FLOW

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LEVELS OF DATA THAT CAN BE COLLECTED

• LEVEL 1 PATIENT DATA

• LEVEL 2 IMPLANT DATA

• LEVEL 3 PROMS

• LEVEL 4 X.RAYS AND RESULTS OF OTHER INVESTIGATIONS

• LEVEL 5 EXPLANT DATA

New Orleans 2014

DATA FROM OTHER SOURCES

• LEVEL 1 IS NJR ON NJR

• SUPPORTIVE EVIDENCE WELCOME BUT CANNOT BE A SUBSTITUTE FOR NJR

• LOOP MUST CLOSE

• REGISTRIES WITH > 90 COMPLIANCE AND COVERAGE MAY BE APPROPRIATE

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REPORT ON UPTAKE

• 17 COMPANIES ARE EITHER WAITING FOR APPOINTMENTS OR HAVE STARTED

• 8 HAVE HAD LEVEL 2 MEETINGS / PRESENTATIONS

• 3 COMPANIES ARE LOADING UP DATA AND ALL HAVE HAD THEIR FIRST REPORTS

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COMPANIES ENGAGED

• 4 OF THE BIG 5 INTERNATIONAL COMPANIES

• 5 OTHERS

• SOME ARE ABHI MEMBERS AND SOME ARE NOT

AWAITING DATES:-

4 COMPANIES

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SOME RULES!

• ALL SURGEONS MUST UNDERGO SPECIFIC TRAINING (BACK TO THE DAYS OF CHARNLEY!)

• NO PLACE FOR DABBLERS

• CHAMPION SURGEONS HAVE TO BE PREPARED TO SHARE THEIR DATA WITH THE REST OF THE GROUP

WE HOPE THAT GOOD SURGEONS WILL BE ATTRACTED TO USING BC IMPLANTS

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EXPLANTS

• WE EXPECT EVERY EXPLANT TO BE RETRIEVED

• MANUFACTURER TO COLLECT AND ORGANISE ANALYSIS

• MANUFATURER TO REPORT BACK RESULTS

• ? LOOK FOR CHANGES IN PHYSICAL AND CHEMICAL PROPERTIES

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COST

• NHS SUPPLY CHAIN PAYS FOR ADMINISTRATION AND INDEMNITY

• COMPANIES PAY FOR RENTING SPACE IN THE DATABASE

• ADVISORY GROUP NOT PAID

• NEEDS TO BE FINANCIALLY COMPETITIVE

New Orleans 2014

BEYOND COMPLIANCE “PROTECTING PATIENTS........ SUPPORTING INNOVATION”

www. Beyond compliance.org.uk

New Orleans 2014

ISAR 14 31ST MAY TO 2ND JUNE BOSTON USA

New Orleans 2014