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Achieving Innovation at
Scale in the NHS:
EPISCISSORS-60
ALEX FISHER
DIRECTOR, ADVANCED GLOBAL HEALTH LTD
EPISCISSORS-60
FIRST SCISSORS DESIGNED TO GIVE AN ACCURATE MEDIOLATERAL EPISIOTOMY; PATENT OWNED
BY PLYMOUTH HOSPITALS NHS TRUST
OBSTETRIC ANAL SPHINCTER INJURIES
(OASIS)
•30,000 new cases each year in UK
•6% in first vaginal births
•Leading cause of anal incontinence in women (9:1 F:M)
Incidence
• £1625 per case for repair + postoperative care
• £48.75 million each yearDirect costs
• 25% of women choose elective caesarean delivery (extra £1100 per
birth; £4.9 million each year)
• £2500 per year/person for fecal incontinence
Indirect costs
LITIGATION COSTS
o PERINEAL TRAUMA IS THE 4TH HIGHEST
REASON FOR CLAIMS MADE IN OBSTETRICS
OVER 10 YEARS.
o £31MILLION IN LEGAL PAYOUTS ALONE
o OASIS BEING MOOTED AS A PATIENT SAFETY
INDICATOR
o £1.6 MILLION DAMAGES FOR OASIS DUE TO
AN ACUTELY ANGLED EPISIOTOMY.
“WHERE EPISIOTOMY IS INDICATED, THE MEDIOLATERAL
TECHNIQUE IS RECOMMENDED, WITH CAREFUL ATTENTION TO
ENSURE THE ANGLE IS 60 DEGREES AWAY FROM THE MIDLINE
WHEN THE PREINEUM IS DISTENDED. (D)”
SUMMARY OF CURRENT PRACTICE: HOW GOOD ARE
WE AT ‘EYEBALLING’ EPISIOTOMY ANGLES?
• 1/3rd doctors & midwives drew episiotomies>400
• (Tincello 2003)Draw on paper
• 15% cut 58-62 degrees
• 37% cut 55-650 when asked to cut at 600
• 63% cut below or above this range(Naidu 2014)
Cut on paper
• No midwife & 22% doctors performed episiotomies with suture angle
>400 (Andrews 2005)
• 43% episiotomies were not mediolateral/lateral (Fodstad 2014)
Actual patients
“SPECIAL SCISSORS DESIGNED TO ENSURE AN INCISION ANGLE OF 60 DEGREES
HAVE BEEN SHOWN TO BE EFFECTIVE IN ACHIEVING THE CORRECT ANGLE29,30.
EVIDENCE LEVEL 3”
RESULTS FROM UK HOSPITALS THAT COMPLETELY
REPLACED ALL OLD EPISIOTOMY SCISSORS WITH
EPISCISSORS-60
o 20% REDUCTION IN CHILDBIRTH ANAL SPHINCTER INJURIES
(OASIS) AT POOLE AND HINCHINGBROOKE HOSPITALS (VAN ROON ET
AL. 2015)
o 40-50% REDUCTION AT CROYDON UNIVERSITY HOSPITAL (LOU, 2016)
o 40-50% REDUCTION AT ROYAL FREE AND BARNET HOSPITALS
(MYERS, 2016, UNPUBLISHED AUDIT).
EPISCISSORS-60 BY NHS ACUTE TRUSTS
PURCHASED/LOOKING TO PURCHASE = 63
TRIALLING AND DISCUSSING INTERNALLY = 15
DECLINED = 34
NO RESPONSE = 31
BARRIERS TO ADOPTION - 1
DIFFICULT IN MAKING A COGENT BUSINESS CASE
- SINCE THESE INJURIES ATTRACT REIMBURSEMENT VIA PAYMENT BY RESULTS, THE HOSPITAL
WOULD LOSE INCOME IF THE INJURY RATE WENT DOWN.
SOLUTION
- ITT TO PROVIDE FUNDS TO BUY SCISSORS
- MAKING CCG’S AWARE OF THE COST IMPLICATIONS TO THEM OF CONTINUED HIGH RATES OF
OASIS (DETAILED IN THE UNIVERSAL GUIDANCE FROM NHS ENGLAND)
BARRIERS TO ADOPTION – 2
SINGLE USE INSTRUMENTATION
- ONE-THIRD OF ENGLISH TRUSTS USE SINGLE-USE BIRTH PACKS
- HAVE OFF-SITE SHARED STERILISATION FACILITIES
- REPORT A 40% REUSABLE INSTRUMENT LOSS RATE OVER 5 YEARS FROM THESE FACILITIES
SOLUTION
- ?
BARRIERS TO ADOPTION – 3
MIDWIVES CONCERNS ABOUT IT LEADING TO RISING EPISIOTOMY RATES
SOLUTION
- STRESSING THAT OVERALL PERINEAL BURDEN REMAINS UNCHANGED; I.E. WE ARE SWAPPING
FIRST AND SECOND DEGREE TEARS THAT OCCUR ANYWAY IF EPISIOTOMIES ARE NOT
PERFORMED
- EPISIOTOMIES DO NOT LEAD TO MORE PAIN, BLEEDING IN HEAD-TO-HEAD COMPARISONS
BARRIERS TO ADOPTION - 4
CLINICAL APATHY
- STATUS QUO IS SATISFACTORY
- NOT ENOUGH ROBUST EVIDENCE ABOUT THE SCISSORS
- NEED A RANDOMISED CONTROL TRIAL (RCT)
SOLUTIONS
- CCG’S SHOULD CHALLENGE TRUSTS TO COME UP WITH OASIS REDUCTION PLANS BY 20-50%
OTHERWISE PBR PAYMENTS SHOULD BE CURTAILED BY THIS LEVEL
- RCT WOULD COST MORE THAN REPLACING ALL EPISIOTOMY SCISSORS IN ENGLAND WITH
EPISCISSORS-60
WHY HINCHINGBROOKE DECIDED TO
ADOPT EPISCISSORS-60
A 60 DEGREE EPISIOTOMY WAS RECOMMENDED AS A WAY TO PREVENT CHILDBIRTH ANAL
INJURIES BY THE RCOG
EPISCISSORS-60 WERE MENTIONED IN THAT GUIDANCE AS BEING A FIXED ANGLE DEVICE THAT
TAKES AWAY THE GUESSWORK AND HUMAN ERROR IN TRYING TO ESTIMATE THE ANGLE AT THE
TIME OF BIRTH
“NO-BRAINER” TO PREVENT AVOIDABLE HARM
BARRIERS TO ADOPTION
MAKING THE CASE INTERNALLY FOR INVESTMENT
- WHICH BUDGET TO DIP INTO FOR FUNDS? CAPITAL OR OPERATIONAL?
- HOSPITALS WOULD LOSE INCOME IF INJURY RATE IS REDUCED
- NO INCENTIVE TO REDUCE INJURY RATE
CHANGING CLINICAL PRACTICE
- INTRODUCING THE COMPREHENSIVE SUPPORT TRAINING PROGRAMME LED TO ‘BUY-IN’
FROM THE MIDWIFERY AND MEDICAL STAFF
- REPLACEMENTS OF ALL EPISIOTOMY SCISSORS WITH EPISCISSORS-60
BENEFITS SEEN BY THE TRUST POST-
IMPLEMENTATION
- 20% REDUCTION IN CHILDBIRTH ANAL SPHINCTER INJURIES WITHIN 5 MONTHS OF
INTRODUCTION
- NOW IT HAS BECOME THE NORM
- HAS INFLUENCED NEIGHBOURING TRUSTS LIKE CAMBRIDGE TO ADOPT EPISCISSORS-60
- INNOVATION TARIFF HAS GREATLY HELPED CONVERT MANY MORE TRUSTS.

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Alex fisher, Episcissors

  • 1. Achieving Innovation at Scale in the NHS: EPISCISSORS-60 ALEX FISHER DIRECTOR, ADVANCED GLOBAL HEALTH LTD
  • 2. EPISCISSORS-60 FIRST SCISSORS DESIGNED TO GIVE AN ACCURATE MEDIOLATERAL EPISIOTOMY; PATENT OWNED BY PLYMOUTH HOSPITALS NHS TRUST
  • 3. OBSTETRIC ANAL SPHINCTER INJURIES (OASIS) •30,000 new cases each year in UK •6% in first vaginal births •Leading cause of anal incontinence in women (9:1 F:M) Incidence • £1625 per case for repair + postoperative care • £48.75 million each yearDirect costs • 25% of women choose elective caesarean delivery (extra £1100 per birth; £4.9 million each year) • £2500 per year/person for fecal incontinence Indirect costs
  • 4. LITIGATION COSTS o PERINEAL TRAUMA IS THE 4TH HIGHEST REASON FOR CLAIMS MADE IN OBSTETRICS OVER 10 YEARS. o £31MILLION IN LEGAL PAYOUTS ALONE o OASIS BEING MOOTED AS A PATIENT SAFETY INDICATOR o £1.6 MILLION DAMAGES FOR OASIS DUE TO AN ACUTELY ANGLED EPISIOTOMY.
  • 5. “WHERE EPISIOTOMY IS INDICATED, THE MEDIOLATERAL TECHNIQUE IS RECOMMENDED, WITH CAREFUL ATTENTION TO ENSURE THE ANGLE IS 60 DEGREES AWAY FROM THE MIDLINE WHEN THE PREINEUM IS DISTENDED. (D)”
  • 6. SUMMARY OF CURRENT PRACTICE: HOW GOOD ARE WE AT ‘EYEBALLING’ EPISIOTOMY ANGLES? • 1/3rd doctors & midwives drew episiotomies>400 • (Tincello 2003)Draw on paper • 15% cut 58-62 degrees • 37% cut 55-650 when asked to cut at 600 • 63% cut below or above this range(Naidu 2014) Cut on paper • No midwife & 22% doctors performed episiotomies with suture angle >400 (Andrews 2005) • 43% episiotomies were not mediolateral/lateral (Fodstad 2014) Actual patients
  • 7. “SPECIAL SCISSORS DESIGNED TO ENSURE AN INCISION ANGLE OF 60 DEGREES HAVE BEEN SHOWN TO BE EFFECTIVE IN ACHIEVING THE CORRECT ANGLE29,30. EVIDENCE LEVEL 3”
  • 8. RESULTS FROM UK HOSPITALS THAT COMPLETELY REPLACED ALL OLD EPISIOTOMY SCISSORS WITH EPISCISSORS-60 o 20% REDUCTION IN CHILDBIRTH ANAL SPHINCTER INJURIES (OASIS) AT POOLE AND HINCHINGBROOKE HOSPITALS (VAN ROON ET AL. 2015) o 40-50% REDUCTION AT CROYDON UNIVERSITY HOSPITAL (LOU, 2016) o 40-50% REDUCTION AT ROYAL FREE AND BARNET HOSPITALS (MYERS, 2016, UNPUBLISHED AUDIT).
  • 9. EPISCISSORS-60 BY NHS ACUTE TRUSTS PURCHASED/LOOKING TO PURCHASE = 63 TRIALLING AND DISCUSSING INTERNALLY = 15 DECLINED = 34 NO RESPONSE = 31
  • 10. BARRIERS TO ADOPTION - 1 DIFFICULT IN MAKING A COGENT BUSINESS CASE - SINCE THESE INJURIES ATTRACT REIMBURSEMENT VIA PAYMENT BY RESULTS, THE HOSPITAL WOULD LOSE INCOME IF THE INJURY RATE WENT DOWN. SOLUTION - ITT TO PROVIDE FUNDS TO BUY SCISSORS - MAKING CCG’S AWARE OF THE COST IMPLICATIONS TO THEM OF CONTINUED HIGH RATES OF OASIS (DETAILED IN THE UNIVERSAL GUIDANCE FROM NHS ENGLAND)
  • 11. BARRIERS TO ADOPTION – 2 SINGLE USE INSTRUMENTATION - ONE-THIRD OF ENGLISH TRUSTS USE SINGLE-USE BIRTH PACKS - HAVE OFF-SITE SHARED STERILISATION FACILITIES - REPORT A 40% REUSABLE INSTRUMENT LOSS RATE OVER 5 YEARS FROM THESE FACILITIES SOLUTION - ?
  • 12. BARRIERS TO ADOPTION – 3 MIDWIVES CONCERNS ABOUT IT LEADING TO RISING EPISIOTOMY RATES SOLUTION - STRESSING THAT OVERALL PERINEAL BURDEN REMAINS UNCHANGED; I.E. WE ARE SWAPPING FIRST AND SECOND DEGREE TEARS THAT OCCUR ANYWAY IF EPISIOTOMIES ARE NOT PERFORMED - EPISIOTOMIES DO NOT LEAD TO MORE PAIN, BLEEDING IN HEAD-TO-HEAD COMPARISONS
  • 13. BARRIERS TO ADOPTION - 4 CLINICAL APATHY - STATUS QUO IS SATISFACTORY - NOT ENOUGH ROBUST EVIDENCE ABOUT THE SCISSORS - NEED A RANDOMISED CONTROL TRIAL (RCT) SOLUTIONS - CCG’S SHOULD CHALLENGE TRUSTS TO COME UP WITH OASIS REDUCTION PLANS BY 20-50% OTHERWISE PBR PAYMENTS SHOULD BE CURTAILED BY THIS LEVEL - RCT WOULD COST MORE THAN REPLACING ALL EPISIOTOMY SCISSORS IN ENGLAND WITH EPISCISSORS-60
  • 14. WHY HINCHINGBROOKE DECIDED TO ADOPT EPISCISSORS-60 A 60 DEGREE EPISIOTOMY WAS RECOMMENDED AS A WAY TO PREVENT CHILDBIRTH ANAL INJURIES BY THE RCOG EPISCISSORS-60 WERE MENTIONED IN THAT GUIDANCE AS BEING A FIXED ANGLE DEVICE THAT TAKES AWAY THE GUESSWORK AND HUMAN ERROR IN TRYING TO ESTIMATE THE ANGLE AT THE TIME OF BIRTH “NO-BRAINER” TO PREVENT AVOIDABLE HARM
  • 15. BARRIERS TO ADOPTION MAKING THE CASE INTERNALLY FOR INVESTMENT - WHICH BUDGET TO DIP INTO FOR FUNDS? CAPITAL OR OPERATIONAL? - HOSPITALS WOULD LOSE INCOME IF INJURY RATE IS REDUCED - NO INCENTIVE TO REDUCE INJURY RATE CHANGING CLINICAL PRACTICE - INTRODUCING THE COMPREHENSIVE SUPPORT TRAINING PROGRAMME LED TO ‘BUY-IN’ FROM THE MIDWIFERY AND MEDICAL STAFF - REPLACEMENTS OF ALL EPISIOTOMY SCISSORS WITH EPISCISSORS-60
  • 16. BENEFITS SEEN BY THE TRUST POST- IMPLEMENTATION - 20% REDUCTION IN CHILDBIRTH ANAL SPHINCTER INJURIES WITHIN 5 MONTHS OF INTRODUCTION - NOW IT HAS BECOME THE NORM - HAS INFLUENCED NEIGHBOURING TRUSTS LIKE CAMBRIDGE TO ADOPT EPISCISSORS-60 - INNOVATION TARIFF HAS GREATLY HELPED CONVERT MANY MORE TRUSTS.