Episcissors-60 Reduces the Risk of Injuries

NHS Innovation Accelerator Fellow: Dharmesh Kapoor

Overview

Episcissors-60 are simple to use surgical scissors, which guide an accurate mediolateral episiotomy at 60 degrees, thereby removing human error in estimating episiotomy angles during childbirth. There is evidence that this product is safer than letting women tear spontaneously in first normal births5

The angle of the cut is important, and the Royal College of Obstetricians and Gynaecologists (GTG29) recommends that cuts need to be at an angle of 60 degrees to reduce the incidence of poor patient outcomes, reconstructive surgery and litigation costs. Studies have shown that Episcissors-60 offer substantial NHS cost savings2, whilst potentially transforming outcomes for thousands of mothers each year4,5

Episcissors-60 are intended to be used by midwives or obstetricians trained in the mediolateral episiotomy technique, and can be used in secondary care midwifery and obstetric units, primary care midwifery units or birth centres, as well as during home births.

Description

Developed by a team led by Professor Robert Freeman at Plymouth Hospitals NHS Trust, Episcissors-60 are adapted surgical scissors made from stainless steel with 5- centimetre long tungsten carbide cutting blades.  The device has a guide-limb angled at 60 degrees to the blades, mounted on the blade pivot point. During use, the guide limb is positioned by the clinician to be vertically in line with the perineal midline and pointing towards the anus to ensure an episiotomy cutting angle of 60 degrees. The guide limb is flexible to accommodate the head of the baby at crowning and maintain the cutting guide position. Two versions of the device are available, based upon operator preference:

  • A straight version with blades in line with the handles, designed to give an incision point directly at the posterior vaginal fourchette.
  • An angled version with blades at 150 degrees to the handles, designed to give an incision point horizontally offset by approximately 1 centimetre from the posterior vaginal fourchette.
Straight Version Angled Version     

Both versions of Episcissors-60 are designed for right-handed use: there is no left handed version available. The device can form part of a reusable equipment birthing pack, following standard device reprocessing procedures.

Medinvent supplies Episcissors-60 in the UK, and providers may purchase the product via the NHS Supply Chain website https://my.supplychain.nhs.uk/Catalogue/product/fcc454.

The Case for Change

Each year 30,000 women across the UK suffer obstetric anal sphincter injuries (OASIS). This is often due to misjudgement of the angle of surgical cuts during childbirth.

Episiotomy angle is a crucial factor in causation of OASIS. Sutured episiotomies angled too close to the midline (<30 degrees) or too far from the midline (>60 degrees) fail to unload the perineum sufficiently and predispose women to OASIS. OASIS is a serious complication and is the single most important cause of anal incontinence (AI) in women in the UK.

With over 15% of all births in England needing an episiotomy, there is a clear unmet clinical need to reduce incidences of OASIS and to protect mothers from avoidable harm, which can otherwise have a devastating impact on their lives.

The cost to the NHS of OASIS is approximately £57 million annually including repair (£1,625 per patient), elective caesarean sections and litigation (a recent High Court Judgement awarded £1.6 million to a single case of OASIS caused by an acutely angled episiotomy).

Progress to Date

The innovator, Dharmesh Kapoor, Consultant Obstetrician and Gynaecologist at the Royal Bournemouth Hospital, was awarded NHS Innovation Accelerator Fellow status for Episcissors-60 in 2015.  Since that time, Dharmesh has focused upon:

  • Building the evidence base for Episcissors-60  by working with Croydon University Hospital
  • Raising awareness of OASIS (and Episcissors-60) through scientific learning events and exhibitions
  • Working with NHS England to secure an Innovation and Technology Tariff, operational from April 2017 (see below).
  • Partnering with the Department of Health (DH) so that Episcissors-60 are now available at a discount to the NHS on the NHS Supply Chain, with DH receiving royalties in international sales.

Episcissors-60 are the subject of a NICE medtech innovation briefing (MIB33), endorsed as the only CE marked device for guided episiotomy.

The Royal College of Obstetricians and Gynaecologists (RCOG) has also recognised the need to decrease the number of occurrences of OASIS and have developed a care bundle designed to standardise intrapartum perineal management. This includes the use of Episcissors-60 to reduce variation in the way that episiotomy is performed.  The development of this bundle is supported by the Health Foundation and by a collaboration between the RCOG, the Royal College of Midwives, the London School of Hygiene and Tropical Medicine, and the Croydon Health Services NHS Trust.

Impacts / Outcomes

Approximately 15% of all births in England require an episiotomy. OASIS occur in 6.1% of first vaginal births in the UK (NICE MIB33).

In effectiveness trials, Episcissors-60 have been found to reduce the incidence of OASIS by 43% (range 20-50%), an absolute reduction in the OASIS rate from 5.6% to 3.2%.3  There are also intangible benefits from Episcissors-60, such as the promotion of safety culture and avoided costs from legal claims in some cases.

York Health Economics Consortium produced an economic impact analysis in August 2017, which found a return on investment for the NHS in Year 1 of 3,056%.2  This positive return on investment is a conservative estimate and will extend beyond the first year, providing Episcissors-60 continue to be used for episiotomies in subsequent years. It does not include the cost of usual episiotomy scissors, complications of OASIS, caesarean sections for subsequent births, the value of time off work for patients needing surgery or any costs from legal claims.

Also, the NHS Innovation Accelerator has developed an Impact Modelling Tool to provide an indication of the savings that could be achieved through implementation of Episcissors-60. This is included in the NHS England Episcissors-60 Toolkit (May 2017) – see Resources below.

Testimonials

I would not want to deliver in a London hospital that does not use the Episcissors-60.

Patient

 

After the introduction of Episcissors-60, we found that 86% of doctors and 100% of midwives were able to achieve post-suturing angles between 40 degrees and 60 degrees… user feedback showed high rates of satisfaction in using Episcissors-60 among all users.

Van Roon et al (2015), International Journal of Women’s Health

 

Of all the improvements in obstetrics in the past 20 years, this truly stands out for its simplicity and effectiveness.

Professor of Obstetrics, Dublin

 

NHS Innovation and Technology Tariff/Reimbursement

Episcissors-60 have been identified by NHS England as one of six innovations eligible for the Innovation and Technology Tariff (ITT), operational from April 2017, to facilitate adoption. As part of the ITT, providers are directly reimbursed by NHS England at £16 per patient use, based on recorded evidence of use. This reimbursement, which is based on an estimate of 20 uses, should cover the costs of the purchase of Epscissors-60 within the first year.

For each period of activity claimed, providers must report, on a monthly basis where possible, the following minimum data set:-

  • Number of mothers requiring surgical repair after obstetric and sphincter injury for the previous quarter.  This is only required for the first claim.
  • Number of guided mediolateral episiotomies undertaken using Episcissors-60 or other approved devices during this period of reporting. Providers will be paid based on this number.
  • Number of mothers requiring additional surgical repair after undergoing guided mediolateral episiotomy during this period of reporting.
  • Average discharge time of mothers who have received a guided mediolateral episiotomy using Episcissors-60 or another approved device.

Reports should be returned to Arden GEM CSU (FinanceQueries@ardengemcsu.nhs.uk).  A reporting template is available.

These requirements are set out in the NHS England Innovation and Technology Tariff 2017 to 2019 Technical Notes and the NHS England Episcissors-60 Toolkit (May 2017) – see resources below.

Uptake Nationally and Locally

Episcissors-60 have been adopted by 50 NHS trusts1, including Liverpool Women’s NHS Foundation Trust; Wrightington, Wigan and Leigh NHS Foundation Trust; Norfolk and Norwich University Hospitals NHS Foundation Trust; the Royal Free London NHS Foundation Trust; University College London Hospitals NHS Foundation Trust; Frimley Health NHS Foundation Trust; University Hospitals Coventry and Warwickshire NHS Trust; Northampton General Hospital NHS Trust; and Chelsea and Westminster Hospital NHS Foundation Trust.

The AHSN for the North East and North Cumbria has supported an independent clinical assessment involving the following organisations:-

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • City Hospitals Sunderland NHS Foundation Trust
  • South Tees NHS Foundation Trust
  • North Cumbria University Hospitals NHS Trust, and
  • Northumbria Healthcare NHS Foundation Trust.

Support for the study and economic evaluation will be provided by Newcastle University, with the final report anticipated by December 2018. It is anticipated that the project will be an exemplar of network-wide collaboration, significantly reducing OASIS rates.

National Clinical or Policy Priorities Addressed

This innovation aims to address maternal health, safety of care, and efficiency.

Further Resources

http://www.medinvent.co.uk/phone/index.html
http://www.medinvent.co.uk/episcissors-60-video.html

NHS England Episcissors-60 Toolkit (May 2017)

NHS England Innovation and Technology Tariff 2017 to 2019 Technical Notes

 

Contacts for Help and Advice

Dharmesh Kapoor, NHS Innovation Accelerator Fellow dharmesh.kapoor@medinvent.net

Carol Nicholson, Deputy Director of Innovation, AHSN for the North East and North Cumbria carol.nicholson@ahsn-nenc.org.uk

Rachel Turnbull, Project Manager, AHSN for the North East and North Cumbria rachel.turnbull@ahsn-nenc.org.uk

 

Evidence Summary (as presented in NHS England Episcissors-60 Toolkit)

  • Comparison of obstetric anal sphincter injuries in nulliparous women before and after introduction of Episcissors-60 at two hospitals in the UK (Van Roon et al, 2015, International Journal of Women’s Health), indicated that most healthcare professionals achieved post-suturing episiotomy angles of between 40 degrees and 60 degrees; a statistically significant reduction in OASIS in nulliparous spontaneous vaginal deliveries; and high rates of satisfaction among all users (Episcissors-60 rated as ‘good’ to ‘very good’ by 84% of users)5.
  • Obstetric anal sphincter injuries after episiotomy: systematic review and meta-analysis (Verghese et al, 2016, International Urogynecology Journal): this research study concluded that the pooled analysis of a large number of women undergoing vaginal birth, most of who were nulliparous, indicates that mediolateral episiotomy (MLE) has a beneficial effect in prevention of OASIS. An accurately given MLE might have a role in reducing OASIS and should not be withheld, especially in nulliparous women4.
  • National Institute of Health and Care Excellence (NICE) conducted an evidence review of Episcissors-60 (published July 2015). At the time of writing, the evidence base was limited to one small comparative study and two non-comparative case series comprising a total of 105 women.  These found that Episcissors-60 successfully cut at the intended 60 degree episiotomy angle and produced a post-delivery suture angle between 30 and 60 degrees. However, all three studies had methodological limitations11
  • Episcissors-60 have now been acknowledged in the RCOG guidance as being effective in achieving the correct angle. This is the apex guidance on the topic in the UK. RCOG GTG29, peer-review draft October 201412.

References

  1. NIA Fellow, June 2017.
  2. York Health Economics Consortium – Economic Impact Evaluation Case Study: Episcissors-60
  3. Lou YY, Thakar R, Sultan AH, Ajay B. Does Episcissors-60 reduce the incidence of obstetric anal sphincter injuries (OASIS)? Croydon University Hospital, UK. BJOG An International Journal of Obstetrics and Gynaecology, June 2016.
  4. Verghese TS, Champaneria R, Kapoor DS, Latthe PM. Obstetric anal sphincter injuries after episiotomy: systematic review and meta-analysis. Int Urogynecol J, 2016 27: 1459-1467.
  5. Van Roon et al. Comparison of obstetric anal sphincter injuries in nulliparous women before and after introduction of the Episcissors-60 at two hospitals in the United Kingdom. International Journal of Women’s Health, 2015: 7 949-955.
  6. Sawant G, Kumar D. Randomized trial comparing episiotomies with Braun-Stadler episiotomy scissors and EPISCISSORS-60 ®. Med Devices (Auckl). 2015; 8:251-254.
  7. Kapoor DS, Thakar R, Sultan AH. Obstetric and sphincter injuries: review of anatomical factors and modifiable second stage interventions. Int Urogynecol J 2015; 26:1725-1734.
  8. Freeman RM, Hollands HJ, Barron LF, Kapoor DS. Cutting a mediolateral episiotomy at the correct angle: evaluation of a new device, the Episcissors-60. Medical Devices: Evidence and Research, 2014: 7 23-28.
  9. Patel R, Ubale S. Evaluation of the angled EPISCISSORS-60 ® episiotomy scissors in spontaneous vaginal deliveries: A case series. Med Devices (Auckl). 2014; 7:253-6.
  10. National Institute for Health and Care Excellence (NICE), Clinical Guidance [CG190], Intrapartum care for healthy women and babies. Last updated: February 2017.
  11. Episcissors-60 for guided mediolateral episiotomy: NICE Medtech innovation briefing (July 2015): https://www.nice.org.uk/advice/mib33
  12. Royal College of Obstetricians and Gynaecologists (RCOG) Guidance [GTG29], Peer Review Draft, October 2014.

 

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