Transvaginal mesh short-life working group minutes: February 2021

Attendees and apologies

Present

• Terry O’Kelly (T'OK), Scottish Government (chair)
• Alan Mathers, NHS Greater Glasgow and Clyde
• Jackie Montgomery, NHS Greater Glasgow and Clyde
• Christine Hemming (CH), NHS Grampian
• Carolyn McKinlay, NHS Fife
• Roseanne McDonald, NHS National Services Scotland
• Lucie Buck, NHS Ayrshire and Arran
• Calum Morrison, NHS Ayrshire and Arran
• Safia Qureshi, NHS Healthcare Improvement Scotland
• Irene Oldfather, The Health and Social Care Alliance
• Ans Khan, NHS Lanarkshire
• Simon Nicholson, NHS Lothian
• Erin Fyfe, Scottish Government
• David Bishop, Scottish Government
• Alana Dickson, Scottish Government (note)

Apologies

• Jennifer Allen, NHS National Services Scotland
• Ibrahim Alsharaydeh, NHS Highland
• Kerry Chalmers, Scottish Government
• Margaret McKeith, The Health and Social Care Alliance
• Corinne Love, Scottish Government
• Craig Wheelans, NHS National Services Scotland
• Wael Agur, Independent
• Marthinus Roos, NHS Orkney
• Colin Fischbacher, NHS Public Health Scotland
• Michelle Watts, Scottish Government
• Heather Currie, NHS Dumfries and Galloway
• Kate Darlow, NHS Borders
• Sara Davies, Scottish Government
• Elaine Henry, Consultant Gastroenterologist
• Julie Christie, Consultant Obstetrics & Gynaecology

Items and actions

Welcome and apologies (T O’K)

The Chair welcomed everyone and noted apologies.

Declarations of interest (T O’K)

The Chair reminded Group members of the importance of maintaining accurate, thorough and up-to-date declarations of interest. The Chair asked if anyone had not completed a declaration or had any new interests to declare and stressed that any interests, not only conflicts, be included.

Minutes of meeting on 4 December 2020 (T O’K)

The Chair went through the minutes of the meeting on 4 December and asked the group to comment on any inaccuracies. The minutes were accepted as an accurate record.

Members of the Group were reminded that the content of the minutes and agenda items are confidential and not for onward circulation until approved and agreed.

It was suggested that a deputy should be identified for each Accountable Officer to ensure attendance and representation from each Health Board if the Accountable Officer could not attend for any reason.

Action point: secretariat to request a deputy from each Health Board (Erin Fyfe)

Chairman’s update (T O’K)

Public petitions committee

The Chair updated colleagues on recent activity regarding the PE1517 Polypropylene Mesh Medical Devices petition. The Chair noted that the Cabinet Secretary and the CMO wrote to the committee last November, and links to these letters were provided with the agenda. The Petition was heard again on 17 February. Following this, the Cabinet Secretary submitted an update to the Committee which was included with the papers for this meeting. The Chair noted that the paper details the initiatives (proposed and ongoing) as well as the ultimate ambition.

The Chair noted the progress that has been made and invited comments on the letter, drawing attention to the last paragraph where the Cabinet Secretary identifies that a number of the initiatives developed in response to the mesh issue could spill over into the health service and women’s health agenda more generally. This includes the importance of informed consent, decision aids and patient involvement. Group members expressed agreement and noted that though the focus of this work has been on an area of sub-specialisation in gynaecology, the issues raised should be a key focus across all specialities.

Credentialing

The Chair noted that in the letter to the Public Petitions Committee in November, the CMO outlined plans for a GMC-approved credential in mesh removal. This is in response to enquiries about training and education of surgeons not only in Scotland, but across the UK.

Since then, the Royal College of Obstetricians and Gynaecologists (RCOG), the British Society of Urogynaecology (BSUG) and the British Association of Urological Surgeons (BAUS) have been working with Health Education England, and are starting to draft a credential in mesh removal surgery. The Cabinet Secretary has written to both RCOG and the General Medical Council (GMC) to express her support for this. The importance of recognising clinical skills is the primary aim, and in doing so, credentialing will provide assurance and help build confidence in the service.

Patient pathway

The patient pathway is an important aspect in the management of mesh injured women. To that end, it is essential that we consider not only the pathway for patients receiving treatment in Glasgow, but also the stages of management prior to and after referral, as well as patients whose management remains within their base Health Board.

Patient Information and decision aids

The development of patient information and decision aids continues to receive attention.

The Chair noted that the management of complications is a national issue. As such, there is broad agreement and consensus throughout the UK by the various health services and patient representative groups that there should be a unified source of information that covers the management of mesh complications and also management of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP).

It was noted that there will be transfer of patients between services in the UK and it is important that everyone has access to the same information and decision aids.

The National Institute for Health and Care Excellence (NICE) has experience and established methodology in this area so are leading this, with input from patients groups. The documents will be sent out for consultation in due course.

Mesh database pilot (CH)

The Chair invited Christine Hemming to give an update on the Mesh Database Pilot.

Christine noted that COVID-19 activity has undoubtedly impacted the progress of the pilot but work has continued in the background.

The application to the Public Benefit and Privacy Panel was completed by NHS Digital and is due to be reviewed shortly.

An Information Governance (IG) sub-group led by Alan Bell has been created for the IG leads at the pilot sites with the aim of agreeing a unified approach for data transfer between each Health Board. NHS Digital is involved and the process is coming together on data transfer needs.

NHS GGC and Grampian are working towards creating a template and adding this onto the system so this can be used for operation notes and discharge letters, which will provide significant core data for the database. It was noted that there is a need for administrative support from each pilot site to help populate the data on the database.

Simon Nicholson has confirmed that NHS Lothian will be part of the pilot going forward, and Ayrshire and Arran are also happy to be involved.

Once everything is agreed in terms of IG, it is hoped that the pilot will start in April, and finish in September. After this, it is expected that the whole of Scotland will be part of the process.

NHS Digital are planning a workshop for the pilot sites, including in Wales and Northern Ireland. NHS Digital also propose a further workshop for clinicians outwith the pilot sites.

The Database Group’s main concern is the time for populating the database. NHS Digital have indicated that some key data may need to be submitted within 24 hours of an operation, which would have a significant impact for clinicians on their daily activities. To ensure the accuracy of data, the Group are going to suggest a weekly bulk upload, possibly undertaken by an administrator. The Group were in agreement that the 24-hour turnaround time was untenable.

It is anticipated that the database will capture all SUI and POP procedures, not just those involving mesh removal.

Christine confirmed that once clinicians upload all of their data to NHS Digital, then NHS Digital will transfer information to BSUG so it does not need to be uploaded twice.

Action point: the Chair requested that Christine Hemming provide a few bullet points and a timeline on the Mesh Data Pilot (Christine Hemming)

Patient engagement led by the alliance (IO)

The Chair invited Irene Oldfather to give an update on patient engagement.

The Alliance have carried out three patient engagement exercises. This involved two focus groups (one with women who had recent experience of surgery at the Glasgow Specialist Centre, and another with a wider group to understand what an ideal Specialist Centre would look like). Alongside these focus groups, an online survey was launched to gather as many views as possible.

The overarching themes from the patient engagement work are effective communication, patient pathways, training of clinicians and how women will be involved going forward. The Report will be published shortly and the Alliance have agreed to set up a Stakeholder Participation Group. An agenda item will be added to the next meeting to discuss how we move forward in a positive and constructive way, with a communications package supporting that.

Action point: consideration to be given to the creation of a working group dedicated to the discussion and development of a consistent patient pathway from primary care to post-operative care (Terence O’Kelly).

Case record review (T O’K)

The Case Record Review has been discussed regularly at these meetings, and has recently attracted some media coverage. The Review has been set up to address concerns raised by women that entries in their records are incorrect, with regard to full and partial removal of mesh.

A Panel has been set up with three clinicians, a moderator and an administrator. The Review is being moderated by Alison Britton, Professor of Medical Law and Ethics at Glasgow Caledonian University.

The Chair noted that the Terms of Reference have been published on the Review’s website. There is an expectation that the Accountable Officers will assist in locating and providing the records for review. In discussion, it was noted that the provision of the medical records (as long as there is a signed mandate) should not be an issue for Boards. However, some older notes may not be available and GP’s may have retained notes which are not otherwise accessible. The Chair also stressed that this process is not intended to replace other mechanisms in place so patients will still have the option to submit complaints to the Health Board and the Scottish Public Services Ombudsman, or to take legal action if they so wish.

Update on the specialist service and centre (RM)

The Chair invited Roseanne McDonald to give an update on the specialist centre from an NSS perspective. The Glasgow Specialist centre is aligned with a UK network and is one of 8 specialist centres in the UK. NHS England specialist centres are due to stand up in April. It was noted that across the UK, Glasgow is recognised as one of the leading centres. A full recruitment plan is underway in Glasgow, and they now have 4 uro-gynaecologists.

It was noted that there has been surgical activity during the pandemic, as well as improvement work on their information and operation procedures. The Service Level Agreement (SLA) is due for renewal for 2021-22. In discussion, the importance of ensuring the feedback from the Alliance’s patient engagement work is included in the revised SLA was noted.

Action point: SLA to be circulated to the group for feedback once it has been drafted (Roseanne McDonald).

Out of NHS referral (T O’K)

A copy of the paper that was presented to Board Chief Executives on the Out of NHS referral option was distributed prior to the meeting. This item was discussed by Board Chief Executives in February, following an earlier discussion that took place at the Scottish Association of Medical Directors (SAMD) meeting in January.

SAMD asked for more detail around governance, and this was covered in the recent paper. The governance section makes it clear that quality and safety of care are of paramount importance. Any centre must comply and meet the standards of quality that we would usually expect, and they must be able to show tangible evidence of this.

This is being taken forward by NSS. The risk of precedent is appreciated and action is thought to be justified on the basis of exceptionality.

The Chair invited Roseanne McDonald to give an update on the Clinical Advisory Panel (CAP). It was noted that work is continuing on the specification and it is hoped that this will conclude shortly. Once NSS receive notes of interest, they will invite providers to submit relevant evidence against the specification. All applications will be considered by the CAP. The timeline for awarding contracts will depend on the jurisdiction in which the provider operates. Additional support from a urogynaecologist, physiotherapist and a specialist nurse would be welcome on the CAP. There is a public representation on the CAP too.

Action point: Erin Fyfe to share feedback from the Chief Executive Board meeting with Roseanne McDonald (Erin Fyfe).

Action point: Roseanne McDonald to take forward suggested additions to the CAP (Roseanne McDonald).

AOCB and next meeting (T O’K)

Date of next meeting to be confirmed.