Te Kāhui Oranga ō Nuku information for members

National Credentialling Framework: Pelvic floor reconstructive, urogynaecological and mesh revision and removal procedures

We are very much aware that the formal release by the MOH of the National Credentialling Framework for Pelvic floor reconstructive, urogynaecological and mesh revision and removal procedures in June, together with the ministry’s request for urogynaecology surgical data has caused concerns amongst RANZCOG Fellows. We thought it may be helpful and somewhat reassuring if we provided a brief history of RANZCOGs involvement in this matter.

RANZCOG has been an active participant in both providing clinical guidance on the use of surgical mesh and in the various activities government initiated meetings and workshops held in Australia and New Zealand to address mesh related concerns. RANZCOG has formally acknowledged the harm caused to women from the use of mesh and has sought to be an active participant in the solutions.

In 2007 RANZCOG developed its guideline “Polypropylene vaginal mesh implants for vaginal prolapse” and in 2014 its “Position statement on midurethral slings”. Both of these documents have been regularly updated as evidence regarding the use of mesh in urogynaecological surgery has emerged.

As a consequence of emerging international concerns regarding mesh products, in December 2017, Medsafe removed from supply in New Zealand all surgical mesh products for treatment of POP via transvaginal implantation and a single incision mini-sling for the treatment of SUI.

On 24 September 2018 the Ministry wrote to district health boards (DHBs) asking them to undertake the following actions:

assess surgeons undertaking urogynaecological surgical mesh procedures against credentialling guidance developed by the Australian Commission on Safety and Quality in Health Care

ensure rigorous informed consent processes that include understanding of the associated risks.

From November 2018 to January 2019, the Ministry of Health conducted a public survey of consumers, family and whānau harmed by surgical mesh. This led to Diana Unwin, Chair in Restorative Justice being commissioned in June 2019, to co-design, deliver and evaluate a restorative approach to surgical mesh harm. Various organisations, including RANZCOG, participated in the impacts and action planning workshop.

In Dec 2019 the report entitled “Hearing and Responding to the Stories of Survivors of Surgical Mesh” was released.

This report included a number of actions agreed to by stakeholder representatives in response to the harms including:

“To establish a credentialing committee by the end of January 2020 to recommend national standards for individual practitioners and services commencing with urogynecology procedures. Minimum standards for insertion, renewal, repair and removal surgery and native tissue repair will be included.”

It was agreed that the Roundtable group which included broad representation, including two RANZCOG nominated fellows, would oversee implementation of the actions agreed. This group has met regularly since its formation in 2020.

To achieve this a credentialing working group was established with representation from RANZCOG fellows and urologists. Oversight was provided by the MOH and the Mesh Roundtable. RANZCOG has consistently advocated for government controls to be limited to those involving surgical mesh and for other urogynaecological procedures to be covered by local credentialing, all be it under a strengthened framework.

In late 2021 the MOH released a draft version of the mesh Credentialing Framework for RANZCOG feedback and endorsement. This document was reviewed in detail by the fellows who had been part of the credentialing working group and Te Kāhui Oranga ō Nuku executive. Written feedback was provided stating our unwillingness to endorse the document 

Our concerns related specifically to:

the inclusion of non-mesh procedures in the framework

the undue emphasis on surgical numbers

the limitations of current data systems to provide prospective detailed surgical and follow up data

the need for urogynaecology quality control and credentialing to be embedded in a strengthened overall credentialing framework

the need for a pathway for introduction of novel surgical procedures

Following this feedback, in February 2022 the Vice-chair of Te Kāhui Oranga ō Nuku and the fellows from the credentialing working group met with the CMO of MOH to further elaborate on our concerns.

Following this the MOH requested that RANZCOG circulate to all fellows a request to complete a survey on urogynaecological surgical procedures carried out between 1 January 2019 and 31 December 2021 to help establish a baseline for future credentialing. This was not an approach recommended by RANZCOG.

RANZCOG feedback to MOH has been that this would be challenging for many fellows to complete, apart from mesh procedures, given the pressures on workforce at present, the impact of covid on surgical volumes, and the general lack of robust quality registers in many units. We are reassured by the MOH that this data is will not be used to look at individual surgeon performance, but rather to understand urogynaecological surgical volumes and outcomes over this time period.

While the data will not be used for surgeon credentialing at this time, the data you collect/submit will be helpful to you when the formal urogynae credentialing process commences. We encourage you to provide the data that you are reasonably able to. It may be for some services this is provided as unit level data. The MOH understand that there will be data shortfalls and that volumes will have been impacted over the last couple of years by the covid pandemic.

In April 2022 another version of the National Credentialling Framework was sent to RANZCOG. This version had addressed some but not all our concerns. Absolute surgical volumes had been changed to indicative volumes but inclusion of non-mesh urogynaecological procedures remained part of the framework. We stated:

“While we would be prepared to support the current version of the document, we believe it could be further strengthened and improved.”

An interim version of the framework has now been made public. RANZCOG concerns have been formally acknowledged. The MOH’s intention is to revise the framework (if required) based on the credentialing experience over the first 12 months. We are informed that an implementation plan has been drafted with an estimated three-month timeframe to develop the resources and guidelines that will support the process of credentialing.

For further information on the progress against mesh actions, including establishment of a credentialing framework see MOH mesh updates website.

Since the emergence of concerns related to the use of mesh in urogynaecological surgery it has been very difficult to plan and deliver surgical care for women with urogynaecological problems. While we still have some concerns about the now published mesh credentialing we believe after our most recent meeting with the MOH and newly appointed Chair of the credentialing committee, Dr Johnathan Christiansen, that this committee will have an opportunity to further refine the framework prior to its roll out.

We are hopeful that the committee, which includes RANZCOG representation, will uncover its shortfalls, and its roll out will ultimately lead to improvements in the care of women with urogynae surgical needs. We will continue to advocate for changes, to the inclusion criteria for procedures, for a strengthening of data collection systems and updating of the overall New Zealand National Credentialing Framework.

Updated
14 July 2022