Ngā korero a ngā mōrehu – he urupare
The Ministry of Health, in collaboration with other health sector agencies, is continuing to progress work on the actions agreed in the report Hearing and Responding to the Stories of Survivors of Surgical Mesh published in December 2019.
Activities since the last May 2020 update include:
Credentialing (Report action #9)
As noted in the last update, the Ministry of Health established a Credentialing Committee in January 2020 in response to action #9 in the report. The principle underpinning this action is to enhance quality assurance processes to ensure appropriate skills and training of clinicians and services undertaking Pelvic Floor reconstructive surgery and urogynaecological procedures, including the implantation and removal of surgical mesh. One of the Credentialing Committee’s tasks is to provide advice on the credentialing of urogynaecology procedures and how this can be further strengthened.
In June a panel was convened by the Committee to understand the process undertaken by nine DHBs to assess surgeons undertaking urogynaecological surgical mesh procedures for stress urinary incontinence (SUI). The panel consisted of a DHB Chief Medical Officer (Chair), two gynaecologists, one urologist, and a consumer, with support from the Ministry of Health.
The panel reviewed the DHBs’ approach, benchmarking against the credentialing guidance developed by the Australian Commission on Safety and Quality in Health Care as requested by the Director-General of Health in September 2018.
The purpose of this was to understand the opportunities and challenges for surgeons and DHBs to achieve credentialing in the New Zealand context, and to aid in the development and implementation of a sustainable, local credentialing framework for all pelvic floor and reconstructive surgical procedures (both mesh and non-mesh).
Key findings included:
- All DHBs were guided by the Australian credentialing document and are substantially meeting the credentialing standards
- The process to confer credentialed status varies between DHBs. Where credentialing is viewed as a quality improvement opportunity, it has led to system and process improvements.
- The number of surgeons performing procedures for SUI involving mesh has decreased and the numbers of procedures being performed are in decline across the country
- There has been improvement in informed consent processes in many DHBs, although there is variability in the choice being offered to women to treat SUI (including conservative treatment and non-mesh sling procedures)
- The methods and amount of outcome data collected is also variable, with limited collection of long-term outcomes (ie, after six months) and patient reported outcome measures (PROMs).
- Some DHBs have established multi-disciplinary team meetings to discuss treatment options and plans.
Further information is being gathered from all DHBs to clarify the findings alongside requests to share their policies and procedures.
These findings were incorporated into a report that was considered by the Credentialing Committee which met on 14 August 2020.
Specialist services (report action #8)
A specialist services group was also convened in January 2020 to advise on a model of care, the expertise required, and the number and location of specialist multidisciplinary centres for those who experience mesh complications. This will be a national service available to residents of all DHBs.
Focus in recent months has been on data and information collation. One aspect of this has involved engaging with the Queensland Pelvic Mesh Service (QPMS) which commenced on 1 April 2019. Key learning from the QPMS has included the importance of co-designing the service with consumers and ensuring a strong multidisciplinary team. They have found the involvement of psychologists, social workers, physiotherapists, occupational therapists, nurses, pain management specialists etc to be equally important as that of surgeons.
The Ministry of Health has also established a working contact with Scotland which recently announced their intention to establish a Complex Mesh Removal Surgical Service.
Physiotherapy
The next meeting of this group is currently being scheduled to discuss the information gathered to-date, consider a proposal for the number and potential sites for specialist services and agree next steps to establish these services.
Education and Harm Prevention (report action #10)
This component of the mesh programme is closely aligned with credentialing and the initiation of specialist services.
A small steering group from ACC, the Ministry of Health and a Consumer representative (Terms of Reference for this group are available) have progressed this work stream since the last update. This has involved discussions with the QPMS in regard to the education and training provided prior to the commencement of that service.
The introduction of an event detection and management system embedded into primary health care patient management systems is currently being explored. The system would identify where alternatives to surgical mesh could be suggested, detect complications early post-surgery and educate clinicians and consumers.
The next steps for this workstream are to expand membership of the group, eg: to include physiotherapy, nursing and medicine, to agree on content and education delivery methods, and create the interdisciplinary education packages. There are three inter-related approaches that will be adopted for the packages:
- Pre-implantation - covering knowledge of; patient selection and diagnostic assessment, mechanical characteristics of specific mesh devices, conservative treatments as the first line of treatment and as an alternative to surgical mesh, referral pathways, patient information including risks and benefits of both mesh and non-mesh procedures.
- Post-implantation – signs and symptoms of potential complications, managing intra-operative and post-operative complications, appropriate diagnostic investigations, referral for further assessment, and pain management advice including non-pharmacological pain management,
- Explantation – mesh excision, including complex removal, patient selection and follow-up care.
The main aim is to prevent and reduce the incidence and severity of harm.
ACC has agreed to fund up to $290,000 for the development of the education/training packages. It is hoped a draft programme will be developed and consulted on by mid-December for roll out in the first half of 2021.
Looking back at declined ACC treatment injury claims (Report action #12)
ACC and consumer representatives designed a three-phase ‘Look Back’ process that is now complete. This was initially undertaken as a targeted approach on 70 previously declined claims, which is approximately 20% of all declined mesh claims.
The purpose of this Look Back was to identify themes in the decisions to inform updated cover guidelines for surgical mesh injuries. ACC has now worked with an External Advisory Group to agree the new guidelines, which are informed by the latest medical evidence including a literature review completed by the
The Look Back also provided an opportunity to identify improvements to the customer experience through the cover assessment process. Several improvements have already been made. For example, all new mesh claims are now assigned to experienced specialist cover assessors who are in contact with the client throughout the process, and some administrative steps have been removed. More improvements will happen over the coming months.
ACC is continuing to work with consumer representatives to determine the next steps for clients with declined claims to have their claim reviewed based on the latest cover guidance.
Pre cover support (Report action #13)
ACC is unable to provide support services while cover decisions are pending. ACC has commissioned explorative customer insight research to identify further improvements throughout the cover process, and these will be applied as appropriate. Initial findings from this research show the relevance of restorative justice for treatment injury claims. ACC is committed to working with the cross-agency group to support the development of restorative practices in the health sector.
Case owner matching (Report action #14)
ACC is currently implementing a new case management system that includes improvements to the way claims are matched to case owners. This will ensure that all existing mesh claims are matched to case owners with appropriate experience for the claim, and according to the level of support the client needs to manage their injury and recovery.
Risk of Harm reporting (Report action #15)
The purpose of Risk of Harm reporting is to provide information to support the prevention of harm to patients by the health sector
ACC updated its risk of harm policy in April 2020 to report the ‘belief of risk of harm to the public’ arising out of treatment injury and related claims, and to share injury prevention information.
ACC is working alongside Ministry of Health, DHBs and registration authorities (eg the Medical Council of New Zealand) to update its reporting process to make sure the relevant information is provided to the authority responsible for patient safety for that treatment. That is, to ensure that the information is provided more directly to those who could prevent the injury happening again.
Surgical Mesh Roundtable (Report action #6)
The Surgical Mesh Roundtable met on 3 July 2020 and continues to provide oversight and monitoring of the surgical mesh work programme. Topics covered at this meeting included:
- Credentialing work stream
- Education and training work stream
- Specialist services work stream
- Data and registers
- ACC ‘Look Back’ on declined claims
The next meeting of the Roundtable is scheduled for 4 September 2020.
Evaluation of the restorative approach
An evaluation of the restorative approach to hear and understand the stories of those harmed by surgical mesh commenced in May 2020. The evaluation is being led by researchers from the Diana Unwin Chair in Restorative Justice, Victoria University of Wellington.
The research team had hoped to complete the evaluation and provide a report to the Ministry of Health by mid-2020, but the COVID-19 pandemic has delayed their ability to meet these timelines. The researchers have now finished collecting information from mesh injured people and their families, health professionals and representatives of the agencies that were identified as being responsible for repairing and preventing harm from surgical mesh. They will be analysing the information over the coming months, aiming to provide an independent report, which will be released publicly, to the Ministry of Health by the end of October 2020.
Release of Baroness Cumberlege report: First Do No Harm
We acknowledge and welcome the release of the report, First do No Harm, by England’s Independent Medicines and Medical Services Safety Review chaired by Baroness Cumberlege.
The Review was announced in February 2018 by the then Secretary of State for Health and Social Care and was tasked to examine how healthcare systems have responded to concerns raised by patients and families about three medical interventions:
- The hormone pregnancy test Primodos
- The anti-epileptic drug Sodium Valproate
- Surgical mesh
The report makes a number of recommendations for the healthcare system as a whole, as well as specific recommendations relating to surgical mesh.
The Ministry notes that many of the themes from the Review align with those identified in Ngā korero a ngā mōrehu – he urupare, and we are considering where there are recommendations and actions that we could learn from.
We recommend that all read the Report which is available at: https://www.immdsreview.org.uk/
Next update
The next update will be provided in November 2020.