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.
In progress recommendations
Recommendation 8
Specialist multi-disciplinary centre(s) are required – a group will meet in January 2020 to advise the number of specialist centres required to ensure equity of access, the model of care, and team required
Status: In progress
The Ministry of Health has contracted with Canterbury and Waitemata District Health Boards (DHBs) to co-design a national mesh complications service model and provide options for delivery of that model. Once both proposals are received the Ministry of Health will work with ACC, and other stakeholders to finalise the model and seek the resources required to deliver the new service.
A combined implementation approach to establishment of the service will follow. The aim is still to have services incrementally established late 2021, although this will be dependent on factors such as recruitment of specialist workforce and an appropriate funding model. Credentialing for mesh removal will need to be completed prior to commencement of the service.
HealthPathways have drafted a national referral pathway for mesh complications. This will be finalised once the service design is confirmed.
Recommendation 9
Establish a credentialing committee by the end of January 2020 to recommend national standards for individual practitioners and services commencing with urogynaecology procedures – minimum standards for insertion, renewal, repair, and removal of surgery and native tissue repair will be included
Status: In progress
The Ministry of Health has secured specialist gynaecologist support to assist with the completion of the credentialing framework, which will be done alongside the group who developed the draft framework in late 2020.
The pelvic mesh removal subcommittee have met three times to finalise that component of the framework. This will be incorporated into the one overall framework comprising of two sections covering all urogynaecological procedures (mesh and non-mesh) and pelvic mesh revision/removal.
The aim is still to have the final framework published and distributed prior to the establishment of the national mesh complications service later this year.
Recommendation 10
The Ministry of Health will lead, supported by ACC, interdisciplinary education and build the capability of the required technical skills to prevent future harm and reduce the severity of existing harm – his action intends to also support the provision of removal surgery
Status: In progress
Work continues on the development of a series of online learning resources for the primary and community healthcare workforce and consumers. ACC has engaged a learning development provider to assist in the co-design and development of the resources.
A review of the Health Navigator existing online self-management resources has been completed by the consumer group. The updates developed are currently being clinically reviewed. Next to review are Health Info and Continence NZ websites.
The secondary and tertiary multidisciplinary package development is on hold due to several co-dependencies with credentialing. The risks remain the same, i.e. Clinicians may not see the need or benefit of upskilling/training and the education packages may not be ready, therefore delaying the credentialing process and the establishment of the mesh specialist centres.
Ongoing or complete recommendations
Recommendation 1
The severity of the harm from surgical mesh should be acknowledged when the report is released publicly
Status: Complete
The Ministry of Health supported the release of the report in December 2019 with the press release Report highlighting the severity of harm from surgical mesh. The Ministry’s Chief Medical and Nursing Officers (at the time) also spoke to this during an interview with Radio New Zealand.
The severity of harm was also acknowledged in press releases by:
- the Royal Australasian College of Surgeons
- the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
- ACC.
Recommendation 2
The Ministry of Health was identified as the coordinating agency for each workstream
Status: Ongoing
The Ministry of Health has taken responsibility for overall coordination of the surgical mesh work programme and workstreams.
Recommendation 3
A collaborative approach is required to respond to harm from surgical mesh, and groups that should collaborate were identified for each workstream
Status: Ongoing
A collaborative approach is being taken with broad representation involved in each workstream.
Recommendation 4
The Health and Disability Commission will promote the visibility of their national advocacy service
Status: Ongoing
The Nationwide Health and Disability Advocacy Service is a free service that operates independently from all health and disability service providers and agencies. They have a freephone 0800 555 050 and website.
Recommendation 5
Attendees will share the final report with their professional members and within agencies
Status: Complete
The report has been widely shared across the health sector by health professionals, including medical colleges, and health organisations.
Recommendation 6
The surgical mesh round table is considered an appropriate group to oversee the delivery of the workstreams – to restore trust, there was an expectation of transparent reporting and regular public updates to communicate progress
Status: Ongoing
Terms of Reference for the Surgical Mesh Roundtable have been published establishing that it is responsible for providing oversight and monitoring of the surgical mesh work programme, including the actions and recommendations arising from the Health Committee and Restorative Justice reports. The group also provides advice and recommendations to the Ministry of Health.
Public updates to communicate progress on the surgical mesh programme and workstreams continue to be published on the Ministry of Health website.
Recommendation 7
Consumers will be reimbursed when participating in the co-design of each workstream
Status: Ongoing
This principle has been established and is clear in the Terms of Reference of the groups established to date.
Recommendation 11
Professional colleges will inform and educate their members about their role in preventing and reducing harm from surgical mesh
Status: Ongoing
The professional colleges are involved in all work to date with representatives on each of the groups as well as the Surgical Mesh Roundtable. They are expected to keep their college members up to date and informed on all work being undertaken.
Recommendation 12
ACC will partner with consumer representatives to design an approach for looking back through declined mesh-related treatment injury claim – recognising those claim outcomes may not change; the process will also aim to learn where improvements can be made to the consumer experience
Status: Complete
On 30 October 2020 ACC announced the opportunity for people with declined surgical mesh claims to have these reassessed based on new cover guidance.
ACC provides regular updates on mesh claims to the Mesh Roundtable and other stakeholders on a two-monthly basis.
Recommendation 13
ACC will explore the potential to provide support services, such as counselling, while cover decisions are pending
Status: Complete
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.
Recommendation 14
ACC recognises the complex and sensitive nature of mesh claims and intends to use an approach that ensures mesh injured clients are matched to case owners with an appropriate background, experience, and skills
Status: Complete
ACC recognises the complex and sensitive nature of mesh claims and ensures clients with mesh injuries are supported by people with appropriate experience and skills. Accepted mesh claims are initially matched to a dedicated ACC case owner who will work with the client to manage their injury. The dedicated cover assessor will manage the transition of the claim to the case owner. Clients can choose if the case owner is male or female.
For clients with ongoing complex needs, they’ll stay with their dedicated case owner who will coordinate their support. If needs have stabilised and supports established, and the client is confident in their recovery, the ACC case owner will discuss with the client about whether it is appropriate to transfer them to ACC’s team management approach.
Recommendation 15
ACC will continuously improve the collation and sharing of information on injuries caused by surgical mesh with key stakeholders and agencies under its Risk of Harm reporting framework to support prevention of future harm
Status: Complete
ACC is currently refreshing its risk of harm reporting process and is working alongside the Ministry of Health, DHBs and regulatory authorities to make sure the information gathered through the claim decision process is provided to the authority responsible for patient safety for that treatment.
From 1 March 2020 ACC started capturing data in a new way and are working on how to provide this information to the right parts of the health sector to promote a learning culture and support safer treatment.
Recommendation 16
National standards of practice and the code of rights for informed consent are already in place – credentialing and training will support these to be embedded in everyday clinical work
Status: Ongoing
The credentialing framework, once finalised, will clearly outline the expected competencies for female pelvic medicine and reconstructive surgery. The framework includes use of appropriate processes to ensure informed consent and choice is provided to patients/consumers.
Recommendation 17
National information resources for mesh-related procedures should be created with consumers and include informed consent processes – Information should incorporate the product safety profile, outcomes and risks, alternative treatments available, and the informed consent process
Status: Ongoing
The patient information resource Considering Surgical Mesh to Treat Stress Urinary Incontinence is available on the Ministry of Health website. Further opportunities to improve national information resources will continue to be considered.
Waitemata DHB has also, with consumers, developed patient information booklets on treatment options for stress urinary incontinence and pelvic organ prolapse, as well as managing complications. These are available on the Waitemata DHB website.
The Health and Disability Commission have recently released a report which reinforces the need for robust informed consent processes to be in place. They have also written to DHB Chief Executives requesting an update on what mesh procedures are being performed in their DHB; is the national patient resource routinely used and if not, what is used; has the informed consent process been audited since August 2018, and the number of complaints received since then, if any.
Recommendation 18
The Ministry of Health and Medsafe will support the Government in modernising the regulation of medical devices in New Zealand, including the development of new legislation (Therapeutic Products Bill) to improve device safety
Status: In progress
An exposure draft of the Therapeutic Products Bill was released for public consultation in December 2018. The Bill will repeal and replace the Medicines Act 1981 to ensure acceptable safety, quality, and efficacy or performance of therapeutic products across their lifecycle to protect public health and welfare. Get more information on our Therapeutic products regulatory regime page.
The team undertaking the work presented to the Mesh Roundtable in April 2021. The Bill is very technical with some different approaches needed for the devices in comparison to those used for medicines.
Recommendation 19
The Ministry of Health will identify the actions and supports required to meet the need for a collaborative approach to safety systems and culture
Status: In progress
The Ministry of Health is collaborating with other health sector agencies to ensure that the lessons from surgical mesh inform wider improvements to safety systems and culture.