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Medical Devices

Published: 23 September 2016
Revised: 21 December 2016
Revised:  31 May 20917

 

Implementation of Government Response to Report of the Health Committee on Petition 2011/102

The Health Committee has considered a petition submitted by Carmel Berry and Charlotte Korte requesting an inquiry into the use of surgical mesh in New Zealand. The petition raised several issues around the quality of surgical mesh, the standards of care for patients and the need for a surgical mesh registry.

On 1 June 2016 the Health Committee’s report was presented to the House. This included seven recommendations in three areas: the investigation of options for a surgical registry, improvement in medical practice and the role of the regulator in pre-market medical device approval. A link to the full report follows. https://www.parliament.nz/en/pb/sc/reports/document/51DBSCH_SCR69220_1/petition-20110102-of-carmel-berry-and-charlotte-korte

The Government carefully considered the Committee’s report and supported all of the Committee’s recommendations. The Government Response was tabled on 24 August 2016. A link to the Government Response follows. https://www.parliament.nz/en/pb/papers-presented/current-papers/document/51DBHOH_PAP69804_1/government-response-to-report-of-the-health-committee-on

The following table specifies each of the seven recommendations made by the Health Committee, identifying the actions to ensure the recommendations are implemented and providing a timeline for the implementation of each action.

Health Committee Recommendations and Timeline for Implementation re Surgical Mesh

Recommendation Actions Timeline
Recommendation 1: That the Government work with relevant medical colleges to investigate options for establishing and maintaining a centralised surgical mesh registry.
  1. New and comprehensive regulatory regime.
To be addressed as part of the development of the new comprehensive regulatory regime to regulate therapeutic products in New Zealand.
  1. The Government has made a series of decisions about the new regulatory regime.
Done: Information on the decisions made by Cabinet can be found at the following link http://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime
  1. The Ministry of Health will carefully consider the utility of a registry to record surgical mesh use and will consult with the relevant parties. The consultation may take place within a wider consideration of the need for medical device registries and also within the context of the development of new therapeutic products legislation. Consultation on the new regime will be wide-ranging and involve all relevant stakeholders including the medical colleges.
To be addressed as part of the development of the new comprehensive regulatory regime to regulate therapeutic products in New Zealand.
Recommendation 2: That a registry be informed by the International Urogynaecological Association classification for recording mesh surgery complications.
  1. This will be considered as part of the decision making around the options for a surgical mesh registry.
See above
Recommendation 3: That the Government suggests that the Colleges take note of the petitioners’ and others’ experiences and review best practice around informed consent for mesh procedures.
  1. Meet with relevant professional colleges to discuss the findings in the Health Committee Report.
Discussed at the Council of Medical Colleges Board Meeting on 8 December 2016

Meeting with representative from the College of Surgeons on 19 December 2016.

Meeting with representatives from RANZCOG 16 January 2017
Recommendation 4: That the Government encourages health providers to ensure that coding for mesh surgery is consistent. This should include a system to allow patients with mesh complications to be identified and monitored.
  1. Work with DHBs and other health providers to ensure the consistency of reporting procedures in regard to the use of surgical mesh is improved.
Mesh reporting included in Clinical Coding teleconference with DHB’s 20 September 2016.
Recommendations for further improvement in reporting were sent 11 October 2016.
Recommendation 5: That the Government encourages utilisation of the adverse events reporting system as applicable to medical devices.
  1. Publish article in Prescriber Update reminding prescribers of the importance of reporting adverse events, to encourage reporting.
Article in December issue of Prescriber Update
  1. Review and reformat adverse events reporting form for use by consumers to be more user friendly.
New consumer adverse event reporting form developed in early November 2016.
  1. Consumer testing of reporting form prior to implementation.
Targetted consumer testing closed 2 December 2016.

New consumer adverse event form published December 2016.
  1. Review and reformat adverse events reporting form for use by healthcare professionals.
New form developed and published December 2016.
  1. Review and reformat adverse events reporting form for use by industry
New form developed and published May 2017
  1. Prepare and publish guidance to assist users to complete reporting forms.
Guidance for consumer adverse event form and healthcare professional report form developed and published in December with new forms.
  1. Work with ACC to ensure all adverse event reports notified to ACC that relate to surgical mesh are also notified to Medsafe.
Work ongoing. Progress to date reviewed in meeting on 6 December 2016.

Agreement with ACC that additional information is to be supplied in relation to treatment injury claims received by ACC from 1 March 2017
  1. Review the location of adverse event reporting information on the Medsafe website, and ensure links are sufficient that this information can be easily found.
Information on the Medsafe website has been updated and new forms published. Links to the information and forms can be located from a number of pages on the website.
Recommendation 6: That the Government endorses the provision of ongoing education for surgeons on the use of surgical mesh and mesh removal surgery.
  1. Discuss with relevant colleges around the need for, and provision of, training in the use of surgical mesh.
Discussed at the Council of Medical Colleges Board Meeting on 8 December 2016

Meeting with representative from the College of Surgeons on 19 December 2016.

Meeting with representatives from RANZCOG 16 January 2017
Recommendation 7: That the Government considers expanding Medsafe’s role over time to assess the quality and safety of a medical device before it can be used in New Zealand. The Government is working on a new and comprehensive regulatory regime to regulate therapeutic products in New Zealand, which will replace the Medicines Act 1981. This regime will modernise the regulatory framework for all therapeutic products, including medical devices, and will be flexible enough to ensure effective control over evolving technology. As part of this there will be a pre-market assessment of medical devices requirement and as such a need to increase capacity in medical devices. To be addressed as part of the development of the new comprehensive regulatory regime to regulate therapeutic products in New Zealand.
Information on the decisions made by Cabinet can be found at the following link http://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime
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