Dispatch Desk

Surgical mesh pause remains as registry built; device regulation moved back to ‘in progress’ after law repeal

The Ministry says 16 of 19 mesh actions are implemented, but a national registry and an updated medical device law are still being worked on.

Source: Ministry of Health
Surgical mesh pause remains as registry built; device regulation moved back to ‘in progress’ after law repeal
The Beehive / Ballofstring via Wikimedia Commons

The Ministry of Health says most actions from its 2019 response to surgical mesh harm are now embedded, but the pause on using mesh for stress urinary incontinence remains in place while a national registry is set up and device regulation is reset.

In an update on the 19 agreed actions, the Ministry reports 16 are “completed” or “implemented”. Three remain in progress: a multidisciplinary education programme (Action 10), regulation of mesh and other devices (Action 18), and work to support a collaborative safety system through the Health Quality and Safety Commission’s System Safety Strategy (Action 19).

Action 18 has been moved back to “in progress” after the repeal of the Therapeutic Products Act. The Ministry and Medsafe will support the Government to modernise medical device regulation through new legislation, with the status of the Medical Products Bill to be monitored by the Ministry.

The pause on using surgical mesh for stress urinary incontinence, recommended by the Surgical Mesh Roundtable in August 2023 due to ongoing safety concerns, remains. The Roundtable set four conditions before it would consider lifting the pause:

  • Mandatory credentialling of clinicians under the National Credentialling Framework
  • Structured informed consent using a patient decision aid
  • Patient case discussion at a multidisciplinary meeting
  • Establishment of a national mesh registry for female pelvic floor procedures involving mesh

The Ministry says the first three conditions are in place. The fourth — a national mesh registry — is being developed by Health New Zealand. Once all four are established, the Roundtable will consider whether the pause can be lifted.

No timeframe was provided for when the registry will be operational or when the new medical device legislation might be introduced.

This article was originally written by AI. You can view the original source here.