Comprehensive list consultation update

Pharmac is close to having a comprehensive list of medical devices used by Health New Zealand Hospitals. 

Pharmac has been building a comprehensive list of all medical devices currently used in public hospitals as it works to improve the way medical devices are managed in New Zealand.

Following seven weeks of consultation, we’re currently considering your feedback. 

Pharmac consulted on the comprehensive list from 10 February to 31 March 2025, and received a range of feedback, says Pharmac’s Director of Medical Devices, Catherine Epps.

Working with health sector leaders

Pharmac’s Strategic Medical Devices Advisory Group (SMDAG) held its quarterly meeting on Thursday 27 March.

Pharmac works with groups of experts to provide advice and recommendations, as needed. Advisory groups give targeted advice on specific issues referred to them.

SMDAG guide and support Pharmac’s work in the hospital medical devices delivery programme. The group is made up of a combination of leaders from across the districts of Health NZ- who between them have clinical, operational, and support services expertise.

Items raised at the meeting included:

• an update on Pharmac’s leadership and consumer engagement
• an update on the comprehensive list of medical devices consultation
• the role of Pharmac’s interim Medical Devices Advisory Group and
• Pharmac’s understanding of the medical devices landscape and how different lists are used by hospital ward staff.

Director of Medical Devices, Catherine Epps, says that Pharmac appreciates the contributions of SMDAG members.

“We are grateful for the SMDAG members’ thoughtful contributions to our work, including sending our medical devices consultation through their networks. We are looking forward to continuing our productive relationship with SMDAG members throughout 2025 as we work towards implementing the Hospital Medical Devices List,” Epps says.

Contracts 101 - International certifications 

Did you know that Pharmac agreements require suppliers to hold the right certifications before their medical devices can be listed on the Pharmaceutical Schedule?

To be listed on the Pharmaceutical Schedule a medical device must: 

• have a notification on the Web Assisted Notification of Devices (WAND) database
• be manufactured to ISO or TGA or CE or FDA standards and approved by the relevant regulatory agency
• Comply with current Standards New Zealand or industry codes of practice applicable to the relevant medical device
• operate a Quality Management System that complies with the requirements of ISO 9001 or ISO 13485.

As part of any procurement process, Pharmac will require suppliers to provide information that demonstrates compliance with these requirements. 

These requirements ensure that medical devices that are included in Pharmac contracts meet the right certifications for Health New Zealand hospitals.  

If there are any changes to the certification details for contracted medical devices, suppliers need to contact their Pharmac Contract Manager. 
 

Supply Issues 

Notification of Supply Issues

As part of Pharmac’s contracts, suppliers have a contractual obligation to report any potential, or actual, failure to supply a medical device.

This means that if a supplier is aware that there may be disruption to the medical devices they supply, they need to let their Pharmac contract manager know. It’s important that potential disruptions of medical devices are flagged early, so that Pharmac can work with the supplier to find a solution.

If a supplier can’t meet their obligation to supply a medical device, they also need to report this.

Reports need to include five things:

1. the supplier product code and description,
2. the reason for the failure to supply and when it occurred;
3. average usage in the previous 12 months by Hospital;
4. stock on hand, and when the issue will be resolved;
5. if the supplier, or another NZ supplier, has an alternative product available and the price difference.

If you have any questions about how to supply issues, please get in touch with your Contract Manager, or send an email to contractmanagement-devices@pharmac.govt.nz

Health System Catalogue

The Health System Catalogue (HSC) is an important source of product data, and suppliers will have noticed Pharmac used it to support its comprehensive list consultation in February to identify products in use for addition to the Pharmaceutical Schedule.

We required less information from suppliers that had to up to date products catalogues on the HSC during this consultation.
 
We continue to encourage suppliers to maintain their information in the HSC as we will continue to use this as an important reference set for product information, simplifying information exchange between suppliers, HNZ and Pharmac.

Device Advice: Tell us what you think 

In this month’s edition of Device Advice, we’re asking readers to give us their feedback.

We want to know what you think of Device Advice – is the information useful, timely, and engaging? Are there things you want to see more of, or less of?

Your feedback will help us make sure that the content in Device Advice is useful and relevant to your work. 

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