Feedback on managing fairer access to hospital medical devices

The purpose of this consultation was to seek views on the best way to manage fairer access to devices.

The consultation opened on 5 March 2019 and closed on 28 June 2019. We received 74 submissions including from a range of DHBs, professional organisations, other health service providers, suppliers, and consumer health organisations.

Feedback received

The health sector feedback on the “managing fairer access” consultation was constructive, and we agree with many of the points raised.  We appreciate the time people took to share their views.

We received a mix of general and specific operational feedback. The key points from the general feedback are summarised below. 

Work is underway to continue to develop the operational approach, taking into account feedback received on our consultation, "Managing Fairer Access to Hospital Medical Devices". We'll be talking with a range of groups to get input into these processes. We will keep you updated as further activities are confirmed. 

Transparency is important

  • Submitters said that we must be transparent about the way we manage the list of hospital medical devices, about how expert advice informs decisions, when and why we change the list of hospital medical devices.
  • Transparency is an important focus for PHARMAC, and we agree that it will be critical when implementing fairer access to hospital devices.  We will work with the sector to develop clear and open processes for the management of hospital devices. 

Hospital medical devices are not the same as medicines 

  • Submitters said that the approach that PHARMAC applies to medicines may not work for hospital medical devices because of the differences between medicines and medical devices. 
  • We agree that there are differences between medicines and hospital medical devices that we need to consider.  The broad principles of the PHARMAC approach are general enough to be applied to medical devices, the differences in details matter.  We have developed a good understanding of these differences through all the work we’ve done so far.  Further consultation and engagement with the health sector is also planned to ensure we consider these differences when developing the operational detail and the implementation plan.

PHARMAC must use appropriate expertise 

  • Submitters said that PHARMAC should seek advice from a wide range of people with appropriate expertise in hospital medical devices including healthcare professionals; DHB operational staff and those involved in the selection and support of medical device; suppliers and consumers.
  • Decisions about medical devices will require different expertise to decisions about medicines.  The consultation feedback we received on the proposed options for seeking this advice will help us ensure we have the appropriate expertise to inform our decisions about hospital medical devices.  

Other themes that were raised in the feedback included timeliness of decision making and the need to take all relevant factors into account.  We will also continue to consider sector views on these issues as we develop the approach. 

Next steps

We will now work on further developing the approach and an implementation plan and timetable.  This work will be informed by previous sector engagement, feedback from this consultation and further engagement with the sector on operational details. 

We recognise that the changes ahead represent a significant shift for DHBs and suppliers.  We are committed to working collaboratively with the health sector and taking the time needed to ensure a smooth transition to the new arrangements. 

Once further work has been done to developing up the operational detail, we will be able to set a date for implementation.

Contact us

What would fairer access to medical devices look like?

The consultation below opened on 5 March 2019 and closed on 28 June 2019. 

Managing fairer access to hospital medical devices - consultation document

The range of devices in scope

The new approach would apply to diverse products and equipment purchased by DHBs for use in hospital or in the community.

Generally, these would be products and equipment used on, in or by a person for a diagnostic or therapeutic purpose. This includes consumable and durable products, implantables and complex equipment – everything from a cotton swab to an orthopaedic implant or home dialysis machine.

Deciding what devices to use

DHBs would decide which devices they use locally, consistent with the rules of the national medical devices list managed by PHARMAC.

 

 

PHARMAC manages the list

PHARMAC would manage the national medical devices list, including deciding which items get added or removed. Our approach would be based on a common set of considerations that are informed by expert advice and take into account the unique circumstances of each decision.

 

Anyone could request changes and contribute to decisions

Anyone could request a change to the national medical devices list, such as seeking the addition of a new device. Consultation during the decision-making process would provide everyone an opportunity to have input into decisions.

 

Using devices outside the list rules

There would be a process for considering access to devices outside the national list. The process would cover how decisions would be made in exceptional circumstances such as urgent or unusual situations.



Decisions would be informed by robust expert advice

High-quality advice would be sought from a range of sources to help us make well-informed decisions.

This would include clinical, technical and operational advice, as well as consumer advice where appropriate.

Support to implement list changes

Support would be available to DHBs to help implement changes to the national medical devices list, such as introducing a new device or changing the range of products available, where these may have a significant impact.

 

Shared responsibilities for contract and supply management

DHBs, PHARMAC and suppliers would all have responsibilities for aspects of contract and supply management that are appropriate to their roles.

 

 

We’ll all be involved in making this work

We will work closely with stakeholders, including DHBs and suppliers, to keep refining the new approach and identify what support will be needed to put it in place.