Device advice - Issue 3

Issue 3 - 12 December 2013

Thanks for your input

PHARMAC received a great response from our consultation on Applying the PHARMAC model for medical devices management seeking input from the sector on the key considerations we need to keep in mind when developing our approach to medical devices management.

The consultation closed on 29 November and we have received over 60 responses, including information we gathered when we were out and about.

PHARMAC held nine forums around the country to outline the consultation and gather feedback from groups about key issues for national management of hospital medical devices.

We found this an excellent opportunity to hear from you in person and gather information help us develop our policies and processes going forward. It was encouraging to see such a wide range of people interested in this work, including clinical DHB staff, procurement teams, clinical product coordinators, clinical engineers and IT teams – to name just a few. There was also a strong representation from medical device industry suppliers – with which we held a special workshop – as well as other interested groups in the health sector.

PHARMAC has also recently attended a number of sector conferences, spoken to many DHB groups – clinical and non-clinical – and a range of other sector organisations.

We wanted to thank everyone who took the time to come along to the various forums and meetings, and those who made a formal submission. It is vital that we have heard from those involved with medical devices at the coal-face in DHBs about what the most important considerations are.

We aim to develop processes that improve national consistency in the treatment of patients, provide for appropriate variation where needed and improve health outcomes from the money spent on medical devices.

Example of key themes

A preliminary review of the information we’ve gained through the various consultations and meetings, shows a number of key themes have emerged. These include – but are certainly not limited to – considerations around:

• One size does not fit all
• Compatibility and interaction between devices, between IT and devices, and between DHB devices and those used by organisations outside of DHBs
• Usability of products chosen
• Guaranteed supply chain
• ‘Whole of life’ cost of a product, not just the initial cost of purchase (attached consumables, supporting services, maintenance and reliability of devices)
• Capital equipment is different from consumables
• Necessity of training and support for product use
• Flexibility for local need
• Sustainability – including wastage
• Retaining capability within DHBs for implementation of device decisions
• The importance of clinical advice in our decision-making
• The importance of preserving innovation and the ability to move quickly on new and emerging technology
• Appropriately managing recalls
• Ensuring devices are fit for purpose and have the appropriate clinical evidential support for their use

As mentioned above, this is not an exhaustive list, but an example of some issues that were repeatedly raised in meetings and submissions.

Next steps

We are now considering all the information we have gathered through this latest consultation. This will be reviewed alongside the input we gained through our previous consultations on the medical devices clinical engagement framework, the wider PHARMAC Operating Policies and Processes Decision Criteria Review, and the HBL-led consultation on the implementation of the Finance, Procurement and Supply Chain – all of which sought feedback on issues pertinent to the development of our approach to medical devices management.

We intend to publish summaries of each of the forums we held during the current consultation. These will be available on our website shortly.

We will analyse all of the information we’ve received and use this to help us shape our proposed direction, which we will consult with you on in the first part of 2014. A full summary of submissions to this consultation will also be published.

PHARMAC aims to have a functional framework for medical devices management in place by mid-2015, with the range of devices being actively managed by PHARMAC increasing over time. This will be working towards full budget management, with a capped budget agreed by the Minister of Health and DHBs, sometime in the future.

For your interest, you can also find the submission summaries of each of the previous consultations.

If you have any further questions about the devices consultation, please email: devices@pharmac.govt.nz.

Update on PHARMAC’s links with other health sector activity

We are continuing to work alongside Health Benefits Limited (HBL), which is implementing the Finance, Procurement and Supply Chain Business Case in DHBs, and other organisations such as healthAlliance, whose work intersects with ours.

While PHARMAC’s organisation design does not fall within the scope of HBL’s work to implement the FPSC Business Case, as part of HBL’s consultation on this work, we have received feedback from the sector on our proposed organisational structure for interim procurement. We will take this information into account alongside the feedback from PHARMAC’s own consultations.

For more information on PHARMAC’s role in this process, please contact us.

Interim Procurement Project

As we advised you in our last newsletter, following consultation with the sector, PHARMAC chose 11 initial product categories for national procurement of hospital medical devices. The first three categories of products were chosen for immediate activity: wound care, sutures and a subcategory of orthopaedic implants covering spine, trauma and maxillofacial products.

But we remain open to approaches about other categories of products where national agreements could be beneficial to DHBs. Following such an approach, we are now also looking to negotiate national pricing for laparoscopic hospital medical devices. We discussed this opportunity with HBL and the Procurement Leadership Team (made up of DHB regional procurement representatives) and it was decided we should go ahead.

Agreements could potentially cover abdominal laparoscopic trocars for all patient requirements, disposable laparoscopic instruments including graspers, scissors, clip applicators, insufflation needles, specimen retrieval bags, and suction/irrigation equipment.

Following a Registration of Interest for suppliers we received 32 proposals for wound care products, and are in negotiation with a number of suppliers currently, with more to follow in the first quarter of 2014.

We have just issued consultations on the laparoscopic equipment and one of the wound care agreements. These consultations close on 24^th December 2013.

We are discussing potential agreements with suppliers of sutures, and have also invited proposals from orthopaedic suppliers for spine, trauma and maxillofacial products.

Details about the framework we are using for all of our interim procurement activity.

Any updates to our activity will also be posted.

We will also commence work, during the interim procurement period, on the eight other initial categories previously identified:

• Anti-embolism stockings
• Disposable sterile instruments
• Hand hygiene
• Interventional cardiology
• Mechanical compression devices and consumables
• Sterile surgical gloves
• Sterilisation wrap, tray liners and associated consumables
• Thermometers

Initially, the national agreements will be discretionary for DHBs to purchase from, with pricing listed on the Schedule. We will consult with clinicians and other stakeholders if this changes in the future.

Keeping you informed

We will regularly be updating all interested groups about the progress of the project.

Feel free to circulate this newsletter to anyone you think might be interested in this work.

You are welcome to contact us directly at any time with proposals, suggestions or concerns.

Email us: devices@pharmac.govt.nz or give us a call: 04 460 4990

You can also find all of our medical devices information on our website.

Other PHARMAC business

If you would like information about other PHARMAC activity, you can also sign up to receive one of our other newsletters like Inpharmation to keep up-to-date with how this work might affect you. There are also regular updates on the HML web pages.

You may be interested in PHARMAC’s activity over the past year and you can read this in our Annual Review [PDF, 938 KB].

If you want to stay in touch with the review of all PHARMAC’s Operating Policies and Procedures go to: https://www.pharmac.govt.nz/about/operating-policies-and-procedures