Decision to list medical devices supplied by Ultramedix Australasia Limited
We are pleased to announce the approval of a listing agreement with Ultramedix Australasia Limited for the supply of obstetrics and gynaecology products to DHBs.
In summary this will result in:
- Ultramedix’s products being listed in Part III of Section H of the Pharmaceutical Schedule from 1 May 2020 under a national agreement that all DHBs may purchase under (“Agreement”); and
- DHBs being able to continue to purchase other suppliers’ brands of obstetrics and gynaecology products.
Any changes to the original proposal?
No changes were made to the agreement following consultation feedback.
Who we think will be most interested
- Suppliers and wholesalers
- DHB clinical staff in a range of clinical settings including:
- Obstetricians and Gynaecologists
- Clinical/Biomedical Engineers
- Sterile services staff
- Outpatient clinic staff
- Theatre and perioperative staff
- Surgical, speciality units, gynaecology and general ward staff
- Delivery suite staff
- Point of Care coordinators
- Medical Scientists
- Laboratory Managers
- DHB procurement and supply chain personnel
Details about this decision
The RFP was for non-exclusive national agreements for listing on the Pharmaceutical Schedule.
After completing the RFP evaluation processes, and consulting on the provisional Agreement reached with Ultramedix, PHARMAC has decided to list Ultramedix’s medical device in Part III of Section H of the Pharmaceutical Schedule from 1 May 2020.
DHBs can continue to choose which obstetrics and gynaecology products they purchase, including those from other suppliers. DHBs that purchase obstetrics and gynaecology products from Ultramedix must do so under the terms and conditions, including pricing, in the Agreement, from 1 May 2020.
The Agreement includes terms and conditions for training and education to be provided by Ultramedix on the appropriate use of its product, which is to be provided at times as agreed with individual DHBs.
Our response to what you told us
We appreciate the time people took to respond to this consultation.
A summary of the main themes raised in feedback and our responses to the feedback are set out below:
Ministry of Health
Advising no technical resource impacts anticipated as a result of the proposal
New Zealand Point of Care Testing Advisory Group
Noted that the Partosure product sold by Ultramedix was a Point of Care Testing (POCT) device and suggested that it should therefore fall under the scope of a POCT category. Stated that tests and devices should be evaluated in NZ to ensure they are fit for purpose prior to a national contract being awarded.
It was also noted that the webpage announcing the consultation process was missing several groups in the “Who we think will be interested” section. Suggested the addition of POCT coordinators, Medical Scientists and Laboratory Managers.
The categories used by PHARMAC are grouped around clinical areas. Whilst the Partosure is a POCT device, it is used exclusively in obstetrics and gynaecology areas and for this reason it has been included in this category. Evaluation (including by advisory groups) and purchasing decisions will remain with the DHBs given that this Agreement is not for sole supply.
The oversight of including point of care specialists in the “Who we think will be interested” section is acknowledged. These groups will be included for any future consultations of similar products.
If you have any questions about this decision, you can email us at firstname.lastname@example.org; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.