Decision to list medical devices supplied by Karl Storz Endoscopy New Zealand Ltd
We are pleased to announce the approval of a listing agreement for the supply of medical devices to DHBs.
What we’re doing
We are pleased to announce the approval of the non-exclusive listing agreement with Karl Storz Endoscopy New Zealand Ltd (“Karl Storz”) for the supply of:
- endomechanical and electrosurgical instruments, and energy platforms and their associated consumables (“endomechanical and electrosurgical products); and
- obstetric and gynaecology devices and related products (“obstetrics & gynaecology products”).
In summary this will result in:
- Karl Storz’s medical devices, across endomechanical & electrosurgical products, and obstetrics & gynaecology products, being listed in Part III of Section H of the Pharmaceutical Schedule from 1 November 2021 under a national agreement that all DHBs may purchase under (“Agreement”); and
- DHBs being able to continue to purchase other suppliers’ brands of endomechanical & electrosurgical products, and obstetrics & gynaecology products as the Agreement is not for sole supply.
Any changes to the original proposal?
This decision was subject to a consultation letter dated 18 August 2021.
There were no changes made to the Agreement as a result of the consultation feedback.
Who we think will be most interested
- DHB Staff
- Clinical engineers
- Surgeons
- Perioperative staff
- Theatre staff
- Procurement and supply chain personnel
- Surgical and general ward staff
- Central sterile services personnel
- Renal Dialysis staff
- Suppliers and wholesalers
Details about this decision
In 2018 Pharmac issued Requests for Proposals (“RFPs”) for:
- supply of endomechanical instruments, electrosurgical instruments, energy platforms and consumable products; and
- supply of obstetric and gynaecology devices and related products.
The RFPs requested proposals for non-exclusive national agreements for listing on the Pharmaceutical Schedule.
Following evaluation of Karl Storz’s responses to each RFP, and consultation on the provisional Agreement with Karl Storz, Pharmac has decided to list Karl Storz’s ranges of endomechanical & electrosurgical products, and obstetrics & gynaecology products in Part III of Section H of the Pharmaceutical Schedule from 1 November 2021.
DHBs can continue to choose which endomechanical & electrosurgical products, and obstetrics & gynaecology products they purchase, including those from other suppliers. DHBs that purchase endomechanical & electrosurgical products, and obstetrics & gynaecology products from Karl Storz must do so under the terms and conditions, including pricing, in the Agreement from the listing date.
The Agreement includes terms and conditions for training and education to be provided by Karl Storz on the appropriate use of their medical devices, which is to be provided at times and in formats as agreed with individual DHBs.
Our response to what you told us
We’re appreciate the time people took to respond to this consultation.
All consultation responses received by 8 September 2021 were considered in their entirety in making the decision to making the decision approve this agreement.
A summary of the main themes raised in feedback and our responses to the feedback are set out below:
|
Theme |
Comment |
|---|---|
|
No technical or resource impacts are expected as a result of the proposal. |
Noted. |
|
Supportive of listing these brands and supportive that this agreement allows other brands to also be purchased. |
Noted. |
|
Request to ensure that Pharmac agreements include terms for suppliers to provide maintenance manuals, supporting tools, training, regulatory information and details of any medical device that has embedded software or connects to a network. |
To the extent applicable to the medical devices included in the agreement this information is included. |
If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.