New Zealand Updates Device Standards

June 23, 2017

New Zealand’s Ministry of Health released new standards that will ensure all medical devices are properly named and identified for clinical and supply chain purposes in the country.

This extends the present standards for the New Zealand Medicines Terminology to the medical device domain. Namely, GS1 Global Trade Item Number (GTIN) is endorsed as the standard for device identification in the supply chain and for product traceability, while SNOMED CT is endorsed as the standard for device terminology in electronic health records and for clinical decision support.

The new standard, HISO 10024.2:2017, applies to medical device terminology and identification standards. The Health Information Standards Organization (HISO) supports and promotes the development and adoption of fit for purpose health information standards for the New Zealand health system.

The new standard covers all medical devices — from wound care products to wearables, to prostheses, to implantable devices and diagnostics — and ensures that medical devices can be safely tracked through the supply chain.

The country’s single funder, Pharmac, manages expenditures for devices in public hospitals and is placing more emphasis on collective approaches to district health boards’ supply chain activity. The standards will inform procurement and distribution decisions, because all devices will have a unique identification number and will replace proprietary and non-standard medical device coding methods.

At the same time, New Zealand is planning to introduce an electronic health record (EHR) system that will document medical devices prescribed, as well as patient allergies, adverse reactions and other medical conditions. When patients are prescribed medical devices, they will be immediately scanned into the SNOMED CT system, which becomes part of the patient’s electronic health record.

The GS1 standards will align New Zealand with international markets by using the GTIN device identifier for UDI codes. The move allows for information to cascade down to clinical coding and decisionmaking, government funding, regulatory and safety information with Medsafe, as well as data from suppliers to initiate recalls more effectively.

Next steps include:

  • A new medical device terminology system built on SYNOMED CT. The new devices portion of the Pharmaceutical Schedule will be translated into this format for funding and procurement decisions;
  • The scope of the New Zealand Universal List of Medicines will be extended to include medical devices and will bridge the clinical and supply sides by linking each container with GTIN codes;
  • Transaction data will include a combined set of data elements and unique device identifiers, including the SYNOMED CT, GTIN, batch number, expiration date and product serial number; and
  • Product labels will be required to include machine-readable UDIs based on GTINs.

Read the notice here: www.fdanews.com/06-20-17-NewZealand.pdf.