The new standard outlines requirements for the accurate and consistent description and identification of medical devices for all clinical and supply chain purposes in New Zealand. The approach is to extend to the medical device domain the same identification principles and standards that have existed in New Zealand since 2011, for medicines.

In summary, two international standards have been adopted:
• Global Trade Item Number (GTIN) for medical device identification in the supply chain and for product traceability.
• SNOMED CT for medical device terminology in clinical documentation and clinical decision support.

Chair of the Ministry of Health’s - Health Information Standards Organisation, Zeeman van der Merwe- says that using the complementary SNOMED CT and GS1 standards for medical device terminology and identification will help to ensure that devices can be safely and effectively used in healthcare. Having a common global language for information sharing is essential for patient safety and effective clinical use, said Mr van der Merwe.

The approach aligns with the health sector’s greater focus on collective approaches to the District Health Board’s (DHB) supply chain activity, which includes medical devices.

Megan Main, Chief Executive, New Zealand Health Partnerships said that it is an exciting milestone for New Zealand to have formally adopted global standards for medical device terminology and identification. “Key to success will be a clear road map to full adoption which takes into account the changes required throughout the supply chain in order for benefits to be realised”, said Megan. The standards will ensure that medical devices can be properly catalogued, ordered, distributed and tracked. The standards will address the needs such as sharing information to support procurement, contract and budget management and replace proprietary and non-standard medical device coding methods.

Faye Sumner, Chief Executive of the Medical Technological Association of New Zealand (MTANZ) says:” MTANZ supports the New Zealand approach to utilise and embed, in the supply chain, internationally recognised medical device terminology and identification standards. This is essential to progress global regulatory harmonisation and support safety and performance of medical devices.”

The standard also supports current international efforts in the development of a global unique device identifier (UDI) using GTIN. In New Zealand, the New Zealand Universal List of Medicines (NZULM) already provides information on subsidised medical devices used in the community. In view of this role and the joint NZULM/GS1 project to harmonise the NZULM and National Product Catalogue, the standard recognises the NZULM as the source for linkage between SNOMED CT based medical device terminology and GTIN.

For more information, visit the HISO website here