Joining with other key industry bodies in a policy paper, AusBiotech has recommended to the Therapeutic Goods Administration (TGA) that global harmonisation and alignment with international coding standards for the Unique Device Identification (UDI) standards are critical elements, and to achieve this, proposes the creation of an Australian-owned and managed database for medical devices.
The joint policy paper on UDI reflects the shared position of the Australian peak industry bodies that collectively represent the majority of companies marketing medical devices in Australia, including the Medical Technology Association of Australia (MTAA), IVD Australia, the Australian Dental Industry Association (ADIA) and AusBiotech.
Industry recommends that the following fundamental principles should be adhered to when implementing the UDI in Australia:
- Adoption of a globally harmonized UDI system, in accordance with the IMDRF UDI guidance IMDRF/UDI WG/N7FINAL:2013;
- Adoption of rules and policies that align with international coding standards of UDI issuing agencies designated in the EU and accredited in the US - Automatic Identification and Data Capture (AIDC) such as linear or matrix bar code, smart cards, biometrics and Radio Frequency Identification (RFID); and Human Readable Interpretation (HRI);
- Establishment of an Australian UDI database (AusUDID) owned and managed by the TGA; the best practice is for regulatory agencies to build their own UDID database. The AusUDID should allow sponsors to update information for their own products free of charge, and should be accessed by the general public free of charge. In addition to the above principles, the Industry supports the recommendations of the Global Medical Technology Alliance (GMTA) in its January 2018 White Paper Unique Device Identification (UDI): Insights and benefits from a single UDI System in the international arena. 7 In the next sections we provide further details explaining Industry’s position.
“As stated in the joint industry policy paper, the adoption of a globally harmonised UDI system is essential to avoiding unnecessary errors, duplication and costs within the healthcare supply chain,” says Lorraine Chiroiu, incoming CEO of AusBiotech. “However, it is important we have an Australian owned and managed database as part of that process.”
The UDI standards, initially introduced by the US Food & Drug Administration in 2013, consist of a series of numeric and alphanumeric characters created according to internationally accepted device identification and coding standards. Improved traceability of medical devices under this standard will enhance post-market safety-related activities on a global basis.
“An Australian owned and managed database should allow Australian companies to update information on their products free of charge and provide free access to the information for the general public,” she said.
Under Australia’s existing system, the Australian Register of Therapeutic Goods (ARTG), registration of devices has two unintended consequences: there is inadequate traceability for low and moderate risk devices; and there is no ability to enter devices in the same product family under the same ARTG entry. Adoption of the UDI standard will improve traceability of a wider range of devices while also reducing administrative requirements for registering a family of devices.
In line with Global Medical Technology Alliance White Paper on the UDI System issued earlier this year, the joint industry policy paper supports a two-year minimum initial implementation timeline in Australia to ensure a smooth transition for the first set of devices subject to the UDI requirements.
The full industry policy paper is available on the AusBiotech website