The Medical Technology Association of Australia has joined with other peak industry bodies in recommending the Therapeutic Goods Administration adopt principles when implementing Unique Device Identifications standards.
The recommendations have been made in a joint policy paper prepared by the MTAA, AusBiotech, IVD Australia and the Australian Dental Industry Association (ADIA).
The recommendations suggest databases should be managed in Australia and administrated by the TGA to better align with international coding standards and global UDI systems.
The UDI standards, initially introduced by the US Food and Drug Administration in 2013, consist of a series of numeric and alphanumeric characters created according to internationally accepted device identification and coding standards.
The standard is designed to enhance the post-market safety of medical devices by improving their traceability.
According to the policy paper, Australia's existing system, under the TGA's Australian Register of Therapeutic Goods (ARTG), 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.
The paper says adoption of the UDI standard will improve traceability of a wider range of devices and reduce administrative requirements for registering a family of devices.
The policy paper recommends the following fundamental principles should be applied when implementing the UDI standards in Australia:
- Adoption of a globally harmonised 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); and,
- creation 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 policy paper says the AusUDID should allow sponsors to update information for their own products free of charge and should also be accessed by the general public free of charge.
“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,” said Lorraine Chiroiu, incoming CEO of AusBiotech. “However, it is important we have an Australian owned and managed database as part of that process.”
“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.
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.