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Review of opportunities for health care providers as a result of certain proposed regulatory changes

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At the time of writing, the Therapeutic Goods Administration has just completed its third and final consultation on the implementation of the ‘UDI system’ in Australia – a UDI is a unique device identifier. This being the case, it seems worthwhile to review the article from Spring 2020 to ensure that Australian health professionals and those who provide them with solutions consider and plan for the opportunities that these regulatory changes may bring.

Health care in Australia is based on very different standards. Many standards have been defined or selected to improve the performance of our healthcare systems, ensure the highest quality and safety of healthcare and enable a more digital healthcare system. These standards are often supported by regulations or similar structures. In the case of UDI, the proposed rule related to the UDI system provides a framework for the use of several global standards supported by a new regulatory database with the specific goal of improving the management of medical devices in our healthcare system.

The original concept of UDI was developed as a mechanism to support increased harmonization of the way medical devices are regulated and managed worldwide. Most importantly, the proposal on UDI systems is a game changer for regulators, it also focused on greater consistency, availability and data collection related to these products to support continuous improvement in safety for patients and consumers. For more information, contact the International Medical Device Regulators Forum (IMDRF).

What is a UDI?

Each country that implements a UDI system does so by balancing local needs with a harmonized global approach. All UDI systems have identification layer and a data collection level using global standards (eg defined and managed by GS1) and a database.

The original 2013 IMDRF UDI guidance document states that the goal of a UDI system is to optimize patient care by improving five elements:

a. traceability of medical devices, especially for field safety corrective actions,
b. adequate identification of medical devices through distribution and use,
c. identification of medical devices in case of adverse events,
d. reducing the number of medical errors,
d. documentation and longitudinal data collection on medical products.
imdrf-tech-131209-udi-guidance-140901

To learn more about specific plans for Australia, you are encouraged to visit them website or participate in the current webinar series.

Does UDI concern product regulation as it relates to a healthcare provider?

Although the part of the sector most affected by UDI implementation will be the manufacturer or sponsor of the product in each market, one of the areas with the greatest potential benefit is the community of healthcare professionals and the patients they serve. While this is true, in many cases health care providers do not consider the benefits they may have. Fortunately, Australia will later introduce these regulations so that our community of health professionals can learn from their international counterparts.

As a result of the fact that other countries have already adopted UDI, we can already identify some benefits for healthcare professionals as a result of these regulations. Among the benefits found are unambiguous identification of medical devices; More effective recall of products; Improved ability to verify the legitimacy of medical products; Improved product data available for patient records; More accurate reporting of adverse events; Optimization of supply chains; Improved cost management; and Improved reimbursement processes.

There are a number of case studies to help Australian health professionals understand the potential benefits they may have. Some examples:

  • St. Joseph’s Hospital, Chinese Taipei — reported a 50% reduction in order processing time, 96% scanning speed after just two months, increased patient safety with the implementation of automatic tracking and alerting, and significant improvements in inventory management
  • Heart Catheterization Laboratory Rigshospitalet Region, Denmark — reported no canceled procedures, reductions in essential supplies, freeing up 3 nurse equivalents (FTE) to focus on patient care
  • Franciscan Missionaries of Our Lady of Health System (FMOLHS), USA — reported improved inventory management, improved patient safety through the implementation of barcode scanning in care processes, increased availability of cost-of-care/cost-per-case information, better outcomes information available to analyze doctors, products and procedures that can link to more value-based approaches to care.

These and many similar stories can be found in GS1 Global Directory 2020/21

The Scan4Safety the UK program, although not based on ‘UDI’, also provides some insight into how standards-based identification and data collection can fundamentally improve patient care and safety, so the evidence report is also a worthy reference.

What steps should healthcare providers take to prepare for the benefits that UDI will bring them?

There are likely to be four key steps to ensure that Australian healthcare providers can benefit from this planned regulatory change.

  1. Assess existing capabilities to collect and use global standard identifiers such as Global Trade Item Number (GTIN) in systems used for product ordering, inventory management and tracking of products used with/on patients. Since these standards are the identifiers used in UDI.
  2. Evaluate existing capabilities for scanning standardized barcodes, including 2D barcodes such as GS1 Datamatrix, as these are the barcodes and data formats commonly used by vendors when implementing UDI data collection.
  3. Understand which processes can benefit from increased standardized identification, barcodes, and data to begin building your plan for how your organization can begin to increase capabilities with a routine BAU system upgrade.
  4. Get involved in the process of developing the UDI system for Australia by contacting the TGA UDI team at udi@Health.gov.au and following updates from the TGA. Your supervisors may also have additional information about their consultation responses that they can share with you.

For more information on GS1 standards, please do not hesitate to contact the GS1 Australia Health Team healthcareteam@gs1au.org

Image credit: iStock.com/gchutka

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