A tracking system for medical devices promises to transform the global healthcare supply chain, allowing for product traceability, with patient safety a strategic priority.

In Canada, we already have a role model in Alberta Health Services (AHS).

“We’re supportive of the work that AHS has done on this initiative,” says Brian Lewis, President and CEO of Medtech Canada. “AHS has proven that a system of tracking a medical device from the Unique Device Identification (UDI) barcode to procurement and Enterprise Resource Planning (ERP) through Clinical Information Systems (CIS), right to the patient’s electronic record, is possible by focusing on interoperable systems throughout the process.”

Setting up an interoperable tracking system, while desirable, is no easy task. It involves complex procedures, and extensive planning to ensure interoperability.

“It’s important to take a longer view of the value proposition within the supply chain,” says Jitendra Prasad, Chief Program Officer, Contracting, Procurement & Supply Management, at AHS. “In Alberta, we have a consolidated ERP system that was implemented 11 years ago.”

AHS relies on an Oracle ERP system, and a common provincial CIS from Epic Systems Corporation. This in turns supports Connect Care, a provincial electronic medical record system. It will give healthcare providers at AHS and its partners a central access point for more complete, up-to-date patient information and best practices. Patients will have better access to their own information, and it will be easier for healthcare providers to communicate with patients and each other. The whole healthcare team, including patients, will have the best possible information throughout the care journey.

From a product perspective, the Alberta Product Item Registry (PIR) has facilitated the integration, as has the implementation of global master data standards, with items mapped at point-of-use for purchasing categories and clinical attributes. A system like this isn’t static: it involves ongoing processes, such as comprehensive data cleansing and standardized item nomenclature.

It’s a lot of work, but, if done right, the benefits are impressive. AHS took a well-thought-out, methodical approach to medical device integration, starting with devices used in procedures – such as in the operating room, diagnostic imaging, cardiac cath labs, and endoscopy – and then expanding to include other devices.

“When UDI is integrated, it enables the tracking and tracing of medical devices and implants through bedside scanning using manufacturer-generated barcodes,” says Prasad from AHS. “Patient information, data archives, and supply chain information can be integrated and managed better, and systems can be standardized with a common data dictionary to reduce duplication of effort, and to minimize errors.”

In support of digital transformation

What AHS has accomplished functions as a clinically integrated supply chain (CISC) that enables a larger move toward digital transformation. For example, the province’s commitment to CISC includes the adoption of digital signatures, voice-recognition and transcription, and the tracking and management of patient beds.

At present, Alberta has a over three million unique medical technologies and supplies integrated into its PIR. Three implementation waves of the CISC have been completed at multiple sites, with another three waves anticipated to be completed over the next couple of years. All major acute care sites are expected to be fully implemented in 2024.

“We have over a 90 per cent success rate in scanning for all device identifiers, such as name, lot and serial number, expiry date, and manufacturer, among others,” says Prasad. “No product relabelling is permitted, and we’ve created a specialized clinically integrated supply team for trouble shooting.”

Interoperability between UDI, ERP and CIS systems also puts AHS in good stead when it comes to facing future challenges.

“As much as we are responding to the COVID-19 pandemic, from a supply chain perspective, we need to be prepared for the next event,” says Prasad. “How do we now make sure that procurement and supply chain connections can support us in the post-pandemic recovery phase. It’s a complex supply chain, and this digital transformation will help us face future challenges.”

Learning from AHS

AHS’s ambitious approach can be seen as a model for other jurisdictions, with important lessons learned. Scanning can be frustrating, and users require support – their feedback needs to be heard when items such as trays and implants are not individually labelled. There can also be issues with substitutes, backorders, and consignment.

“It’s important to make sure that there’s an understanding of the impact on organizational processes,” says Prasad. “Manufacturers also need to give us proper warning in advance of a change, given that we need complete information on all items, which is then created in the registry and the ERP system.”

It is important for healthcare organizations to have the funding, commitment, and capabilities to move forward with UDI. Vendors also need time to comply and provide the required data. This is especially true for smaller vendors, some of whom may not have the infrastructure to comply immediately.

Overall, it is anticipated that it will require several years to fully implement UDI in Canada. In the rest of the world, major jurisdictions such as the US, EU, and China are also implementing UDI over several years based on the International Medical Device Regulators Forum guidance. This makes sense: rushing the system may cause errors and possibly contribute to market confusion.

Getting it right for the long haul

The next step is for Canada to develop a harmonized, government-controlled registry. To date, virtually all major jurisdictions that have either brought a system into place, or have published plans to do so, have indicated that their registry will be run by a government entity.

A national registry run by Health Canada would ensure that the system is sustainable over time, while reducing the risk of having private organizations introduce their own business needs. For Alberta – as well as for many other jurisdictions around the world, and ideally Canada at large – the recommended approach is the implementation of an open-source model which allows for linkages to multiple data sources, and minimal unique requirements.

At the end of the day, having a national system that is informed by the AHS experience will be well worth it. Canada’s healthcare system will have better financial controls, with information centralized, integrated, and more accessible to everyone concerned. With point-of-care scanning and analytical tools embedded into the clinical environment, product features will be tracked and linked to specific care procedures, and to patient records. Most importantly, these processes will then allow clinicians to validate the correct care, and to track and improve patient outcomes.