HSE outlines plan for electronic tracking of medical devices

The HSE plans to establish a new national system to electronically trace medical devices as part of efforts to improve patient safety.

The National Scan4Safety Programme is designed to “transform traceability” in healthcare through accurate, real-time identification of products, implants, consumables, patients, staff, locations, and clinical events.

The details are included in HSE documents published as part of a market sounding exercise. The plans have been approved by the HSE senior leadership team. A tendering process is due to be launched this year.

The new system will use GS1 global traceability standards, which are a framework for tracking products through supply chains.  The system will provide “full traceability” at the point-of-care, issue automated alerts for unknown, recalled, or expired products, and ensure “accurate recording of clinical events in line with international best practice”.

It will allow for end-to-end traceability from “supplier to bedside”, automatic capture of products and procedures at the point-of-care, and improved inventory and stock management.

The system will reduce waste and disruption, enable faster and more efficient recall and expiry management, and provide structured, interoperable data to support national registries and clinical audits, according to the HSE.

In particular, the system will support the traceability of class III implantable medical devices, such as Mirena coils and contraceptive devices; pain implants such as spinal cord implants; endocrinology infusion and implant devices; phrenic nerve stimulators and other neuromuscular support devices.

“This should enable the electronic tracking of surgical implants to ensure traceability in the use of implants, across the product lifecycle, and enable patient identification and follow-up, if needed, post-implantation, particularly where safety issues arise,” the HSE stated.

It is planned that the Scan4Safety system will be implemented in 33 sites nationally, including voluntary hospitals and surgical hubs. It will be deployed on a phased basis, with the first phase focusing on class III medical devices.

It is understood the system is due to be fully implemented by 2029.