Summary
On 7 May 2026, the Mater Misericordiae University Hospital uploaded 1,921 device serial numbers from a Boston Scientific Field Safety Notice, affecting the Accolade family of pacemakers and CRT-Ps, into the HRI Field Safety Module. Within 3 minutes the system had matched 1,867 serial numbers to patient records, automatically identified 330 as deceased, flagged 33 duplicate serial numbers and isolated 21 unmatched serials for investigation.
Under the previous manual process, the Mater estimates this would have taken approximately 150 hours of physiologist time.
“We've used HRI for FSN management for years, but for a Field Safety Notice of nearly 2,000 devices, searching for each serial number one by one just isn't practical. With the Field Safety Module, we uploaded the full list and had every patient identified, categorised, and flagged in 3 minutes. It's a completely different capability.”
The challenge: when scale outgrows manual processes
The Mater manages an active follow-up population of approximately 7,000 patients with cardiac implantable electronic devices. For smaller advisories affecting a handful of devices, the existing serial-by-serial approach within HRI worked well: search for each serial number, check the patient's status, and manage the response through normal clinical channels.
For a notice of nearly 2,000 devices, that approach breaks down. The Mater estimates it would have required about 150 hours of physiologist time: roughly 100 hours searching for serial numbers and 50 hours verifying patient status. With busy clinics to run, typically only one physiologist could be spared at a time, so the work would have stretched across weeks.
The Boston Scientific Accolade SMR6 notice
The notice was the release of SMR6, a software update adding a daily impedance monitor to mitigate the potential for these devices to enter Safety Mode if a device were to exhibit high battery impedance later in its service life. The recommended action is a software update at the patient's next follow-up appointment. Boston Scientific issued the notice in March 2026; for the Mater it covered 1,921 individual serial numbers.
The response
1. Bulk upload and automated matching
The Mater uploaded all 1,921 serial numbers in a single action. Within 3 minutes the module had cross-referenced every serial number against the national registry and returned a categorised breakdown. Previously, this step alone would have consumed the bulk of the estimated 150 hours.
2. Recommendation assignment and patient flagging
The 330 deceased patients were bulk-marked as resolved. The manufacturer's recommended software update was then assigned to all remaining living patients in a single action. A priority flag and clinical note were attached to every affected patient's HRI profile, visible to every clinician who accesses the record at any participating hospital.
3. Live dashboard and completion tracking
The remaining work is clinical: getting each patient through a follow-up appointment to receive the update. As each patient is seen, the treating physiologist confirms the action within HRI, and a timestamped note records what was done, when, and by whom. The Mater expects to work through all living affected patients over 12 months through routine clinic schedules.
Cross-hospital safety net: proven within the first week
As an implanting centre, the Mater holds serial numbers for patients who receive their routine device checks at smaller centres across Ireland. When an affected patient presented at any other HRI-connected hospital, the treating physiologist immediately saw the flag and the clinical note.
Connolly Hospital Blanchardstown
An affected patient attended a follow-up at Connolly Hospital Blanchardstown four days after the notice was uploaded. The treating physiologist saw the flag, applied the software update and confirmed resolution in the system, leaving the note “Software upgrade installed.” The Mater's dashboard reflected the completion automatically, without any phone calls or emails between hospitals.
This removes one of the most persistent risks in field safety management: patients who receive follow-up care at a different hospital from where their device was implanted. Under HRI they are caught automatically, regardless of where they present.
Results
| Serial numbers processed | 1,921 uploaded and categorised in 3 minutes |
|---|---|
| Patient records matched | 1,867 of 1,921 (97.2%) |
| Deceased patients identified | 330, automatically identified and resolved |
| Duplicates flagged | 33 |
| Estimated manual process | Approximately 150 hours |
| Recommendation assigned | Software update assigned to all affected living patients in bulk |
| Cross-hospital follow-up | Proven in practice within the first week |
| Audit trail | Every action timestamped and attributed to a named physiologist |
| Expected completion | 12 months, through routine clinic schedules |
The network effect
Patients do not stay in one hospital. They transfer, relocate and receive care across multiple sites over the lifetime of their device. A flag set by the Mater follows the patient across every HRI-connected hospital in Ireland, and when it is resolved elsewhere, the Mater's dashboard updates automatically.
Each additional hospital increases the safety net for every patient. That is the core value of registry-based field safety management, and the capability hardest to replicate without national-scale infrastructure.
Manufacturer partnership
Effective field safety management depends on collaboration between device manufacturers, hospitals and the registry. In this case Boston Scientific provided the Mater with a comprehensive, high-quality list of affected serial numbers, enabling rapid action with full confidence in the scope of the notice. Manufacturers need assurance their advisories are acted on, hospitals need the workload to be manageable, and regulators look for evidence of systematic follow-up.
What this means in other markets
The workflow transfers to any market with cardiac implant centres and device traceability requirements. Even in a single hospital or trust, the module replaces manual serial-by-serial searching with rapid matching, status identification, recommendation assignment, dashboard tracking and audit-ready documentation. As further hospitals, trusts, networks or state systems join, the value compounds by extending cross-site visibility.
The ~150-hour figure is the Mater's estimate of the previous manual workload. Screens shown in the PDF version are simulated.