Why a registry changes field safety
Patients do not stay in one hospital.
They are implanted in one centre, followed up in another, and turn up unplanned in a third. The hospital that receives the manufacturer's notice is often not the hospital that next sees the patient.
A standalone clinic database searches the patient population it holds. HRI can match against the shared registry across participating hospitals. The action then carries across participating hospitals and reports back to the one that raised it.
The gap in the manufacturer's list
The list a manufacturer sends a hospital covers the devices it knows were implanted there. It may not include patients the hospital has since taken on for follow-up from another centre. They carry the affected device, and without a longitudinal registry they may be on nobody's list.
Open until it is closed
Identification is only the first step. Each affected patient needs an assessment, a recommended action and a way to confirm it was done. A case stays open and visible until the action is completed, wherever that happens.
What regulation expects
The EU Medical Device Regulation requires health institutions to store the UDI of Class III implantable devices, preferably electronically. Pacemakers, ICDs and CRT devices are in that class. Electronic traceability is a safety requirement, not an administrative preference.
The workflow, in order
As shown in the film, recorded in HRI Pro with demonstration data.
- Everything begins with the advisoryOne spreadsheet template takes any manufacturer's serial list.
- Describe the noticeAttach the serials and the advisory letter, and set the manufacturer and type.
- Match, then act on all of them at onceAdd a recommendation, a note and a priority to every matched patient in one step.
- Every serial is accounted forMatched, unmatched and duplicates are separated and all inspectable.
- The advisory becomes a work listSerial still in place, possible explant, deceased: flagged, not hidden.
- Triage on the rowPriority, recommendation and status are set in the list, or one decision is applied to a group of patients.
- Notes where they are neededAdd a note to every affected chart, or only the high-priority ones.
- Work through a cohortFilter down to exactly the patients you are dealing with, with the device and its history open without leaving the notice.
- Add and exportSearch by serial to add a patient to an open notice, and take the whole notice out as a spreadsheet.
- The safeguardAn open safety notice must be acknowledged before the follow-up is saved, so it cannot be missed in clinic.
- Across a groupA group super-admin sees every hospital they cover.
- ArchiveA closed notice is retired from the list and kept on the record.
What it gives each group
Patient safety
Matched, unmatched, duplicate and deceased records are separated automatically, so every serial on the list is accounted for and the exceptions are investigated rather than lost. Cross-hospital visibility then flags affected patients wherever in the network they present.
Audit readiness
Every action is timestamped and attributed, creating a record that supports regulator and internal governance requirements. Documentation is generated as the work is done, not assembled afterwards.
Operational efficiency
Hospitals manage several notices a year. Staff time moves from manual cross-referencing to direct patient care, and the gain compounds with every notice.
Questions about Field Safety
How is this different from a recall search in a clinic database?
A standalone clinic database searches the patient population it holds. HRI can match against the shared registry across participating hospitals. Affected patients are identified wherever they were implanted within the network, and the flag appears on the patient's record at any participating hospital.
Does it work for a single hospital?
Yes. Bulk serial matching, status identification, group recommendations, dashboard tracking and the audit trail all work within one hospital from go-live. Cross-site visibility is added as more hospitals join.
What happens to serials that do not match?
They are isolated as unmatched for investigation, alongside duplicates, so every serial on the manufacturer's list is accounted for.
How do clinicians see an open notice?
The notice appears on the affected patient's record, and an open safety notice must be acknowledged before a follow-up can be saved.