Stage 1 of 6 in the device journey
What happens, in order
This is the workflow as shown in the film, recorded in HRI Pro with demonstration data and fictional patients.
- Choose the device typePacemaker, ICD, loop recorder, S-ICD or EV-ICD.
- Choose the procedureGrouped by chamber: single, dual and CRT, with leadless and VVD options marked. More than 180 clinical procedure templates are built in, from first implant to box change, upgrade, revision, reposition and explant.
- Choose the consultantTheir report template arrives in their own words.
- Enter the patient onceName, address, date of birth, mobile, MRN, diagnosis and indication.
- Attach the signed consentIt uploads the moment the record exists.
- Date and staffToday's date in one tick, with the consultant already set as first operator.
- Scan the leads, then the generatorLength and fixation fill in from the barcode, and the generator serial is checked against every patient on the registry.
- Review and submitYou see the report as it will be filed. One submit creates the patient, the implant and the PDFs.
Why it matters
Traceability from minute one
When a device or lead is scanned, the Unique Device Identifier, serial number, expiry date and full specification are captured exactly as the manufacturer encoded them. No transcription errors, no missing fields. That is what makes a field safety notice answerable in minutes years later.
One entry, many outputs
The same submission creates the patient record, the implant record and the consultant's report, so there is no second system to update afterwards.
Validated against the registry
Each generator serial is checked against every patient on the registry at entry. Where older records were typed by hand, a later follow-up can show up a mismatch between the registry serial and the one read from the device, so it can be corrected.
What regulation asks for
Under the EU Medical Device Regulation, health institutions must store the UDI of Class III implantable devices, preferably electronically. Pacemakers, ICDs and CRT devices fall in that class. Australia introduced mandatory UDI requirements for Class III and IIb devices from 1 July 2026, and HRI's barcode-based implant workflow supports hospitals incorporating UDI into device identification and traceability.