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Operating theatre traceability

tracenza. hospital

Every device, from the stockroom to the patient.

The traceability platform that brings together RFID, UDI codes and artificial intelligence. Built for the operating theatre, where every swab and every batch counts; ready for warehouses, assets and production.

Theatre 3 · surgery in progress● live
DeviceBatchExpiry
Hip prosthesis · stemL24-091703/2029
Absorbable suturesS88-11211/2026
Orthopaedic set 2ster. 22/09valid
Swab count 10×1020 total · 8 used · 12 remaining✓ OK

Example screen

Challenges in the operating theatre

Where paper and memory are no longer enough.

  • Manual device tracking, prone to errors and omissions.
  • Risk of retained swabs and instruments when counts are not systematic.
  • Expired devices that nobody monitors continuously.
  • UDI codes to be recorded, as required by the Medical Device Regulation (EU) 2017/745.
  • Stock and consignment managed by hand: waste and hidden costs.

Three technologies, one platform

The device identifies itself.

RFID

Tagged devices are detected automatically in the operating theatre, with no scanning one by one.

UDI / GS1

UDI codes are read and GTIN, batch, expiry date and serial number extracted automatically.

Artificial intelligence

Photographed delivery notes become structured data: supplier, products, batches, expiry dates, quantities.

The surgical workflow

Every step tracked, verified and archived.

  1. 01

    Patient

    Identification by scanning the wristband.

  2. 02

    Devices

    RFID detection and UDI reading in real time.

  3. 03

    Surgical count

    Swabs, needles and instruments counted automatically.

  4. 04

    Confirmation

    Procedure summary sent to the hospital systems.

  5. 05

    History

    Every step archived, with an operations log.

Modules

Turn on only what you need.

Each module is enabled through configuration: start with one department and grow from there.

Real-time procedure

A grid with code, description, batch, expiry date and quantity of every device used. Duplicate operations on the same patient are blocked.

Surgical count

Counting swabs, needles and sponges from the pack down to the single item, with instant alerts on discrepancies and optional double sign-off.

Instrument sets

Instrument trays with sterilisation date, usage history and protection against duplicate records.

Stockroom

Guided picking by theatre, goods receipt with UDI reading, stock with minimum and maximum levels and reorder alerts.

AI for delivery notes

Take a photo of the delivery note and the data is ready: no more manual entry line by line.

Expiry and consignment

Alerts at 30, 60 and 90 days, expired devices highlighted, consignment usage and exports for reports.

Dashboard and OR Board

Procedures in progress, occupied theatres, average durations. A theatre status board for the surgical suite corridor.

UDI databases

Device lookup in the local catalogue, in EUDAMED and in FDA AccessGUDID; pack and single item linked.

Integration

It speaks the hospital’s language.

HL7 v2 for messages from existing systems (patient records, orders, results) and HL7 FHIR for modern API integrations. Direct synchronisation with the hospital information system, CSV exports for reporting.

HL7 v2HL7 FHIRHIS / OracleEUDAMEDFDA AccessGUDIDCSV

Data security

  • Patient identifiers encrypted
  • Complete, exportable audit trail for inspections
  • Role-based permissions and brute-force protection
  • Secure sessions and defences against common web attacks
  • Designed in line with GDPR and NIS2

The tracenza. family

The same approach, for everything you need to track.

tracenza. hospital is part of a family of solutions with a shared core: an identity for every item, a history of every step, integration with your systems. With tracenza. passport we bring it to products in every sector.

FAQ

Before you request a demo.

Do all devices need an RFID tag?

No. Tagged devices are detected automatically; the others are recorded by reading their UDI code with a standard barcode scanner.

Does it integrate with the hospital information system?

Yes: it supports HL7 v2 and HL7 FHIR and integrates directly with hospital management systems to synchronise patients and procedures.

How is patient data protected?

Identifying data is encrypted, access is controlled by role and every operation is recorded in an exportable audit trail, in line with GDPR and NIS2.

Can it be used outside healthcare?

Yes. The traceability engine is the same for warehouses, assets and production: only the active modules and the integrations change.

Shall we see tracenza. hospital in your operating theatre?

A demo on your real workflows, then a pilot in one theatre or department.