Compliance
Implant traceability (UDI)
Implant traceability (UDI) organises device identification, movement and association with documented use for clinical and materials teams. Jovimed supports record review and notification follow-up; authorised professionals retain patient assessment and care decisions.
Configuration, integrations and availability are discussed in your demonstration.
FOR
Operating theatres · Device leads · Surgical teams
CONTEXT FOR THE TEAM
Organise records and responsibilities for applicable requirements; competent staff review documents and decisions.
Content reviewed on .
WORKFLOW PREVIEW
Illustrative workflow stages
Conceptual preview · Illustrative data
STAGE 1
The device enters the register
UDI and receipt documentation are linked to the same record.
- Identifier
- UDI · example
- Document
- Receipt linked
STAGE 2
The implant connects to a procedure
The authorised team checks device and procedure references.
- Procedure
- Clinical reference
- Access
- Authorised team
STAGE 3
A notice can be traced
The identifier is searched across stock and procedure history.
- Result
- Relevant records
- Action
- Clinical assessment
CAPABILITIES
One identifier. A traceable history.
Keep device context from receipt through to safety follow-up.
UDI identification
Capture available identifiers, lot, serial and relevant device information. A missing or ambiguous identifier stays visible for examination; staff consult device documents before establishing the correct association.
Receipt and circulation
Preserve supplier details, documents and the history of devices received or supplied. Received, moved and used material has distinct states with the documents and people involved in each relevant movement of the device.
Procedure linkage
Associate the implant with its procedure and patient reference under controlled clinical access. The designated person examines device identity and intervention context before the association is used to support follow-up of a case.
Patient information
Support preparation and recording of implant cards and required information where applicable. Patient documents are prepared under applicable requirements and examined by staff before they are provided or completed for use.
Safety notices and recalls
Match identifiers in a notice against stock and devices linked to procedures. Notification source and scope are examined; a search result identifies a dossier to review rather than determining a clinical response.
Action follow-up
Assign checks and clinical follow-up, keeping acknowledgements and completion evidence. Each action records its owner and review evidence while observations needing additional clinical assessment remain distinct and visible to authorised staff.
IN PRACTICE
Find the records associated with a lot.
A safety notice identifies an implant lot. The team needs to find relevant stock and procedures. Before establishing relevant records, the owner examines the notification source and device identifiers. Material remaining in stock and material with documented use need different follow-up. Staff record observations and retain the authorised professional’s decision so a technical association alone is not treated as assessment of a patient or a recommendation for clinical action.
Enter the identifiers from the verified notice.
Identify associated devices and clinical references.
Assign and document the necessary actions.
A clear path from the notice to affected records and follow-up.
RECORDS & TRACEABILITY
The device history, available to the team.
Bring provenance, use and safety documentation together. During a batch enquiry, the dossier needs to distinguish stock from material with documented use. Staff examine identifiers and associations before contacting relevant people. Access to patient information and follow-up decisions remain with authorised professionals, and a list of associated records still needs examination before it supports a response.
- UDI, lots, serials and receipt documents
- Procedure and patient references
- Implant cards and patient information where required
- Notices, checks and follow-up actions
BEFORE YOUR DEMONSTRATION
Useful questions.
Do all implants have the same card requirements?
No. Identification and implant-card requirements are distinct, and the applicable framework includes exceptions. Competent staff examine the device type and documents before configuration. Jovimed organises records and available information without determining device classification or the obligation applicable to an individual case on its own or on behalf of the hospital.
Does a notification produce medical advice?
No. A notification can lead staff to records relevant for examination, but authorised professionals decide what happens for a patient. The owner examines identifiers, source and notification scope before action. Documents and approved steps remain followed without turning a batch association into an automatic clinical conclusion about care.
How is association with an intervention examined?
A designated person examines the device identifier and intervention documentation in the hospital’s workflow. A receipt record alone does not demonstrate use in a patient. The demonstration addresses available fields, identification and responsibilities so records distinguish received material, its movement and documented use rather than assuming that each receipt represents implantation.
START WITH A CLEARER PERSPECTIVE
Let’s talk about
your hospital.
Discover how registries, traceability and resource management fit into the way your team works.