Implant & Tissue Compliance Tracker

Principal workflows

• Receive and store: Implants and tissue grafts are scanned on arrival, the barcode is parsed into its identifiers, and the item is checked against the order and the supplier's information before it is placed in storage.
• Monitor inventory: The Tracker watches expiration dates and storage conditions, and flags items that need attention before they are issued.
• Issue and implant: Items are scanned when issued to the operating room and again at the point of use, linking each one to the patient and procedure, or recording that it was wasted or returned.
• Respond to recalls: Recall notices and supplier notifications are matched against inventory and implant records, and the response is tracked until every affected item and patient has been addressed.

Who uses it

• Tissue services coordinators and tissue program leads in hospitals and surgical centers
• Perioperative nurses who document implants at the point of use
• Supply chain and materials management teams who receive and stock implants
• Quality, risk and patient safety teams who manage recalls and adverse events
• Accreditation and compliance staff who prepare for surveys

Reporting

• Inventory by location with expiration dates
• Temperature excursions and the review of each affected item
• Tissue disposition for every graft received
• Open recalls with items and patients still to be addressed
• Implants by procedure, surgeon and supplier
• Waste and returns with reasons

Features

• Barcode parsing: GS1, HIBCC and ISBT 128 barcodes read at each scan, with device identifier, lot, serial, expiration and tissue identification codes captured without retyping.
• Device identifier lookup: Device identifiers looked up in the FDA's Global Unique Device Identification Database (GUDID) to fill in device description and attributes.
• Receiving checks: Order match, packaging, shipping conditions and supplier documentation checked and recorded for each item on arrival.
• Storage temperature monitoring: Readings from your temperature monitoring system or staff logs, with excursions flagging every item in the affected unit for review.
• Expiration warnings: Items approaching expiration listed by location, and expired items blocked at issue.
• Point-of-use documentation: Implants scanned in the operating room and linked to the patient and procedure, with waste and returns recorded.
• Recall matching: Recall notices and supplier notifications matched against inventory and implant records by device identifier, lot, serial or donor code.
• Recall response tracking: Quarantine, return and patient follow-up tasks assigned and tracked until every affected item and patient is accounted for.
• Tissue disposition records: The final disposition of every tissue graft, whether implanted, wasted, returned or discarded, recorded with who did it and when.
• Device tracking records: Patient information for tracked devices kept and prepared for return to the manufacturer as 21 CFR Part 821 requires.
• Adverse event records: Implant- and tissue-related adverse events recorded and linked to the item, supporting your team's decisions on reporting to the FDA and to the supplier.
• Audit trail: Every scan, check, disposition, recall action and change is logged with the person and time, and cannot be edited.

Integrations

• Electronic health record: Patient, encounter and procedure information, and implant documentation written back to the operative record, through HL7 v2 or FHIR interfaces mapped during implementation.
• Supply chain and ERP: Purchase orders, receipts and item masters from your materials management or ERP system, so receiving checks match against orders.
• FDA GUDID: Device identifiers looked up in the FDA's public Global Unique Device Identification Database for device attributes.
• Recall sources: FDA recall information and notices from manufacturers and tissue suppliers, entered by your team or loaded from the sources you subscribe to.
• Temperature monitoring: Readings and alarms from the temperature monitoring system on your tissue freezers and refrigerators.
• Single sign-on: Staff sign in through your identity provider (SAML or OpenID Connect).
• Work API: Inventory, disposition and recall data available to your data warehouse and reporting tools through the Moraph Work API.

Deployment

• Moraph cloud: Hosted and operated by Moraph in the United States region. United Kingdom and Australia regions are available for organizations outside the US.
• Dedicated environment: A single-tenant environment for health systems whose policies require isolation, scoped in the proposal.
• With a managed service: Optionally run alongside Moraph's managed integration engine for interface monitoring and support.

Security and privacy

• Single sign-on: Staff sign in through your identity provider, so your password and multi-factor policies apply.
• Role-based access: What each person can see and do follows their role; materials staff see inventory, not patient details.
• Business associate agreement: Implant records link items to patients, and Moraph signs a business associate agreement with you.
• Encryption and keys: Client data is encrypted, with keys Moraph staff cannot use without explicit, time-bound authorization.
• Complete audit trail: Every scan, view of a patient record, change, disposition and export is logged with the person and time, and cannot be edited.
• Data residency: Data stays in the hosting region you choose: the United States, the United Kingdom or Australia.

Limitations

• The Tracker records and traces items; it does not decide whether an item is safe to use. Release from quarantine and use are decisions of your staff.
• Traceability depends on items being scanned at each step. Items that bypass scanning are not tracked until they are recorded.
• It does not submit reports to the FDA or to suppliers. Your team decides what to report and submits it, using the records the Tracker keeps.
• Recall matching depends on the recall information received and on the identifiers captured at scanning; items recorded without lot or serial numbers may not match.
• It is not a blood bank system. Blood components and transfusion records are managed separately.
• It is not a temperature monitoring system; it uses readings from yours or from staff logs.
• It does not manage purchasing or consignment billing, which stay in your supply chain system.
• Patient notification and clinical follow-up after a recall are decided and carried out by your clinicians; the Tracker assigns and records the tasks.

Next steps

Book a demonstration or a technical briefing at www.moraph.com/solutions/implant-and-tissue-compliance-tracker. Purchasing routes and company information: www.moraph.com/how-to-buy.