Implant & Tissue Compliance Tracker

The Implant & Tissue Compliance Tracker records each implantable device and tissue graft by barcode as it is received, stored, issued and implanted, so every item can be traced from its supplier to the patient who received it, or to its disposal. It warns about expiring stock and storage problems, and matches recall notices against your inventory and implant records. When a recall or supplier notification arrives, your team sees which items are on the shelf and which patients received them, and records every step of the response.

The problem it solves

Implant and tissue records are often split between a supply system that knows what was received, a paper or spreadsheet tissue log, and the operative record in the EHR. Lot and serial numbers are copied by hand, storage temperatures are logged on paper, and expired items are found on the shelf rather than flagged. When a manufacturer recall or a tissue supplier notification arrives, finding the affected items and patients means searching several systems, and proving that every graft was accounted for at survey takes days of reconciliation.

Who it’s for

• 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

1. Receive and storeImplants 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.
2. Monitor inventoryThe Tracker watches expiration dates and storage conditions, and flags items that need attention before they are issued.
3. Issue and implantItems 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.
4. Respond to recallsRecall 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.

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.

Tissue coordinator

Oversees tissue receipt, storage and disposition, reviews temperature excursions and returns recipient records

Materials staff

Receives, stocks and counts implants and tissue, and records receiving checks

Perioperative nurse

Scans items at issue and implant, links them to the patient and records waste and returns

Recall coordinator

Records recalls and supplier notifications and manages the response until it is closed

Program lead

Owns the tissue and implant program, approves policies and sees all records and reporting

Surveyor or auditor (read-only)

Views records, reports and the audit trail, with no ability to change them

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.

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.

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.

Interfaces and data mapping

We connect to your EHR, supply chain system and temperature monitoring, and map items, locations and procedures. We need interface specifications and contacts from your integration and supply chain teams.

Scanning setup

Scanners and workstations at receiving, storage and operating rooms are configured and tested with the barcode formats your suppliers use.

Inventory baseline

Existing implant and tissue inventory is counted and loaded, and open tissue records from your current log are brought across by agreement.

Policies and checks

Receiving checks, storage rules, excursion review steps and recall procedures are configured to your policies with your program lead.

Workflow and roles

Roles, locations, waste reasons and notifications are configured to match how your tissue program, materials and perioperative teams work.

Training and go-live

Materials staff, perioperative nurses, tissue coordinators and recall coordinators are trained on their own workflows before scanning starts.

• 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.

• Scan a sample of the implant and tissue labels you receive today and check what the Tracker reads from each
• Follow one graft from receiving to implant and confirm the record your surveyors would ask for
• Simulate a temperature excursion and walk through the review of each affected item
• Load a past recall and check that the affected items and patients are found
• Review the implant record that would reach your EHR's operative record
• Confirm role separation: who sees patient details, who can release quarantined items and who can close a recall