Healthcare · Moraph software

Implant & Tissue Compliance Tracker

Track every implant and tissue graft from the supplier to the patient, and find affected patients when a recall arrives

Book a demonstrationRequest a technical briefingFactsheet

Overview

What you are buying

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.

  • Lot, serial and donor identification numbers are transcribed by hand between systems
  • Expiring items and storage temperature problems are found late
  • Recalls and supplier notifications require manual searches to find affected patients
  • Tissue disposition and recipient records are hard to evidence at survey

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

Requirements it supports

FDA Human Cells, Tissues, and Cellular and Tissue-Based Products (21 CFR Part 1271)FDA Unique Device Identification System (21 CFR Part 830)FDA Medical Device Tracking Requirements (21 CFR Part 821)FDA Medical Device Reporting, user facility requirements (21 CFR Part 803)Joint Commission Transplant Safety (TS) standards for tissue acquisition, storage and trackingCMS Conditions of Participation for hospitals, organ, tissue and eye procurement (42 CFR 482.45)

The product supports these requirements; meeting them remains your organization’s responsibility.

See how it works

A short walkthrough

Illustrative screens with fictional sample data. They show the workflow, not any client’s data or configuration, and the layout of the product itself differs. A live demonstration uses the product with sample data.

  1. Step 1

    Inventory and expirations

    Tissue coordinators and materials staff see every item on hand, where it is stored and when it expires.

    ItemTypeLot or tissue codeLocationExpiresStatus
    Bone allograft, cancellous chipsTissueTX-SAMPLE-0418Tissue freezer 2In 9 daysAvailable
    Hip stem, size 12 (sample)ImplantLOT-A7731Ortho core, shelf CIn 14 monthsAvailable
    Tendon allograft (sample)TissueTX-SAMPLE-0392Tissue freezer 1In 3 monthsQuarantined
    Bone screw set (sample)ImplantLOT-B2204Ortho core, shelf AIn 2 yearsAvailable
    Skin allograft (sample)TissueTX-SAMPLE-0455Tissue refrigeratorIn 21 daysIssued to OR 4
    Tissue coordinators and materials staff see every item on hand, where it is stored and when it expires.

  2. Step 2

    Receiving a graft

    At receiving, the barcode is read into its identifiers and each check is recorded before the graft is stored.

    Tendon allograft (sample) · Example Tissue Supplier (fictional)

    Tissue identification code
    TX-SAMPLE-0392
    Expiration
    Shown from barcode
    Purchase order
    PO-55120 (fictional)
    Shipping temperature indicator
    Within range
    Assigned location
    Tissue freezer 1

    Receiving checks

    • Packaging intact
    • Supplier documentation present
    • Matches purchase order
    At receiving, the barcode is read into its identifiers and each check is recorded before the graft is stored.

  3. Step 3

    A temperature excursion

    When a storage unit goes out of range, every item inside is flagged and reviewed one by one.

    Tissue freezer 1 · Example Hospital (fictional)

    Excursion
    Above set range for 47 minutes
    Detected by
    Temperature monitoring alarm
    Items in unit
    6
    Reviewed
    2 of 6
    Reviewer
    Tissue coordinator

    Review against supplier storage requirements

    • TX-SAMPLE-0392: quarantined pending supplier advice
    • TX-SAMPLE-0401: released, within supplier limits
    • 4 items still to review
    When a storage unit goes out of range, every item inside is flagged and reviewed one by one.

  4. Step 4

    From shelf to patient

    Each graft's history, from receipt to implant, is kept in one record.

    Skin allograft (sample) · TX-SAMPLE-0455

    1. Received, checks passed, stored in tissue refrigeratorMaterials staff
    2. Issued to OR 4 for Patient 80316 (fictional), expiration checkedTissue coordinator
    3. Scanned at implant and linked to the procedurePerioperative nurse
    4. Implant record sent to the operative record in the EHRSystem
    5. Recipient information returned to supplierTissue coordinator
    Each graft's history, from receipt to implant, is kept in one record.

  5. Step 5

    A recall arrives

    Recall details are matched against inventory and implant records, showing affected items on the shelf and patients who received them.

    Recall RL-0263 · Hip stem (sample) · Example Device Maker (fictional)

    Source
    Manufacturer notice
    Affected lots
    LOT-A7729 to LOT-A7733
    Items in inventory
    3
    Patients implanted
    2
    Response owner
    Recall coordinator

    Tasks created

    • Quarantine 3 items in Ortho core
    • Return quarantined items to manufacturer
    • Notify surgeons for 2 patients for follow-up decision
    Recall details are matched against inventory and implant records, showing affected items on the shelf and patients who received them.

  6. Step 6

    Tracking the response

    Every open recall shows what has been done and what remains, until each item and patient is accounted for.

    RecallItemItems quarantinedItems returnedPatients to follow upStatus
    RL-0263Hip stem (sample)3 of 30 of 32In progress
    RL-0259Bone allograft (sample)1 of 11 of 10Ready to close
    RL-0251Bone screw set (sample)0 of 00 of 00Closed, none affected
    Every open recall shows what has been done and what remains, until each item and patient is accounted for.

Workflows

The principal workflows

  1. 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.

    • Item scanned at receiving; device identifier, lot or serial and expiration read from the barcode
    • Tissue grafts recorded with the supplier's distinct identification code and expiration
    • Packaging, shipping temperature and documentation checks recorded
    • Item assigned to a storage location, including a monitored freezer or refrigerator for tissue
    • Unacceptable items quarantined and returned with the reason recorded

  2. Monitor inventory

    The Tracker watches expiration dates and storage conditions, and flags items that need attention before they are issued.

    • Expiring items listed by date and location
    • Storage temperature readings received from your monitoring system or recorded by staff
    • Excursions flag every item in the affected storage unit for review
    • Reviewer releases or quarantines each affected item with a reason
    • Periodic inventory counts reconciled against the Tracker

  3. 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.

    • Item scanned when issued to a case, with expiration and recall status checked
    • Item scanned at implant and linked to the patient and procedure in the EHR
    • Opened but unused items recorded as wasted with a reason
    • Unopened items returned to stock and rescanned
    • Tissue recipient information prepared for return to the supplier where they require it

  4. 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.

    • Recall or notification recorded from the FDA, the manufacturer or the tissue supplier
    • Matching items found by device identifier, lot, serial or donor identification code
    • Items on the shelf quarantined and returned; implanted items listed with their patients
    • Patient follow-up assigned to the responsible clinicians and recorded
    • Recall response closed when every item and patient is accounted for

Roles and permissions

Who does what in the product

Each role below is a starting point. During implementation we set them up to match your teams, and every action anyone takes is recorded in the audit trail.

Tissue coordinator

Tissue services coordinator, tissue bank supervisor, perioperative tissue nurse

Oversees the tissue program day to day, so every graft is stored correctly and accounted for.

Sees

  • All tissue inventory, storage locations and expiration dates
  • Temperature readings and excursions for tissue storage units
  • Tissue disposition and recipient records
  • Open supplier notifications involving tissue

Does

  • Reviews temperature excursions and releases or quarantines affected items
  • Issues tissue to cases and checks expiration and status
  • Records final disposition for wasted, returned or discarded grafts
  • Prepares recipient information for return to the supplier
  • Reconciles tissue inventory counts

Cannot

  • Close a recall response; that belongs to the recall coordinator
  • Change storage rules or receiving checks without program lead approval
  • Edit a disposition after it is saved; corrections are recorded as new entries
Approvals
Release of an item quarantined after an excursion can require program lead approval, as your policy sets.
Notified about
Temperature excursions, tissue nearing expiration, and recipient records still to return.

Materials staff

Materials management technician, supply chain coordinator, receiving clerk

Receives and stocks implants and tissue so every item enters the Tracker correctly.

Sees

  • Purchase orders and items expected
  • Inventory by location, without patient details
  • Expiring items in the locations they manage

Does

  • Scans items at receiving and records receiving checks
  • Assigns storage locations
  • Quarantines items that fail checks and records returns to suppliers
  • Performs inventory counts

Cannot

  • See which patients received an item
  • Release items from quarantine after an excursion
  • Record recalls or close recall tasks other than quarantining and returning items
Approvals
None in the Tracker; their receiving checks are reviewed by the tissue coordinator for tissue grafts.
Notified about
Items expiring in their locations and quarantine and return tasks assigned to them.

Perioperative nurse

Circulating nurse, perioperative nurse, surgical technologist

Records implants and grafts at the point of use, linking each one to the patient.

Sees

  • Items issued to their cases and their status
  • The patient and procedure for their cases
  • Warnings for expired or recalled items at scan

Does

  • Scans items at implant and links them to the patient and procedure
  • Records opened but unused items as waste with a reason
  • Returns unopened items to stock
  • Records tissue preparation details where your policy requires

Cannot

  • Override an expired or recalled item warning
  • See implant records for patients outside their cases
  • Change inventory or storage records
Approvals
None; warnings at scan stop the item from being recorded as implanted until resolved by the tissue coordinator or program lead.
Notified about
Warnings at scan and implant records not yet completed for their cases.

Recall coordinator

Recall coordinator, patient safety manager, risk manager, quality specialist

Manages each recall and supplier notification until every affected item and patient is accounted for.

Sees

  • All recalls and notifications and the items and patients they affect
  • Implant records for affected patients
  • Adverse event records linked to items

Does

  • Records recalls and supplier notifications with affected identifiers
  • Runs recall matching and assigns quarantine, return and follow-up tasks
  • Tracks tasks to completion and closes the response
  • Records implant- and tissue-related adverse events and the reporting decision

Cannot

  • Decide on patient follow-up; that rests with the responsible clinicians
  • Edit scan or disposition records
  • Close a recall with tasks still open
Approvals
Closing a recall involving implanted items can require program lead sign-off, as your policy sets.
Notified about
New recall matches, overdue recall tasks and new adverse event records.

Program lead

Tissue program medical director, director of perioperative services, quality director

Owns the implant and tissue program and answers for it at survey.

Sees

  • Every item, disposition, recall and adverse event record
  • All program reporting
  • Policies, receiving checks and storage rules, with their history
  • The audit trail

Does

  • Approves policies, receiving checks and storage rules
  • Approves release of items quarantined after excursions where policy requires
  • Signs off recall closures involving implanted items
  • Prepares survey and committee reporting

Cannot

  • Edit or delete entries in the audit trail
  • Delete item or disposition records
Approvals
Approves policy changes, quarantine releases and recall closures as your policy sets.
Notified about
Quarantine releases awaiting approval, recall closures awaiting sign-off, and open recalls with patients to follow up.

Surveyor or auditor (read-only)

Internal auditor, accreditation surveyor, compliance reviewer (under temporary access)

Reviews tracking, disposition and recall records without being able to change anything.

Sees

  • Item histories and disposition records within the scope granted
  • Recall responses and program reports
  • The audit trail

Does

  • Searches and reads records within their scope
  • Exports reports they have been given access to, with each export logged

Cannot

  • Change, approve or delete anything
  • See records outside the scope and dates granted
  • Keep access after it expires
Approvals
Their access is approved by the program lead or an administrator, with a scope and an end date.
Notified about
Nothing by default; access granted and expiring is confirmed to the person who approved it.

Administrator

Application administrator, clinical systems or supply chain systems administrator

Manages users, roles, locations, scanners and interfaces.

Sees

  • Users, roles and location assignments
  • Interface and scanner status
  • The record of permission changes

Does

  • Adds and removes users, or maps them from single sign-on groups
  • Assigns roles and locations
  • Maintains storage locations, waste reasons and scanner settings
  • Runs access review reports

Cannot

  • Record scans, dispositions or recall actions
  • Change policies or storage rules without program lead approval
  • Grant themselves another role without a second administrator
Approvals
Role changes that grant access to patient details follow your organization's access approval process.
Notified about
Interface failures, access reviews coming due and accounts not used for a period your policy sets.

Permissions at a glance

ActionTissue coordMaterialsPeriop nurseRecall coordProgram leadAuditorAdmin
Receive and store itemsFullFullNo accessNo accessView onlyView onlyNo access
Issue items to a caseFullNo accessNo accessNo accessFullNo accessNo access
Record implant, waste or returnFullNo accessOwn work onlyNo accessFullNo accessNo access
View patient implant recordsView onlyNo accessOwn work onlyView onlyView onlyView onlyNo access
Review temperature excursionsFullNo accessNo accessNo accessFullView onlyNo access
Release quarantined itemsFullNo accessNo accessNo accessApprovesNo accessNo access
Record recalls and run matchingView onlyNo accessNo accessFullFullView onlyNo access
Close a recall responseNo accessNo accessNo accessFullApprovesView onlyNo access
Record adverse eventsFullNo accessFullFullFullView onlyNo access
Change policies and storage rulesNo accessNo accessNo accessNo accessApprovesNo accessNo access
View audit trailNo accessNo accessNo accessView onlyView onlyView onlyView only
Manage users and rolesNo accessNo accessNo accessNo accessApprovesNo accessFull
  • Full
  • Own work only
  • Approves
  • View only
  • No access

How access is controlled

  • Separation is built in: materials staff handle inventory without seeing patients, nurses record implants only for their own cases, and recall closures and quarantine releases can require program lead sign-off.
  • Roles are configured with you during implementation. You can rename them, create custom roles, and limit them by facility or storage location, so each team sees only what it is responsible for.
  • Every permission change is recorded in the audit trail with who made it and when, and access review reports list each person's roles for periodic certification by the program lead.
  • Staff sign in through your identity provider, and roles can follow its groups. Surveyors and auditors get temporary read-only access with a defined scope and an end date, rather than shared accounts.

Features

What it does

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

How it connects to your systems

Connects toHowWhat flows
Electronic health recordPatient, encounter and procedure information, and implant documentation written back to the operative record, through HL7 v2 or FHIR interfaces mapped during implementation.In: patients, encounters and scheduled procedures. Out: implant records for the operative record.
Supply chain and ERPPurchase orders, receipts and item masters from your materials management or ERP system, so receiving checks match against orders.In: orders, item master, receipts. Out: consumption and waste.
FDA GUDIDDevice identifiers looked up in the FDA's public Global Unique Device Identification Database for device attributes.In: device descriptions and attributes.
Recall sourcesFDA recall information and notices from manufacturers and tissue suppliers, entered by your team or loaded from the sources you subscribe to.In: recall and notification details with affected identifiers.
Temperature monitoringReadings and alarms from the temperature monitoring system on your tissue freezers and refrigerators.In: storage unit readings and excursions.
Single sign-onStaff sign in through your identity provider (SAML or OpenID Connect).In: user identity and group membership for role assignment.
Work APIInventory, disposition and recall data available to your data warehouse and reporting tools through the Moraph Work API.Out: items, dispositions, recalls and response status.

Each integration is confirmed in discovery and specified in the design. See how an engagement progresses.

Security and privacy

How your data is protected

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.

Company-wide controls, independent audits (SOC 2 Type II and ISO/IEC 27001) and data residency are described in our Trust Center, where you can request the evidence pack.

Reporting

What you can report on

11 standard reports, grouped by who uses them. Each shows who it is for, how it can be broken down, how it is delivered and what it is used for. The data behind them is also available to your own reporting tools.

Inventory

Expiring inventory

For tissue coordinators and materials staff

Items on hand by location, ordered by expiration date, with those already expired or in quarantine marked.

Break down by
Location, Item type, Supplier, Expiration window
Delivered as
Live dashboard; scheduled email; CSV export
Used for
Using or returning items before they expire and keeping expired items off the shelf.

Inventory reconciliation

For materials staff and tissue coordinators

Results of each inventory count against the Tracker's records, with discrepancies and how they were resolved.

Break down by
Location, Count date, Discrepancy type
Delivered as
Live view; CSV and PDF export
Used for
Showing that physical inventory matches the records.

Waste and returns

For program lead, perioperative managers, supply chain

Items opened but not used, and items returned, with the reasons recorded.

Break down by
Reason, Service, Surgeon, Item type, Period
Delivered as
Live dashboard; CSV export
Used for
Reducing avoidable waste and supporting supplier credit discussions.

Traceability

Tissue disposition

For tissue coordinators, program lead, surveyors

Every tissue graft received and its final disposition, with any graft still without a disposition highlighted.

Break down by
Supplier, Tissue type, Disposition, Period
Delivered as
Live view; PDF and CSV export
Used for
Showing that every graft is accounted for from receipt to final disposition.

Implants by procedure

For program lead, perioperative managers, quality

Implants and grafts used by procedure, surgeon and supplier, linked to the patient records the viewer is entitled to see.

Break down by
Procedure, Surgeon, Supplier, Item type, Period
Delivered as
Live dashboard; CSV export
Used for
Understanding implant use and answering questions about specific items.

Recipient records outstanding

For tissue coordinators

Grafts and tracked devices whose recipient information has not yet been returned to the supplier or manufacturer.

Break down by
Supplier, Implant date, Item type
Delivered as
Live dashboard; scheduled email
Used for
Completing the records suppliers and manufacturers require.

Safety and recalls

Open recalls

For recall coordinator, program lead, quality committee

Each open recall or supplier notification with items quarantined, returned and patients still to follow up.

Break down by
Recall, Source, Item type, Task status
Delivered as
Live dashboard; PDF; CSV export
Used for
Driving every recall response to completion.

Temperature excursions

For tissue coordinators and program lead

Each excursion, the storage unit, duration, items affected and the review decision for each item.

Break down by
Storage unit, Period, Decision
Delivered as
Live view; PDF and CSV export
Used for
Evidencing that excursions were reviewed and acted on.

Adverse events

For recall coordinator, quality and patient safety committees

Implant- and tissue-related adverse events, the items involved and the reporting decisions recorded.

Break down by
Item type, Supplier, Event type, Reporting decision, Period
Delivered as
Live dashboard; PDF; CSV export
Used for
Spotting patterns across items and suppliers and evidencing reporting decisions.

Accreditation and audit

Survey evidence pack

For accreditation and compliance staff

Receiving checks, storage records, dispositions, recall responses and policies for a chosen period, assembled for surveyors.

Break down by
Period, Facility, Evidence type
Delivered as
On request in the product; PDF and CSV export
Used for
Answering surveyor requests without reconciling records by hand.

Item history extract

For internal audit, surveyors, recall coordinator

The complete history of a selected item, lot or patient: every scan, check, decision and person involved.

Break down by
Item or lot, Patient, Date range, User
Delivered as
On request in the product; CSV and PDF export
Used for
Tracing a single item or answering a specific question from a supplier, auditor or surveyor.

Exports, access and evidence

  • Every report can be exported to CSV, and summary and evidence reports to PDF. Reports can be scheduled to arrive by email for the people entitled to see them.
  • Each report can be filtered and the filters saved, so tissue coordinators, materials staff and the program lead can keep their own views. Reports that need a different shape can be built in your own tools from the data described below.
  • Inventory, disposition and recall data is available through the Moraph Work API, and can be delivered to your data warehouse or business intelligence tool alongside supply chain and quality data.
  • Reports respect each viewer's role: materials staff see inventory without patient details, nurses see their own cases, and surveyors can be given read-only access to reports and the audit trail.
  • Traceability and survey reports can be run as of a past date and give the same result each time. Running and exporting a report is itself recorded in the audit trail.

Deployment

Where and how it runs

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 controls, independent audits and data residency are set out in our Trust Center. Engagement models and what drives a quotation are on Working with Moraph.

Implementation

What a rollout involves

The general phases are on Working with Moraph. For this product, they involve the following.

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.

Limitations

What it does not do

Worth knowing before you evaluate it.

  • 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.

Evaluation checklist

What to test in a demonstration or pilot

Questions worth putting to us, and to any other vendor you are considering.

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

Questions

Frequently asked questions

Which barcodes can it read?

GS1, HIBCC and ISBT 128 barcodes used on implants and tissue. Labels your suppliers use are tested with your scanners during implementation.

Does it report recalls or adverse events to the FDA?

No. It keeps the records your team needs to decide what to report, and your team submits reports through the FDA's own channels and to the supplier.

Do we have to change our supply chain system?

No. Purchasing and billing stay where they are. The Tracker receives orders and item information from your system and sends back consumption and waste.

How is it priced?

As a subscription, usually measured by the number of facilities or storage locations covered, with implementation charged separately. See Working with Moraph for what drives a quotation.

Do you sign a business associate agreement?

Yes. Implant records link items to patients, and Moraph signs a business associate agreement before any patient data is loaded.

Is there an accessibility conformance report?

Ask for one through the procurement request form at /how-to-buy/request, naming the version you are evaluating.

Next steps

Evaluate Implant & Tissue Compliance Tracker

Book a demonstration

See the product working with sample data, focused on your workflows.

Request a demonstration

Request a technical briefing

Architecture, integrations, security and hosting, with our engineers and your technical team.

Request a briefing

Factsheet

This page on two sides, to share with colleagues or add to your evaluation file.

Open the factsheet

Buying through a formal procurement? See How to buy for purchasing routes, accessibility conformance reports and company information. Documentation: Implant & Tissue Compliance Tracker guides on docs.moraph.com (getting started and security guides are public; setup, administration and integration guides are for client accounts). Support: Implant & Tissue Compliance Tracker support guide.

Related products