Implant tissue traceability software that closes the loop from donor to recipient and back
Implant tissue traceability is the record that lets a hospital or tissue bank follow a human cell or tissue product in both directions: donor to consignee or final disposition, and consignee back to the donor. FDA requires that system under 21 CFR 1271.290, built on a distinct identification code that may not contain a name, a social security number or a medical record number. Neurobird holds that code and its history.
Neurobird Implant Tissue Traceability in short
- Hold the distinct identification code as the primary key, without a name or a medical record number in it
- Record disposition for every unit, including product that was discarded rather than implanted
- Relate a new code to an old code when a product is reassigned, as the rule requires
- 21 CFR 1271.290 Requires a tracking system that follows every HCT/P from the donor to the consignee or final disposition, and from the consignee back to the donor. eCFR, 21 CFR 1271.290
- 1 code A distinct identification code must be created specifically for tracking, and it may not include an individual's name, social security number or medical record number. eCFR, 21 CFR 1271.290
- Pricing runs 450 to 2400 US dollars per month across 3 tiers. Early access is free.
What tissue banks and hospital tissue programmes actually deal with
Why it stays broken
Tissue crosses a supplier, a storage location, an operating room and a patient chart, and each of those has its own system. None of them owns the identification code end to end. So traceability exists as four partial records that a person reconciles under pressure, which is exactly when it needs to be instant.
FDA requires tracking from the donor to the consignee or final disposition, and from the consignee back to the donor.
As part of your tracking system, you must establish and maintain a method for documenting the disposition of each of your HCT/Ps, to enable tracking from the donor to the consignee or final disposition.
The trace, as your coordinator would run it
Tick a unit to record its disposition and watch the donor and consignee trace resolve.
Tap an asset to log a scan and timestamp the inspection.
Neurobird Implant Tissue Traceability Inspection Tracking Platform
One record per graft, keyed on the distinct identification code: where it came from, where it was stored, who received it and what happened to anything not used. It answers a recall in one direction or the other.
- 1Hold the distinct identification code as the primary key, without a name or a medical record number in it
- 2Record disposition for every unit, including product that was discarded rather than implanted
- 3Relate a new code to an old code when a product is reassigned, as the rule requires
- 4Produce the accompanying records for an audit without assembling them from four systems
What changes with Neurobird Implant Tissue Traceability?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird Implant Tissue Traceability |
|---|---|
| The distinct identification code is recorded in three systems and only one of them is the one an inspector asks for | Hold the distinct identification code as the primary key, without a name or a medical record number in it |
| A recall arrives naming a donor and the search for every affected recipient starts with a phone call | Record disposition for every unit, including product that was discarded rather than implanted |
| Tissue arrives with paperwork that gets filed, so the link between the graft and the patient lives in a chart note | Relate a new code to an old code when a product is reassigned, as the rule requires |
Who is this for?
The same identification code, three different obligations.
You implant what others supply
You need the graft tied to the patient and the disposition of everything you did not use, in a form an inspector recognises.
You distribute to consignees
You need to identify the consignee of any unit promptly, which is the specific thing the rule asks for.
You store in several places
A unit moves between sites before it is used. The trace has to survive the move rather than restart at each one.
How does Neurobird Implant Tissue Traceability work?
Receive on the code
Every unit is booked in against its distinct identification code and the records that must accompany it, so the tracking key exists before the tissue is stored.
Follow it to disposition
Storage, issue, implant or discard are all disposition events against the same unit, which is what makes the trace work in both directions.
Answer a recall in minutes
A donor identifier resolves to every unit and every consignee, and a consignee resolves back to the donor, without a phone tree.
What the tracking rule actually requires
The federal requirements a tissue traceability system is measured against.
Requires a tracking system that follows every HCT/P from the donor to the consignee or final disposition, and from the consignee back to the donor.
eCFR, 21 CFR 1271.290A distinct identification code must be created specifically for tracking, and it may not include an individual's name, social security number or medical record number.
eCFR, 21 CFR 1271.290Sets out which records must accompany an HCT/P after the donor eligibility determination, and requires that they carry no information identifying the donor.
eCFR, 21 CFR 1271.55Where a new code is assigned to a product, procedures must relate the new code to the old one, so the chain does not break at reassignment.
eCFR, 21 CFR 1271.290The device quality system rule on traceability, which applies where an implant is a device rather than a tissue product.
eCFR, 21 CFR 820.65Implant tissue traceability software questions, answered
Key terms
- What is implant tissue traceability?
- It is the ability to follow a human cell or tissue product in both directions: from the donor to whoever received it or to its final disposition, and from that consignee back to the donor. FDA requires a system that does this under 21 CFR 1271.290, keyed on a distinct identification code.
- What is a distinct identification code?
- It is the tracking key assigned to a product specifically for tracking. The rule is explicit that it may not include an individual's name, social security number or medical record number, so it cannot simply be a patient or donor identifier reused.
Does this replace our electronic health record?
No. The chart records the clinical event. This records the unit: where it came from, where it was held, what happened to it, and the code that ties those together. The two reference each other.
What happens when a product is reassigned a new code?
The rule requires procedures relating the new code to the old one. The system keeps both and the link between them, so a recall against an old code still resolves.
Why we are building this
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Where the requirement comes from
Primary sources, straight from the regulators.
- eCFR, 21 CFR 1271.290, tracking The two directional tracking requirement and the rules governing the distinct identification code.
- eCFR, 21 CFR 1271.55, accompanying records Which records travel with a product after donor eligibility, and the duty to retain them for FDA inspection.
- eCFR, 21 CFR 820.65, device traceability The parallel traceability duty where the implant is regulated as a device.
- eCFR, 21 CFR 820.70, production and process controls The surrounding production control requirements an implant manufacturer works to.
How much does Neurobird Implant Tissue Traceability cost?
Priced per site because storage, procedure and the inspection that follows are site level things. Units, codes and users are unlimited on every tier.
- One facility
- Unlimited units and codes
- Two directional trace
- Disposition log
- Multi department
- Recall resolution view
- Accompanying records vault
- Inspection export
- Unlimited sites
- Inter site transfers
- Supplier integrations
- Priority support
Get free early access
Early access means we model your product types and supplier record formats before you enter anything, and you keep the account free while we do it.
Straight answer on where this is: The software is in development. Nothing is purchasable today. Early access means you shape it and pay nothing while we build.
Prefer email? Write to office@neurobird.com and a person will reply. No autoresponder.