Dural Graft Lot Traceability: What Hospitals Expect in Implant Records

Hospitals expect every implanted dural graft to be traceable from the manufacturer’s lot number to the patient’s record. The manufacturer records which lots it shipped and where; the distributor records receipt, storage and delivery by lot; the hospital records the product, size, lot and expiry in the implant log for each case.

This article looks at dural graft traceability from the distributor’s position in the middle of that chain. It complements our broader article on dural graft traceability, UDI and storage, with a focus on the records hospitals expect and the routines that make them reliable for products such as DURASHEET and DECOLL.

Why is a dural graft treated as an implant record item?

A dural graft stays in the patient after surgery. Like other implants, it must be identifiable if a question ever arises about a particular production lot, whether through a manufacturer’s field safety action, a complaint investigation or a clinical review. Hospitals therefore record implants at the level of the individual lot, not only the product name.

Collagen grafts of animal origin add a further reason. Manufacturers working under the ISO 22442 framework maintain traceability from raw material to finished device lot. That upstream traceability is only useful if the downstream chain, through the distributor to the patient, is equally complete.

What does the hospital expect to record?

Implant logs differ between hospitals and electronic record systems, but most capture similar information for each graft used.

• Manufacturer and product name, for example DESU DURASHEET.
• Size or reference number as printed on the label.
• Lot or batch number and expiry date.
• Date of surgery, procedure and surgeon.
• The patient record into which the implant information is entered.
• Any graft opened and not implanted, recorded as waste.

Most of this information comes straight from the device label and packaging. Labels use standardized symbols for the lot, expiry date and manufacturer, defined in ISO 15223-1, so OR staff can find the right fields quickly. Where the hospital scans barcodes, the scanned data should be checked against the label the first few times a new product is used.

What must the distributor record at each step?

The distributor’s records connect the manufacturer’s shipment to the hospital’s implant log. If a lot is ever in question, the distributor must be able to say quickly which accounts received it and how many units remain in its own stock.

Recording lots at every step sounds obvious, but it is often skipped when shipments are urgent or when stock is moved between a rep’s car, a consignment cabinet and the warehouse. Those informal movements are where traceability usually breaks.

Trunk stock deserves particular attention. A graft carried by a rep for an urgent case is still part of the distributor’s inventory, and its lot must be recorded when it leaves the warehouse and again when it is delivered or returned. A simple rule helps: no unit moves anywhere without its lot being written down.

Which documents should accompany each shipment?

Traceability depends as much on paperwork as on labels. Each shipment from the distributor to a hospital should carry a delivery document that lists product, size, lot, expiry and quantity, so that the hospital’s receiving team can check the physical goods against the paper and record lots at the dock rather than in the OR.

Hospitals increasingly expect this information electronically as well, through their purchasing or inventory systems. Whatever the format, the content should be identical to what is printed on the device labels. Discrepancies, such as a lot on the delivery note that does not match the box, should be resolved before the product is put away.

Upstream, the distributor should file the manufacturer’s shipping documents for each incoming consignment and keep them for the period required by its own quality procedures. If a question ever arises about a lot, those documents are the starting point of the trace.

How does consignment change traceability?

Consignment places the distributor’s stock inside the hospital. That is convenient for the OR, but it splits responsibility: the hospital records implants, while the distributor still owns the unused stock and must know which lots are where.

A reliable consignment program reconciles three records regularly: the distributor’s consignment list by lot, the hospital’s usage and bill-only records, and a physical count of the cabinet or shelf. Differences should be resolved promptly. A unit that cannot be accounted for is not only a financial loss; it is a gap in the implant traceability chain.

What happens if a lot needs to be traced?

If a manufacturer issues a field safety notice or a hospital raises a question about a specific lot, the speed of the response depends on the quality of the records. A well-prepared distributor can do the following within a short time:

• Identify every account that received the lot, with dates and quantities.
• Identify units of the lot still in its own warehouse, in consignment and in evaluation stock.
• Quarantine those units and confirm the count to the manufacturer.
• Contact each account’s designated person with the manufacturer’s information.
• Record every action taken, with dates, for the manufacturer’s file.

The hospital then uses its implant records to identify any patients concerned and decides on clinical follow-up. The distributor’s role is to make sure no unit falls between the records.

Each account should have a named contact for such notices, usually in supply chain or risk management, with a deputy for absences. Confirm these contacts once a year. A notice sent to someone who left the hospital months ago is a delay that nobody intended but everybody regrets.

Run a drill

A simple exercise once a year shows whether the system works. Choose a real lot number, ask the team to locate every unit and every account that received it, and time the result. Gaps found in a drill are far easier to fix than gaps found in a real event.

How can traceability errors be prevented?

• Never split a unit from its labeled packaging before it reaches the sterile field.
• Use first-expiry-first-out rotation, so the oldest lots are used first and expiry checks stay simple.
• Scan or record lots at every movement, including transfers between consignment locations.
• Train reps and hospital staff on where the lot number and expiry date appear on the label.
• Reconcile consignment and evaluation stock on a fixed schedule, not only when problems appear.

DESU manufactures its dural grafts under an ISO 13485 quality management system, which includes traceability of production lots. Distributors can ask DESU how lot information is presented on labels and shipping documents, so that their own receiving process captures it consistently.

Talk to a DESU product specialist

If you are setting up receiving, consignment or recall routines for DURASHEET and DECOLL, DESU’s product specialists can explain the labeling and shipping documents and help align your records with the hospital’s expectations. Contact sales@desu.tr or use the contact page.