Dural Graft Samples and Evaluation Units: How to Run Them Properly

Dural graft samples come in two broad kinds: demonstration material for handling outside the sterile field, and sterile evaluation units used in real cases. Running them properly means agreeing purpose, quantity, sizes, records and an end date with the hospital before the first unit is handed over, and accounting for every unit afterwards.

Evaluations are where a new dural graft line is won or lost. A well-run evaluation of DURASHEET or DECOLL gives surgeons a fair chance to judge the product and gives the value analysis committee the information it needs. A poorly run one leaves stray units in storage rooms, incomplete feedback and a decision that never comes. This guide sets out a practical approach for distributors and hospital teams.

What is the difference between a demonstration sample and an evaluation unit?

The two terms are often used loosely, which causes confusion with hospital staff. It is worth being precise from the first conversation.

What is available for a particular evaluation should be agreed with the manufacturer in advance. A distributor should never repurpose a sterile unit as a handling sample, or allow material intended for demonstration to drift into a clinical area.

Why do hospitals have rules about samples?

Most hospitals require any product that will be used in a patient to pass through a defined route, typically a new product request and value analysis review, before it reaches the OR. Sterile evaluation units are no exception. A surgeon’s enthusiasm does not replace that process, and a distributor who bypasses it risks losing access to the account.

Hospitals also have vendor policies covering who may enter clinical areas, how products are delivered and how samples are logged. Infection prevention teams may want to know how sterile units were stored and transported. Supply chain teams want evaluation units to appear in their records so that traceability is not broken.

Learning these rules early, usually from the value analysis coordinator or the OR materials manager, saves weeks. It also signals to the hospital that the distributor understands how it works.

Who should own the evaluation inside the hospital?

Every evaluation needs a named owner on the hospital side, usually the champion surgeon together with the OR materials manager or the value analysis coordinator. The surgeon owns the clinical judgment; the materials or value analysis contact owns the process, the stock and the paperwork. Without both, evaluations tend to stall.

The distributor’s counterpart should be one named rep who knows the plan, holds the log and attends the first cases where the hospital allows it. Changing reps halfway through an evaluation is one of the most common reasons feedback goes missing.

Agree at the start how often the three of them will check progress. A ten-minute call every two weeks is usually enough to catch problems early, such as a size running short or a surgeon who has not yet had a suitable case.

How many units, and which sizes?

The number of evaluation units should follow from the number of cases the evaluation is meant to cover, not from what fits in the rep’s bag. Start from the account’s procedure map: which surgeons will participate, which procedures they expect to perform during the evaluation period and which sizes those procedures typically need.

Because DURASHEET and DECOLL each come in four sizes, the plan can be specific. A cranial tumor surgeon may need a different size profile from a spine surgeon who uses grafts only after an incidental durotomy. Allocating units by surgeon and size avoids two common problems: running out of the size that matters in the middle of the evaluation, and leaving a pile of sizes nobody used.

A modest buffer for unplanned cases is sensible, particularly for spine teams. It should be agreed and recorded like the rest of the plan. Check expiry dates before handing units over: evaluation stock should have ample remaining shelf life, so that units are not lost to expiry if the evaluation runs slower than planned.

How should evaluation units be tracked?

A sterile evaluation unit implanted in a patient is an implant, with the same traceability needs as purchased stock. The distributor and the hospital should be able to answer, at any time, where every unit is and what happened to it.

• Product, size, lot number and expiry date for each unit handed over.
• Date of delivery, receiving person and storage location in the hospital.
• For each use: date, procedure type and the hospital’s implant record reference, kept within the hospital’s own systems.
• Units opened but not implanted, with a short reason.
• Units remaining at the end, and whether they were returned, purchased or disposed of.

The distributor’s log should hold no patient-identifying information. The link between a lot number and a patient lives in the hospital’s implant record. For more on implant records, see our article on dural graft traceability and storage.

What should the evaluation capture?

A short feedback form, completed after each case, is more useful than a long survey at the end. Surgeons and scrub staff remember handling details for a few hours, not a few weeks. Useful questions include:

• Procedure type and the size used; whether the size was right or had to be changed.
• Placement technique: sutured, onlay or combined with an adjunct.
• Handling: preparation, trimming, conformability and, for DURASHEET, suturing.
• Anything the surgeon or scrub team would want changed or explained before the next case.
• An overall rating and whether the surgeon would use the product again.

The distributor compiles the forms into a one-page summary for the committee. Negative comments belong in that summary too; they are often the most useful input for the manufacturer and for the next evaluation.

What happens to unused units at the end?

The end of an evaluation is where control is most often lost. Units sit on a shelf, the champion surgeon moves on to other priorities and, months later, nobody is sure whether they were part of an evaluation or purchased stock. Agree in advance what happens on the end date.

Typical options are returning the units to the distributor, converting them to purchased stock if the product is adopted, or recording their disposal if they are close to expiry. Whatever the choice, the evaluation log should be closed with a final count signed off by the hospital contact. That record protects the hospital, the distributor and the manufacturer if questions arise later.

Converting an evaluation into an order

If the evaluation is positive, the next steps should already be prepared: item numbers for the hospital’s system, a proposed size mix based on what the evaluation showed, pricing and delivery terms. The best moment to agree a first order is while the surgeons’ experience is still fresh.

Talk to a DESU product specialist

If you are planning an evaluation of DURASHEET or DECOLL with a hospital, DESU’s product specialists can help you define the plan, sizes and documentation. Write to sales@desu.tr, use the contact page, or request a quote for evaluation and first-order quantities.