Running a Dural Graft Evaluation in a Neurosurgery Department

A dural graft evaluation in a neurosurgery department works best when it is defined before the first case: which surgeons and procedures, which criteria, how many cases and over what period. Supply chain must be aligned, the OR team trained and feedback collected after each case, so that the department can reach a clear, documented decision at the end.

Many product evaluations fail not because the product is unsuitable but because the evaluation was never properly defined. Units arrive without a plan, a few cases happen with no structured feedback, and months later nobody can say what was learned. This article sets out a department-level process that distributors and clinical champions can use to evaluate DESU's DURASHEET and DECOLL, or any dural graft, in a way that produces a credible result.

Why does structure matter?

A structured evaluation protects everyone. The surgeons get a fair comparison based on their own cases. Supply chain gets a documented basis for a decision. The OR team knows what to expect. The distributor gets a clear answer, positive or negative, instead of an evaluation that fades away.

Structure also makes the result transferable. A documented evaluation in one department can support a decision in another hospital of the same system, or at the next contract review. An informal trial leaves nothing behind but impressions.

Structure also respects the hospital's processes. Most hospitals require new products to go through value analysis or a similar review, even for an evaluation. An evaluation that skips those steps may be stopped halfway, and the distributor's relationship with supply chain will suffer.

What should be defined before the first case?

Agree the following points in writing with the clinical champion and supply chain:

• Purpose: what the department wants to learn, for example whether a suturable collagen graft meets its needs in convexity and posterior fossa cases.
• Products: which products and sizes will be evaluated, such as DURASHEET for sutured repairs and DECOLL for onlay repairs.
• Surgeons: who will use the product, ideally more than one surgeon.
• Procedures: which case types are included and which are excluded.
• Number of cases and timeline: a defined number agreed in advance, realistic for the department's volume.
• Criteria: what will be assessed and how.
• Decision: who decides at the end, and how.

Clarity at this stage avoids disagreements later. If the surgeons expect a different outcome from supply chain, the evaluation will end in confusion.

How should supply be set up?

Before any unit reaches the OR, the product should be properly set up in the hospital's systems. That usually means:

Product entry and pricing

The product must be entered in the hospital's item master or equivalent, with the correct codes and the agreed evaluation pricing or no-charge arrangement. Implants used without proper setup cause billing and traceability problems.

Stock and sizes

Agree which sizes will be stocked, where and how many. DESU's membranes each come in four sizes; stock the sizes the evaluating surgeons expect to use, with the next size up available. Make sure stock has adequate remaining shelf life for the evaluation period.

Documentation

Provide the IFU, certificates and safety summaries to supply chain and to the value-analysis team before the first case, so that any questions are answered in advance.

Which criteria should be assessed?

Use a short feedback form, completed after each case by the surgeon and, separately, by the scrub or circulating nurse. A sample structure:

Keep the form short enough to complete in a minute. A long form is not completed, and an incomplete form is worthless.

Include the procedure type, the product and the size used on each form, without any patient-identifying information. That allows feedback to be grouped by case type: a graft may be rated highly in convexity cases and less so in posterior fossa cases, which is useful information for the department and for DESU.

Paper forms kept in the OR, or a simple electronic form if the hospital allows it, both work; what matters is that they are collected. Clinical outcomes should be followed according to the hospital's normal practice; an evaluation of this kind is not a clinical study and should not be presented as one.

How should the OR team be prepared?

Train the OR team before the first case, not during it. A short in-service covering the products, sizes, labels, opening and recording is enough. Make sure night and weekend staff are included if the evaluation covers unplanned cases, such as trauma or spinal durotomies. Leave a reference card at the shelf with the products, sizes and the distributor's contact.

Include the surgeons' preferences in the training. If one surgeon wants the graft trimmed before it is passed and another prefers to trim it themselves, the scrub team should know. Ask the surgeons beforehand and add their preferences to the reference card.

Whenever possible, the distributor's representative should be available for the first cases, in line with the hospital's vendor policy. Their presence is for product support only; they should never take part in the clinical decision.

How should feedback be handled during the evaluation?

Collect forms promptly after each case. Review them regularly with the clinical champion, at intervals agreed at the start. If a recurring problem appears, such as a missing size or confusion between products, fix it during the evaluation rather than waiting for the end.

Any complaint or adverse event must be handled through the proper channels: recorded with the lot number, reported to the hospital's systems as required and passed to DESU without delay. A distributor who handles a problem openly during an evaluation often gains more trust than one whose evaluation runs without incident.

How should the evaluation end?

Hold a decision meeting at the agreed point with the clinical champion, the evaluating surgeons, an OR representative and supply chain. Present the feedback summary, the number of cases, any issues and how they were resolved. Then let the department decide.

If the result is mixed, for example positive for one product and negative for the other, or positive for some case types only, record that precisely. A department may decide to adopt DURASHEET for sutured repairs while keeping its current onlay product, or the reverse. A clear, partial decision is better than an unclear overall one.

Whatever the result, write a short summary and share it with the participants. A positive result goes forward to value analysis or contracting. A negative result should include what the department would need to reconsider, which is valuable information for DESU and for future conversations. Thank everyone who took part.

Talk to a DESU product specialist

If you are planning a dural graft evaluation in a neurosurgery department, DESU's product specialists can provide evaluation documentation, IFU, labels and training material for DURASHEET and DECOLL and discuss what your market requires. Contact sales@desu.tr, use the contact page, or request a quote.