Gamma-Sterilised Dural Grafts: What the Label Means
What “gamma sterilised” means on a dural graft label: the STERILE R symbol, what the label does not promise, and how it differs from an EO-sterilised product.
On a dural graft label, “gamma sterilised” means the graft was sterilised by gamma irradiation, usually shown by the STERILE R symbol. It tells you how sterility was achieved, not what the graft is made of or how it should be used. DESU dural grafts, DURASHEET and DECOLL, are both gamma sterilised and supplied ready to use.
Key takeaways
- “Gamma sterilised” states how sterility was achieved, usually shown by the STERILE R symbol.
- The sterility statement says nothing about collagen type, technique or size.
- DESU dural grafts are gamma sterilised; DESU shunts are EO sterilised; the Adjustment Kit is non-sterile.
- The sterile claim depends on an intact package within its date, and the IFU has the final word.
The science of the process is covered in our article on gamma sterilisation of collagen dura membranes. For the nurses, sterile store staff and buyers who read the label, what counts is what its words and symbols let you conclude, and what they do not.
What does “gamma sterilised” mean on a dural graft label?
It names the sterilisation method. Gamma sterilisation uses ionising radiation, and it is normally applied to the product in its sealed packaging. For the reader of the label, three practical points follow:
- The product is presented as sterile, so it does not go through hospital sterile processing.
- The method does not make the product radioactive, so no radiation precautions apply to storage or handling.
- The claim holds under the conditions on the label: an intact package, within its date.
Which label elements matter most?
Medical device labels use the standard symbols of ISO 15223-1. The table lists the ones most relevant to a sterile graft. Always read the pack in your hand.
| Symbol or statement | What it means | What to do |
|---|---|---|
| STERILE R | Sterilised using irradiation | Treat as sterile only if the barrier is intact |
| Use-by date | The last date for use | Check before opening; rotate stock |
| Do not use if package is damaged | The sterile barrier may be compromised | Set aside under local policy |
| Do not resterilise | Must not go through another sterilisation | Do not send to sterile processing |
| Do not re-use | Intended for one use only | Do not keep for a later case |
| LOT | The batch of the product | Copy into the implant record |
| REF | The reference number | Match against the request |
| Consult instructions for use | The IFU contains essential information | Read it for handling and use |
The REF is the quickest check on the right item. DESU codes start with DRS for DURASHEET and DCL for DECOLL, and the digits give the size: 2525, 5050, 7575 and 100100 for 2.5 × 2.5, 5 × 5, 7.5 × 7.5 and 10 × 10 cm. So DRS5050 is a 5 × 5 cm DURASHEET, and DCL5050 is the same size of DECOLL.
What does the label not tell you?
A sterility statement answers one question. It is easy to read more into it than it says:
- Material: the method says nothing about the collagen. That DESU membranes are pure Type I bovine collagen is a separate statement.
- Technique: both membranes can be applied as an onlay, while the suturable, two-surface design belongs to DURASHEET. The sterilisation method does not distinguish them.
- Performance: the method is not a claim about how a graft behaves at the repair site.
- Sterility after a breach: a damaged or opened package is no longer covered by the statement.
The difference between DURASHEET and DECOLL therefore cannot be read from the sterility symbol, because it is the same on both. Check the product name and the REF.
How does a gamma label differ from an EO label?
A hospital that buys several DESU product groups will see more than one sterility statement on the same shelf:
| DESU product | Sterility statement | Symbol to expect |
|---|---|---|
| DURASHEET and DECOLL | Gamma sterilised | STERILE R |
| Defit, Decurve and Depus shunt systems | Single-use, sterilised with EO | STERILE EO |
| Depus Adjustment Kit | Non-sterile, reusable | No sterile symbol |
A sterilisation method is chosen and validated for a particular device and its materials. The method on one product therefore tells you nothing about another, even from the same manufacturer. Staff should read each label on its own terms and not assume that everything from one supplier is handled the same way.
Is “ready to use” the same as “gamma sterilised”?
No. “Gamma sterilised” describes how the sterile state was reached. “Ready to use” means DURASHEET and DECOLL need no pre-processing before application. They are related but separate statements, and one does not imply the other. Our article on ready-to-use dural grafts follows the second idea through the operating room.
What should staff check before opening?
- Product and size: the name and REF match what the surgeon asked for.
- Sterility: the sterile symbol is present and the package is intact, with no tears or damaged seals.
- Date: the use-by date has not passed.
- Traceability: the LOT is ready to be recorded in the implant record.
Opening technique, handling and placement follow the IFU and the hospital’s own policy. Clinical decisions about the graft belong to the surgeon.
What can a buyer ask for?
A label is a summary, and a buyer may need the documents behind it. Reasonable requests to a manufacturer include the IFU, a sample label, a statement of the sterilisation method and the standard it follows (the ISO 11137 series covers radiation sterilisation), and the quality certificates. DURASHEET and DECOLL are CE marked and made under an ISO 13485 quality management system.
Talk to a DESU product specialist
For label samples, IFU copies or sterilisation documentation for DURASHEET and DECOLL, write to sales@desu.tr, use the contact page or request a quote.
Frequently asked questions
Is STERILE R the same as STERILE?
The R adds detail. The symbol shows that the product is sterile and that irradiation was the method used. Other methods have their own marking, such as STERILE EO for ethylene oxide.
Can an opened but unused graft be sterilised again?
No. Do not resterilise a graft from a package that has been opened or damaged. Follow the label, the IFU and the hospital’s disposal policy.
Are DURASHEET and DECOLL sterilised differently?
No. Both are gamma sterilised, and both come in the same four sizes. Their differences lie in the design of the membrane, not in the sterilisation method.
Does the label show how to store the graft?
Storage conditions and the expiry date are stated on the label and in the IFU, and those are the values to follow.
Related standards
- ISO 15223-1: Medical devices — Symbols to be used with information to be supplied by the manufacturer
- ISO 11137 series: Sterilization of health care products — Radiation
- ISO 13485: Medical devices — Quality management systems