Shunt Systems: What the Single-Use, EO Sterile Label Says
DESU shunt systems are supplied single-use and sterilised by ethylene oxide. What the label means for the OR team, and what to check before opening a kit.
The label on a DESU shunt system tells the OR team two things before anything else: the device is single-use, and it was sterilised with ethylene oxide (EO). Together they mean that one pack serves one patient, and that a pack which is opened, damaged or expired cannot be made usable again by the hospital.
Key takeaways
- All DESU shunt systems are supplied single-use and sterilised by ethylene oxide (EO).
- A pack that is opened, damaged or past its use-by date cannot be made usable again by the hospital.
- Valve family, size, pressure, options and reference code should be read back before a kit is opened.
- Sterility statements differ across the range: EO for shunts, gamma for dura membranes, non-sterile for the Depus Adjustment Kit.
All three DESU valve families, Defit, Decurve and Depus, are supplied this way. The label on the pack and the instructions for use (IFU) always take precedence. For what is inside each pack, see the VP shunt kit contents checklist.
What does “single-use” mean on a shunt system?
Single-use means the manufacturer intends the device for one patient in one procedure. It is a statement about what has been validated: the device has been shown to perform and to be sterile for that one use. Cleaning, resterilisation and a second use have not been validated.
For an implanted valve and its catheters this seems obvious. The discussion usually starts with the cases where part of a kit is never implanted:
- A kit is opened, the surgeon changes plan and the valve is not used.
- A component in the kit is not needed, such as a connector.
- A pack is opened onto the sterile field and the case is then cancelled.
The single-use statement applies in each case. A part that has left its sterile packaging does not go back into stock, and the hospital’s own procedure decides how it is recorded and discarded.
What does EO sterilisation mean for the OR team?
Ethylene oxide is a low-temperature gas sterilisation process, widely used for medical devices made from polymers or with internal channels. The gas reaches the device through its packaging, and a period of aeration then removes the residual gas. ISO 11135 sets out how the process is developed, validated and controlled, and ISO 10993-7 deals with the limits for residues.
Three practical points follow:
- The device arrives sterile. There is no sterilising step for the hospital, and a shunt kit does not go through the hospital’s steriliser.
- Sterility depends on the packaging. If the sterile barrier is torn, punctured, wet or unsealed, the contents can no longer be treated as sterile.
- EO is one sterilisation method among several. The label names the method, which is useful when records or documents are checked, and handling at the point of use follows the label and the IFU.
Which label symbols should the team recognise?
Labels on sterile medical devices generally use the symbols of ISO 15223-1, so the same information can be read in any language. The table lists the ones that matter most for a shunt case. The symbols and details printed on the actual pack are the reference.
| Label item | What it means | What the team does with it |
|---|---|---|
| STERILE EO | Sterilised using ethylene oxide | Confirms the sterilisation method; keep the pack closed until it is needed |
| Crossed-out 2 | Do not re-use | One patient, one procedure |
| Do not resterilise symbol | The device must not be sterilised again | Discard according to hospital procedure; do not reprocess |
| Hourglass | Use-by date | Compare with the date of surgery |
| LOT | Batch code | Copy into the implant record and the patient file |
| REF | Reference number | Match against the surgeon’s request |
| Damaged package symbol | Do not use if the package is damaged | Set the pack aside and open a replacement |
| Open book symbol | Consult the instructions for use | Keep the IFU available to the team |
What should be checked before a shunt kit is opened?
Shunt packs can look alike while differing in several ways, so a short read-back between the circulating nurse and the surgeon is worth the few seconds it takes. Before opening, confirm:
- Valve family and size: for example Defit Ultra Small, Small or Regular, or paediatric or adult Decurve.
- Pressure: low, medium or high, or an adjustable Depus valve.
- Configuration: valve alone or complete kit, ventriculoperitoneal (VP) or lumboperitoneal (LP).
- Options: an antisiphon device, shown by a reference code ending in “-ASD”, and any antibiotic-impregnated components.
- Use-by date and the condition of the packaging.
The reference code carries much of this information. DFS-M-VCK-ASD, for example, is a medium-pressure Defit Small shunt with a VP catheter kit and an antisiphon device. Reading the code aloud against the request is simpler than comparing descriptions.
Colour helps only after the pack is open: antibiotic-impregnated catheters are orange and standard ones white. The decision to open should rest on the label.
Is every DESU product in the OR sterilised the same way?
No, which is a good reason to read each label separately. Three different statements apply across products that may sit on the same theatre shelf:
| Product | Supplied as | Sterility statement |
|---|---|---|
| Defit, Decurve and Depus shunt systems | Single-use | Sterilised by ethylene oxide |
| DURASHEET and DECOLL dura membranes | Ready to use | Gamma sterilised |
| Depus Adjustment Kit | Reusable, in a dedicated case | Non-sterile |
The Depus Adjustment Kit is the one to keep apart. Its locator, compass and magnet are used to find, read and set an adjustable Depus valve non-invasively. The kit is not an implant, it is reusable, and it is supplied non-sterile, so it should never be treated as part of the sterile shunt pack.
What if a pack is damaged, expired or opened by mistake?
The answer is the same in all three cases: that pack is not used. Set it aside, open a replacement and follow the hospital’s procedure for recording it. Keep the label information, because the reference code and lot number are what a supplier needs if a packaging problem is reported.
Expired or damaged stock should leave the shelf at once so that it cannot be picked up for the next case. Because a replacement may be needed at short notice, it helps to know before the list starts whether a second unit of the required size and pressure is available. The wider principles of storing sterile goods and rotating stock are covered in our sterile packaging and storage checklist, written for EVD kits.
Talk to a DESU product specialist
If your team would like documentation or a walk-through of DESU shunt system labels and reference codes, DESU’s product specialists can help. Write to sales@desu.tr, use the contact page, or request a quote.
Frequently asked questions
Can an unopened shunt kit be used after its use-by date?
No. The use-by date on the label is the limit for use, even if the pack looks intact. Remove the pack from stock and follow the hospital’s procedure for expired devices.
Can a hospital resterilise a shunt kit that was opened but not used?
No. DESU shunt systems are supplied single-use, and the label and IFU are the reference. A second sterilisation cycle has not been validated, whether or not the device was implanted.
Are DESU shunt systems gamma sterilised?
No. All DESU shunt systems are sterilised by ethylene oxide. Gamma sterilisation is the method used for the DURASHEET and DECOLL collagen dura membranes.
Does the Depus Adjustment Kit come sterile?
No. It is non-sterile and is kept in a dedicated reusable case. It comes in 3 Pressure and 5 Pressure versions, and its care between uses follows the IFU.
Related standards
- ISO 11135: Sterilization of health-care products — Ethylene oxide
- ISO 15223-1: Medical devices — Symbols to be used with information to be supplied by the manufacturer
- ISO 7197: Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components