Storing medical devices: UDI and ÜTS

Medical devices are stored under the conditions on their label, and their lot numbers and expiry dates are recorded at receipt and dispatch. UDI gives each device an identity that carries model and production data. ÜTS is the system in which devices are registered in Türkiye and their movements reported.

Medical devices cover a wide range. A sticking plaster and a pacemaker both belong to the group. In storage they share two needs: keep to the conditions the manufacturer puts on the label, and never lose track of a unit. The two keys to that tracking are UDI and ÜTS.

What is UDI?

UDI (Unique Device Identification) is the system that gives medical devices a unique identity. The identity has two parts. The UDI-DI identifies the device model. The UDI-PI carries production data: the lot or serial number, the expiry date and the manufacturing date, whichever apply.

In the European Union the UDI system was set up by the Medical Device Regulation, Regulation (EU) 2017/745 (MDR). Türkiye has aligned its medical device rules with the MDR.

What is ÜTS?

ÜTS (Ürün Takip Sistemi) is the product tracking system that TİTCK runs for medical devices. Devices are registered in it and their movements are reported to it. The logic resembles İTS for medicines: the records show where a product is in the chain.

For a warehouse, this means lot numbers and expiry dates are recorded in full at receipt and at dispatch. A movement can only be reported correctly if it was recorded correctly first.

What to watch in storage

The storage condition is set by the manufacturer’s label and instructions for use. It varies from product to product: some in-vitro diagnostic reagents, for example, need 2–⁠8 °C.

Sterile products need particular care. A device whose sterile barrier is damaged can no longer be treated as sterile. Units with crushed or torn packaging are therefore separated at receipt and in storage, quarantined and reported to the product owner, who decides what happens to them.

The other rules are more familiar:

Stacking limits on cartons are respected; too much weight can crush both the packaging and the device inside.
Goods are kept out of direct sunlight.
Moisture is a risk, especially for carton and paper-based packaging. We cover its effects in a separate article.
With lot and expiry on record, stock of devices that carry an expiry date can rotate by FEFO.

What does ISO 13485 say?

ISO 13485:2016, the quality management standard for medical devices, covers the preservation of product during storage and distribution in clause 7.5.11. It asks for the device’s conformity to requirements to be preserved throughout.

For an organisation that stores devices, the practical meaning is short: a device should leave the warehouse in the condition in which it arrived.