Traceability of medical devices helps ensure patient safety

Medical device manufacturers identify the devices they manufacture. Identifying information, such as a unique device identifier (UDI), a serial number and a batch number, makes it possible to identify the device throughout its life cycle. Manufacturers are obliged to monitor the safety and performance of the devices they manufacture. Traceability enables this monitoring. Operators in the equipment distribution chain must take device tracking into account. In addition, professional end-users shall maintain traceability through a comprehensive monitoring system. The Finnish Medicines Agency (Fimea) has observed that the obligation to trace medical devices has been recognised to varying degrees and is sometimes poorly implemented.

What is traceability?

Traceability plays an important role in monitoring the usage performance of commissioned medical devices and in ensuring patient safety. Traceability information reaches devices handed over to or installed in patients. Traceability information can be used to determine which device is in question.  A question on the information can be posed, for example, by a device manufacturer which seeks the devices it has manufactured through a distributor. On the other hand, a professional user must be able to identify, for example, which device or device belonging to which production batch it has in its warehouse. 

The need for traceability may arise for various reasons, such as a safety bulletin issued by the manufacturer. Traceability information is also needed, for example, to identify a device involved in a hazardous situation. The operators that are part of the delivery of the device must ensure that traceability is realised for their part so that the manufacturer can find the device and monitor its performance. The obligation applies to all medical devices, such as software, single-use products and fixed-installation devices. 

The traceability of devices in professional use must be realised

A professional user must be able to trace which devices it has in use and delivered. The professional user’s obligation to enable the traceability of medical devices has been implemented to varying degrees. The Finnish Medical Devices Act (719/2021) obliges a professional user to compile the device’s identifying information in the monitoring system for traceability.

The identifying information of devices must be stored for medical devices that are used, handed over or otherwise under the control of the professional user or installed in the patient. In addition, it must be possible to store a unique device identifier (UDI) (Unique Device Identifier) for risk class III implantable medical devices. For implantable medical devices, an implant card must also be made available to the patient, allowing the patient to obtain information on the devices installed in the patient. 

More information:

How to identify a medical device?

Monitoring system (in Finnish) 

Unique Device Identifier (UDI), European Commission website

Regulation:

Medical Devices Act 719/2021 (Finlex) 

Medical Devices Regulation 2017/745 (EUR-Lex) 

In Vitro Diagnostic Medical Devices Regulation 2017/746 (EUR-Lex)