Medical devices can also be handed over to patients outside the hospital

Patients increasingly need and are given access to medical devices. As treatments grow more diverse and the needs of patients expand, medical devices are also required for patients outside of healthcare units. The unit staff should pay special attention to the environment in which the device is used and instructing the patient when handing over the device. The professional user who handed the medical device over to the patient is responsible for the safety of the device. 

The manufacturer is responsible for instructions on taking environmental factors into account 

Under the EU Medical Device Regulation, the manufacturer must assess and manage the risks associated with the use of the device. These also include providing instructions on the intended operating environment of the device. The manufacturer must assess the potential risks associated with the design and manufacture of the device, such as the impact of temperature, humidity, electromagnetic compatibility, and biological and chemical factors.  

In the instructions for use, the manufacturer must provide sufficient information on the conditions for which the device is designed and any restrictions on its safe use. The use of software is also essentially related to user interface requirements. For example, the manufacturer may have issued limitations on the compatibility of the software versions of mobile devices. 

Professional users need to have a high level of awareness of the safe use of devices 

The professional user handing over the device plays a key role in ensuring the safe use of the device. The device must be handed over in accordance with the intended use indicated by the manufacturer and the instructions given in connection with the device. When handing over a medical device, aspects such as the following must be assessed: 

• whether the place of use is suitable for the safe use of the device 
• how other devices, structures and systems in the surrounding environment affect the operation of the device 
• are electrical and communications connections at a safe level 
• whether it is safe to connect the device to other equipment 
• whether the user has sufficient competence for using the device. 

In addition, national legislation requires that the professional user must verify the validity of the installations, service and repairs done by external service providers. 

Changing environments bring new risks 

The Finnish Medicines Agency Fimea has observed in its supervision that there is a need to steer health care units in a preventive direction regarding the handover of medical devices; they should be able to identify risks before the device is deployed. They should also carry out assessments as the operating environment changes. Fimea instructs units to assess, for example, whether the manufacturer has designed the device to be used in the planned conditions and whether the user has verified any other devices in the environment. 

Risks can change rapidly in spaces where several devices are used simultaneously, liquids are handled, or operations take place in technologically challenging conditions, such as old buildings, for example. The question ‘Does the environment meet the manufacturer's requirements?’ is essential to each application of a device. 

Fimea wants professional users to pay increasing attention to the requirements related to the handover of a medical device. The obligations referred to in this article are described in Chapter 4 of the Medical Devices Act (719/2021) of Finland regarding the obligations of professional users. 

Definition of medical devices   

Devices in healthcare and social services