Safety and Vigilance

The safe operation of medical devices is a shared responsibility between the manufacturers, the health care units and the users, while the Competent Authorities have the responsibility for the implementation of the EU Directives, as well as the notification and evaluation of adverse incidents. Member States are called to adjust their practices in accordance to the Directives and set up the mechanisms required for the proper and effective operation of the Vigilance System for Medical Devices.

Hospital and users are responsible according to the EU regulations, implemented as national laws to maintain their equipment in proper conditions, assuring that they continue to function as intended by the manufacturers. Additionally, they must report any adverse event that involved a medical device, resulting in harm or death of a patient.

INBIT provides Functional Status and Electrical Safety tests for certain types of medical equipment and a service related to medical devices vigilance including information related to recalls. Monitoring of safety issues, ensures the best possible level of security to be provided by a hospital to its patients and staff. This also covers both the hospital and its medical and paramedical personnel from legal implications arising from the use of medical devices. 
Electrical safety testing is of major importance for all medical devices and particularly those which are located in critical areas of the hospital (e.g. operating rooms, ICU etc.) and those that are used for diagnostic purposes and carry energy to the patient or record vital signs (e.g. diagnostic ECG, monitors).

Furthermore, periodical safety testing of critical equipment such as diathermy, defibrillators and monitors should be part of the hospital yearly safety program, to ensure that critical parameters such as output power, leakage currents, etc. are within the limits and therefore the operation of the equipment is safe.

INBIT is a unique agency, which for more than two decades has been involved in many European actions to tackle the problem of Medical Devices Vigilance . Also, through international collaborations, INBIT has access to primary sources of information, has created and constantly updates a database of adverse incidents that have been reported worldwide. Part of the services provided by INBIT is the identification of medical devices that are installed in a hospital and which have previously been reported in adverse incidents. In such cases, a report on the necessary actions to be taken is elaborated and submitted to the hospital.