INCIDENTS INVOLVING MEDICAL DEVICES
With a large number of medical devices in use or on the market, incidents can arise during their use, which can be serious or even pose a public health threat. Incidents related to medical devices and in vitro medical devices are recorded in the medical device vigilance system, which is governed by the Regulation (EU) 2017/745 on medical devices (MDR), Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and Medical Devices Act (ZMedPri-1, Official Gazette of the Republic of Slovenia no. 40/25).
The medical device vigilance system has been set up to protect public health and the health and safety of patients and other users of medical devices through the introduction of field safety corrective actions and the reduction of the possibility of recurrence of a medical device-related incident that has been noted in the past.
Activities performed by the JAZMP in relation to the vigilance system include collecting and evaluating serious incident reports in cooperation with the manufacturer of medical devices or its authorised representative, monitoring the manufacturer or its authorised representative during incident investigation, implementing any further measures necessary to complement the measures taken by the manufacturer or its authorised representative, and participating in the international medical device vigilance system.
‘Incident‘ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use error due to ergonomic characteristics, as well as any undesirable side effect, any inadequacy in the information provided by the manufacturer and any harm as a conseguence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.
‘Serious incident‘ means any incident that directly or indirectly led, might have led or might lead to any of the following:
- the death of a patient, user or other person;
- the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health;
- a serious public health threat.
‘Serious public health threat‘ means an event which could result in an imminent risk of death, a serious deterioration in a person’s state of health, or a serious illness, which may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.
Participants in the medical device vigilance system report any serious incident involving medical devices that occurs in the territory of the Republic of Slovenia to JAZMP.
FIELD SAFETY CORRECTIVE ACTIONS
‘Field safety corrective action‘ means corrective action (action taken to eliminatethe cause of a potential or actual non-conformity or other undesirable situtation) taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
The medical device manufacturer or its authorised representative must notify JAZMP of any safety corrective action to be implemented in the territory of the Republic of Slovenia and inform the USERS of the device in question.
