Reporting serious incidents from healthcare facilities
Healthcare facilities have an obligation to report serious incidents that have or may have a connection with the use of a medical device
Mandatory reporting for medical device
Entities handling medical device are legally obligated to report incidents that may be related to the use of medical device and that have led to or could have led to death or serious deterioration of a patient's, user's, or another person's health condition. This is referred to as a serious incident.
The reporting obligation is triggered by any malfunction or deterioration in the properties or performance of the medical device that has led or could lead to a serious incident, or when there is suspicion of a serious incident related to medical device.
It is important to note that the facility is responsible for handling medical device in accordance with instructions accompanying the device (such as user manuals). This includes:
Maintenance, alterations, and repairs
Storage and handling
Reports of serious incidents allow the manufacturer to investigate whether their device may have contributed to the incident, whether there may be a failure in the device, or if it has been handled correctly. Such reports also help in identifying and rectifying errors or deficiencies in medical device. If an error is caused by systematic failures or deficiencies, the manufacturer can implement corrective safety measures to rectify/improve/recall the device, ensuring that similar incidents does not recur.
Who should report?
Entities subject to reporting obligations include both public and private healthcare services such as hospitals, pharmacies, dental clinics, opticians, beauty clinics, and others using the medical device within their facilities. Facilities or healthcare services that provide medical device to individuals, for example, through loaning assistive devices, are also covered by these obligations.
How to report a serious incident?
Reports of serious incidents involving medical device should be submitted on the website melde.no. The platform is used for reporting various types of patient-related incidents.
Do you need to report a serious incident involving a medical device?
Melde.no is intended for use by healthcare professionals and other employees in healthcare and social services. Private individuals are encouraged to contact their healthcare provider, distributor, or the entity that provided the medical device.
When a serious incident occurs:
- Prevent further damage
- Do not discard the medical device, packaging, or accessories
- Quarantine the medical device - manufacturers often request the return of the device for investigation
- Consult with the manufacturer before any further investigations are performed on the device
When reporting a serious incident, include the following information:
- Unique identifier for the emedical device (Serial number, UDI, etc., or lot/model)
- Device name
- Manufacturer and distributor names
- Detailed description of the incident and how the medical device was involved
- Contact information for the reporter, whom the manufacturer can contact
Do not include sensitive personal data when reporting.
If there is doubt about whether an incident should be reported, it is better to report than not to report.
What happens to the report?
The Norwegian Medicines Agency assesses and forwards reports of any suspicions about serious incidents linked to a medical device to the manufacturer. It is the manufacturer's responsibility to investigate whether their device may have caused/contributed to the incident in any way, to report to the Norwegian Medicines Agency, and take appropriate follow-up actions.
It is common for the manufacturer to contact the person who reported the incident for additional information and if possible, have the device returned for further investigations.
The Norwegian Medicines Agency monitor the manufacturer's investigations and follow-up actions.
The conclusion and any actions taken by the manufacturer are communicated to the person who reported the serious incident.
can report serious incidents, but are encouraged to contact their healthcare provider, dealer, or others from whom they obtained the relevant medical device.
Other incidents in healthcare facilities
Incidents can also fall under other reporting systems. All entities providing healthcare and social services, for instance, have an obligation to notify the Health Supervisory Authority about deaths and extremely serious injuries to patients or users related to healthcare. This can also be done through the Melde.no portal.
Incidents not meeting the reporting criteria of a serious incident and not reported to the Norwegian Medicines Agency should still be considered for reporting to the manufacturer.