Incidents involving medical devices that are classed as serious and occur in Switzerland must be reported to Swissmedic. Examples of notifiable incidents include the following:
- A patient dies following the use of a defibrillator, and there is reason to believe that something is wrong with the defibrillator.
- An infusion pump stops unexpectedly without issuing an alarm.
- A user finds glass particles in a contact lens bottle.
- Pain caused by a hip implant leads to revision surgery
Swissmedic systematically collects and evaluates these reports.
This reporting system is designed to protect the health of patients and users. In particular, it aims to avoid recurrences of incidents based on problems with the design, manufacture or use of medical devices.
Field Safety Corrective Action (FSCA)
Problems with medical devices may require the manufacturer to recall devices or implement other safety measures. Such safety measures and recalls are covered by the term Field Safety Corrective Actions (FSCAs). Swissmedic monitors all FSCAs for medical devices that are manufactured or marketed in Switzerland.