What is Techno-surveillance?
The purpose of Techno-surveillance is to guarantee the medical devices available in the market are working in the way that is indicated and intended by the manufacturer. In case it is not, its purpose is to take the corresponding actions to correct and/or diminish the probability of adverse incidents.
Official Definition NOM-240-SSA1-2012
Techno-surveillance (surveillance of the safety of medical devices) is the term used to the set of activities that identify and evaluate the adverse incidents produced by the use medical devices, as well as the detection of risk factors linked to such devices. This based on the notification, registration and systematic evaluation of the reports of adverse incidents.
What is and adverse incident?
An adverse incident is any event proved to be related to the use of a medical device, counting with convincing evidence causally relating the incident and the medical devise. This can be caused by a malfunction or an alteration of the device’s characteristics, which can cause death or a severe deterioration of the user’s health.