A comparison between French and Mexican Technovigilance process

Abstract

In the Medical world, one of the new goals is to pay attention to the patient safety. The surveillance of medical devices is called Technovigilance. Several laws exist in the world to apply those rules in hospitals, institutions or industry. The objective is to prevent the recurrence of adverse incidents and risks of serious incidents involving medical devices and to take preventive and corrective actions. To control this process, there are health and sanitary agencies located in France and Mexico. To understand how these agencies work, we will compare their organization and to which standards they refer. Also, asking the staff working at the hospital and students involved in biomedical engineering seemed important to us. Most of the people who answered the questionnaire did not have information about Technovigilance and its relation with medical devices. Concerning the comparison, we found similar laws and standards but in Mexico these laws are not operative.