Medical Device Vigilance Is the Identification, Reporting, Assessment, And Collection of Trends Related To Medical Devices

Medical Device Vigilance

Medical Device Vigilance is an integrated system of collection, identification, and reporting of any adverse events involving the use of medical devices, preventing their occurrence in the workplace. A device is considered hazardous when it is used inappropriately or improperly in a way that causes harm to the patient, colleague, or other individuals. These adverse events may result from a misdiagnosis, misidentification, and spillage, exposure to toxins or infectious agents, or adverse reactions to medications or contaminated solutions. Adverse events must be reported immediately so that they can be assessed, categorized, and brought to the attention of management. A list of the incidents that require immediate assessment and reporting can be compiled and continuously monitored.

An effective Medical Device Vigilance program includes four major elements: application, assessment, reporting, and identification. An application identifies the problem. It also identifies the person or persons involved, the product involved, the environment in which the product was used, and the steps that need to be taken to control the problem. Next, an assessment of the medical device vigilance program is performed to determine if there are safety concerns.

Based on the identified safety concerns, a recommendation is made to the device users to report the incident to the manufacturer. In regions such as the United States, the increasing prevalence of hospitals has increased the usage of medical device vigilance. For instance, according to the American Hospital Association, there are around 6093 hospitals in the U.S.

Once a Medical Device Vigilance report of an adverse event has been made to the manufacturer, it is reviewed. Based on the identified problems, the manufacturer will ask for the assistance of their designated Safety Management Information System (SMS) team. The SMS team will perform an assessment of the problem and provide recommendations on how to prevent the problem from occurring again. If a recall is needed, the SMS team will notify the facility and provide a contact number for them to reach in the event of an incident. Finally, the medical device vigilance assessment team will provide a report outlining their findings and recommendation on how to mitigate the risk of an adverse event reoccurrence.

Post-market monitoring, adverse effects, events, and recalls of medical equipment are all part of medical device vigilance. Medical Device Vigilance primary goal is to enhance patients' health and safety by lowering the frequency of incidents connected to the use of medical devices. Medical device use can lead to adverse responses, which can have serious repercussions.