Medical device vigilance includes post-market surveillance, adverse reactions, incidents, and medical device recalls. The primary purpose of medical device vigilance is to improve patient health and safety by reducing medical device-related occurrences. Adverse reactions to medical equipment are possible and can have catastrophic consequences.
The Medical Device Vigilance System's purpose is to improve patient, healthcare professional, and other users' health and safety by minimizing the likelihood of events associated with the use of a medical device repeating.
Companies that fail to properly disclose incidents may face harsh consequences. Manufacturers must be proactive in reporting incidents since there is no acceptable excuse for failing to do so. When a manufacturer takes action to reduce the risk of serious health deterioration, such as a recall, a Field Safety Corrective Measures (FSCA) report must be sent to the Competent Authority where the device is supplied.
Furthermore, favorable government policies for medical device monitoring to ensure patient safety will serve as an impact rendering aspect that will support corporate growth. Increased pressure on medical device manufacturers to provide safe medical equipment, as well as tight safety criteria set by regulatory agencies on medical device pre- and post-commercialization, will drive market growth. However, the disregard for product safety by manufacturing enterprises may hinder the growth of the medical device vigilance industry in the next years.