The proliferation of medical devices and resulting adverse events have doubled over the past 5 years. In 2016, the average monthly number of reported adverse events was 65,000. In 2020, the average was 127,000 per month. A 100% increase. The reasons for this increase are the continued introduction of new devices and the improving transparency in reporting of adverse events driven by the FDA and patient advocacy groups.
This Signals Newsletter highlights the general trends in adverse events for all devices as reported to the FDA and captured in the FDA MAUDE database and provides insight into recent news worthy events.