Medical Device related Patient infections reported to the FDA jumped by 93% in 2019 and continued smaller increases in 2020 and 2021. For the past 10 years, there has been a 20% increase in the number of MDRs reported to the FDA, and infections followed that increase on average. In 2022, the trend reversed, and the number of patient infections reported as a percentage of MDRs dropped by 31%.
Check out the data below:
Medical Device related Patient Infections until 2022
Medical Device related Patient Infections as a percentage of total MDRs
When manufacturers prepare Medical Device Report (MDR) submissions to the FDA, they collect data from healthcare providers. The information from health care providers sometimes mentions that a patient had an infection during the course manufacturer’s medical device usage. The cause of the patient’s infection might or might not have anything to do with the device. Nevertheless, the manufacturer is required to submit that information to the FDA.
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Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user-friendliness. Built on the Salesforce.com Platform and utilizing the latest AI and Machine Learning innovations, Smarteeva Software is a true partner to its business users.
