“We assume the FDA has the data that they need to crack down on manufacturers that have bad devices, or to recall a product, and they don’t have that…Devices can be on the market for years and cause many deaths, many injuries, before it becomes known to the public.”
Madris Tomes is the Founder and CEO of Device Events, a software company that extracts, consolidates, and provides easy to use data on medical device adverse event reports and recalls that have been filed with the FDA. In other words, her company offers a groundbreaking service to healthcare organizations: up-to-date and reliable data–a key element in the movement for medical device safety.
Madris was previously an FDA Analyst, focusing on Unique Device Identification (UDI) and Adverse Events initiatives. Her experience brings incredible insight to the crucial need for dependable, usable data. Experts agree that the ability to better report and track device adverse event reports will have a remarkable impact in patient safety, uncovering trends, helping avoid delays in recalls and allowing both doctors and patients to make better-informed co-shared decisions about their treatment.
Madris has fought for patient’s rights and data transparency by supporting the efforts of the E-Sisters and other patient groups by offering industry guidance and joining their meetings with the FDA and Members of Congress.
“The Bleeding Edge” filmmakers celebrate Madris Tomes’ career-long commitment to medical device safety and to sustainable and long-term change in the industry.
Watch Madris Tomes in the Netflix Original documentary, “The Bleeding Edge”.