“Just because you have a new technology doesn’t mean it’s innovation. Too often I hear people say, ‘Oh, you’re going to stifle innovation.’ They’re not talking about stifling innovation; they’re talking about putting untested devices on the market. That’s not innovative.”
– Dr. Rita Redberg
For more than ten years, Rita Redberg has studied medical device surveillance issues and adverse event reporting, being fearlessly vocal on many fronts, including fighting against proposals to delay reporting medical device malfunctions to the FDA and questioning low-dose CT screening for lung cancer as well as power morcellation.
When she’s not holding the FDA to task for a weak and inadequate medical device adverse event reporting system, Redberg, an editor for JAMA Internal Medicine, is also a professor of medicine and cardiologist at the University of California San Francisco.
Redberg’s pioneering studies focus on the medical device regulatory process, and its relationship to public health policy. In “The Bleeding Edge”, Redberg’s expertise revealed how risky devices get FDA clearance through the 510(k) process – a loophole in which a device can be cleared if it is substantially equivalent to a previously cleared device, even if the previously cleared device has been recalled for safety issues. Redberg’s trailblazing research on the matter was crucial to exposing the risk medical device companies hand to patients without their knowledge.
Redberg takes a strong stand in emphasizing the need for high-quality data to accompany the approval and marketing of a new device as a means to ensure patient safety. As part of her relentless advocacy, Redberg has testified before Congress numerous times to promote the necessity of strong and accurate data to support the often lax medical device approval process.
As an editor for JAMA Internal Medicine, she led the publication to devote their efforts to patient safety and health care reform, as part of her focus on the groundbreaking less-is-more approach to medicine, which aims to reduce patient harm by preventing unnecessary intervention. In explaining her less-is-more approach to previous “The Bleeding Edge” Hero, Jeanne Lenzer, Redberg said, “We have been told for decades now that detecting cardiac disease early is better than waiting for symptoms to appear, which on the surface sounds reasonable. However, years of experience belies this supposed axiom, and in fact some screenings, in the guise of ‘early detection,’ can be downright dangerous.”
Redberg shares her expertise in the many books she has written, edited and contributed to, including “You Can Be a Woman Cardiologist,” and “Coronary Disease in Women: Evidence-Based Diagnosis and Treatment.” She has been interviewed countless times and contributed to significant pieces on health related topics in various outlets, such as The New York Times, Wall Street Journal, and National Public Radio.
Redberg’s tenure and impact in the medical field reveals her unrelenting commitment to patient health and safety. Her work illustrates that safety does not need to be sacrificed in the name of innovation, but in fact, innovation thrives when coupled with strong evidence.
“The Bleeding Edge” filmmakers commend Dr. Redberg for her dedication to exposing the flawed regulatory process through her work in academia and research, and promoting a patient centered approach to medicine.
Watch Dr. Rita Redberg in the Netflix Original documentary, “The Bleeding Edge”.