Radiology gadfly Dr. Rita Redberg is taking aim again at the medical device industry, this time with a new editorial charging that the U.S. Food and Drug Administration (FDA) should require new clinical trials for changes made to high-risk devices that have already been approved.
Writing in the Annals of Internal Medicine (March 25, 2014), Redberg and co-author Sarah Zheng of the University of California, San Francisco (UCSF) took issue with the FDA's premarket approval (PMA) supplement process, in which device manufacturers are allowed to make modifications to devices that have approved PMAs without having to commission new clinical studies.
While PMA supplements were originally intended to enable device manufacturers to make improvements or minor changes to approved devices, vendors are making cumulative modifications to originally approved products, Redberg and Zheng noted. This is resulting in a final product that could differ significantly from the originally approved device, they wrote.
They cited two examples of defibrillator leads that went through several PMA supplements and eventually had to be recalled for high failures rates -- some of which caused patient deaths.
The desire for flexibility in the device approval process should be balanced against the need to "protect patients from preventable harm," Redberg and Zheng stated. Clinical data should be required for everything except cosmetic or packaging changes for PMA devices, according to the authors. They also suggested that publicly accessible data registries be developed to record clinical outcomes and adverse events for all devices.
In January, Redberg co-authored an op-ed article in the New York Times along with UCSF colleague Dr. Rebecca Smith-Bindman that linked radiation from CT scanning to cancer and death in patients.
