A new study published in JAMA: The Journal of the American Medical Association assesses the process for Food and Drug Administration (FDA) approval of high-risk cardiac devices. The study, authored by second-year HMS student Benjamin N. Rome, Aaron S. Kesselheim, HMS assistant professor of medicine at Brigham and Women’s Hospital and Daniel B. Kramer, HMS instructor in medicine at Beth Israel Deaconess Medical Center, found that most new cardiac implantable electronic devices currently used in patient care, such as implantable pacemakers and defibrillators, are approved as changes, or “supplements,” to already-approved devices.
The researchers analyzed FDA data on all cardiac implantable electronic devices approved from 1979 through 2012. During that time, the FDA approved 77 of these devices through the original premarket approval (PMA) process. These devices led to approval of 5,829 supplements, translating to an average of 50 supplements per PMA. More than a third of the supplements involved a change to a device’s design or materials, and in the majority of these cases, the supplements were approved without the FDA requiring submission of new clinical data.
“The PMA supplement process allows manufacturers to update high-risk medical devices more quickly, allowing patients to benefit from useful new device technologies,” explained Rome. “However, we found that most new cardiac implantable electronic device models currently in use were deemed safe and effective without requiring new clinical data.” In addition, the authors found that several small changes made in successive supplements can add up over time and lead to a device that looks very different from the original approved device. This outcome may have important implications for patient safety. Two recently recalled defibrillator leads—Medtronic Sprint Fidelis and St. Jude Medical Riata—were both approved via the PMA supplement process.
The HMS researchers note that approval of many high-risk devices as PMA supplements reinforces the need to perform rigorous post-market surveillance. They hope that their results will encourage the clinical community to conduct more comparative effectiveness studies to guide clinicians who need to choose among many similar device models.
Adapted from a Brigham and Women's Hospital news release
