Following the recent recalls of nearly 150,000 implantable cardioverter defibrillators (ICDs) and cardiac pacemakers, FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) released the findings of a major study on the malfunction of cardiac rhythm management devices. The report covers the likely causes and incidence of device failure, as well as ways to improve device monitoring and public communications. The results were presented in mid September at the "Policy Conference on Pacemaker and ICD Performance," sponsored by the Heart Rhythm Society (Washington, DC).

FDA's Gottlieb: Addressing the challenge.

The findings of the study were presented by Scott Gottlieb, MD, FDA deputy commissioner for scientific and medical affairs. "Pacemakers and ICDs have saved many lives and the benefits of the devices clearly outweigh the risks," Gottlieb said. "Our challenge remains to uncover these risks, measure them, and make information available to patients and doctors to help guide their personalized decisions about where the benefits of technologies like these outweigh known or potential risks from their use."