The Heart Rhythm Society on Sept. 28 released its final recommendations for handling recalls of implantable cardioverter defibrillators. The guidelines include recommendations for physicians, manufacturers, the Food and Drug Administration and Congress in an effort to better identify, report, communicate and prevent device malfunctions.
Overall objectives include greater transparency in post-market surveillance, analysis and reporting; new systems to identify malfunctioning devices sooner; and standard notification and communication to physicians and patients when a malfunction is identified. Cardiac care physicians and other experts developed the guidelines over the past year following several ICD recalls.
[ via AHA News Now ]