HRS works closely with our industry partners, domestic and global professional societies, and federal regulatory agencies to communicate safety concerns with HRS members.
HRS Safety Alert Response Working Group
The field of cardiac electrophysiology (EP) relies on technological advances that improve patients' lives. However, there are also EP device software/hardware updates, safety notices, advisories, and recalls that occur periodically.
Therefore, in 2014, HRS created the Safety Alert Response Working Group, which convenes on an as-needed basis, to review any EP device -related advisory issue or safety notification that may affect HRS members and their patients.
The goals of the Working Group are to review these advisory or safety issues and to communicate with HRS members in a timely manner to enhance awareness of these issues in the EP community.
HRS will continue to work closely with our industry partners, domestic and global professional societies, and federal regulatory agencies in a collaborative, interactive manner to provide our membership with clear, accurate information concerning EP device advisories and other safety issues. The Safety Alert Response Working Group aims to provide concise, useful information (and recommendations when appropriate) without excessively burdening clinicians as these safety issues arise
Reporting Adverse Events
The Heart Rhythm Society encourages healthcare professionals and patients to report adverse events or product problems to FDA through MedWatch, the FDASafety Information and Adverse Event Reporting Program. There are several options for reporting: