An independent panel established by Guidant Corporation was contracted to evaluate and advise the company on post-market device surveillance and public communication issues. The panel released a candid report calling for numerous changes in the Guidant's Cardiac Rhythm Management (CRM) business unit. The report also emphasizes to the entire implantable medical device industry the need for reform.Among the changes, the panel recommended that Guidant provide greater oversight of its Cardiac Rhythm Management business by corporate management and develop specific processes to quickly identify and act on potentially life-threatening product performance problems. These include establishing an in-house physician to oversee patient safety and product performance issues, as well as the use of an external committee of experts to advise the company and recommend potential actions when post-market problems arise. (MEDSCAPE)
