The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

On September 29, 2006, The Heart Rhythm Society (HRS) finalized recommendations for revising the system used by industry, regulators and clinicians to monitor and publicize implantable-device performance problems. Key goals of the recommendations include:
• improved recognition of potential device malfunctions
• postmarket surveillance and reporting of any problems
• communication among industry, federal agencies, clinicians and patients
This document is one of several fixes to the system used by device companies and the US Food and Drug Administration to track and respond to malfunctions in pacemakers and implantable cardioverter defibrillators (ICDs). The shortcomings of the present system were widely criticized in 2005 after a highly publicized recall of Guidant ICDs with potentially fatal design flaws; Guidant was criticized, too, for how they responded to the recall. Even though the company reported the problems to the FDA, they did not promptly inform clinicians and the public.

The final HRS document is essentially unchanged from the April 2006 draft. The guidelines have been published online and are scheduled for publication in the October 2006 issue of the society’s journal Heart Rhythm.

Comments are closed.

Of Interest