Feature | August 28, 2006| Kim Phelan

Especially, says HRS, when ICD malfunction is involved

The day our May issue went to press, April 26, the Heart Rhythm Society held a telebriefing for the media to announce release of its draft policy recommendations for pacemaker and ICD performance. Final guidelines are expected to be published in the October issue of Heart Rhythm Journal, but I believe highlighting some of Dr. Anne Curtis’ remarks is of immense value to all cardiology practitioners.
Emphasis on clear communication practices is among the standout messages I take away from the recommendations — perhaps because I’ve always preferred clarity to clouding, straight talk rather than empty loquacity.
The need for the Society to take a stand about ICD and pacemaker performance and malfunction mitigation is obvious in view of product recalls last year following some serious adverse patient events, including deaths.
“While the life-saving benefits of pacemakers and ICDs has been confirmed by numerous clinical trials, recent events have raised questions about the effectiveness of the current systems and processes used for postmarket surveillance and analysis of these cardiac devices,” said Dr. Curtis. “Industry communications to physicians and patients about the performance of these devices have also been called into question.”
She stated that physicians are not currently, systematically involved in determining if and when a device safety concern exists or in the response to a safety concern. Of all the document’s recommendations, Dr. Curtis noted two as among the most significant:
(1.) “We suggest that manufacturers establish independent, standing committees of outside experts to analyze device performance reports and to recommend appropriate action.”
(2.) “We recommend the FDA establish standing postmarketing advisory committees to analyze data on device performance and to suggest actions to address device malfunctions.”

Simple, Straight and Standardized
When so much is at stake, communication related to device malfunction should not be clouded with complex and inconsistent terminology, the Society asserts. Device manufacturers and the FDA are therefore urged to use identical terminology when classifying device malfunction.
Simple language should be used by the FDA in communicating important malfunction information, stated Dr. Curtis. She also emphasized how the present absence of a standardized reporting format and of a standard mechanism for FDA classification of all advisories creates confusion, the first hindering physician and patient understanding of key clinical issues at stake and the second potentially leading to over or under emphasis on any particular advisory issue. Manufacturers must contribute to the solution, she indicated.
“In addition to the physician advisory notification letters, we suggest that manufacturers use a standardized physician device advisory notification format for all industry advisories to physicians regarding potential device malfunctions.”

What’s Your Story?
In the next issue of Diagnostic & Invasive Cardiology, we will cover the prevention and treatment of heart failure. If you are a physician who is involved in the advances of heart failure therapy, please call or email me during the month of July. We would like to hear about your work and share your story with your peers in this DAIC-exclusive feature.
Meanwhile, thanks for reading this issue!

Related Content

Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Predictive Models May Help Determine Which Patients Benefit From ICDs
News | Implantable Cardioverter Defibrillators (ICD)| July 06, 2017
Two predictive models may help cardiologists decide which patients would most benefit from an implantable cardioverter...
Medtronic Reactive ATP Therapy Slows Progression of Atrial Fibrillation in Real-World Population
News | Atrial Fibrillation| July 03, 2017
Medtronic recently announced that its Reactive ATP therapy slows the progression of atrial fibrillation (AF) in...
Sponsored Content | Videos | Cardiovascular Ultrasound| June 29, 2017
Leyla Elif Sade, M.D., MESC, professor of cardiology at Başkent University, Ankara, Turkey, discusses use of echo for
Biosense webster multielectrode balloon RF ablation catheter

The Biosense Webster multi-electrode balloon RF ablation catheter. Each electrode can have varied power settings to avoid damage to underlying tissues like the esophagus. 

Feature | EP Lab| June 22, 2017 | Dave Fornell
Electrophysiology (EP) technology has been advancing rapidly the past few years with new ablation tools to improve...
Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases
News | Pacemakers| June 20, 2017
Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European...
Sponsored Content | Videos | Implantable Cardioverter Defibrillators (ICD)| June 01, 2017
Lucas Boersma, M.D., Ph.D., FESC, St.
Sponsored Content | Videos | EP Lab| May 26, 2017
DAIC Editor Dave Fornell takes a tour of some of the most innovative new electrophysiology (EP) technology at the 201
Sponsored Content | Videos | Leads Implantable Devices| May 25, 2017
Bruce Wilkoff, M.D., director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, discusses advancemen
Overlay Init