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

News | Pacemakers

June 1, 2023 — Every year more than one million people receive a pacemaker. Until now, leadless versions were only ...

Home June 01, 2023
Home
News | Pacemakers

May 25, 2023 — Abbott announced late-breaking results from the AVEIR dual-chamber (DR) i2i Investigational Device ...

Home May 25, 2023
Home
News | Pacemakers

May 12, 2023 — Biotronik, a leading global medical technology company with 60 years of experience in developing trusted ...

Home May 12, 2023
Home
News | Pacemakers

May 1, 2023 — Medtronic plc, a global leader in healthcare technology, announced it has received U.S. Food and Drug ...

Home May 01, 2023
Home
News | Pacemakers

December 12, 2022 — The global pacemakers market is set to grow at a compound annual growth rate (CAGR) of 5.4% between ...

Home December 12, 2022
Home
News | Pacemakers

June 9, 2022 — Holes help make sponges and English muffins useful (and, in the case of the latter, delicious). Without ...

Home June 09, 2022
Home
News | Pacemakers

April 5, 2022 — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the Aveir single-chamber ...

Home April 05, 2022
Home
News | Pacemakers
February 16, 2022 – A revolutionary pacemaker that re-establishes the heart’s naturally irregular beat is set to be ...
Home February 16, 2022
Home
News | Pacemakers

August 9, 2021 — Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of incorrect ...

Home August 09, 2021
Home
News | Pacemakers

June 16, 2020 - Biotronik has today announced its commitment to giving physicians additional tools to pace in the His ...

Home June 16, 2020
Home
Subscribe Now