Implementation of the Device Performance Recommendations

2011

FDA Panel Supports Expanded Indications for CRT-D Devices (12/07/11) —On Wednesday, December 7, the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices advisory panel voted to expand therapeutic indications for Medtronic’s cardiac resynchronization therapy-defibrillator devices. Indications for cardiac resynchronization therapy defibrillators (CRT-Ds) could be widened to include symptomatic New York Heart Association (NYHA) class 2 patients who meet additional criteria.
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Alliance of Specialty Medicine Comments on IOM's Report on 510(k) Process (09/30/11) —On Friday, September 30, the Alliance of Specialty Medicine submitted a letter to the Food and Drug Administration (FDA) commenting on the Insitute of Medicine's report on the 510(k) process. As outlined in the letter, the Alliance supports the FDA's position not to eliminate the 510(k) process. The Alliance recommends that Congress provide additional funding for the FDA to address the issues detailed in the report.
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IOM Recommends Replacing FDA 510(k) Clearance Process (07/29/11) — On Friday, July 29, the U.S. Institute of Medicine (IOM) released its long-awaited report “Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years.” The report, which was commissioned by the FDA in 2009, evaluates the FDA's 510(k) clearance process and recommends that it be replaced.
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2008

Society Testifies at the FDA Risk Communication Advisory Committee Meeting (08/27/2008) — On August 14, William Maisel, MD, MPH testified on behalf of the Heart Rhythm Society at the FDA Risk Communication Advisory Committee. Maisel presented the recommendations of the 2006 Device Performance Policies and Guidelines document and urged the panel to reconsider the use of the word “recall.” Learn more »

Network will E-mail Patient Safety Alerts to U.S. Physicians (07/02/2008) — U.S. Physicians and their staff can elect to receive e-mail drug safety alerts and review them on-line. The Health Care Notification Network (HCNN) aims to deliver important patient safety alerts (“Dear Doctor Letters”) in a fast and effective manner, before patients learn about them in the press. No e-mail addresses will be sold or disclosed to any third parties. Learn more »

Heart Rhythm Society Continues to Influence FDA Risk Advisory Notices (02/29/2008) — On February 29, the Heart Rhythm Society presented a statement from our recommendations in the 2006 Device Performance Policies and Guidelines document during testimony in front of a newly established FDA Risk Communication Advisory Committee. Learn more »

2007
FDA Launches MedSun Adverse Event Reporting Subnetwork for EPs — In response to the Heart Rhythm Society's Device Performance Recommendations, FDA launched a new MedSun adverse event reporting subnetwork called “HeartNet” that allows MedSun hospital participants with electrophysiology labs to report adverse events through a specialized data collection tool. Lean more »

FDA Issues New Guidance in Response to HRS Device Performance Recommendations (07/19/2007) — In response to the Heart Rhythm Society's Device Performance Recommendations, this FDA Guidance Document aims to standardize communications to implanting physicians while helping physicians, other health professionals, and patients make the appropriate decision for each patient. Learn more »

Heart Rhythm Society Addresses FDA Workshop On Post-Market Medical Device Surveillance Network (03/16/2007) — Dwight W. Reynolds, MD, FHRS testified on March 7, 2007 at FDA’s public workshop about the FDA’s Sentinel Network, an electronic network that would integrate existing and planned efforts to collect, analyze, and disseminate medical device safety information to health care practitioners and patients. Learn more »

History of the Device Performance Recommendations

2005
Washington Report: Proceedings Document from the Policy Conference on Pacemaker and ICD Performance Now Available (10/2005) — The Heart Rhythm Society Proceedings Document, from the Policy Conference on Pacemaker and ICD Performance summarizes each speaker's presentation, panel discussions, and open question and answer periods from the September 16, 2005 conference. Learn more »

Washington Report: The Society Convenes Device Performance Policy Conference with Major Stakeholders (09/17/2005) — On September 16, 2005, the Heart Rhythm Society convened an unprecedented one-day Policy Conference on Pacemaker and ICD Performance to discuss the current state of ICD and pacemaker technology, performance, and post-market surveillance. Topics on the agenda included the role of external databases in post market surveillance, risk/benefit communication, and issues related to manufacturer/FDA/patient/physician communication. Learn more »

Heart Rhythm Society Advisory Regarding Recalls for ICDs (02/01/2005) — The Heart Rhythm Society was encouraged by members, industry, and the Food Drug Administration (FDA) to comment on our responsibilities to patients when a potential implanted medical device failure is identified. The Board of Trustees and the Health Policy Committee have approved the following statement. Learn more »

The Society is developing guidelines on ICD Recalls (01/21/2005) — The Heart Rhythm Society has formed a task force to begin drafting recommendations for uniform notification standards to inform physicians and patients about safety alerts and recalls of implantable cardioverter defibrillators (ICDs). Learn more »