HOME >> MEDICINE >> NEWS
Heart rhythm society issues draft recommendations on performance policies for pacemakers and ICDs

WASHINGTON--The Heart Rhythm Society today released the first comprehensive recommendations for the surveillance, analysis and performance reporting of pacemakers and implantable cardioverter defibrillators (ICDs). The draft guidelines offer detailed recommendations to physicians, the Food and Drug Administration (FDA), and Congress about performance issues and advisories for implanted cardiac devices.

The recommendations also provide heart patients with clearer, timelier and more consistent information about the recall and advisory process.

"As the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, we believe these suggested changes will ensure that patients continue to have access to these lifesaving treatments," said Anne B. Curtis, M.D., President of the Heart Rhythm Society. "We believe these draft guidelines are an important step towards strengthening patient and physician knowledge, confidence and trust."

The draft guidelines call for: 1.) greater transparency in the post-market surveillance, analysis, and reporting of information 2.) the establishment of new systems to identify malfunctioning devices more quickly and 3) standard notification and communication to physicians and patients from the manufacturer when a device malfunction is identified. Manufacturers, the FDA, and physicians are encouraged to work together to prevent adverse events due to device malfunctions.

Select highlights from the recommendations include the following:

Physicians:

  • Should inform patients not only about the benefits and risks of devices, but also about the overall expected performance of devices, including potential malfunction rates.
  • Should return all malfunctioning devices after explant to the manufacturer for analysis whether the replacement is routine or because of a malfunction. This will lead to more timely identification of potential malfunctions an
    '"/>


Contact: Rachael Lille Moore
rmoore@HRSonline.org
202-464-3476
GYMR
26-Apr-2006


Page: 1 2 3

Related medicine news :

1. Drug-eluting stent controversy explored in the American Heart Hospital Journal
2. Heart-failure patients benefit from pharmacist care
3. Study offers clues to Broken Heart Syndrome
4. Heart Failure 2007
5. Heart failure medication does not improve survival, compared to more widely used medication
6. UCLA neurologist honored with American Heart Associations Stroke Council Award
7. Heart failure: Mayo Clinic reveals abnormality in filling of the heart is frequent culprit
8. Heart catheters do not benefit patients
9. Heart Rhythm Society publishes final recommendations for heart patients
10. Heartburn drug may help to slow progression of chronic heart failure
11. Heart failure drugs may be beneficial for patients with hardening of the arteries

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
(Date:10/12/2017)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... ... 2017 , ... Dr. Parsa Mohebi, the Los Angeles based ... the newly revamped Cosmetic Town journal section, featuring articles written by ... as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I enjoy ...
(Date:10/12/2017)... GRAND RAPIDS, Mich. (PRWEB) , ... October 12, ... ... OnSite Wellness, has been named one of Michigan’s 2017 Best and Brightest in ... Best and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/25/2017)... 2017   Montrium , an industry leader ... the IQPC Trial Master Files & Inspection Readiness ... EastHORN Clinical Services has selected eTMF Connect ... management. EastHORN, a leading European contract research organization ... transparency to enable greater collaboration with sponsors, improve ...
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
Breaking Medicine Technology:
Cached News: