Navigation Links
FDA Looking for Tougher Standards for External Defibrillators
Date:1/25/2011

By Steven Reinberg
HealthDay Reporter

TUESDAY, Jan. 25 (HealthDay News) -- Following a series of recalls of external defibrillators, the U.S. Food and Drug Administration is asking an expert panel to vote Tuesday on whether these devices should be held to stricter standards.

Over the past five years, there have been 68 recalls of these devices, which are used to shock a patient in cardiac arrest in hopes of getting the heart to beat normally again. Defibrillators are found in a variety of public places, from hospitals to malls and arenas, and are considered by many to be the best way of countering a cardiac arrest.

In addition to the recalls, the FDA has also received 23,591 reports of malfunctions of these devices, "including some where the device failure occurred during a rescue attempt and may have contributed to patient harm or death," the agency noted.

When defibrillators were first brought before the FDA, they went through an accelerated approval program designed for low-risk devices that included products such as hospital beds and artificial hips.

This 510(k) system allows fast approval of devices that are similar to products already on the market. Defibrillator manufacturers, including Philips Healthcare, Cardiac Science Corp., Defibtech and others, have asked the FDA to keep their devices in this category.

However, the agency said it is asking the panel to recommend stricter standards because manufacturers didn't fix the problems that led to the recalls.

The FDA wants these manufacturers to be subject to regular inspections and to be required to submit additional clinical data before introducing a new version of a defibrillator. This is the standard for implantable defibrillators, heart valves and some other devices, the agency noted.

External defibrillators have pads that are placed on a patient's chest to determine whether the heart is beating with an abnormal rhythm. If the problem is ventricular tachycardia or ventricular fibrillation, abnormal rhythms that can be treated, the pads deliver an electric shock that resets the heart's pumping sequence.

Each year, some 300,000 Americans suffer a cardiac arrest, according to the FDA. It has been estimated that nearly 500 of these lives are saved as a result of bystanders using an external defibrillator.

However the panel votes Tuesday, the FDA is not bound to follow its recommendations. But the agency typically follows the advice of its advisory panels.

More information

For more on cardiac arrest, visit the U.S. National Library of Medicine.

SOURCE: U.S. Food and Drug Administration, Jan. 24, 2011


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Looking older than your age may not be a sign of poor health: Study
2. Sirius XM to broadcast Doctor Radio Reports: Understanding Autism -- Looking for Answers
3. The Real Housewives of New York City Know What Questions to Ask When Looking for a Plastic Surgeon
4. With Cosmetic Surgery Becoming More Common, Ft. Lauderdale Doctor says Choosing a Board Certified Plastic Surgeon is Important for Safe, Natural-Looking Results
5. Swanson Health Products is Looking for Tasty, Healthy Culinary Creations
6. Arizona Attracts Businesses Looking For Data Center Experts
7. Brad Aspin and Health and Wellness Company GBG Now Looking for Leaders Nationwide
8. Ecobumz Diapers are Going Green While Investing in its Own Community and Employing Women Looking to Enter or Re-enter the Workplace
9. Depression With Psychotic-Like Symptoms Seems Tougher to Treat
10. Common anxiety disorders make it tougher to quit cigarettes
11. Short-Term Overeating Could Make Long-Term Weight Loss Tougher
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Looking for Tougher Standards for External Defibrillators 
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/26/2016)... PLAINSBORO, N.J. (PRWEB) , ... June 27, 2016 , ... ... same sources, yet in many ways they remain in the eye of the beholder, ... Oncology (EBO), a publication of The American Journal of Managed Care. For the full ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... ... fertility once they have been diagnosed with endometriosis. These women need a treatment ... also require a comprehensive approach that can help for preservation of fertility and ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the ... Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , “We ... new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... offering. The current unmet ... for MedImmune to enter. The US ageing population creates a ... considerable growth for effective anti-influenza medications. The introduction of a ... development is still in its infancy. Key ...
Breaking Medicine Technology: