Navigation Links
FDA Looking at 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 a panel of advisers Tuesday to recommend that the devices be held to stricter standards.

Over the past five years, there have been 68 recalls of automated external defibrillators, which are used to shock a patient in cardiac arrest in hopes of getting the heart to beat normally again, and are considered by many to be the quickest and best response to such an emergency.

In addition to the recalls, the FDA has also received 23,591 reports of device malfunctions, "including some where the device failure occurred during a rescue attempt and may have contributed to patient harm or death," the agency noted in an executive summary released before the meeting of its Circulatory System Devices panel.

When external defibrillators were first brought before the FDA, they went through an accelerated approval program designed for low-risk devices that included such products as hospital beds and artificial hips. This so-called 510(k) system allows fast approval of devices that are similar to products already sold. Defibrillator manufacturers -- including Cardiac Science Corp., Defibtech, Philips Medical Systems, Zoll Medical Corp., and others -- have asked the FDA to keep their devices in this category, the Associated Press reported.

However, the agency said it was asking the advisory panel to recommend stricter standards because manufacturers did not fix the problems that led to the recalls, the AP reported.

The FDA wants the manufacturers to undergo regular inspections and provide additional clinical data for any new version of an external defibrillator, a procedure already in place for implantable defibrillators, the AP said.

External defibrillators are computerized medical devices that can check a person's heart rhythm and recognize a rhythm that requires a shock. They can also tell a rescuer when a shock is needed by using voice prompts, lights and text messages, according to the American Heart Association.

Each year, approximately 300,000 Americans suffer a cardiac arrest, according to the FDA. External defibrillators used by bystanders seem to save an estimated 474 lives a year, according to the FDA executive summary, and the devices are associated with almost doubling the survival of out-of-hospital cardiac arrest cases.

While the FDA is not bound to follow the recommendations of its advisory panels, it typically does so.

More information

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

SOURCES: U.S. Food and Drug Administration, Jan. 24, 2011; Associated Press


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

Related medicine news :

1. Ecobumz Diapers are Going Green While Investing in its Own Community and Employing Women Looking to Enter or Re-enter the Workplace
2. Brad Aspin and Health and Wellness Company GBG Now Looking for Leaders Nationwide
3. Arizona Attracts Businesses Looking For Data Center Experts
4. Swanson Health Products is Looking for Tasty, Healthy Culinary Creations
5. With Cosmetic Surgery Becoming More Common, Ft. Lauderdale Doctor says Choosing a Board Certified Plastic Surgeon is Important for Safe, Natural-Looking Results
6. The Real Housewives of New York City Know What Questions to Ask When Looking for a Plastic Surgeon
7. Sirius XM to broadcast Doctor Radio Reports: Understanding Autism -- Looking for Answers
8. Looking older than your age may not be a sign of poor health: Study
9. FDA Looking for Tougher Standards for External Defibrillators
10. Anemia tougher to tackle in black children with kidney disease
11. Short-Term Overeating Could Make Long-Term Weight Loss Tougher
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Looking at Tougher Standards for External Defibrillators 
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... PurhealthRX ... CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will ... and providing a CBD form that can be easily incorporated into liquid products, while ...
(Date:10/13/2017)... ... 2017 , ... Apple Rehab Shelton Lakes , which specializes in the ... facility as part of a disaster drill on October 3rd. , Apple Rehab participated ... Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid Plan ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network ... advocate for action towards gender equality at their inaugural Summit in New York City ... and reached a social audience of over 3 million. To watch the Mobilize Women ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/13/2017)... ... , ... “America On The Brink”: the Christian history of the United States ... creation of published author, William Nowers. Captain Nowers and his wife, Millie, have ... thirty years in the Navy. Following his career as a naval aviator and ...
Breaking Medicine News(10 mins):
(Date:10/4/2017)... , Oct. 4, 2017  According to the Centers for Disease Control ... of October . PhysicianOne Urgent Care is helping communities across ... NY , by offering no-cost* flu shots through the end of ... by certain health insurance regulations. ... best time to get a flu shot is by the end of ...
(Date:10/2/2017)... Labs announces the European launch of their new low volume, high ... in Cambridge, U.K on October 4th. The ... with unprecedented speed and sensitivity while using far less sample volume ... ... ...
(Date:9/27/2017)... , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global ... that its MyDario product is expected to appear on The Dr. Oz ... Dr. Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked ... The segment features ...
Breaking Medicine Technology: