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:8/21/2017)... (PRWEB) , ... August 21, 2017 , ... ... with events taking place all over the country. , Outdoor running increases exposure ... runners are at an increased risk of melanoma, and only half may be ...
(Date:8/21/2017)... CA (PRWEB) , ... August 21, 2017 , ... The ... how exactly are we supposed to get things done in a healthy way these ... And, they’re launching a crowdfunding campaign on August 28 to introduce Deskcise Pro™– the ...
(Date:8/21/2017)... ... ... The American Hospital Association (AHA) has elected Claire Zangerle, Chief Nurse Executive ... of Trustees for a three-year term beginning January 1, 2018. , The ... are committed to the improvement of health in their communities. Founded in 1898, the ...
(Date:8/21/2017)... CA (PRWEB) , ... August 21, 2017 , ... ... health services business of UnitedHealth Group (NYSE: UNH), has made a multi-million dollar ... responders affected by post-traumatic stress disorder (PTSD) and traumatic brain injuries (TBI) over ...
(Date:8/20/2017)... ... August 20, 2017 , ... A total solar eclipse will occur across the ... as the moon moves between the sun and Earth. This rare event will be magnificent ... can help keep you safe on the road during the total eclipse of the sun. ...
Breaking Medicine News(10 mins):
(Date:8/2/2017)... and BENTON, Ky. , Aug. 2, 2017   Marshall County ... its environmental services (ES) team to proactively reduce the risk of hospital-acquired infections (HAIs). The ... disinfection robot that uses UVC light energy to kill deadly pathogens such as C. ... Tru-D SmartUVC ... Tru-D in action in ...
(Date:8/2/2017)... a next-generation full-service pharmacy, has announced the launch of its ... Washington D.C. metropolitan area. CaryRx aims to ... through the convenience of its patient-friendly mobile app. Prescriptions can ... to any location in D.C. ... Washington D.C. ," says Areo Nazari , ...
(Date:7/31/2017)...  Diplomat Pharmacy, Inc. (NYSE: DPLO), has been named one ... by Crain,s Detroit Business . The annual ... three-year revenue growth. This year,s edition measures growth from 2013 ... the complete list, visit crainsdetroit.com/awards/fast_50/2017 .  ... said Phil Hagerman , CEO and chairman of Diplomat. ...
Breaking Medicine Technology: