Navigation Links
FDA Panel Recommends 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, a U.S. Food and Drug Administration panel of experts recommended Tuesday 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.

No official vote was taken by the panel, according to the New York Times, but most of the panel members said they felt the defibrillators should be placed in a high-risk category.

Dr. John W. Hirshfeld Jr., chairman of the advisory panel and a professor of cardiovascular medicine at the University of Pennsylvania, noted that "there are a number of signals that raise questions about quality and reliability," the Times reported.

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; New York Times


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

Related medicine news :

1. AADR testifies to the FDA advisory panel on dental amalgam
2. FDA Panel Calls for Safety Review of Mercury in Dental Fillings
3. New Diet Pill Wins FDA Panels Backing
4. NIH-sponsored panel issues comprehensive US food allergy guidelines
5. Expert panel addresses safety in medical imaging
6. FDA Panel Votes Against Drugs Said to Prevent Prostate Cancer
7. FDA Panel to Vote on Drugs Said to Prevent Prostate Cancer
8. FDA Panel to Vote on Drugs to Prevent Prostate Cancer
9. Medicare Panel Endorses Vaccine for Prostate Cancer Patients
10. Teens Should Get Meningitis Booster Shot: CDC Panel
11. Expert Panel Links Popular Bone Drugs to Rare Fracture
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Recommends Tougher Standards for External Defibrillators 
(Date:10/13/2017)... , ... October 13, 2017 , ... ... serving communities in the greater Dallas, Miami, and Raleigh regions, is organizing an ... to overcome a rare and deadly chromosome abnormality. , After struggling since birth ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International ... promote standards of excellence for the field of eating disorders, announces the opening ... 25, 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term ... long-term care insurance companies have a waiver for care if the client has a ... when the family pays for care, is often waived, so the benefits from their ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... giving viewers the lowdown on sciatica in a new episode of "Success Files," ... on current events and innovation and investigates each subject in-depth with passion and ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
(Date:9/12/2017)... reviews on the independent review site Consumer Affairs have ... hearing aids, ranking it higher than Miracle Ear ™, Beltone™, ... ... Aids ... that provides high performance, state-of-the-art, German-engineered hearing aids directly to consumers ...
Breaking Medicine Technology: