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 pr
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2

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:4/25/2015)... 25, 2015 The Hon. Ellen Tauscher, ... issues the following statement following the deadly earthquake in ... Nepal, resulting in the deaths of more than 1,000 ... felt across Nepal, Bangladesh, India and other parts of ... condolences to the people of Nepal and the families ...
(Date:4/25/2015)... (PRWEB) April 25, 2015 By definition, a ... data for the enterprise relying on their judgement and expertise ... But according to an article published in National ... times actually be doing a disservice to their responsibilities by ... dotted and t’s are crossed when it comes to company ...
(Date:4/25/2015)... 25, 2015 Parker and Sons projects growth ... has spiked in Arizona alongside the growing economy. As a ... employees for April to help account for the rising need ... in April is something we are enthusiastic about. It means ... Kelly, president at Parker and Sons. , Indeed, Parker and ...
(Date:4/25/2015)... For thirteen years, the Twin Cities DI Day has been ... nation! This year, on May 5th, 2015, Secura Consultants is ... Day on the road by supporting the first ever National ... CLTC, Chief Executive Officer at Secura Consultants and co-creator of ... stating, "The first Twin Cities DI Day was a hugely ...
(Date:4/24/2015)... (PRWEB) April 24, 2015 As the ... and the unique sacrifices of these young men and ... Service members, Veterans and their Families” presents a special ... is designed to gain a better understanding of the ... and wellness. For those – civilian and military – ...
Breaking Medicine News(10 mins):Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 2Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 4Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 5Health News:Parker and Sons Plans to Expand in 2015 2Health News:Secura Consultants Takes DI Day On The Road 2Health News:Coalition Presents Resiliency Training to Raise Awareness during Month of the Military Child (#MOTMC2015) 2
... ... MRSA. Jan-Pro, Global Leader in Commercial Cleaning, Once Again Leads the Way in Infection ... Solution in the control of infectious microorganisms - EnviroShield Disinfectant Technology , ... (PRWEB) June 1, 2010 -- ...
... , ... of Midbrook, Inc.) is proud to announce they have recently been awarded an agreement with ... the nation’s largest healthcare group purchasing organizations and serves 2,300 hospitals and more than 66,000 ... ...
... GIA announces the ... Proteins market is anticipated to reach 472.3 million pounds by 2015, driven largely by functional ... processing and investments in R&D are other major driving forces for the growth of the ... San ...
... ... purchase used equipment from CosmeticLaserWorld.com can now rely on a brand new buy back ... (PRWEB) ... and doctors, recently unveiled yet another reason savvy spas should purchase equipment from the ...
... resulting from an inherited defect that prevents the proper metabolism ... milk. Exposure of affected people to galactose, can damage most ... to study the disease is limited by a lack of ... and flies may provide scientists with useful clues. The ...
... The American College of Radiology,s (ACR) Task Force on ... Organizations has proposed several steps that can help improve ... they service, according to an article in the June ... of Radiology ( www.jacr.org ). "The ...
Cached Medicine News:Health News:JAN-PRO Launches Exclusive “EnviroShield™” Disinfecting System - Kills Harmful Bacteria, Including MRSA 2Health News:JAN-PRO Launches Exclusive “EnviroShield™” Disinfecting System - Kills Harmful Bacteria, Including MRSA 3Health News:Midbrook Medical Announces Agreement with Premier Partners L.P. 2Health News:Midbrook Medical Announces Agreement with Premier Partners L.P. 3Health News:US Whey Proteins Market to Reach 472.3 Million Pounds by 2015, According to New Report by Global Industry Analysts, Inc. 2Health News:US Whey Proteins Market to Reach 472.3 Million Pounds by 2015, According to New Report by Global Industry Analysts, Inc. 3Health News:CosmeticLaserWorld.com Gives Buyers Peace of Mind Through Industry-Leading Investment Protection Plan 2Health News:Flies offer insight into human metabolic disease 2Health News:ACR task force makes recommendations for improving relationships between radiologists and hospitals 2
(Date:4/23/2015)...  AbbVie (NYSE: ABBV ) has announced that ... its New Drug Application (NDA) and granted priority review ... of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV). The ... genotype 4 (GT4) hepatitis C virus (HCV) infection. ... being evaluated by the FDA for patients in ...
(Date:4/23/2015)... , April 23, 2015 Once again, ... strengthening our commitment to patient safety. BeaconMedaes, ... fight against infectious disease. The next generation ... Medical gas sensors are now mounted in the assembly, ... need to open ceiling tiles potentially releasing dust spores ...
(Date:4/23/2015)... FRANCISCO , April 23, 2015 Nektar Therapeutics ... the first quarter ended March 31, 2015 on Thursday, April ... Howard Robin , president and chief executive officer, will host ... p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT). ... the conference call can be accessed through a link that ...
Breaking Medicine Technology:U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 2U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 3U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 4U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 5U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 6U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 7BeaconMedaes launches new Zone Valve Box Assembly 2Nektar to Announce Financial Results for the First Quarter 2015 on Thursday, April 30, 2015, After Close of U.S.-Based Financial Markets 2
... Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company ... from its consumer trial with Allumera™, a breakthrough cosmetic ... The RevitAll study was performed with a standard ... Allumera™ improves skin appearance, when compared to exposure by ...
... Inc. (Hologic or the Company) (Nasdaq: ... of premium diagnostics products, medical imaging systems and ... of women, announced today the U.S. Food and ... Makena™ (hydroxyprogesterone caproate injection), formerly known as Gestiva™. ...
Cached Medicine Technology:Photocure Announces Positive Allumera™ Trial Results for Delivering Significant Skin Appearance Improvements 2Photocure Announces Positive Allumera™ Trial Results for Delivering Significant Skin Appearance Improvements 3Photocure Announces Positive Allumera™ Trial Results for Delivering Significant Skin Appearance Improvements 4FDA Approves Hologic's Makena™ (Formerly Referred to as Gestiva™) Pharmaceutical 2
Avant E-Z Rack Premium Low Binding 10 l Pipet Tips are accurate, contamination free, and allow quantitative transfer of your samples without relying on silicone....
... an innovative, quick and easy automated ... 60% less space on your laboratory ... this amazingly easy-to-use, one-hand system, you ... whole range of Diamond Tips. All ...
... its wide orifice tip, the Finntip Wide ... suspensions and macromolecules like genomic DNA. This ... cell fragmentation. It is excellent for use ... model, the inside diameter of the orifice ...
... designed to optimize the accuracy and precision ... products is widely recognized by customers throughout ... extended over the years and now covers ... tips including filter tips, certified pure tips, ...
Medicine Products: