Navigation Links
Dangerous Medical Device Loophole Puts Patients At Risk
Date:5/21/2012

WASHINGTON, May 21, 2012 /PRNewswire-USNewswire/ -- Consumers Union, the policy and advocacy arm of Consumer Reports, is calling attention to a dangerous medical device loophole that puts patients at risk in a full-page print ad in Politico today. The ad is running as the Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.

The ad notes that the FDA does not have the power under current law to require device makers to prove they have fixed design flaws when they want to sell a new device based on one that has been recalled by manufacturers for safety problems. Consumers Union has urged lawmakers to give the FDA the authority to require device makers to demonstrate that the safety flaws have been corrected in the new device.

"It's time to close this absurd loophole and give the FDA the power it needs to protect patients," said Lisa McGiffert, director of Consumers Union's Safe Patient Project. "But so far, the politically powerful medical device lobby has blocked this common sense reform. Medical device makers should have no objection to proving they have fixed safety flaws in order to sell products based on ones that are dangerous to patients."

The medical device industry claims that the FDA has the authority it needs to address this problem. However, Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, has confirmed in media interviews that the agency does not have the power it needs to prevent device makers from repeating safety flaws when new devices are cleared based on their similarity to ones recalled by manufacturers. While the Senate and House bills being considered this month include some important reforms, both bills are mi
'/>"/>

SOURCE Consumers Union
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. 42 Top U.S. Scientists and Specialists Explore Cutting-Edge Innovations to Defend America From Dangerous Zoonotic Diseases
2. CareFusion Acquires Technology for Sorting and Managing Dangerous Pharmaceutical Waste
3. More Dangerous Than Drunk Driving, Hope Paige Designs Promotes a THUMBAND for Safe Texting
4. Rottenstein Law Group Heeds Groundswell of Grievances Against Manufacturers of Defective, Dangerous Hip Replacement Devices
5. Herbal Supplements May Cause Dangerous Drug Interactions in Orthopaedic Surgery Patients
6. FDA CONSUMER HEALTH INFORMATION - Improperly Discarded Sharps Can Be Dangerous
7. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
8. You May Have a Thyroid Problem and Not Know It - Particularly If Youre Over 60, Says a New Harvard Medical School Report
9. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
10. Globus Medical Raises $110 Million in Series E Financing Round
11. Quark Pharmaceuticals Appoints New Chief Medical Officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/7/2015)... --  Bionik Laboratories Corp. (OTCBB: BNKL), a ... focus in robotic exoskeleton technology for users with ... that it has completed an additional sale to ... common stock and warrants for aggregate gross proceeds ... transaction.  This equity financing is the sixth and ...
(Date:7/7/2015)... 2015 Oasmia Pharmaceutical AB, ... within human and veterinary oncology, today announced that ... the United States , designed to ... animal therapeutic.      (Logo: http://photos.prnewswire.com/prnh/20150420/740096) , ... , Paccal Vet-CA1 was previously distributed ...
(Date:7/7/2015)... 2015  Monopar Therapeutics LLC, an emerging biopharmaceutical company ... co-founder and CEO, Chandler D. Robinson MD, ... Entrepreneurial Award. The British Council selected one recipient from ... India , and the United States ... entrepreneurs who have leveraged their U.K. education in their ...
Breaking Medicine Technology:Bionik Laboratories Completes US$13.1 Million Private Placement 2Bionik Laboratories Completes US$13.1 Million Private Placement 3Oasmia Pharmaceutical Launches US Brand and Sales Platform 2Monopar Therapeutics Announces Founder And CEO Chandler Robinson Awarded The British Council's Education U.K. Alumni Award 2Monopar Therapeutics Announces Founder And CEO Chandler Robinson Awarded The British Council's Education U.K. Alumni Award 3
... (Prime), a thought leader in pharmacy benefit management, has ... 2011 Transparency in Pharmaceutical Purchasing Standards(SM) (TIPPS) certification from ... year that Prime has received this certification. ... (PBMs) that have agreed to provide pharmacy cost information ...
... Oct. 19 Ingenuity® Systems, the leading provider ... TransMed Systems, a translational medicine software and services ... and XB Bio-Integration Suite (XB-BIS).  Researchers can now ... managed and statistically analyzed by XB-BIS, directly into ...
Cached Medicine Technology:Prime Therapeutics Receives 2011 TIPPS Certification 2Ingenuity Systems and TransMed Systems Integrate Software to Support Personalized Medicine Research 2
(Date:7/7/2015)... Madison Wisconsin (PRWEB) , ... July 07, 2015 , ... ... 2015 Best of Madison winners in the home service category. This honor can only ... popularity is growing because of the safety of the products and methods they use ...
(Date:7/7/2015)... ... 2015 , ... Difass USA, a modern supplement brand committed to excellence, understands ... work is knowing that there is hopefully a vacation to look forward to this ... Planning for a vacation can be quite stressful, and it’s difficult sometimes to fully ...
(Date:7/7/2015)... , ... July 07, 2015 , ... ... highlights rumors about possible facial rejuvenation that have emerged about Hillary Clinton. Two ... Secretary of State looks more youthful than she has in some time and ...
(Date:7/7/2015)... York, NY (PRWEB) , ... July 07, 2015 , ... ... the email newsletter and website that helps active people find the most fun activities ... and active lifestyle coverage for millennials. It also increases Greatist’s opportunity for events, e-commerce, ...
(Date:7/7/2015)... ... July 07, 2015 , ... Illinois cannabis cultivation centers and ... permit holders. The Medical Cannabis Alliance of Illinois’ (MCAI) board and its members ... committed to making sure patients have access to cannabis as a viable medical ...
Breaking Medicine News(10 mins):Health News:Environmentally-Friendly House Cleaning Company Wins Best of Madison Magazine Award 2Health News:Difass USA Offers Eight Tips to Help Relax and Enjoy Summer Vacation 2Health News:Difass USA Offers Eight Tips to Help Relax and Enjoy Summer Vacation 3Health News:Recent Article on Hillary Clinton Plastic Surgery Speculation Illuminates the Reasons Many Professionals Explore Facial Rejuvenation, says Dr. J 2Health News:Recent Article on Hillary Clinton Plastic Surgery Speculation Illuminates the Reasons Many Professionals Explore Facial Rejuvenation, says Dr. J 3Health News:Greatist Acquires Active Lifestyle Brand Blood, Sweat & Cheers 2Health News:Cannabis Growers and Dispensaries Form Medical Cannabis Alliance of Illinois 2
... S.C., Nov. 12 What does a,thirty-nine foot Airstream ... cancer? For more than 800 midlands, men last month, ... risk for the disease. The Drive Against Prostate ... for prostate cancer. Doctors Care and WIS-TV,sponsored The Drive ...
... DALLAS, Nov. 12 Hurley Medical Center, a ... physician referral and,class registration services so they will ... a day, seven days a week. The medical ... healthcare-exclusive customer,interaction center, as its partner to provide ...
... Nov. 12 /Xinhua-PRNewswire-FirstCall/ -- China Pharma,Holdings, Inc. ("China Pharma") ... host a conference call at 11:00 a.m. EST on ... quarter of 2007. Joining Ms. Zhilin Li, President ... Chief Financial Officer. The Company plans to release its,earnings ...
... might keep participants from trials , , MONDAY, Nov. 12 (HealthDay ... trial may have placed participants at higher risk of infection ... the case remains unclear. , What is clear ... would-be trial participants away from future AIDS vaccine studies. , ...
... ), the most advanced method of massage,aromatherapy and ... retained one of Florida,s fastest growing PR firms, ... experience on,the planet. "We see the SpaCapsule(R) ... matter,of minutes can take you from planet stress ...
... the Nation,s Premier Centers for Medical ... Education will Host, Live call-in format will ... Nov. 12 SIRIUS Satellite Radio,(Nasdaq: SIRI ) ... Radio Powered by NYU Medical Center," an exclusive, pioneering,24/7 ...
Cached Medicine News:Health News:UCI Medical Affiliates, Inc. Sponsors Doctors Care Record-breaking Drive Against Prostate Cancer 2Health News:Hurley Medical Center Enhances Customer Service Capabilities With Beryl Partnership 2Health News:China Pharma Holdings, Inc. Announces Conference Call to Discuss Third Quarter 2007 Results 2Health News:Fallout From Failed AIDS Vaccine Could Dampen Research 2Health News:Fallout From Failed AIDS Vaccine Could Dampen Research 3Health News:Fallout From Failed AIDS Vaccine Could Dampen Research 4Health News:The Ultimate Stress Reliever, SpaCapsule(R), the Capsule that Takes You on a Rejuvenating Journey to the Spa, Retains TransMedia Group for Soothing PR 2Health News:SIRIUS Satellite Radio to Launch 'Doctor Radio,' a Groundbreaking, 24/7 Health and Wellness Channel, in Partnership With NYU Medical Center 2Health News:SIRIUS Satellite Radio to Launch 'Doctor Radio,' a Groundbreaking, 24/7 Health and Wellness Channel, in Partnership With NYU Medical Center 3Health News:SIRIUS Satellite Radio to Launch 'Doctor Radio,' a Groundbreaking, 24/7 Health and Wellness Channel, in Partnership With NYU Medical Center 4Health News:SIRIUS Satellite Radio to Launch 'Doctor Radio,' a Groundbreaking, 24/7 Health and Wellness Channel, in Partnership With NYU Medical Center 5
... Surgical Access ...unlike any trocar system you've ... is actually four systems in one ... clinically adaptive to all of your needs., ... bladed or dilating tip styles, OnePort™ can ...
... Trocar Sleeve consists of a ... designed to prevent puncture or ... the cavity has been entered. ... on the sleeve which enhance ...
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
Medicine Products: