Posts Tagged ‘ Consumers Union ’

Consumers Union: Manufacturers Should Warranty Knees and Hips

Sep 12th, 2013 | By
Consumers Union: Manufacturers Should Warranty Knees and Hips

Your big screen television and new car comes with a warranty- why not the most important medical purchase you will make in your life? Consumers Union, an arm of Consumer Reports, has come up with a novel and common sense approach. Manufacturers of medical devices should warranty their products. They claim they are safe and
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FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA Asks Consumers to Report Product Failures

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements.
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FDA Helps Industry Push Medical Device Innovation

Dec 4th, 2012 | By
FDA Helps Industry Push Medical Device Innovation

December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices. The newly formed nonprofit group,  Medical Device Innovation Consortium (MDIC), has a goal of speeding up and simplifying the design and testing of medical devices, reports CBS
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MDUFA for Another Five Years

Aug 7th, 2012 | By
MDUFA  for Another Five Years

August 6, 2012 ~ The U.S. Food and Drug Administration (FDA) has a renewed source of funding for the review of medical devices, at least for the next five years. On October 1, 2012 the Medical Device User Fee Amendments of 2012 or MDUFA III will go into effect. It will expire October 1, 2017.
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Patient Advocate Joleen Chambers Needs Your Vote!

Jul 17th, 2012 | By
Patient Advocate Joleen Chambers Needs Your Vote!

Texas-based patient advocate, Joleen Chambers heads FIDA, FAILED Implant Device Alliance, their website is here. Chambers is interested in winning a Mayo Clinic Center for Social Media Scholarship (more here). She needs daily votes! All you have to do is add a Facebook Like or Twitter Tweet button at the bottom of each post to
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FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Jun 14th, 2012 | By
FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a prominent warning that would have told them what they were in
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Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24th, 2012 | By
Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote,  96-1,
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Politico Ad: Consumers Union Warns the FDA Cannot Protect Patients

May 22nd, 2012 | By
Politico Ad: Consumers Union Warns the FDA Cannot Protect Patients

May 22, 2012 ~ The U.S. Food and Drug Administration (FDA) has as its mission the protection of the American people from dangerous consumer products such as food, pharmaceuticals and medical devices – right? Consumers Union in a recent poll found most Americans  believe safety is the FDA’s mission, so why then is the consumer
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Suffering in Silence: Nonie Wideman ~ Canadian Child Advocate and Rancher Sidelined By Transvaginal Mesh

May 21st, 2012 | By
Suffering in Silence: Nonie Wideman ~ Canadian Child Advocate and Rancher Sidelined By Transvaginal Mesh

Nonie Wideman might be considered one of those angels on earth who pays it forward by taking into her home kids with all sorts of special and emotional needs – those who have suffered trauma and abuse, autism, ADHD, fetal alcohol syndrome, and handicaps, among other issues. Wideman, 57, and her husband Bob, 65, have
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Consumer Reports: Dangerous Medical Devices

Apr 2nd, 2012 | By
Consumer Reports: Dangerous Medical Devices

April 1, 2012 ~ The May issue of Consumer Reports (here)  features an investigation into synthetic mesh and artificial hips – medical devices that escape rigorous testing to assure safety. Tens of millions of Americans are living with medical devices and whether a defibrillator, artificial hip or surgical mesh, – 90 percent of those devices
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.