Posts Tagged ‘ Safe Patient Project ’

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 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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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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Sick of Suffering in Silence

Mar 19th, 2012 | By

MARCH 19, 2012 ~ By Jane Akre    A story before I tell this story.  I was commissioned to write a 2,100 word piece for the Chicago-based magazine “In These Times.”  I had pitched the long-time editor and he said they were very interested. Great I thought. The money wasn’t much but the exposure for an
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Consumer Reports Campaign email Alerts Million About Defective Medical Devices

Mar 13th, 2012 | By
Consumer Reports Campaign email Alerts Million About Defective Medical Devices

MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart may
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Call to Action This Week!

Feb 12th, 2012 | By
Call to Action This Week!

Call to Action The stories in Patient Profiles show something within the FDA is clearly broken, and needs to be fixed. Most blame the 510(k) process which is sort of an ‘honor system’ allowing medical device makers to market their products, while the FDA and consumers hope the devices are safe and effective. We know
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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.