The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
Consumers Union’s Safe Patient Project will host its second Twitter chat on Thursday, May 17 at 1pm EST to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills.
In the wake of several high profile, device-related public health disasters–such as faulty surgical mesh that rips into women’s organs, metal-on metal hips that seep cobalt poisoning into people’s bloodstreams, and cardiac defibrillators that unnecessarily shock patients—we need Congress to make some common sense changes to the device regulatory system to ensure the safety of medical devices and protect the public health. Unfortunately, the medical device industry has been pressuring Congress to get the medical device user fee package passed as soon as possible, even though both bills do not address one glaring safety problem with the way most medical devices are approved by FDA.
Currently, over 90% of device applications are OK’d for sale through a “fast track” that does not require the companies to show that the devices have been clinically tested for safety. As long as they show that this new device is similar to one already on the market, the FDA has to “clear” it for sale – this is even the requirement when the old device has been recalled for safety reasons. The FDA can’t even ask the device maker if its new device has fixed the flaws of the recalled device to which it compares itself. The device industry says it is “unnecessary” to change this FDA approval process but we say that is not the case. The industry has been misleading Congress on this issue.
What: Twitter chat on medical device safety
Host: Consumers Union’s Safe Patient Project [@CUsafepatient]
When: Thursday, May 17, 1-2pm EST / 12-1pm CST / 10am-12pm PST
Where: Twitter (hashtag #sppchat)
Consumers Union’s Safe Patient Project has been working to protect consumers from legislative changes that would weaken the current system to give medical device manufacturers more leeway to push potentially unsafe devices on the market. Check out our first Twitter chat transcript on medical devices here.
I look forward to learning more about the role of Congress in regulating implanted medical devices. I understand that 4% of physicians choose to be primary care physicians and that our government financially subsidizes programs for medical specialty training. These specialties consume a larger proportion of the pharma and medical device products. Perhaps this is why it is so difficult to change direction from profit (fee for service) to patient safety (preventative healthcare).
I am at a LOSS and don’t know where to go. I got a drug implant installed in Oct 2011 by a trusted doctor. But in January 2012 I discovered by searching about the manufactured on the internet, that the pump was actually FDA Class I Recalled in June 2011. When I called Medtronic’s about it, they verified this, and I found my serial number as part of the recall. When I called my doctor’s office, he wouldn’t take my call, but his Physicians assistant denied any knowledge, and her Medtronic’s rep also denied any knowledge. The doctor never called me back, in spite of many requests. I changed doctors shortly after that. My civil rights were taken away. What rights do I have?
Dear Jackie, Please help me be the voice for thousands of harmed patients at the Mayo Clinic Social Media Summit October 15-19, 2011. You can do this by reading my essay and at the bottom click the buttons for Twitter, LIKE (FaceBook) and POST COMMENT.
You are welcome to contact me and follow failed medical device information on my blog.
I wish you well.
http://socialmedia.mayoclinic.org/2012/07/16/joleen-c-scholarship-contest-essay/
http://fida-advocate.blogspot.com/