Posted by Daniela Nunez on May 11, 2012
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 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.
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.