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.
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