Consumers Union’s Safe Person Task will host its 2nd Twitter conversation on Thursday, May 17 at 1pm EST to debunk industry claims regarding the FDA’s device approval process and discuss what customers truly require to know about the medical gadget customer fee bills.
In the wake of numerous high profile, device-related public health catastrophes– such as defective surgical mesh that rips into ladies’s organs, metal-on steel hips that permeate cobalt poisoning into individuals’s blood streams, and cardiac defibrillators that unnecessarily shock individuals– we require Congress to make some sound judgment modifications to the gadget regulatory system to ensure the safety and security of clinical devices as well as secure the public health. Sadly, the clinical gadget market has been pressing Congress to obtain the clinical tool individual cost bundle passed as quickly as possible, although both bills do not address one glaring safety problem with the way most clinical gadgets are approved by FDA.
Currently, over 90% of device applications are OK would certainly up for sale with a “fast track” that does not require the business to show that the tools have actually been scientifically tested for security As long as they show that this brand-new gadget resembles one already on the market, the FDA has to “clear” it offer for sale– this is even the demand when the old tool has been recalled for safety and security factors. The FDA can not also ask the tool manufacturer if its new device has actually dealt with the defects of the recalled device to which it compares itself. The tool industry says it is “unneeded” to alter this FDA approval procedure but we claim that is not the case. The industry has actually been misleading Congress on this concern.
What: Twitter conversation on medical device security.
Host: Consumers Union’s Safe Client Project [@CUsafepatient]
When: Thursday, May 17, 1-2pm EST/ 12-1pm CST/ 10am-12pm PST
Where: Twitter (hashtag #sppchat).
Consumers Union’s Safe Person Project has actually been working to secure consumers from legislative adjustments that would compromise the existing system to give medical gadget manufacturers extra flexibility to push possibly unsafe tools on the market. Look into our initial Twitter conversation transcript on clinical tools here.