FDA's Medical Device ID System Still Inactive
The new bipartisan legislation, the Medical Device Patient Safety Act, or S.1995, was introduced last December by Sen. Charles Grassley (R-Iowa), with co-sponsors Sen. Richard Blumenthal (D-Conn.), Sen. Jeff Merkley (D-Ore.), and Sen. Herbert Kohl (D-Wis.).
With the proposed law now referred to a Senate committee, Childs doubts there will be a specific hearing on the bill. "This is bipartisan legislation, it passed overwhelmingly, and now it's just a question of getting it done," he says.
So more than ever, Premier needs to fire up public opinion, which in no small part prompts this column today. Having covered tech in Washington D.C. for nearly a decade, I fully appreciate the slowness of federal bureaucracies. So, everybody get ready to get out pen and paper and write your Congress people.
When you do, remind them of the following salient benefits of unique medical device identification:
- It can allow hospitals and the FDA to spot trends in the numbers and types of device recalls, including the types of devices recalled and causes of recalls.
- It can identify the length of time needed for a person subject to a device recall to complete the recall.
- It can identify which persons have been subject to the most device recalls.
- The system can be set up in such a way to protect patient confidentiality.
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