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House Hearing on FDA and Medical Devices: Even God Doesn’t Guarantee Safety

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A sluggish FDA is partly a response to our demand that they arbitrate safety

Great Power. Still Human.

[Full disclosure: I consult for the medical device industry.]

Tomorrow’s hearing with the House Oversight and Government Reform Subcommittee on Health Care is all about looking for a better way to get medical devices approved. MassDevice reports Minnesota Rep. Erik Paulsen will be there to push for an “ ‘innovation pathway’ for pioneering medical devices.” Paulsen is also there to try to block a proposed $20 billion tax on the medical device industry.

Lives ride on the safety of medical devices. The companies I work for take this very seriously and institute redundant processes to check, double- and triple-check that all the right things were done. They take a great deal of pride in their record and FDA oversight is likely a boon to Minnesota’s culture of medical device safety.

That the FDA is slow to approve medical devices and is often seen as a bottleneck for innovation does not surprise me. How could it be otherwise, given that Americans want iron-clad guarantees that everything with the FDA seal is perfectly safe? We want and expect the FDA to play a God-like role in assuring us nothing harmful every escapes their jurisdiction. And sharp-toothed lawyers constantly circle and swim in at the first hint of blood, so it is also a big-money game.

Do we expect too much from the FDA? Is anything ever truly safe and entirely understood? Though the FDA would likely argue that they are simply applying “reasonable standards for safety,” the public doesn’t see it that way. FDA “approval” means something far more to most of us: that nothing should ever go wrong. That’s too big a role for a person or an agency. Even God doesn’t issue a decree like that: He only says that it all works out in the end for those in relationship with Him. By the way: my experience is that the FDA never “approves” anything. They just clear it for market release. Subtle difference, right?

We all need to be reminded again of what constitutes a reasonable standard for safety.


Image credit: Kay-too

Written by kirkistan

June 1, 2011 at 10:43 am

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