The first thing that needs to be said about medical devices is that we should stop calling them medical devices. They are, in every sense, medical technology.
And technology, as we all know, is what makes the world go ‘round.
That being said, we must take medical technology as seriously as we do pharmaceuticals.
And, as the use of medical technology (from stents to scans) becomes ever more important and more pervasive, so too must we focus on safety.
But we must not fall into the false security of the Precautionary Principle which warns us to do nothing until we know everything. Why is this a bad idea? Because we can never “know everything.†And when it comes to FDA regulated products, be they drugs or devices or combination products – there will always be risk that comes along with benefit.
Can we do a better job regarding medical technology safety? Yes. Must we? Absolutely. Are we?
Here’s what Dan Schultz, director of CDRH had to say in today’s Wall Street Journal on that point:
"Are there ways to identify problems more quickly? I think the answer is yes. But if you require a clinical trial for every design change, what does that do to the ability of bringing new technologies to market?"
What, you mean there's no easy answer? Sorry Senator Grassley.
Here’s a link to the article:
http://online.wsj.com/article/SB119370397918375690.html?mod=hps_us_pageone
Vigilance must not supplant progress. They must advance together and learn from each other.
And technology, as we all know, is what makes the world go ‘round.
That being said, we must take medical technology as seriously as we do pharmaceuticals.
And, as the use of medical technology (from stents to scans) becomes ever more important and more pervasive, so too must we focus on safety.
But we must not fall into the false security of the Precautionary Principle which warns us to do nothing until we know everything. Why is this a bad idea? Because we can never “know everything.†And when it comes to FDA regulated products, be they drugs or devices or combination products – there will always be risk that comes along with benefit.
Can we do a better job regarding medical technology safety? Yes. Must we? Absolutely. Are we?
Here’s what Dan Schultz, director of CDRH had to say in today’s Wall Street Journal on that point:
"Are there ways to identify problems more quickly? I think the answer is yes. But if you require a clinical trial for every design change, what does that do to the ability of bringing new technologies to market?"
What, you mean there's no easy answer? Sorry Senator Grassley.
Here’s a link to the article:
http://online.wsj.com/article/SB119370397918375690.html?mod=hps_us_pageone
Vigilance must not supplant progress. They must advance together and learn from each other.
