03/26/2013 - The PBS program "Need to Know" devoted a portion of their March 22 program to discuss medical devices.
They began by posing a question: is the federal government doing enough to protect our safety? Not from crime or terrorism but from the very real dangers of some medical devices cleared for use by the Food and Drug Administration. While the vast majority of these devices are safe and effective, the Government Accountability Office reports that hundreds are recalled every year. And the impact of an un-safe device? It can be devastating.
Joining host Jeff Greenfield on the program was Pew's Dr. Josh Rising, project director of the medical devices initiative at The Pew Charitable Trusts. Here is a portion of their conversation.
"JEFF GREENFIELD: Now I mentioned that you’re interested in regulation here and abroad. When you look abroad and look at other countries, how are they doing on the whole issue of regulation, medical safety, the safety of these medical devices, how do we stack up against some other first world countries?
DR. JOSH RISING: I think there’s one other very relevant example from Australia that I think would be illustrative to show the kind of potential of what can be done if you have a system that really tracks the medical devices. So in Australia they have what’s called a registry which tracks everybody in their country who’s gotten a hip or knee replacement. And this has been going on for about the past 10 or 12 years in Australia. And with this information, as they saw what happened with patients, they followed the patients over time, they discovered that patients who had metal on metal hip replacements, they discovered that patients had a much higher revision rate – meaning that the hip implants were having problems, and the surgeries need to be redone in these patients. And this was happening at a much higher rate than with patients who had other hip implants. So the registry communicated this information…and the docs in Australia stopped using these metal on metal hip replacements years before we stopped using them here in the United States. So it shows the potential that’s out there if we’re able to collect information on what’s happening in the real world with medical devices and what’s happening with medical devices and we can take appropriate action when we find if there are some devices that do have some problems.
JEFF GREENFIELD: We've heard from some companies that you put on more regulation, what you're going to do is you’re going to increase cost, you’re going to slow innovation. Is that relevant to what you’ve been talking about in terms of what you want to see done? Is that a legitimate concern?
DR. JOSH RISING: You know certainly we think of a better system of post market surveillance of figuring out what’s happening in the real world as being a win for both safety and innovation.
You know there’s some people who talk about safety and innovation as being diametrically opposed that if you improve safety, you’re going to hurt innovation or vice versa. But we see post market surveillance as a way where you can really achieve the best of both worlds. And that’s if we’re able to collect real time information on what’s happening with medical devices we can improve safety because we can identify devices that might be problematic and then remove them from the market place, but it’s also going to help innovation because this is also going to give manufacturers much more information about what’s happening with their devices than they have now, and they’re going to be able to use that information in the next generation of their devices, so we really see this need to collect more information on these devices as being both a win in the safety and innovation columns.''