Regulating Home Medical Devices
by: Laurie Johnson, September 17, 2007 5:09:00 am
When doctors talk about medical devices, they're covering a broad spectrum of items. The FDA considers everything from band-aids to an artificial heart as a medical device. And most of those devices are used at home, with little to no expert supervision. Dr. Dan Schultz is the FDA's director for the Center for Devices and Radiological Health. He says the FDA is working to figure out what the agency can do to ensure devices are designed appropriately so they can be used safely and effectively at home.
"It includes things like home dialysis units, respirators used in the home, various prosthetic devices, wheelchairs, things like that. So there really is a very wide variety and obviously what is right for one type of device may not exactly be right for another. So it starts to get very complicated very quickly."
To further complicate matters, the U.S. population is aging and the Baby Boomer generation is poised to be both a financial boon and a staffing burden on the home healthcare industry.
"I think we all are excited about having people spend less time in the hospital, get home quicker - I think there are a lot of advantages to that. I think there are also a lot of advantages to having technology migrate into the home. But how do we make sure that lay users are trained appropriately since now there won't be the kind of oversight by healthcare professionals."
So the FDA is holding a series of workshops and conferences with medical personnel and patient advocates. Dr. Cliff Dasco is a physician at The Methodist Hospital and a Distinguished Research Professor at the University of Houston. He says a lot of what is discussed at these meetings is theoretical, but the industry needs to remember medical devices are not an end, but rather a means to healthcare and prevention.
"The device itself does not answer the problem. The problem still exists. It's how do we get this device out into the community, used by people who understand it, used by people who can make informed judgments about their own health, take power over their illness, take some authority over their own sickness, responsibility - and act on it."
Laurie Johnson, Houston Public Radio News.