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Stroke Smart Magazine

January/February 2008

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If It's New, Should I Try It?

by Stephen J. Page, Ph.D.

Just because a medical device is new, doesn't mean it's the answer to your problems. Despite the millions of dollars spent on marketing devices from wheelchairs to bedpans, we often don't know whether they work, on whom they work, or how much or how often we need to use them for them to work best. You may assume new devices - especially those used by a hospital - must work. This is not always the case.


People assume that devices with approval from the Food and Drug Administration FDA have been through the same rigorous testing that is required for drugs. Actually, the FDA requirements for device approval are not near as strict as those required for drugs. The most common approval process for devices requires "equivalency," which means that the new device is equivalent to an existing, legally marketed one. For example, a newly developed brace will probably receive FDA approval if the manufacturer can prove it is similar to devices on the market that claim to do the same thing. No human testing with the new device is required. The new device does not have to prove it works better than - or even as good as - existing devices.


Furthermore, you may think that a hospital system that has invested in new approaches to stroke rehabilitation is on the "cutting edge" and will provide better care. But, a hospital is a business. And like other businesses, it has to compete for customers. These hospitals know that having the "latest and greatest" devices to treat stroke will attract survivors to their facilities. As a competitive strategy, they purchase new devices and market the fact that they have them. The actual care offered by these providers may or may not be based on scientific evidence.


What Can Help

Before making any decisions about medical devices, do your homework. Start by going to Medline at http://www.pubmed.gov/. The online Consumer Reports for healthcare products,

Medline is free, easy to use, and supported by your tax dollars. Here you can find out if there is scientific evidence supporting a device, and whether you are likely to benefit from it. Type in the name or category of the device, and the site will show you published articles about research on the device. Type in the diagnosis e.g., aphasia or spasticity, and you can see which devices work best for it. This is important, since companies

or health systems who endorse a particular device may not tell you about a competing device that works as well or better.


After you've done your research, talk to your doctors and therapists. They know your specific needs and can help you determine if a product is right for you. 


Stephen Page, Ph.D., is an Associate Professor of Rehabilitation Sciences, Physical Medicine and Rehabilitation, and Neurosciences, all at the University of Cincinnati Academic Medical Center. He is also Director of the Neuromotor Recovery and Rehabilitation Laboratory at Drake Rehabilitation Center in Cincinnati, Ohio. You can learn more about the ongoing research of Dr. Page and his team at http://www.rehablab.org/.





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National Stroke Association’s mission is to reduce the incidence and impact of stroke by developing compelling education and programs focused on prevention, treatment, rehabilitation and support for all impacted by stroke.

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