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Medical device safety ratings on tap at new site

Don Fluckinger, News Director

Clarimed.com, a medical device safety and quality site launching today, aspires to do two things -- sort through the morass of jargon and sometimes tough-to-find information in the Food and Drug Administration's medical device

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adverse event database and organize it so that average patients can find what they need to know to make choices for their own treatments.

The site is also designed with health care professionals in mind, giving physicians, consultants and IT staffers faster access to adverse event information to help them make more informed treatment decisions and technology implementations.

"Right now, if you want to find information about medical devices, there's not a place you can really go…and do that easily," said founder and CEO Nora Iluri, a biomedical engineer whose resume includes serving as a senior director at Philips Healthcare. "We are hoping to make a lot of the information available out there -- or available through government agencies and other sources -- a lot more transparent and readable by humans."

Among the site's future plans is a ratings system for medical devices so consumers can quickly see how safe and effective a device really is.

For several reasons, the ratings system will take some time to develop, Iluri said. Chief among them is the need for the FDA to normalize data.

At present, it's difficult to figure out if one medical device has had more adverse events than another because it's less safe, or because a larger patient base is using it. Clarimed.com is working with the FDA to sort through this issue in order to develop the safety component of its rating system, which remains under wraps.

Health care pros, Iluri hopes, will also find the adverse event data Clarimed plans to mash up with purchaser and payer data helpful in making purchasing decisions on an institutional level. If nothing else, this new data set will give clinicians and inventory managers more light to shed on a purchasing decision beyond what they have now. For most devices, this is limited clinical guidance written for physicians and the premarket studies that vendors must complete before the FDA clears a device for health care use. Surgeons, for example, rely on conversations with other surgeons for recommendations of one device over another.

"Purchasing decisions really are more brand-driven today for these folks than they are true fact-based decisions," Iluri said. "We really want to elevate the conversation to quality and performance-based decision-making rather than…the clinical study that happened on a small group five years ago."

Launch begins with medical device safety reports

The fledgling site unveils its new diet section and expanded medical device safety data during today's Health 2.0 conference in San Francisco. The "launch" technically means the site goes from alpha to beta.

Clarimed has yet to catch the attention of device vendors, Iluri said -- but when it does, she'll be ready for them. In fact, she's expecting push-back from vendors that discover her site and what it says about their devices.

"If you look at what happened when J.D. Power and Associates first entered the market for the auto industry, auto quality and safety was pretty sad," Iluri said. "Within a decade of [J.D. Power] starting to rate cars -- and those initial ratings weren't that reliable, either -- that kind of scrutiny elevated quality across the industry….Automakers [probably] weren't too happy J.D. Power was trying to rate them. But nobody complains now, especially when their car wins one of those little trophies."

Let us know what you think about the story; email Don Fluckinger, Features Writer.


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