Day: July 19, 2005

IOM Questions Safety of Medical Devices in Report

The Institute of Medicine published a report critical of the safety of medical devices for children and the regulatory oversight provided by the FDA. According to this story (registration required) in the New York Times, Monitoring of medical devices sold for children must be improved, a major new report concludes, citing missed opportunities to uncover side effects and make crucial treatments safer for the tiniest patients. Improved tracking of device safety and other steps will also benefit adult recipients of medical devices, notes Monday's report from the Institute of Medicine. Among the panel's recommendations: Congress should give FDA the authority to require postmarket studies of any device; today, it can force them to perform such studies only for certain products. Congress should require FDA to establish a public database showing those studies' status and findings. Congress should fund improved postmarket surveillance for device-related problems in both adults and children. Lawmakers authorized an extra $6 million this year for FDA to do that but ultimately never provided the money, the report said. AdvaMed, the medical device industry trade group, declined immediate comment but had told the IOM panel that FDA has adequate authority to ensure device...

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More Hospital Systems Adopt Metropolitan Area Networks

Fibertech Networks, a metropolitan-area network vendor operating in mid-size U.S. cities, announced it has signed nine new contracts in the first half of this year with major healthcare providers. Fibertech's footprint (i.e., the geographic area served by Fibertech) includes Hartford, Bridgeport, Stamford and New Haven, Connecticut; Providence, Rhode Island; Pittsburgh, Pennsylvania; Syracuse, Rochester, Buffalo, Binghamton, White Plains and Albany, New York; Indianapolis, Indiana; Wilmington, Delaware; Concord, H.H.; Columbus, Ohio; and Worcester and Springfield, Massachusetts. Health care clients include Greenwich Hospital, Connecticut, Community Health of Indianapolis, Baystate Medical of Springfield, Massachusetts, and Catholic Health of Buffalo. Besides the obvious enterprise applications, hospitals are using private fiber networks for things like centralized monitoring surveillance for hospital-wide patient monitoring deployed in multiple hospitals. If you're in one of the mid market cities above, Fibertech Networks even has a cool mapping tool that will overlay your facilities on a map of their...

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Why Barcoding Medical Devices is a Bad Idea

The idea of the FDA mandating the barcoding of medical devices has never struck me as particularly good. In the following open letter to the FDA, Michael Depsey, founder and CTO of Radainse describes why he thinks it's a bad idea. Open Letter to FDA By Michael Dempsey The Honorable Lester Crawford, Acting Commissioner Food and Drug Administration 5600 Fisher Lane Parklawn Bldg., Rm 14-7 Rockville, MD 20857 July 19, 2005 Dear Acting Commissioner Crawford: Recently several members of the U.S. House of Representatives, the American Hospital Association, and several other leading national healthcare organizations have written to you encouraging swift action to require bar codes on medical devices as a way to promote patient safety, cost effectiveness, and supply chain efficiency. They urged you to reconsider this issue after bar-coding of medical devices was excluded from the Food and Drug Administration's final rule in February 2004 requiring bar codes on hospital-administered medications and biologics. We applaud them for their efforts to encourage safety, quality, and efficiency in healthcare, but we believe their approach is shortsighted because it limits the solution to a particular technology rather than addressing the real need: to be able to immediately and accurately identify medical devices in the context of the healthcare environment. The issue is not whether bar codes have value. They clearly do, but bar coding is only one tool in a...

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HIT Legislation Tracking Expanded

Last month I noted that HIMSS was providing a Legislative Cross-walk (Word document) for tracking and comparing pending national legislation. Now they've added a State Legislation Tracker to track HIT bills in state houses (currently at 98...

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