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Urodynamix, Motion Computing Team Up on RFID-enabled Diagnostic Device
RFID helps protect patients against possible infection by ensuring that disposable components utilized with the diagnostic device are not reused.
"A common problem in the medical device industry is the reuse of single-use, disposable components, and there are reasons why we don't want that to happen," says Barry Allen, CEO of Urodynamix, headquartered in Vancouver, British Columbia. "First and foremost, there's patient safety."
To use the RFID capability, a physician enters the patient's name into the C5, then waves the device over each patch (the read distance is 1 to 2 inches) just before affixing the patches to the patient. When the C5 reads the patch's tag, the system associates the tag ID number with that person's name, along with the date and time, then permits the test to be carried out. Later that day, if the patient needs to be retested, the UroNIRS 2000 Bladder Monitor System will let the doctor reuse the patch on that same patient within a specific period of time. If, however, the system is presented with a patch that had already been utilized for a different individual, it will issue an alert and not allow testing to proceed.
In addition, Urodynamix's distributors can leverage the RFID tags to ensure customers purchase patches only from them. "The RFID tags offer protection to our distributors," Allen explains, "some of which want to sell the system on the assumption that they will get revenue from the consumables used with that device." The distributor can buy batches of RFID-enabled tags with unique ID numbers that include its company code, and those tag numbers can be preprogrammed into the UroNIRS Bladder Monitor System. If the monitor fails to capture a tag number, or if the tag number it captures is not one preprogrammed by the company, the system will not operate.
In early January 2009, the U.S. Food and Drug Administration granted Urodynamix permission to market the device, as required by Section 510(k) of the Food, Drug and Cosmetic Act. With such clearance, the UroNIRS 2000 Bladder Monitor System can be marketed and commercially distributed within the United States. Urodynamix has also applied for the CE mark for European approval of the device, which it expects to receive in the first quarter of 2009, for a European launch in the second quarter.
The UroNIRS 2000 Bladder Monitor System is available now.
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