U.S.A. FDA studies RFID medical device recognition follow up system actively
American food medicines administration bureau FDA health spa, will work out medical equipment and articles and discern the system specification draft of tracing at the end of 2008.
At present, the final user participation proposal that this office has been soliciting RFID industry actively and already trying RFID system on the market of medical treatment and health care.
Two years ago, FDA began to study the unique device identification system (UDI) Function in information of automatic collection. In August of 2006, this organization gave notice, collected the appraisal opinion of the apparatus industry, health care industry and apparatus user that used UDI at that time.
After summarizing the appraisal opinions of 3 months, FDA has planned to draw up the system specification proposal at the beginning of 2007, and release to for the public to examine and comment on, but because U.S.A. will exert pressure and fail to achieve one's goal.
The spokesman Ann Ferriter of CDRH talks about, CDRH if use RFID technology in the hospital or other medical health-care facilities while studying now, whether will produce the radio frequency disturbance or health risk. Ferriter quote can distinguish the intersection of RFID and the intersection of reader writer and pulse and pacemaker, heartbeat of pulse for example perhaps, enumerate others include the intersection of infusion and pump, acouophone, defibrillate device and programmable the intersection of cardiac valves and inner sensitive apparatus also, prove that has not found any RFID interference phenomenon.
Ferriter says, FDA has realized RFID function in the field of health product tracing of the hygiene. However, CDRH can do further study, especially lays particular emphasis on studying 13.56 MHz wrist strap used in the hospital.
CDRH senior consultant Jay Crowley says, has no concrete medical instrument follow up system or seriation to appraise the system in U.S.A. at present. Though prescribed medicine adopts the identification number label to mark the products type, but the medical equipment is not. At present, FDA is studying the tracing descent system that is directing against medicines now.
Crowley point out medicines it imitates to be very frequent, imitate the medical equipment of high value, have, just uncommon. In addition, the position that can find out the particular apparatus rapidly in medicines are recalled is very important. Employ medical equipment recall system seem very important, have to system that medical equipment recalls at present.
FDA may consider implementing a similar descent system to the medical equipment finally, but not worked out in the draft.
Crowley points out, up until now, none of countries can implement the inner medical equipment follow up system of the range of China. For this reason, FDA is with Japan, China, European Union and several South America country at present, can research and develop the generally acknowledged unified follow up system at the international level together.
Crowley says, FDA is still studying the market of medical equipment at present, attempts to solve appearance and operating principle problem of this identification system. Discern target's medicine support from rubber gloves to 30,000 dollars of value, and concrete tracing requirement and tracing technology look at different apparatus but different to some extent.
Finally, Crowley says, " have a lot of device types, can or should use RFID technological tracing, however, the bar code is under deliberation. We will keep technological neutrality. "
















