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On December 6, 2011, Orionce Labs will launch the Program for Testing Medical Devices for Susceptibility to RFID, to determine potential adverse events of radio frequency identification (RFID) emissions on electronic medical devices. After months of development with AIM Healthcare Initiative (HCI) and the U.S. Food and Drug Administration (FDA), the Program’s test protocol can now undergo validation using actual medical devices. Orionce Labs is launching the program with a free informational webinar.
Medical device manufacturers are invited to participate by submitting representative devices to Orionce Labs for testing, which will take approximately one day to complete for each submitted device. Eligible medical devices are those covered by the IEC 60601 family of standards.
There are several benefits to participation. Submitted equipment will be tested in several different RFID frequency bands and participants will receive a confidential test report. If equipment is found to be susceptible to RF interference, Orionce Labs will assist manufacturers with strategies for minimizing or eliminating interference effects.
The confidentiality of manufacturer participation and individual test results will be strictly maintained. Orionce Labs will only share or publish aggregate, unattributed data that relates to the validation and/or further development of a final test protocol with the AIM RFID Experts Group. Orionce Labs will not share or publish any results without the explicit, written consent of the medical device manufacturer.
The increasing use of wireless monitoring devices in RF-rich environments (from RFID, wireless LANs and other devices) makes this research critical in the prevention of potential adverse effects from RFID emissions on patient safety.
Upon completion and acceptance by AIM, Inc., the final test protocol will be submitted to recognized national and international standards organizations so that it may be publically available.
Interested medical device manufacturers are asked to participate in a free informational webinar on December 6, 2011 that will provide more details about the program. Those interested but unable to attend should complete an online interested party form. Eligible form completers will receive a Program Information Packet that includes a sample test report.
