The document, “Radio Frequency Wireless Technology in Medical Devices—Guidance for Industry and Food and Drug Administration Staff,” contains a series of nonbinding recommendations aimed at a broad array of intended RF wireless medical devices, including “those that are implanted, worn on the body or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories and blood establishments.”
“These issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) (including the former Medical Implant Communications Service (MICS) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products” that operate under certification or license from the Federal Communications Commission, the FDA guidance said.
Proper maintenance and monitoring of devices throughout their life cycles is also advised for “erratic or unexpected behavior,” the guidance said “Examples of such behavior include reprogramming of stimulation devices, commands missed or misinterpreted by operating room controllers, unexplained inconsistencies of an infusion pump, and failure to activate alarm signals in alarm conditions.”
Potential problem areas to consider are electromagnetic interference (EMI), other environmental conditions, other equipment used in conjunction with the device, and failures with the same device elsewhere at a provider's own locations or in other geographical areas.
Points on the proper servicing of these devices are also among the FDA recommendations.
“Care should be taken to ensure EMI protection is present and in good condition,” the FDA said. “Such EMI protection can include components that may be removed during service such as shields, metal covers, ferrite beads, bonds, screws, ground wires and straps. In addition, FDA recommends that you do not paint metal surfaces that are intentionally left bare for RF shielding continuity. To reduce EMI susceptibility as electronic equipment ages, we recommend that you clean connector contacts that might have oxidized because oxidized contacts can act as semiconductors.”
A draft of this guidance was first published in 2007. In July 2011, the FDA signaled that it is preparing a separate draft guidance for developers of mobile medical applications for smartphones and other mobile devices.
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