In the FDA Voice blog, Bakul Patel, senior policy advisor in FDA’s Center for Devices and Radiological Health, unravels the kinks inherent in usage of wireless devices that support health care delivery.
What if a diabetic’s blood glucose monitor should malfunction and transmit a wrong glucose reading to a physician because another wireless device in the clinic interfered with its signal? What if a signal is completely interrupted from a monitor the patient relies on to transmit time-sensitive health care data? Precise functioning of wireless medical devices can mean the difference – in these instances, literally – between life and death.
Click here to read Patel’s blog post, and click here to read the FDA’s final guidance titled, “Guidance for Industry and Food and Drug Administration Staff; Radio Frequency Wireless Technology in Medical Devices,” issued on August 13.
[Source: FDA]
