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FDA Publishes Guidance for Wireless Medical Devices

Maintaining the balance between innovation and safety

Bakul Patel
Wed, 08/14/2013 - 16:39
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Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance. Data from a patient-worn or implanted medical device goes directly to the health care professional. The transfer of data is immediate, accelerating communication, decision time, and when necessary, intervention.

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However, the stakes can get high.

What if a diabetic’s blood-glucose monitor malfunctions and sends a wrong glucose reading to a doctor because another wireless device in the clinic interfered with its signal? What if a signal is completely interrupted from a monitor that the patient depends on to transmit time-sensitive healthcare data? In such cases, the proper functioning of wireless medical devices can mean the difference—literally—between life and death.

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Comments

Submitted by umberto mario tunesi on Wed, 08/21/2013 - 02:14

Alice's Adventures in Wonderland

Well said, Mr. Patel: last May I was hospitalized to tele-monitor a heart ailment of mine, one week monitoring. Pity that, after a couple of days there was an energy blackout, as it seasonally occurs when storms take place where the hospital lies. So the testing had to be repeated, from beginning: why haven't the device engineers been tested for knwoledge of local seasonal weather conditions?

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