The FDA EMC/Wireless Lab houses a large anechoic chamber for electromagnetic compatibility and wireless coexistence testing.
The lab is equipped with a robotic system used for electromagnetic field measurements
Wireless Coexistence Testing of Bluetooth Medical Devices.
Medical device manufacturers are incorporating wireless communication into medical devices at an increasing rate to help spur innovation in healthcare. To address the risks associated with wireless technology, the FDA released the RF Wireless Technology in Medical Devices Guidance. A key concern raised in this guidance is wireless coexistence. Wireless coexistence is the ability of one system to perform a task in a given shared environment where other systems performing tasks may, or may not, be using the same set of rules. The reliability of wireless communications that operate in the Federal Communications Commission (FCC) unlicensed bands is a concern and could be susceptible to radio frequency (RF) interference.
Wireless coexistence is not adequately addressed in IEC 60601-1-2 standard. Research into adequate test methodologies is an on-going effort at the FDA to facilitate innovative use of wireless technology in medical devices while addressing wireless coexistence concerns. The primary deliverables in this research area are to: (1) enhance the assessment tools used by the FDA to evaluate wireless medical devices in regulatory submissions; (2) develop collaboration amongst federal agencies, standard bodies, academic researchers, and healthcare information technology workers to create a scientific tool to support medical device innovation; and (3) explore the role of wireless and information technologies in new medical applications.
Current funding sources
Mohamad Omar Al Kalaa, Ph.D.
FDA EMC/Wireless Lab
Relevant standards & guidances
- C63.27 Standard for the Evaluation of Wireless Coexistence
- AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems
- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Selected Peer-Review Publications
- Seidman and LaSorte, An Experimental Method for Evaluating Wireless Coexistence of a Bluetooth Medical Device
- Al Kalaa et al., Estimating the Likelihood of Wireless Coexistence Using Logistic Regression: Emphasis on Medical Devices, IEEE Transactions on Electromagnetic Compatibility, 2017
- Al Kalaa et al., Practical aspects of wireless medical device coexistence testing, IEEE Electromagnetic Compatibility Magazine, 2017
- LaSorte et al., Experimental Method for Evaluating Wireless Coexistence of Wi-Fi Medical Devices, Biomedical Instrumentation & Technology, 2016