The Federal Communications Commission and Food and Drug Administration on March 31 held a workshop in Washington to discuss the role of wireless test beds in promoting medical technology innovation.
Wireless test beds are meant to ensure that these technologies work as intended and do not pose risks to patient safety through interference with other wireless users in either hospital or residential settings. With the growth of clinical applications and consumers increasingly using wireless care management tools at home, government regulators are wrestling with the challenges that these environments pose.
We owe it to consumers and clinicians to ensure that medical devices are safe and reliable. We must, therefore, take into account the need for wireless coexistence, FCC Commissioner Mignon Clyburn told the workshop, arguing that wireless test beds are a critical piece of ensuring safe, reliable technologies. Individual medical devices must work together on wireless networks to create a transformed and improved healthcare system.
William Maisel, M.D., deputy director at the FDAs Center for Devices and Radiological Health, said a seemingly unlimited number of wireless medical devices are changing healthcare delivery, posing both opportunities and challenges. With the convergence of communications, the healthcare industry must ensure that these technologies deliver on their promise by establishing test beds that properly evaluate these devices for wireless coexistence.
In 2013, the FCC reformed its experimental licensing program and established a medical testing license to permit healthcare facilities to undertake clinical trials of cutting-edge wireless medical technologies.
As much testing as we can do in our lab environment, it does not 100 percent correlate to the performance of our devices in a hospital network, said Phil Raymond, wireless architect for Philips Healthcare. There is a gap there. Its a challenge we face as a medical device manufacturer working with the hospitals to understand that gap, to understand their capabilities and what they can test to.
A test bed certification program can fill that gap, Raymond argued. I dont think we ever get away from a hospital having to have its own testing capabilities and networking competencies around wireless connectivity, he added. But having this test bed certificationor whatever we end up calling itis a key component in my opinion of filling in that gap between the medical device manufacturer and the hospital.
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