FDA www.fda.gov and FCC www.fcc.gov cohosted a workshop on March 31, 2015 to examine the challenges and benefits of using what are called wireless test beds. A wireless test bed enables medical devices to be evaluated across a range of potential interference scenarios seen in healthcare and home environments.
Acknowledging the rapid pace of innovation, William Maisel, MD Chief Scientist and Deputy Center Director for Science at FDA’s Center for Devices and Radiological Health (CDRH), said, “Today, so many devices are operating wirelessly from continuous glucose monitors that allow parents to keep track of their children’s blood sugar levels to being able to track surgical sponges left in patients”.
Stephen Berger, President of TEM Consulting www.temconsulting.com plus a number of other workshop participants want to see a unified definition and consistent vocabulary to address the need for a common language.
There is a need for a common language since there are a range of disciplines involved that includes hospitals, device manufacturers, and wireless carriers, with the result that too many words used with wireless can have different meanings for each individual person and discipline.
Discussions also took place on the design and evaluation of the test beds. Phil Raymond, Wireless Architect at Philips Healthcare www.usa.philips.com/healthcare in Andover, Massachusetts, said “Device manufacturers test their products in a lab environment, but those results might not translate over to a hospital network.” He also suggested that a test bed certification program could prove to be useful in filling the gap between the manufacturer and hospitals.
Michelle Jump Principal Regulatory Affairs Specialist at Stryker www.stryker.com suggested, “While some manufacturers already use test beds, smaller organizations might not have the resources to do so. This testing is important for small organizations since companies are dealing with so many different devices out there”.
The Association for the Advancement of Medical Instrumentation (AAMI) www.aami.org reports that the biggest mistake a healthcare delivery organization can make with wireless is fail to create a strategic plan on how to use and implement wireless technologies.
AAMI expresses the viewpoint that each wireless technology whether WMTS telemetry, cellular telephones, Wi-Fi networks, or proprietary technologies for RFID, requires a significant investment in infrastructure and presents multiple risks.
These risks can include security breaches, patient safety issues, and adverse impacts to other wireless applications. Failure to create a foundational strategy only increases the probability that the risks can become adverse events.