Cutting Cords: The Present State of Wireless Medical Devices

Dec 04, 2014 | Labs Blog

Austen PaulsenBy Austen Paulsen for BiolawToday blog.

Medical devices are being increasingly equipped with wireless capabilities. The wireless technology in these devices can be used to send patient data to other sources, control and program the devices, and to monitor patients remotely. Many patient benefits can be derived from these devices; the most significant benefits being patient mobility and physician access to real-time patient data. Wireless medical devices make it possible for patients to move around a hospital easily or even enjoy the comfort of their own homes while their vital signs are constantly monitored, eliminating the need for patients to be trapped in a hospital bed. The ability of physicians to monitor patient data in real-time allows physicians to alter patient dosages in real-time and detect any negative changes earlier, reducing the risk of negative consequences to patients.

Although wireless medical devices have become extremely popular, they have faced several hurdles and there are still problems with these devices. Several hospitals that use wireless medical devices have experienced severe dropouts in their wireless networks as a result of interference caused by television broadcasts. Incompatible wireless devices present within hospitals such as laptops, smartphones, and microphones have also caused interference with wireless medical devices causing unexpected movements and false readings in devices. The biggest fear associated with wireless medical devices is the risk that these devices can be hacked or attacked by malware. Several researches have demonstrated ways to wirelessly hack and manipulate medical devices. For example, in his article “Hacking Medical Devices for Fun and Insulin: Breaking the Human SCADA System” Jerome Radcliffe details how he was able to hack an insulin pump and wirelessly manipulate the amount of insulin pumped by this device.

In conjunction with the FCC, the FDA released the “Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff” on August 13, 2013 in order to address some of the issues that have occurred with wireless medical devices. This report provides advice for the selection of wireless technology, the necessary level of service and performance, methods for managing conflicts between devices, effective security measures, and consideration of electromagnetic compatibility (EMC). This report is a great resource for hospitals in creating and maintaining wireless networks for medical devices and resolving some of the issues that have emerged in these devices.

In addition to providing healthcare providers with instruction for creating and maintaining wireless networks, the FDA guidance also provides recommendations for premarket submissions for devices that incorporate radio frequency wireless technology. The FDA specifically suggests tests that companies should perform before submitting their devices and precise labelling instructions. This is important to the healthcare industry of the future because it encourages companies to think about how wireless technologies that they produce can be integrated into a cohesive system before they submit their devices. This description will likely aid companies that produce devices utilizing wireless technology in submitting their devices to the FDA and healthcare providers in selecting which devices to use in their wireless networks.

Austen is currently a second year law student at the University of Utah S.J. Quinney College of Law and a Center for Medical Innovation Fellow.  Austen graduated from the University of Utah with a B.S. in Chemical Engineering and is planning on pursuing a career in intellectual property law. He is an avid mountain biker, snowboarder, runner, weight lifter and lover of all things outdoors.