Outcome of the Joint FCC-FDA Workshop
March 31, 2015 - Washington D.C.
I attended this workshop yesterday, entitled Wireless Test Beds Workshop, Promoting Medical Technology Innovation – the Role of Wireless Medical Test Beds, a Joint FCC-FDA Workshop.
I applaud the FCC and the FDA for putting on this workshop. The purpose of this public workshop was to discuss the role of wireless test beds and their influence on the development of converged medical technology for clinical and non-clinical settings.
“Wireless medical devices must work as intended…They must reliably, safely, and securely transmit the data that they collect”, as was stated in the welcome message.
As someone who has been in the wireless medical device world for thirty years, this was a lot of ground to cover. It seemed like we were “boiling the ocean”. A lot was discussed regarding WLAN (wireless LAN), co-existence testing, cellular, home healthcare, and dedicated spectrum versus unlicensed, etc. A lot of really good information was presented.
If we go back to the title of the overall workshop, it was about the Role of Wireless Test Beds. In this author’s opinion and experience this translates into the area of “how do you ensure a wireless connected medical devices and its application works as appropriate for its safe and intended use” within the healthcare institution. (This is specific to the hospital). Additionally, for any “RF/radio technology” to be available to the general public in the United States it has to pass certain EMI/EMC testing to meet EIRP (effective isotropic radiated power) guidelines for FCC approval.
In this case, I believe that wireless testing should center on:
1. Design of the wireless embedded module within the medical device to ensure effective roaming and security supplicant passing. Pre-testing should be carried out before the product is manufactured and for pre-submittal for a FDA 510(k).
2. Validation and verification of EMC/EMI in the presence of wireless emitters that measures validation and verification of network performance.
3. The design of the wireless network needs to support the intended use. This includes adequate RF coverage for areas of use of the clinical application.
4. Continued validation and verification of the wireless medical device in situ to ensure that any changes to the network performance does not degrade the intended application performance.
While I applaud this initial meeting; it would be helpful to have more of an engineering centric discussion next time. For example, case presentations could be:
1. Here are the problems and issues that we have encountered.
2. This is the testing and design of the solution that solved these problems over a variety of use models and environments.
3. These are the best practices for risk management of wireless medical devices when deployed in an enterprise healthcare environment.
At the end of the day, questions still came up from the audience about how to address the most basic problems of network security and quality of service in a wireless-enabled medical device network.
See the attached white papers that I have authored, that describe the process and testing that has been done with multiple medical device companies.