Use of 4G/5G modules in Medical Devices - Coexistence

[guilhermegf]

Hi,

I'm struggling to find a concrete answer on the applicability of the ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence on a medical device (MD) that we're developing for the US market, as the FDA cites this standard in its Guidance for Wireless Medical Devices. We are considering embedding a pre-FCC-certified 4G/5G module into our MD only to send PHI (name and treatment data) to our cloud-based Electronic Patient Record (EPR) after the treatment is performed using the MD. There are no other wireless connectivity (WiFi, Bluetooth, etc.) features, so if there is a coexistence issue, it would likely be with other medical devices in the clinic/hospital and smartphones. However, as I've described, and if applicable, the function of the "wireless feature" would be Category D (Negligible).

Besides, IMHO, the definition of functional wireless performance (FWP): "The subset of the total functionality that both uses the wirelesscapabilities of the EUT and would result in unacceptable consequences if degraded or disrupted" might not even fit the above-mentioned feature, as there wouldn't be an unacceptable consequence or risk.

Does anyone have a different opinion and could provide insights or other considerations? Because, right now, although I have listed it as an applicable standard in the product requirements, I'm tending to believe that only justification could be enough to avoid testing besides the usual EMC IEC 60601-1-2 and FCC Part 15.

Thanks in advance for any advice!

 

[FelipeSchneider]

Hello Guilherme, have you tried to post your question in the Other Medical Device Related Standards forum?

 

[Ed Panek]

What is the product code? I can review recent competitive FDA clearances to see what's listed, if it's included.

 

[d_addams]

Hi,

I'm struggling to find a concrete answer on the applicability of the ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence on a medical device (MD) that we're developing for the US market, as the FDA cites this standard in its Guidance for Wireless Medical Devices. We are considering embedding a pre-FCC-certified 4G/5G module into our MD only to send PHI (name and treatment data) to our cloud-based Electronic Patient Record (EPR) after the treatment is performed using the MD. There are no other wireless connectivity (WiFi, Bluetooth, etc.) features, so if there is a coexistence issue, it would likely be with other medical devices in the clinic/hospital and smartphones. However, as I've described, and if applicable, the function of the "wireless feature" would be Category D (Negligible).

Besides, IMHO, the definition of functional wireless performance (FWP): "The subset of the total functionality that both uses the wirelesscapabilities of the EUT and would result in unacceptable consequences if degraded or disrupted" might not even fit the above-mentioned feature, as there wouldn't be an unacceptable consequence or risk.

Does anyone have a different opinion and could provide insights or other considerations? Because, right now, although I have listed it as an applicable standard in the product requirements, I'm tending to believe that only justification could be enough to avoid testing besides the usual EMC IEC 60601-1-2 and FCC Part 15.

Thanks in advance for any advice!

In this specific case it seems you are talking about what would be an MDDS (Medical Device Data System) function that is incorporated into a Medical Device. If you've architected the MDDS functionality to be separate from the Medical Device functionality, it could be ok to treat this part of the design not as a MD. However, this takes careful planning deep in the system architecture and implementation of the design. Without that you'll be challenged as to why is it acceptable for data transfer to not occur? Is that not part of the mission and intended use of the medical device?