The use of 4G/Wi-Fi dongles in medical devices

[FelipeSchneider]

Hey everyone, we are having some trouble understanding all the steps necessary during the certification of a medical device that has (natively) a 4G or Wi-Fi connection.

Then, I was discussing the design of this medical device with some peers and they proposed the following approach:

• Do not add a native 4G/Wi-Fi connection to this device
• Allow the user to connect a 4G/Wi-Fi dongle to the medical device
• Add multiple warnings to the GUI and IFU informing the user that he/she must only connects certified CE and FCC dongles
• Prepare the software and its documentation taking into consideration that it will be connected to the internet (data safety, GDPR...)
• Follow with the standard IEC 60601-1 and IEC 60601-1-2 test as if there was no internet connection
• We might even not consider selling or providing the dongle to avoid the requirements that accessories have.

One relevant detail is that the connection to a 4G/Wi-Fi network is not essential to the device's operation. It will only work to upload patient and treatment data to our server which will later be available to the physician.

I must admit that this seems rather tempting, but it also seems like trying to exploit a loophole.
What do you guys think of this?
Has anyone gone down this path?

Thank you for the help.

 

[Ed Panek]

Is your message to the "FDA Idiot user" that 4G WiFi is required for use? Makes a better experience? Whats the message behind why you suggest a WiFi connector? Are you presenting a non functioning medical device that requires something else the user has to figure out to get it working?

your explanation above sounds confusing. Do you need the connection for its intended purpose?

 

[FelipeSchneider]

I am sorry if I was not clear enough in my first message, let me try again.

One relevant detail is that the connection to a 4G/Wi-Fi network is not essential to the device's operation. It will only work to upload patient and treatment data to our server which will later be available to the physician.

So no, the internet connection is not necessary for the intended purpose and is there only to upload patient data to an online database, for the ease of the medical team. This can be performed by a USB stick, or not performed at all.
In this case, the medical team will not have access to the patient data and treatment online, only in the device's GUI.

Do not add a native 4G/Wi-Fi connection to this device

Here I meant Do not add a native 4G/Wi-Fi module to this device

Is it clear now?

 

[yodon]

Your software is written to enable communications over WiFi, right? I don't see the dongle approach as feasible. There could also be cybersecurity issues with the approach.

 

[FelipeSchneider]

Your software is written to enable communications over WiFi, right? I don't see the dongle approach as feasible. There could also be cybersecurity issues with the approach.

The software is written to operate with and without internet.
Indeed, someone can use a dongle that transmit the data to another pirate server, but it seems rather improbable to me.

Do you see any other problems?

 

[Al_Z1]

Do you see any other problems?

If you allow using these 4G/WiFi dongles with your device, you should justify excluding it from being connected to the device during IEC 60601-1 and 60601-1-2 tests, regardless of internet connection, just assessing from EMC and electrical safety side.
Also, IMHO, you should be aware, that by using this dongle you could possibly transform your device from being apparatus to being system (in terms of IEC 60601-1 definition).

 

[FelipeSchneider]

If you allow using these 4G/WiFi dongles with your device, you should justify excluding it from being connected to the device during IEC 60601-1 and 60601-1-2 tests, regardless of internet connection, just assessing from EMC and electrical safety side..

I agree with you, I would then add that this is an "easy" fix, we could add one dongle during the EMC tests. We would still perform the normal IEC 60601-1-2 route without the more difficult FCC path. (Maybe we are just too afraid of the FCC path...)

Also, IMHO, you should be aware, that by using this dongle you could possibly transform your device from being apparatus to being system (in terms of IEC 60601-1 definition).

I Agree.