ISO 60601-1-2 : classe IIb device, distance to pacemaker..

Brainy

Registered
Hi,

I am currently working on the Instructions for Use (IFU) for my Class IIB medical device, which is a non-invasive temperature monitoring system that communicates with a monitoring device (an Android device) via Bluetooth Low Energy (BLE).

My understanding is that the IEC 60601-1-2 standard specifies that my device should be resilient to electromagnetic interference (EMI). However, I am unsure how to address the potential risk of interference with pacemakers in the IFU.

Specifically, should I include a statement in the IFU such as "keep a distance of XX cm between our device and any pacemaker"?

In my risk analysis, I have identified a risk that "our device could interfere with a pacemaker," which is obviously a serious concern for patient safety. How should I manage this risk?

Can I state in my risk analysis that "my device is compliant with IEC 60601-1-2, so this risk is mitigated," and provide supporting test reports to justify this claim?

I want to ensure that I am handling this appropriately and providing clear and accurate guidance in the IFU.

Thank you very much in advance!

B.
 

Bryan Ye

Starting to get Involved
Hello,

See clause 7.9.2.2 below, you may need to provide a warning to avoid such an application.

The instructions for use shall include information regarding potential electromagnetic or other
interference between the ME EQUIPMENT and other devices together with advice on ways to
avoid or minimize such interference.
 

Brainy

Registered
Hello,

See clause 7.9.2.2 below, you may need to provide a warning to avoid such an application.

The instructions for use shall include information regarding potential electromagnetic or other
interference between the ME EQUIPMENT and other devices together with advice on ways to
avoid or minimize such interference
Thank you very much for your answer, Bryan.

I appreciate the guidance provided in clause 7.9.2.2.

However, I am still uncertain about how to determine the appropriate distance between my device and other equipment. Specifically, my device is designed to be worn on the upper arm, approximately 10 cm away from the heart.

Could you please provide further insights or references on how to accurately establish these safe distances to ensure compliance and patient safety? I feel a bit stuck in a loophole here.

Thank you.
 

Bryan Ye

Starting to get Involved
You need to define the scope of use of your device.
For example, use a warning label that says ‘This device cannot be used by users with pacemakers’ (which I would suggest is a good idea).
If you just define the distance from the heart, you basically can't prevent the device from being misused, and the severity of the harm is very high in this case.
 

Brainy

Registered
You need to define the scope of use of your device.
For example, use a warning label that says ‘This device cannot be used by users with pacemakers’ (which I would suggest is a good idea).
If you just define the distance from the heart, you basically can't prevent the device from being misused, and the severity of the harm is very high in this case.
I will stick with the label that says ‘This device cannot be used by users with pacemakers’ !

Thank you again.

B.
 

Avidan B

System Eng, Medical devices safety&reg. consultant
Hi,
My "2 cents" ,
in general, labeling (warning) does not reduce the risk score (shall not be use as a unique mitigation for AFAP or unacceptable risks).

Hance, I would have thought about adding a kind of a SW safety alert which warns the user about using the device on patients which have implantable devices. (only upon user ack, the device shall become operative)..
 

Brainy

Registered
Hi,
My "2 cents" ,
in general, labeling (warning) does not reduce the risk score (shall not be use as a unique mitigation for AFAP or unacceptable risks).

Hance, I would have thought about adding a kind of a SW safety alert which warns the user about using the device on patients which have implantable devices. (only upon user ack, the device shall become operative)..
Hi Avidan,

That makes sense. We considered implementing a pop-up message upon startup to address all contraindications, and I will definitely add pacemakers to the list!

Thank you for the suggestion. Have a nice day.

Best, B
 

Avidan B

System Eng, Medical devices safety&reg. consultant
make sure the user will have to press an Ack button to continue.
in addition, use " implantable electrical devices (like pacemakers, neuro-stimulators , etc. " and not just "pacemakers "... :)

Avidan
 

Bryan Ye

Starting to get Involved
The person above has made this issue complicated.
According to the logic here, the user needs to carry a sign that says "People with pacemakers, please don't come near me."

A good way to see if risk measures are effective is to see if similar measures used in the market for a long time are effective.

Many medical devices cannot be used in MR environments, and you never see such confirmation buttons on these medical devices.
Many home medical devices cannot be used outdoors or in swimming pools; you never see such buttons.
Basically, it is enough to use warning statements in the instructions.
 

Avidan B

System Eng, Medical devices safety&reg. consultant
As Brainy wrote "In my risk analysis, I have identified a risk that our device could interfere with a pacemaker, which is obviously a serious concern for patient safety. "
so I understand that he had identified a high risk.
in that case, labeling could not reduce the risk score (as a single mitigation) , this I why I thought about a SW warning.
 
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