Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

So we have our catheter (applied part) connected to our system (accessible part), all good so far. 

Our catheter is an over-the-wire catheter, It is not part of the ME, but we use it to achieve our intended use.

Is the following correct? : 

From my perspective, the guidewire will be considered a patient connection and not an applied part. Therefore I will still be required to ensure insulation between the guidewire and the system. 

Indeed, your understanding is accurate. The guidewire utilized alongside the over-the-wire catheter is classified as a patient connection rather than an applied part.

Given its classification as a patient connection, it is essential to implement suitable insulation and electrical safety measures to ensure the device operates safely and effectively. It is necessary to have insulation in place between the guidewire and the system to prevent any potential electrical hazards or negative impacts during device usage.

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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
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Original Message:
Sent: 02-Jun-2023 19:13
From: Anonymous Member
Subject: 60601-1 Applied Part - I am confused.

This message was posted by a user wishing to remain anonymous

So we have our catheter (applied part) connected to our system (accessible part), all good so far. 

Our catheter is an over-the-wire catheter, It is not part of the ME, but we use it to achieve our intended use.

Is the following correct? : 

From my perspective, the guidewire will be considered a patient connection and not an applied part. Therefore I will still be required to ensure insulation between the guidewire and the system. 

This message was posted by a user wishing to remain anonymous

Thank you!

 So I can make that isolation of components. Still, at the end of the day, for defibrillation-proof, for example, if the proximal end of the guidewire (the part that is outside of the patient) is on the operating table, there is so much I can do about the measures I can put in place so that the defibrillation energy will not be delivered to the patient. 

I can do that for my system, so it will be considered safe if the users accidentally touch it. But not for the entire setting, as there will always be an exposed part of the guidewire. 

Original Message:
Sent: 06-Jun-2023 12:14
From: Rajeswari Devanathan
Subject: 60601-1 Applied Part - I am confused.

Indeed, your understanding is accurate. The guidewire utilized alongside the over-the-wire catheter is classified as a patient connection rather than an applied part.

Given its classification as a patient connection, it is essential to implement suitable insulation and electrical safety measures to ensure the device operates safely and effectively. It is necessary to have insulation in place between the guidewire and the system to prevent any potential electrical hazards or negative impacts during device usage.

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 02-Jun-2023 19:13
From: Anonymous Member
Subject: 60601-1 Applied Part - I am confused.

This message was posted by a user wishing to remain anonymous

So we have our catheter (applied part) connected to our system (accessible part), all good so far. 

Our catheter is an over-the-wire catheter, It is not part of the ME, but we use it to achieve our intended use.

Is the following correct? : 

From my perspective, the guidewire will be considered a patient connection and not an applied part. Therefore I will still be required to ensure insulation between the guidewire and the system.