Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all, 
I wonder if somebody can provide some reference/guidance on cleaning and disinfection validation of non-critical medical devices (intact skin only). 
We identified the remote control of the device as the worst case component to be tested. The process is manual and is performed through cleaning/disinfecting wipes.

Based on the FDA guidance and AAMI TIR12 and TIR30, our testing lab proposed a cleaning validation protocol that includes at least a visual inspection and two quantitative tests (we chose TOC - Total Organic Carbon - and protein detections). The proposed standard soil composition is made of eggs, sucrose and blood.
We have some concerns on whether:
1) we are overkilling the problem, considering the fact that the device is non-critical and risks of contaminations are low. A possible strategy to reduce the burden could be to skip cleaning validation and focus only on disinfection validation or to perform only visual inspection (and no quantitative tests).
2) soil composition for cleaning is not so relevant, as our device is not in contact with blood
3) we have hard times defining the acceptance criteria for TOC and Proteine, as we don't find references for non-critical devices. The testing lab proposed the limits used for endoscopes, but again we feel they are too strict and not very relevant for our case.
Anybody can share his/her own experience on this topic or any reference that can help our decisions?
Thanks in advance for the help

This message was posted by a user wishing to remain anonymous

Anybody that can provide some hints on this subject, please?
Thanks in advance
Original Message:
Sent: 08-Apr-2021 10:10
From: Anonymous Member
Subject: remote controller Cleaning/Disinfection validation - FDA

This message was posted by a user wishing to remain anonymous

Hi all,
I wonder if somebody can provide some reference/guidance on cleaning and disinfection validation of non-critical medical devices (intact skin only).
We identified the remote control of the device as the worst case component to be tested. The process is manual and is performed through cleaning/disinfecting wipes.

Based on the FDA guidance and AAMI TIR12 and TIR30, our testing lab proposed a cleaning validation protocol that includes at least a visual inspection and two quantitative tests (we chose TOC - Total Organic Carbon - and protein detections). The proposed standard soil composition is made of eggs, sucrose and blood.
We have some concerns on whether:
1) we are overkilling the problem, considering the fact that the device is non-critical and risks of contaminations are low. A possible strategy to reduce the burden could be to skip cleaning validation and focus only on disinfection validation or to perform only visual inspection (and no quantitative tests).
2) soil composition for cleaning is not so relevant, as our device is not in contact with blood
3) we have hard times defining the acceptance criteria for TOC and Proteine, as we don't find references for non-critical devices. The testing lab proposed the limits used for endoscopes, but again we feel they are too strict and not very relevant for our case.
Anybody can share his/her own experience on this topic or any reference that can help our decisions?
Thanks in advance for the help