ISO17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue.”
Hence, if your device can withstand it, a validated automated cleaning method should always be provided.
AAMI TIR30:2011 provides some background information as to why automated or mechanical cleaning is preferred over manual cleaning. As indicated in AAMI TIR30, mechanical cleaning processes are advantageous because they are, as the name implies, performed by machines, and are therefore considered to be more reproducible. Additionally, mechanical cleaning allows for the reusable devices to be exposed to higher water temperatures during the cleaning process. From a user’s standpoint, mechanical cleaning is also preferred because it minimizes the exposure of healthcare personnel to harmful microorganisms and chemicals; thus, providing reproducible levels of cleaning effectiveness while increasing worker safety.
It is up to the reusable device manufacturer to assess whether automated cleaning is possible for their device depending on the device’s characteristics. At the end of the day, the cleaning method that is selected should be effective, safe for the personnel performing the task, but should not affect the functionality of the device.
Something else to consider is the user base of your reusable device. Not all your users may have access to an automated cleaning system. Therefore, it may be necessary to include a validated manual cleaning procedure to your instructions for use document in addition to an automated cleaning method.
In conclusion, you should have a validated automated cleaning process if the reusable device can withstand such conditions. Additionally, a manual cleaning process should aslo be considered. If the device cannot withstand automated cleaning, the users should be alerted to this issue and a validated manual cleaning process should be provided.
