Regulatory Open Forum

Does anybody know about medical device cleaning validations for blood contacting devices or implants.  Specifically, I am trying to find guidance on a limit/maximum amount of TOCs allowed.  TOCs are total organic carbons.  Thanks in advance!

Debbie

I've read summaries of an ISO document ISO/WD TR15883-5 Washer - disinfectors- Part 5: Test Soils and Methods for Demonstrating Cleaning Efficacy.  The summaries I've seen state that level of TOC is <12μg/cm². Big Caveat: I do no have the document so I cannot verify that is accurate, so before anyone quotes this it'd be a good idea to actually see this in print and in what context.

Hope this is somewhat helpful.

Regards

Pat

Does anybody know about medical device cleaning validations for blood contacting devices or implants.  Specifically, I am trying to find guidance on a limit/maximum amount of TOCs allowed.  TOCs are total organic carbons.  Thanks in advance!

The reference above to the ISO 15883WD is a draft document and is in the early stages of development, which means it is very likely to change repeatedly before publication. To the best of my knowledge, FDA have been asking device manufacturers to justify their choice of soils during validations, based on the device's intended use. The marker for cleaning validation is typically based on protein, although other analytical methods such as TOC may be used. As for min/max levels, this drives right to the issue of "how clean is clean" and how is it measured, not only by manufacturers but also by users. It is equally important to note that the acceptable "clean" level (or rather Clean as Possible level) for a device should be based on validation, risk assessment, human factors related to cleaning, and repeatability and reproducability of cleaning instructions and verification methods.

See also ISO 17664: Steriization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices. This document is also currently under revision but much closer to completion that the Washer Disinfector standard.

Does anybody know about medical device cleaning validations for blood contacting devices or implants.  Specifically, I am trying to find guidance on a limit/maximum amount of TOCs allowed.  TOCs are total organic carbons.  Thanks in advance!