Re-cleaning Medical Device Vendor Parts

Q. Current medical device cleaning procedure calls for an ultrasonic bath at 69C for 20 mins with Liquinox and DI water. Then calls for another such DI bath at 69C with NO detergent for 20 mins. Then a 1 min DI water flushing. Is Liquinox appropriate? When I clean the parts, they have already been cleaned by vendor in the exact same manner, essentially I re-clean them. Is this overkill?

A. When in doubt, you obviously want to lean more on the side of doing too much cleaning rather than too little. We do not consider it unusual to re-clean a medical device part that has been cleaned by a vendor. Many of our medical device reprocessor customers do exactly that.  It is very important to be sure the parts are cleaned and is a good risk mitigation practice to do your own additional cleaning.  These types of orthogonal, or independent procedures, are intrinsic to robust, critical cleaning. Among other control parameters, this will control any contamination or residue redeposition that may have happened in transit.

What may be slightly “overkill”  is the time and temperature.

In general, for medical device cleaning, a temperature of 60C for 10 minutes is fairly typical. It is certainly not wrong to clean at 60C and 20 minutes, just slightly more than needed. The two part rinsing and making sure the rinse is at the same temperature as cleaning is recommended. Rinsing at a lower temperature than the wash risks breaking formed emulsions due to thermal shock, and may redeposit residue. 

Liquinox® Critical Cleaning Liquid Detergent is an excellent, high foaming manual cleaner for organic residue removal.  However, if these parts are exposed to bodily fluids or other proteinaceous residues, we would recommend Tergazyme® Enzyme-Active Powdered Detergent. It is a powerful organic residue remover in concert with proteolytic enzymes.

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