There is a critical piece of reprocessing validations that has been largely overlooked for a long time: the cleaning chemicals. The devices and instruments used for the validations tend to get most of the attention.
Recently Alpa Patel, Principal Scientist at Nelson Labs and someone who has specialized in healthcare reprocessing her entire career, joined the Beyond Clean Podcast to discuss this topic. If you have half an hour to listen, it’s a great episode. If you only have five minutes, this blog post provides a general overview.
Standards do specify four enzymes that should be considered to formulate a detergent for cleaning reusable devices. These enzymes are protease, amylase, cellulase, and lipase. The concentration and type of enzymes used to make a detergent vary from detergent to detergent. Most detergents don’t contain all four of the recommended enzymes.
Each of the enzymes works to break down the organic molecules of the soil that the device would likely see during use. For example, proteases break down protein, lipases break down lopes, amylases break down starch, and cellulases break down carbohydrates.
Moreover, enzymatic detergents have optimal concentration and temperature ranges in which they are effective. If they are used or stored under conditions outside of the recommended ranges (e.g., at temperatures that are too cold or too hot), their effectiveness will be reduced.
There are a lot of factors that play a role in the selection of the optimal detergent for reprocessing validations. Even though third-party laboratories often do the research about the best detergents to be used, the healthcare facilities purchasing the detergents consider the ones that are the most economical. Often detergents that are used for validation are not the ones that are being used in the healthcare facilities for cleaning reusable medical devices and instruments. This disconnect between science and budget is what has brought standard committees together to help solve the problem. Detergent manufactures are stepping up too. They have begun to participate in these committees to understand how they can help.
It is not necessary to figure out the universal detergent for cleaning reusable devices. It is more important to better understand what is being used to clean reusable medical devices.