Important Points In Medical Device Cleaning Validation


With innovations in materials, medical devices are more durable, have longer life cycles and can be used over and over again. While this can save on the cost of treatment or disease management for patients and medical facilities, it also creates concerns about ensuring that devices are cleaned and sterilized between use to prevent issues with cross contamination.

Common Solutions Used for Cleaning

The most common types of medical devices reused in facilities are in surgical units, intensive care units, and emergency treatment areas. The disinfectants used in cleaning the medical devices after use can include several different chemicals and compounds. This can include OPA solutions provided by several different manufacturers and in different concentrations.

GTA is the other common solution used in these types of settings. As with OPA, this is a solution that can be used on medical devices that are not suitable for sterilization in an autoclave or similar processes due to the heat-sensitive nature of the material in the device.

How To Validate Cleaning Processes

Cleaning of the medical devices using the appropriate concentration of the right cleaner is the first step. However, a very important part of the medical device cleaning validation process is to ensure that the solution is effective and is actually providing the cleaning required. Often these solutions are reused, so testing is critical to validate the effectiveness of the GTA or OPA solution prior to the cleaning process.

Test strips are a simple option for use in medical device cleaning validation. They are very easy to use and simply require the solution to be placed on the indicator pad of the test strip.

The test itself takes just seconds with a clear color change displaying if the solution meets the MEC (minimum effective concentration) approved by the FDA. With easy to read and use test strips as an effective and fast medical device cleaning validation process, facilities can be sure the solution is providing the necessary level of protection for patients.

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