The U.S Food and Drug Administration (FDA) has set forth guidelines for validation of cleaning processes used in medical facilities. There are also guidelines for the inspection and validation of bulk pharmaceutical chemicals as well as for the biotechnology industry. The CDC (Centers for Disease Control and Prevention) also provides a similar guideline that includes the same detail in validation and evaluation of cleaning methods.
The purpose of medical device cleaning validation is to ensure that the equipment used with patients is both clean as well as free from residue from the cleaning chemicals and processes used. There are several components to the cleaning processes that are used on medical devices in hospital and healthcare settings and the validation is designed to confirm those processes are providing contaminant-free devices or with levels acceptable and deemed safe for use with patients.
Written Procedures
One of the basic elements of medical device cleaning validation under the FDA guidelines is to have a written operating procedure or SOP (standard operating procedure) that details the complete cleaning process as well as the chemicals and cleaners used as well as validation methods.
In most cases, there will be a written SOP for different categories and types of devices. This will include the specific types of enzymatic detergents a well as how samples will be collected and tested to demonstrate safe levels of any residual amounts of these cleaners.
Options for Validation of the Method
One common option for testing for the presence of active enzymes in the cleaning solutions of manual bath solutions is a test strip type of method. This type of test can verify the presence of active enzymes, which are required for correct cleaning, by a simple strip test color change.
Changes in the color of the test strips for medical device cleaning validation are then compared to the color blocks provided on the bottle label. This is a fast, simple and effective to ensure the enzyme cleaner is providing the level of cleaning and sterilization required.
The same types of tests are also available or medical washers and ultrasonic cleaners that also use the enzymatic detergent. These strips will go through the cycle with the medical devices and will indicate the effectiveness concentration and activity of the enzymes, the time, the wash temperature and the mechanical action.
These test strips provide a pass or fail color change. This allows for easy interpretation and logging of results with the test strips retained for verification and accuracy of records.
