Not all medical equipment is disposable. Some are not one use. Instead, they are reusable. Since the items must achieve high levels of cleanliness before they are utile once more, medical facilities as well as manufacturers have to put into place certain measures. In fact, such instrumentation and equipment must undergo a medical device cleaning validation.
Selecting the Right Validation Method
The method employed in cleaning medical instruments varies. Largely, it does depend upon the specific item or instrument. The same is true for validation methods. They must suit the equipment and its application. The FDA is responsible for establishing what is the basic cleaning validation criteria, however, other parties are responsible for the actual accomplishment of the task, including the manufacturers.
Common Aspects
Validation methods may differ. They do possess, nevertheless, certain common characteristics. In general, they all follow a basic pattern from the initial development to the studies and monitoring of every aspect of the validation process. This includes ongoing monitoring and even revalidation.
What is also a basic component each manufacturer and developer must meet is the demand by government agencies and end facilities for complete documentation. Medical device cleaning validation demands reports on the process. They usually contain the following material:
- Assessment Reports: These indicate how the equipment in question performs
- Results: Refers to process tests results
- Variations : This provides the consumer and the agency with information on how any deviations may impact
- Acceptance criteria: This focuses specifically on showing how the validation tests meet the specific set criteria
The company must also provide documentation of the processing parameters as well as documented evidence that their claims of validation for the equipment are valid.
Medical Device Cleaning Validation
Reusable equipment must be safe to use in medical setting. It must meet certain requirements. Medical device cleaning validation tests are one means of assuring the validity of this promise is met at the manufacturing stage.
