Improper sterilization of a medical device can produce severe consequences. While various methods of sterilizing surgical and other medical equipment are available, it is up to both the original manufacturer and the hospitals to establish basic control procedures to prevent any issues arising from the existence of contaminants. Commonly employed methods of sterilization include the following:
* Moist Heat
* Dry Heat
* Gas: Ethylene oxide
* Radiation: Gamma, Electron
* Others: UV, Steam and formaldehyde, hydrogen peroxide
All require sterilization validation to ensure the preferred procedure will produce consistent results.
Choosing the Validation Method
The mode of cleaning medical instruments does vary. The methods of sterilization differ. The choice of the sterilization method rests upon the product. It must be appropriate. This also applies to the validation method. While the FDA is responsible for setting the basic criteria, it is up to the manufacturer to develop an exhaustive program for medical device sterilization validation.
Common Elements in Sterilization Validation
The actual type of validation varies according to the medical equipment sterilization procedure. This is not a one-size-fits-all approach. However, certain elements are common to all validation processes. These are:
* Development of the sterilization cycle
* Measurement controls of both the physical and biological
* Empty chamber studies
* Loaded chamber studies
* Ongoing monitoring of regular use
* Maintenance, validation and even revalidation
What is also common to all forms of validation is the documentation provided by manufacturers to those who use their equipment. Validation reports must contain specifics about certain aspects of the process. They must include:
* Assessments: These pertain to the equipment and its performance
* Results: Refers to those process testing
* Deviations: Shows impact it could have on the validation study
* Acceptance criteria: Reveals how the tests meet the requirements
* Processing parameters: The documents show establishment of this essential part of a validation test
Furthermore, before the reusable medical instrument can make its way into the field, the company must also prove their sterilization validation claims in documented evidence.
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