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Validation or Verification?


When completing equipment and product quality assessment checks in the Central Sterile Service Department (CSSD), the terms validation and verification often are used interchangeably. However, the definitions do not have the same meaning. Manufacturer's complete validation tests to prove the ability to reprocess their product(s) or that the equipment manufactured provides a reliable process for reprocessing and to meet the FDA 510K process requirements. CSSD professional complete verifications test to substantiate the ability to reprocess or to substantiate equipment reliability when following the manufacturer's instructions for use (IFU), thus proving the validation processes that the manufacturer's used works in their environment.


Why complete verification processes if the manufacturer has already validated the process? First off, there are too many variables for each manufacturer to cover when completing their validation test. There are too many equipment manufacturers, parameters, detergents, packaging materials, utility differences, etc., for each manufacturer to test without creating financial challenges when bringing their new products to the market. Again, the verification process provides feedback to the CSSD professionals that the product or equipment in question can or cannot be processed or provides a reliable process when using the IFU requirements and using the constraints in their department (i.e., equipment, utilities, packaging).


Understanding IFUs and being able to follow them is one of the challenges. Some manufacturers are better than others at providing good instructions. When reading IFUs that state that the user can establish their own policies for use or design their own cycles for reprocessing, you now have moved from a verification process to a validation process. The validation process follows Good Laboratory Practice (GLP) guidelines, and to establish criteria outside of the IFU instructions; you now must validate them. If you can not follow the GLP guidelines, you must hire someone who can.


Other issues that can come with the verification process are:

1. If you aren't using the same verification products ( e.g., washer check devices, detergent, etc.) that the manufacturers of the equipment used to establish their process, some manufacturers will balk during the maintenance process if the equipment is not performing up to standards.

2. There are many ways that verification products are designed to verify processes; some are better than others.

3. If you are forced into a validation process, third party validation providers are costly.

Establish a baseline for performance by using verification products. Learning how to interpret them is important. Exploring products other than the OEM's may have advantages. Establish a quality assessment program in our department. Doing so increases your chances of providing quality care and puts your patients first.

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