Product quality assurance testing: one hospital's experience.

Testing of routinely sterilized products should be part of a healthcare facility’s quality control program, and ANSI/AAMI ST79:2006, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, recommends that quality assurance testing of routinely processed items be performed on an ongoing basis. The standard provides information on where to place biological indicators (BIs) and chemical indicators (CIs); the placement of packs throughout the load; and criteria for acceptance of test results. However, ST79 does not provide specific information on how to conduct this testing. These decisions are up to the discretion of the individual hospital and depend on what the hospital actually sterilizes. Resurrection West Suburban Medical Center in Oak Park, IL, used a science-based approach similar to that used in industry for validation of sterilized products. All sterilized items were reviewed and assigned to product families. Master products for each of the product families were identified and used to conduct product quality assurance testing; BIs and CIs were placed in designated locations within the master product. Finally, each sterilizer cart was loaded with the master product in designated locations, while the remainder of the cart was filled in with routinely sterilized product. A sterilization cycle was run with the parameters designated for that product family. It was decided that product quality assurance testing would be conducted on the following schedule: 1) initial testing would be conducted and then repeated on a quarterly basis for one year; 2) after one year of achieving satisfactory results, testing would be repeated semi-annually for a second year; and 3) if results remain satisfactory at that point then testing would continue to be conducted on an annual basis. Product testing would also be performed when major changes were made in packaging; wraps; or load configuration such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper. The test program includes both BI and CI testing and an evaluation of post-sterilization moisture content (i.e., the occurrence of “wet packs”). A product quality assurance testing protocol was developed and presented to the hospital’s Infection Control Committee for approval.