Steam Sterilization Validation for Implementation of Parametric Release at a Healthcare Facility

Hospitals are under continual pressure to improve turnaround times for surgical procedures and to find ways to release sterilized product without the need to wait for biological indicator (BI) results. Current procedures used in healthcare do not allow for release of sterilized products based on parameters because hospitals do not validate their sterilization processes. Once a sterilization process is validated for a particular product family, those loads may be released based upon evaluation of the sterilization parameters achieved in the cycle, i.e., parametric release. Typically, hospitals do not perform validation studies to demonstrate that a sterility assurance level (SAL) of 10−6 is being achieved in the sterilized product, relying instead on inactivation of BIs and/or chemical indicators (CIs) in each load. If a healthcare facility can demonstrate achievement of a SAL of 10−6 in a particular product family then it will be possible to release the products in that product family based on achievement of parameters without waiting for BI results. This does not mean that the healthcare facility can eliminate use of all BIs and CIs as part of the criteria for a comprehensive quality assurance program, but dependence on their results and the cost of their use may be greatly reduced. Validation provides another component in a quality assurance program to demonstrate that the highest SAL possible is being provided to patients while still providing the services required by today's healthcare facility.