Sterilization (microbiology) equal to the probability of a non-sterile unit. For high-risk applications, such as medical devices and injections, a sterility assurance level of at least 10 is required by the United States Food and Drug Administration (FDA). A widely used method for heat sterilization is the autoclave, sometimes called a converter or steam sterilizer. Autoclaves use steam heated to under pressure. To achieve sterility, the article is placed in a chamber and heated by injected steam until the article reaches a temperature and time setpoint. Almost all the air is removed from the chamber, because air is undesired in the moist
Medical equipment management orders or statistical sampling of randomly selected work orders. Randomly selected work orders should place more stringent statistical controls based on the clinical criticality of the device involved. For example, 100% of items critical to patient treatment but only 50% of ancillary items may be selected for sampling. In an ideal setting, all work orders are checked, but available resources may dictate a less comprehensive approach. Work orders must be tracked regularly and all discrepancies must be corrected. Managers are responsible to identify equipment location Accurate, comprehensive data are needed in any automated medical equipment management system. Data quality initiatives