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 professionals with patient-safety experience in a variety of settings. Patient safety is among the most important goals of every healthcare provider, and participation in a variety of committees and processes concerned with patient safety provides a way for biomedical managers and clinical engineering departments to gain visibility and positively affect their workplace. This program helps the medical treatment facility avoid the likelihood of equipment-related risks, minimize liability of mishaps and incidents, and stay compliant with regulatory reporting requirements. The best practice is to use a rating system for every equipment type. For example, a risk-rating system might rate defibrillators as