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 considered high risk, general-purpose infusion pumps as medium risk, electronic thermometers as low risk, and otoscopes as no significant risk. This system could be set up using Microsoft Excel or Access program for a manager's or technician's quick reference. In addition, user error, equipment abuse, no problem/fault found occurrences must be tracked to assist risk management personnel in determining whether additional clinical staff training must be performed. Risk management for IT networks incorporating medical devices will be covered by the standard ISO/IEC 80001. Its purpose is: "Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example,