Transitioning from High-Level Disinfection to Sterilization for Semicritical Devices

摘要

According to this system, semicritical items are medical devices that contact mucous membranes and, at a minimum, must be subjected to a high-level disinfection (HLD) process, which would be expected to destroy all microorganisms other than large numbers of bacterial spores. Most importantly, processing semicritical devices via HLD has resulted in infectious outbreaks. [...]finding other means of microbial destruction is necessary. The meeting involved more than 40 stakeholders representing healthcare professional organizations, manufacturers, testing labs, independent research groups, academia, patient and clinical end users, the FDA Center for Devices and Radiological Health, and the Centers for Disease Control and Prevention. HLD provides a finished product that is wet and unpackaged. Because they are not packaged, storing and handling items that have undergone HLD requires more diligence to prevent contamination. Knowledge of turnaround time will be needed for scheduling cases. * Clear identification items. Because they are not packaged, items that undergo HLD are visible and can be clearly identified. [...]of important note, some essential semicritical medical devices may lack a sterilization validation claim. [...]an alternative emerges, these items will need to be purchased.