Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
|Publication Date:||1 January 2014|
This TIR identifies the necessary steps to effectively manage medical devices not owned by the health care facility in which they are used.
This TIR addresses the management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection by the receiving facility prior to patient use. This document includes processes for the request, receipt, return, and documentation of loaned medical devices. Included are the roles and responsibilities of the health care facility ("receiver"), the lending entity ("sender"), and individuals.
This TIR does not address department design considerations, personnel considerations, cleaning and other decontamination processes, packaging, preparation, or sterilization (see ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities; ANSI/AAMI ST41, Ethylene oxide sterilization in health care facilities: Safety and effectiveness; and ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities). Processes for management of non-critical loaned medical devices and single-use medical devices, as well as off-site reprocessing facilities, are outside the scope of this document.