Published in ASORN EYE Know Newsletter: September 2021
Author: Barbara Ann Harmer, MHA, BSN, RN – ASORN Past President
Ambulatory Surgical Centers (ASCs) and hospitals have long struggled with the problem of providing one standard of care to each and every patient. With increasing surgical volumes, healthcare organizations have an increasingly difficult time meeting the demands of medical device sterilization. Historically, it was customary for instrument trays that had been previously terminally sterilized to be reused again later in the day for other patients by subjecting them to a “flash” cycle. “In 2011, the term “flash” was retired, and a new concept and process was created called Immediate Use Steam Sterilization (IUSS). Utilizing an IUSS prepared product because it is convenient or there is insufficient instrumentation are no longer acceptable explanations to regulators. Organizations continue to receive deficiencies from state DOH offices, accreditation organizations, and CMS when IUSS is used in instances that are not urgent. However, with repeated citations with failure to correct this deficiency, an immediate jeopardy can be issued by the surveying organization. An immediate jeopardy determination from a CMS survey can threaten the ability to keep your organization CMS certified and, in some specialties, especially in ophthalmology, it could mean the closure of the facility. Staff involved in the processing of medical devices are familiar with the terms IUSS and terminal.
What most staff do not know is that these terms are not used by the FDA. The FDA clears sterile barrier systems (packaging systems) with a designation of either with storage or no storage. IUSS and terminal are definitions that are found in industry publications and guidelines. Users need to blend these two designations; terminal sterilization is defined as a sterile barrier system with storage and IUSS sterilization as a sterile barrier system that cannot be stored (or held for any time after sterilization). As defined by AAMI, immediate-use steam sterilization is a “sterilization method that involves the shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use nor held from one case to another.” While terminal sterilization is a “process by which the product is sterilized within a sterile barrier system that permits storage for use at a later time.” The major difference between IUSS and terminal is one word, STORAGE. Shelf life is another confusing industry term. Organizations have a choice that can be made when deciding their own internal policies and procedures. Event-related sterility maintenance is based on the premise that sterilized items are considered sterile until an event occurs that renders it unsterile or compromised in any way. An expiration date is not indicated on the product; event-related sterility practices are not time related. If expiratory dating is chosen, the expiration date is placed on the product, defining its estimated useful life. If the organization uses event-related principles in its’ practice, then it is the organization’s policies and processes that define what shelf life means to them. Patient safety is a chief focus for all healthcare providers. When medical devices are safely prepared and packaged for patient use in a terminal fashion, the entire processing and surgical teams can have increased confidence and trust in the sterilization process. Sterilization processes are complex. Education, training, and competency in all phases of the sterilization process is a necessity. Many organizations have recognized this process as multifaceted and have initiated specific initiatives to streamline the sterilization process. Organizations have a choice. Choose one standard of care for each and every patient that receives surgical care from your organization. Do it right every time.