• CMS

    Strong advocacy and education efforts by ophthalmology resulted in the Centers for Medicare & Medicaid Services (CMS) releasing clear guidance on the short-cycle steam sterilization approach used by the vast majority of ophthalmologists who practice in ambulatory surgical centers (ASCs). The agency clarifies that short-cycle steam sterilization is permissible as long as practitioners follow manufacturer’s directions for use.

    The agency specifically defines short-cycle as a form of terminal sterilization that is acceptable for routine use for a wrapped/contained load where pre-cleaning of instruments is performed according to manufacturer instructions for use; includes use of a complete dry time and a wrap or rigid sterilization container packaging that is validated for later use.

    The Guidance - Sterilization of Ophthalmologic Surgical Instruments

    The S&C: 14-44-Hospital/CAH/ASC “Change in Terminology and Update of Survey and Certification (S&C) Memorandum 09-55 Regarding Immediate Use Steam Sterilization (IUSS) in Surgical Settings,” was released in August of 2014. IUSS is the term currently accepted to describe the process for steam sterilizing an instrument that is needed immediately, not intended to be stored for later use, and which allows for minimal or no drying after the sterilization cycle. IUSS is not acceptable for use as a routine method of sterilization. Concerns about routine use of IUSS are based on a lack of time to accomplish adequate pre-cleaning, increased risk of inadvertent contamination during transfer to the sterile field, damage to the instruments, risks related to wet instruments, and the potential for burns. Therefore use of IUSS, even when all steps are performed properly, should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using terminal sterilization.

    The term IUSS is of relatively recent origin and results from a consensus statement, Immediate Use Steam Sterilization, of multiple organizations coordinated by the Association for the Advancement of Medical Instrumentation. It replaces the much less precise and outdated term “flash sterilization.”

    The S&C 14-44 also made clear that IUSS is not the same thing as “short cycle” sterilization, which is a form of terminal sterilization that is acceptable for routine use for a wrapped/contained load where pre-cleaning of instruments is performed according to the manufacturers’ instructions, and the load meets the device manufacturer’s instructions for use (IFU), includes use of a complete dry time and is packaged in a wrap or rigid sterilization container validated for later use. Use of short cycle sterilization is particularly common in facilities that perform eye surgery and is acceptable when all IFU (i.e. sterilizer, device, and container manufacturer’s) are followed. However, there appears to be confusion in the field about the differences between IUSS and short cycle sterilization, and misuse of the term IUSS to refer to what is in fact short cycle sterilization. Facilities performing surgery should understand the differences between IUSS and short cycle sterilization in order to ensure that they comply with Medicare infection prevention and control requirements.

    Background

    Concern arose last fall when CMS updated guidance to say that immediate-use steam sterilization, previously known as flash sterilization, could no longer be routinely used in surgical center settings. Such a policy appeared to require surgery centers to utilize terminal sterilization units and perhaps acquire many more sets of instruments.

    In response, the Academy, the American Society of Cataract and Refractive Surgery, and the Outpatient Ophthalmic Surgery Society, met on two occasions with CMS to express concerns about the new policy. The meetings focused on educating CMS staff on the etiology of toxic anterior segment syndrome and endophthalmitis, as well as provide the results of a recent survey of surgery centers on their current sterilization and instrument cleaning practices.

    At least half of all ambulatory surgery centers sterilize their surgical instruments between cases, and at least 42 percent of Academy members own or have an ownership interest in ASCs.

    Guidance Reference

    MLN Connects™ Provider eNews, Thursday, February 26, 2015

    ©2015 American Academy of Ophthalmology®
    P.O. Box 7424 / San Francisco, CA 94120 / 415.561.8500