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REGULATORY REVIEW


Sorting Sterilization What you need to know about short-cycle and immediate use


steam processes BY KARA NEWBURY


Short-cycle sterilization has caused much confusion lately, especially in the ophthalmic ASC set- ting where instruments


are needed quickly following ster- ilization. In February, the Centers for Medicare & Medicaid Services (CMS) released an announcement that clarifies information it had released previously on this topic (see Medi- care Learning Network [MLN] Pro- vider eNews announcement at www. ascassociation.org/CMSOphthal mologicSterilization).


The announcement highlights the


difference between Immediate Use Steam Sterilization (IUSS), which CMS says should not be used on a rou- tine basis, and short-cycle sterilization, which is a form of terminal steriliza- tion permissible as long as all device manufacturers’


instructions for use (IFU) are followed.


Background In August 2014, CMS released a memo updating its policy on IUSS (see 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 Set- tings,” available at www.ascassociation. org/SteamSterilizationCMSMemo).The memo announced that CMS would no longer use the term flash sterilization and, based on recommendations from nationally recognized infection preven- tion organizations, such as the Asso- ciation for the Advancement of Med- ical Instrumentation (AAMI), would replace that term with the term IUSS. The memo also updated information regarding nationally recognized infec- tion control guidelines and profession-


32 ASC FOCUS JUNE/JULY 2015


Despite CMS’ attempt to clarify the kind of sterilization that is or is not acceptable on a routine basis, confusion about the differences between IUSS and short-cycle sterilization remains. Facilities performing surgery should understand the differences between the two to ensure that they comply with Medicare’s infection prevention and control requirements.”


—Kara Newbury, ASCA


ally acceptable standards of practice with respect to IUSS. Ultimately, in this memo, CMS clarified that IUSS was not acceptable for use in ASCs on a rou- tine basis.


In the memo, CMS explained that


“IUSS is not equivalent to ‘short cycle’ sterilization. Regardless of the cycle duration, correct use of a steriliza-


tion cycle for a wrapped/contained load that meets the device manufac- turer’s instructions for use (IFU) is the equivalent of terminal sterilization and is not IUSS if it includes use of a dry time and is packaged in a wrap or rigid sterilization container intended to be stored for later use.”


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