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REGULATORY REVIEW


vertent contamination during trans- fer to the sterile field, damage to the instruments, risks related to wet instru- ments, and the potential for burns.” Even when all steps are performed properly, CMS confirms, IUSS should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using ter- minal sterilization.


Short-Cycle Sterilization— Acceptable CMS acknowledges that short-cycle sterilization is particularly common in ophthalmic facilities, and confirms that this process is acceptable as long as all IFUs (i.e., sterilizer, device and container manufacturers’) are fol- lowed. According to the AAMI paper cited earlier in this article, “steriliza- tion cycles with little or no dry time are


Track the Latest Regulatory and Legislative News for ASCs


Visit ASCA’s web site every week to stay up to date on the latest government affairs news affecting the ASC industry. Every week, ASCA’s Government Affairs Update newsletter is posted online for ASCA members to read. The weekly newsletter tracks and analyzes the latest legislative and regulatory developments concerning ASCs.


www.ascassociation.org/ GovtAffairsUpdate


efficacious when used in compliance with validated written instructions pro- vided by the device manufacturers, sterilization equipment manufacturers, and (if applicable) container manufac-


turers and when done in accordance with professional guidelines.” CMS has indicated that it will edu- cate Medicare surveyors regarding this clarification of its policy. Although CMS views the clarify-


ing information as sufficient to guide facilities and surveyors alike, additional confusion about whether certain prod- ucts provide short-cycle sterilization or IUSS continues. ASCA will continue to work with CMS to reemphasize the safe, effective practices that ASCs employ and seek additional clarification of this policy where needed. The Academy, ASCRS and OOSS also have convened an expert panel to update existing guide- lines regarding the cleaning and steril- ization of ophthalmic instruments.


Kara Newbury is ASCA’s regulatory counsel. Write her at knewbury@ascassociation.org.


34 ASC FOCUS JUNE/JULY 2015


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