CMS outlines flash sterilization clarifications for ASC surveys
By Matt Gunn
News Editor/Writer
In a September letter clarifying flash steam sterilization guidelines for ASC surveys, the Centers for Medicare & Medicaid Services (CMS) told its Survey and Certification Group that sterilization of unwrapped or uncontained loads should not be routine practice in ASCs. The CMS letter states:
CMS stated flash sterilization should not be the norm, but rather, should only be used in the event of an urgent and unpredicted need for a specific device, such as to clean an instrument that was dropped on the ground during a procedure. The guidelines, effective for fiscal year 2010, were revised following CMS consultation with the Centers for Disease Control and Prevention and the Food and Drug Administration.
“We applaud CMS’ effort to recognize that issue,” said Ramona Conner, RN, MSN, CNOR, AORN manager for Perioperative Standards and Recommended Practices. “Sterilization is a critical process and should be part of any ambulatory surgery center’s infection prevention program.”
The CMS memo to surveyors reinforced the use of short sterilization cycles of wrapped or contained loads as an acceptable practice, as long as facilities follow all manufacturer guidelines for the devices involved. However, CMS instructed its surveyors to factor in whether the surgery center is using a sterilizer that has been cleared by the FDA to run flash steam sterilization cycles and that when flash cycles are used, they are done so within sterilizer manufacturers’ instructions for use.
Surveyors are to use the following questions to assess an ASC’s sterilization process:
- Is the sterilizer labeled for this cycle by the manufacturer?
- What is the sterilizer manufacturer-recommended load for that cycle?
- Is the containment device used labeled by its manufacturer for use in that cycle?
- For what load is the containment device recommended by its manufacturer?
- Is the chemical indicator used labeled for use in this cycle by its manufacturer?
- If a biological indicator is used, is it labeled for use for this cycle by its manufacturer?
- If the cycle is used frequently, is it checked regularly with a biological indicator?
While the new surveyor guidelines work to clarify and add detail to the process, Conner said it all comes back to following recommended practices. Whether it’s an ASC or an inpatient facility, everyday adherence to already-established guidelines should see most facilities through a CMS survey.
“They have got to deliver a sterile product to their patient, and the way that’s done is specified in our recommended practices,” Conner said.
The CMS memo also stressed the significance of following manufacturers’ instructions; if manufacturers’ sterilization instructions are not being followed, the facility’s employees are essentially “doing guesswork,” the letter states.
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