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    Guidelines Issued on Short-Cycle Steam Sterilization

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    If sterilizer manufacturers’ in­structions for use are followed, surgical centers can safely employ short-cycle steam sterilization of unwrapped instruments for sequential same-day cataract surgeries, a multiorganizational task­force has concluded.1 This comes witha significant caveat, however: The tran­sit time to the operating room (OR) should be 3 minutes or less.

    “We concluded that the common practice of transporting still wet but sterile instruments directly to the OR for prompt use was safe as long as the instruments were in a rigid, covered containment device and were then han­dled by sterile gloved personnel within the OR,” said task force cochair David F. Chang, MD, who practices in Los Altos, California.

    Validation

    VALIDATION. Colored scanning electron micrograph of G. stearothermophilus, which was used as the challenge organism.

    Impetus. In 2014, the Centers for Medicare & Medicaid Services issued a policy that addressed acceptable sterilization methods. However, some terminology used in that policy led to confusion among cataract surgeons. In response, the Academy, the American Society of Cataract and Refractive Sur­gery, and the Outpatient Ophthalmic Surgery Society convened the Ophthal­mic Instrument Cleaning and Steriliza­tion (OICS) Task Force.

    Investigation. The OICS task force initiated several studies to test the effec­tiveness of short-cycle steril­ization practices commonly followed by ophthalmic ambulatory surgery centers (ASCs). In an initial 2014 survey of 182 ophthalmic ASCs, the task force found that short-cycle sterilization was routinely used between same-day cases by more than half of respondents. Results of the survey also indicated that the AMSCO (Steris) and STATIM (SciCan) brands were the most popular sterilizers.

    Bacterial challenge. For this study, the task force evaluated a STATIM 2000 with the STATIM metal cassette and an AMSCO Century V116 with a SteriTite container system (Case Med­ical). Surgical instruments consisted of phaco tips and handpieces from 3 major manufac­turers, all of which were contaminated with the highly heat-resistant bacterium Geobacillus stearothermophilus.

    Findings. “Our analysis confirmed that the wrapped inoculated instru­ments completing the full sterilization and drying cycles with either sterilizer brand were sterile with no growth of the target organism after being stored for 7 days,” the task force reported.1

    What about recontamination risk? However, in busy cataract surgery cen­ters, instruments are sterilized between cases, repeatedly over the course of a day, and then reused in sequential sur­geries on the same day. Consequently, it is common for the drying cycle to be interrupted, when allowed by the IFU (instructions for use), Dr. Chang said.

    “Because of a potential wicking ef­fect, instrument moisture can compro­mise the microbial barrier of a pack­aging system and allow contamination from the environment or nonsterile hands,” he said. “However, we were able to show that unwrapped, sterilized instruments that were still wet could be transferred to the OR within a rigid, covered containment device without recontamination for up to 3 minutes of transit time.”

    These OICS guidelines provide “new evidence and support for common short-cycle sterilization practices for sequential same-day anterior segment surgery. They will hopefully assist sur­veyors in determining whether specific practices are safe and acceptable,” Dr. Chang said.

    He added, “I understand that one accrediting organization, the Institute for Medical Quality, is already training their surveyors with the new OICS guidelines.”

    —Linda Roach

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    1 Chang DF et al. Ophthalmology. Published online March 27, 2018.

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    Relevant financial disclosures—Dr. Chang: None.

    For full disclosures and the disclosure key, see below.

    Full Financial Disclosures

    Dr. Chang Carl Zeiss: C; Eyenovia: O; Iantech: C,O; Icon Bioscience: O; iDrops: C,O; Ivantis: C,O; Johnson & Johnson Vision: C; Mynosys: O,C; PowerVision: C,O; Presbyopia Therapies: O; RxSight: O,C; Slack: P; Versant Ventures: O.

    Dr. Holekamp Alimera Sciences: C,L,S; Allergan: C,L,S; BioTime: C; Genentech: C,L,S; Katalyst: C,P; NotalVision: S; Novartis: C; Ophthotech: S; Ohr Pharmaceutical: S; Re­generon: C,L.

    Dr. Shantha Santen: C.

    Dr. Yeh Alcon: S; Clearside Biomedical: C; Santen: C.

    Dr. Yin None.

    Disclosure Category

    Code

    Description

    Consultant/Advisor C Consultant fee, paid advisory boards, or fees for attending a meeting.
    Employee E Employed by a commercial company.
    Speakers bureau L Lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
    Equity owner O Equity ownership/stock options in publicly or privately traded firms, excluding mutual funds.
    Patents/Royalty P Patents and/or royalties for intellectual property.
    Grant support S Grant support or other financial support to the investigator from all sources, including research support from government agencies (e.g., NIH), foundations, device manufacturers, and/or pharmaceutical companies.

     

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