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. 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.”
1 Chang DF et al. Ophthalmology. Published online March 27, 2018.
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.
||Consultant fee, paid advisory boards, or fees for attending a meeting.
||Employed by a commercial company.
||Lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
||Equity ownership/stock options in publicly or privately traded firms, excluding mutual funds.
||Patents and/or royalties for intellectual property.
||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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