Eyeworld

3 May 2018 by Liz Hillman EyeWorld Senior Staff Writer many of which were initiated by task force members," Dr. Chang continued. "These included studies on reuse of titanium phaco tips, on failure to eliminate microscopic enzyme residues from intraocular instruments, and on short-cycle sterilization practices for sequential same-day cataract surgeries. We also reference recent studies from the Aravind Eye Hospital system that raise the possibility that many of our traditional ophthalmic OR protocols may increase cost, waste, and carbon footprint, without any actual safety benefit. Further study is warranted, but because our surgi- cal endophthalmitis rate is already so low, we would caution against arbitrarily changing or adding more regulations for instrument process- ing without some scientific evidence of benefit." Richard Hoffman, MD, Eugene, Oregon, a member of the OICS Task Force, said having guidelines agreed upon by ASCRS, AAO, and OOSS gives them "unprecedented validity" that "will hopefully go a long way for standardizing how we clean and sterilize our distinct instrumenta- tion, in addition to allowing manu- facturers the rational to change the current [instructions for use (IFU)] to be more in line with ophthalmic needs. "Anyone working within an ASC should read this document and have it available for their employees and anyone wishing to defend their current clinical practices," Dr. Hoff- man continued. cleaning and sterilization procedures for cataract surgery from other types of general surgery," Dr. Chang said, explaining the need for ophthalmol- ogy to have specialty-specific clean- ing and sterilization guidelines. "In our complex regulatory ecosystem, where the default is to apply general guidelines that are broad enough to cover all surgeries, it is import- ant for ophthalmology to establish specialty-specific guidelines for cataract and intraocular surgery. The guideline document is intended to be educational for ophthalmologists, ASC staff, and the organizations charged with assuring ophthalmic patient safety. "We based many recommen- dations in these guidelines on new or recently published studies, Next step: Task force requests manufacturers change IFUs according to published research E vidence-based specialty- specific guidelines for the cleaning and sterilization of intraocular instruments were developed and issued through a 3-year collaborative effort spearheaded by ASCRS. The guide- lines were released on April 5, 2018, and announced in the April issue of EyeWorld. Under the leadership of co- chairs and ASCRS Executive Com- mittee members David F. Chang, MD, Los Altos, California, and Nick Mamalis, MD, Salt Lake City, the "Guidelines for Cleaning and Sterilization of Intraocular Surgical Instruments" were developed by the Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force composed of representatives from ASCRS, the Ophthalmic Outpatient Surgery Society (OOSS), and the American Academy of Ophthalmol- ogy (AAO). These guidelines were created with evidence from scien- tific, published studies that address the use of enzymatic detergents for intraocular instruments, the safety and efficacy of short-cycle steam sterilization for sequential same-day ophthalmic procedures, and the car- bon footprint of cataract surgery. "The small size of our instru- ments and the unique susceptibility of the eye to microscopic con- taminants differentiates optimum EW ASCRS NEWS "We want to make sure that the instruments are in fact sterile; we want to make sure they are clean and they're not going to promote or cause infection," said Francis Mah, MD, La Jolla, California, a member of the OICS Task Force. "On the other hand, we don't want to create a scenario where the cleaning itself and the chemicals used cause prob- lems in the eye." Dr. Mah explained manufactur- ers often list what might have been validated and tested for safety and efficacy for cleaning and steriliza- tion of instruments used in other surgical situations, creating broad instructions for use that might not be suitable for ophthalmic instru- ments. IFUs directing enzyme de- tergents and the residues that have been associated with toxic anterior segment syndrome (TASS) are an example, Dr. Mah said. One of the first projects of the task force was surveying OOSS member ASCs. Dr. Chang said more than 200 centers responded and the average endophthalmitis rate, based on self-reported data, was 0.02%, which he called "very reassuring." "For sequential, same-day cases, roughly half of respondent ASCs do not use enzyme to clean instruments and about half employ short-cycle sterilization," Dr. Chang noted. "There was no difference in the overall pooled infection rates compared to ASCs routinely using enzyme or routinely using full, ter- minal wrapped sterilization cycles for consecutive same-day cases." Dr. Mamalis stated that analyses of recent TASS outbreaks found that issues with the cleaning and steril- ization of ophthalmic instruments were the most common factors involved, with the use of enzymatic detergents frequently associated with TASS. 1 This prompted several studies, performed at the Moran Eye Center, to look specifically at enzyme residue that might be left on surgical instruments, even after rinsing according to the IFUs, and the effect that such residue might have. Research by Tsaousis et al. studied two types of reusable phacoemulsification needles under- going multiple sterilization cycles with and without the use of enzyme detergents, which was followed by OICS Task Force issues guidelines for cleaning and sterilization of ophthalmic instruments continued on page 8 " The small size of our instruments and the unique susceptibility of the eye to microscopic contaminants differentiates optimum cleaning and sterilization procedures for cataract surgery from other types of general surgery. " —David F. Chang, MD Billing for corneal crosslinking update Important development since the "Crosslinking reimbursement" article in the April issue of EyeWorld A vedro (Waltham, Massachusetts) submitted a request for the reconsideration of a separate J code for Photrexa. On May 7, Healthcare Common Procedure Coding System (HCPCS) preliminary results were released in favor of a J code for Photrexa. The public meeting will take place on May 14, at which time meeting participants will hear presentations and have the opportunity to ask questions. It is important to note that the preliminary recommen- dations are not final or binding upon any payer and are subject to change. The final decision will be made in late November, which would then be effective on January 1, 2019. EW

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