Eyeworld

8 May 2018 EW ASCRS NEWS Dr. Mamalis said. "We're going to continue meeting, and the next step is going to be working with industry to try to get them to update their directions for use, especially in instrument cleaning, sterilization, and more specifically in the use of enzymatic detergents." EW References 1. Bodnar Z, et al. Toxic anterior segment syn- drome: Update on the most common causes. J Cataract Refract Surg. 2012;38:1902–10. 2. Tsaousis KT, et al. Comparison of different types of phacoemulsification tips. II. Morpho- logic alterations induced by multiple steam sterilization cycles with and without use of enzyme detergents. J Cataract Refract Surg. 2016;42:1353–1360. 3. Mamalis N. Toxic anterior segment syndrome: Role of enzymatic detergents used in the cleaning of intraocular surgi- cal instruments. J Cataract Refract Surg. 2016;42:1249–1250. 4. Chang DF, et al. Evaluation of ophthalmic surgical instrument sterility using short-cycle sterilization for sequential same-day use. Ophthalmology. 2018. Epub ahead of print. Editors' note: The physicians have no financial interests related to their comments. Contact information Chang: dceye@earthlink.net Hoffman: rshoffman@finemd.com Mah: Mah.Francis@scrippshealth.org Mamalis: nick.mamalis@hsc.utah.edu Whitman: whitman@keywhitman.com rinsing with sterile water. 2 After- ward, the researchers analyzed the phaco tips with scanning electron microscopy and energy-dispersive X-ray microscopy to assess any physical changes to the phaco tips and the presence of any enzyme residue. While Tsaousis et al. found that rinsing the phaco tips did re- duce enzymatic residue, such residue was still present on the phaco tips despite rinsing. Further, research on a rabbit model showed that enzymatic detergents of different dilutions (like those that would be considered residue even after rinsing) caused anterior segment inflammation that mimics a TASS reaction. 3 With these recent studies in mind, the new OICS guidelines state, "if intraocular surgical instru- ments are thoroughly rinsed with critical water promptly after each use, the routine use of enzyme deter- gents is unnecessary and should not be required for routine decontam- ination of ophthalmic intraocular instruments." Another recommendation that is evidence based, born out through scientific research, Dr. Mamalis noted, is the validation of short-cy- cle steam sterilization for cleaning instruments between cases. Chang et al. evaluated short-cycle sterilization (using two common steam steriliz- ers) of unwrapped phaco handpieces from three manufacturers that were inoculated with relevant bacteria. These were compared to controls that went through a full wrapped, dry cycle. 4 The research found that unwrapped, short-cycle sterilization, following the IFUs for the machines used, effectively sterilized the in- struments for same-day use. "A full drying phase is not necessary when the instruments are kept within the covered sterilizer containment de- vice for prompt use on a sequential case," Chang et al. wrote. Task force members took on this research after, as described in the April 5 ASCRS member alert announcing the guidelines, "Sep- arate challenges came from The Joint Commission, which originally required a full terminal wrapped and dry cycle for sequential same- day cases, and from a CMS ruling that immediate use steam steriliza- tion (IUSS) could not be performed routinely for any type of surgery." Due to efforts by the task force, CMS clarified its acceptance of short-cycle sterilization for sequential same-day ophthalmic cases as long as the IFUs are followed. Jeffrey Whitman, MD, Dallas, president of OOSS, said these studies give scientific evidence that supports cleaning and sterilization practices that have not changed since the early days of phacoemulsification. "We now have published litera- ture that says this is what works and we need to put that in action for the [instructions for use]. This is one of the largest effective changes for sur- gery center sterilization procedures since I've been an ophthalmologist, and I've been an ophthalmologist for 30 years," Dr. Whitman said. The work does not stop here though. Dr. Whitman said he and other task force members are meet- ing with manufacturers, presenting them with this data in an effort to get them to formally change their IFUs. "Some of these things have changed already, but what we need is the vendors and their published material, their [IFUs], to say this is the right thing to do. The surgery center in doing the right thing should not have to constantly defend themselves," Dr. Whitman said, noting that some inspectors will stick to what the IFU says, even when presented with published re- search that might show otherwise. Dr. Hoffman explained that the manufacturer's IFUs, even despite these evidence-based recommenda- tions, are the ultimate guideline that government auditors use to deter- mine compliance. Thus, there is still work to be done to update these instructions. "The guidelines were a huge first step, but it's not the end," OICS continued from page 3

• Blank Page
• Blank Page (1)