Eyeworld

EW NEWS & OPINION 8 August 2016 (AAMI) on the problem of requiring ASCs to use enzymatic detergents to decontaminate intraocular ophthal- mic instruments. In December 2015, ASCRS, AAO, and OOSS released a joint advisory statement to their respective memberships warning about the potential for enzymatic detergent residue to cause TASS. A recent study at the Intermountain Ocular Research Center of the Uni- versity of Utah found that enzyme residues can persist on phacoemulsi- fication tips despite proper rinsing, and other studies have shown that small amounts of enzyme residue can cause TASS. Because the potential for enzymatic detergent residue on ophthalmic instruments is problem- atic, the Task Force is working with the ophthalmic instrument industry to eliminate the requirement for routine use of enzymatic detergents for decontamination of intraocular surgical instruments as stated in the DFUs. If intraocular surgical instru- ments are thoroughly rinsed with sterile distilled or deionized water promptly after each use, then the routine use of enzymatic detergents should not be necessary. While the OICS Task Force recognizes that enzymatic detergent cleaning could be necessary in some instances, our goal is to eliminate the routine requirement in some instrument DFUs for decontamination with enzymatic detergent in every case. The OICS Task Force and the FDA have concluded that the best way to eliminate this risk of TASS would be to have manufacturers validate alter- nate decontamination methods that do not require enzymatic detergents. Through the OICS Task Force, ASCRS, AAO, OOSS, and ASORN have formally recommended that intraocular instrument manufactur- ers devise and validate methods to clean and decontaminate instru- ments without using enzymatic detergents. EW References 1. Cutler Peck CM, et al. Toxic anterior seg- ment syndrome: common causes. J Cataract Refract Surg. 2010;36:1073–1080. 2. Bodnar Z, et al. Toxic anterior segment syn- drome: Update on the most common causes. J Cataract Refract Surg. 2012;38:1902–1910. Editors' note: Drs. Mamalis and Chang have no financial interests related to this article. Contact information Chang: dceye@earthlink.net Mamalis: nick.mamalis@hsc.utah.edu Joint continued from page 3 Improve Patient Safety and Eliminate a Risk Factor for TASS Background Over the past year, ASCRS, AAO, OOSS, and ASORN have been participating in a task force focusing on the cleaning and sterilization of intraocular surgical instruments. In addition to meeting with CMS, the task force most recently met with both the Association for the Advancement of Medical Instrumentation (AAMI) and the FDA specifically on the issue of the required enzymatic detergent use in the cleaning/sterilization process of intraocular ophthalmic instruments. In December 2015, ASCRS, AAO, and OOSS released a joint advisory document (see page 3 of the January 2016 issue of EyeWorld) warning about the potential for enzymatic detergent to cause toxic anterior segment syndrome (TASS). Studies have shown that while following the manufacturers' DFUs, even the slightest enzyme residue can cause TASS. A new study has suggested that enzyme residues may persist despite proper rinsing. During the FDA meeting, all agreed that the potential for enzymatic detergent residue is problematic. Objective Elimination of Requirement for Routine Use of Enzymatic Detergent for Decontamination of Intraocular Surgical Instruments, as stated in the Directions for Use (DFUs) Some intraocular instruments' DFUs for reprocessing include the requirement to use enzymatic detergent following each use. In many cases, prompt rinsing with sterile water should be adequate if the instruments are not contaminated with a significant bio burden. An earlier survey of ophthalmic ASCs by our task force revealed that more than half of the respondents avoid the use of enzymatic detergent for intraocular instrument decontamination. However, DFUs commonly require routine use of enzymatic detergent and have caused surgeons and surgical centers to be cited by CMS or other regulators because they are not using enzymatic detergent. We recognize that enzymatic detergent cleaning may be necessary in some instances. However, our goal is to eliminate the requirement in some intraocular surgical instruments' DFUs that decontamination and reprocessing must include the use of enzymatic detergent in every case. The FDA has concluded, and we concur, that the best way to effect change would be through manufacturer validation testing of alternate decontamination methods that do not require enzymatic detergent. What is Included Class 1 and Class 2 surgical devices for intraocular use. Class 1 devices would not require a resubmission of the DFUs to the FDA, however, Class 2 devices would need FDA review. Request ASCRS, AAO, OOSS, and ASORN request intraocular instrument manufacturers validate cleaning instructions without enzymatic detergent and update DFUs accordingly. FDA's guidelines for cleaning and disinfection of reusable ophthalmic devices: www.fda.gov/downloads/ MedicalDevices/Device RegulationandGuidance/ GuidanceDocuments/ UCM253010.pdf Labeling Regulations: www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=801

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