Eyeworld

3 EW NEWS & OPINION by Nick Mamalis, MD, and David F. Chang, MD Joint Task Force makes recommendations to industry regarding the elimination of enzymatic detergents for routine cleaning of intraocular surgical instruments August 2016 with the Centers for Medicare & Medicaid Services (CMS), the FDA, and the Association for the Advance- ment of Medical Instrumentation T oxic anterior segment syndrome (TASS) is an acute, sterile postoperative inflammation secondary to intraocular toxic substances introduced during anterior segment surgery. The ASCRS TASS Task Force has analyzed causes of TASS during 2 periods: 2007 through 2009 and 2009 through 2012. 1,2 Data from 130 questionnaires and 71 site visits to affected ambulatory surgery centers (ASCs) resulted in 1,454 reported cases of TASS out of approximately 69,000 concomitant cataract surger- ies. The most commonly identified risk factors for TASS included inad- equate flushing of handpieces, use of enzymatic detergents, and use of ultrasound baths. Human and animal studies have shown that enzymatic detergents are toxic to the corneal endothelium, and in the clinical analyses, enzy- matic residue was implicated as a source of TASS when incompletely rinsed from the ophthalmic instru- ments prior to sterilization. The enzymatic residues are not deacti- vated by autoclave sterilization. Fur- thermore, enzymatic detergents are intended to remove bulk biomaterial from surgical instruments; howev- er, anterior segment ophthalmic instruments acquire little bioburden during surgery and the material they do collect can be completely removed with prompt rinsing and manual cleaning. Therefore, en- zymatic detergents (including pH neutral agents) appear to elevate the risk for TASS without providing any offsetting benefit. It was the con- clusion of the TASS Task Force that enzymatic detergents should not be used for routine decontamination of anterior segment ophthalmic instruments. Unfortunately, the manufac- turer's directions for use (DFU) that accompany instruments and ultrasound cleaning baths often call for the use of enzymatic detergents. Hospitals and ASCs are required by CMS to strictly adhere to ophthal- mic instrument DFUs during the cleaning process, and surveyors are increasingly citing facilities for fail- ure to use enzymatic detergent if so required. Perhaps as a result of these rulings, the TASS Task Force is seeing an increase in TASS cases associated with enzyme use. Over the past 2 years, a joint Task Force on ophthalmic instru- ment cleaning and sterilization (OICS) with representatives from the American Society of Cataract & Re- fractive Surgery (ASCRS), American Academy of Ophthalmology (AAO), Outpatient Ophthalmic Surgery So- ciety (OOSS), and American Society of Ophthalmic Registered Nurses (ASORN) has focused on regulatory issues relating to the cleaning and sterilization of intraocular surgi- cal instruments. The Task Force is chaired by the 2 authors of this article. Members of the OICS Task Force have had separate meetings continued on page 8 IMPORTANT PRODUCT INFORMATION FOR THE ACRYSOF ® IQ RESTOR ® FAMILY OF IOLs CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof ® IQ ReSTOR ® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presby- opia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light con- ditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects. Clinical studies with the AcrySof ® ReSTOR ® lens indicated that posterior capsule opacification (PCO), when present, devel- oped earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associat- ed with the AcrySof ® IQ ReSTOR ® IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof ® Natural IOL and normal color vision. The effect on vision of the AcrySof ® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS ® or BSS PLUS ® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. © 2016 Novartis 3/16 US-RES-16-E-0790 " Human and animal studies have shown that enzymatic detergents are toxic to the corneal endothelium, and in the clinical analyses, enzymatic residue was implicated as a source of TASS when incompletely rinsed from the ophthalmic instruments prior to sterilization. "

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