Eyeworld

March 2015 EW CATARACT 88 by Maxine Lipner EyeWorld Senior Contributing Writer Short-cycle steam sterilization usage permissible in ophthalmic ASCs ACRYSOF® IQ INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO THE SALE BY OR ON THE ORDER OF A PHYSICIAN. INDICATIONS: THE ACRYSOF® IQ POSTERIOR CHAMBER INTRAOCULAR LENS IS INTENDED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THIS LENS IS INTENDED FOR PLACEMENT 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. CAUTION SHOULD BE USED PRIOR TO LENS ENCAPSULATION TO AVOID LENS DECENTRATIONS OR DISLOCATIONS. 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. LENSX® LASER IMPORTANT PRODUCT INFORMATION CAUTION: UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE AND USE BY OR ON THE ORDER OF A PHYSICIAN OR LICENSED EYE CARE PRACTITIONER. INDICATION: THE LENSX® LASER IS INDICATED FOR USE IN PATIENTS UNDERGOING CATARACT SURGERY FOR REMOVAL OF THE CRYSTALLINE LENS. INTENDED USES IN CATARACT SURGERY INCLUDE ANTERIOR CAPSULOTOMY, PHACOFRAGMENTATION, AND THE CREATION OF SINGLE PLANE AND MULTI-PLANE ARC CUTS/INCISIONS IN THE CORNEA, EACH OF WHICH MAY BE PERFORMED EITHER INDIVIDUALLY OR CONSECUTIVELY DURING THE SAME PROCEDURE. RESTRICTIONS: PATIENTS MUST BE ABLE TO LIE FLAT AND MOTIONLESS IN A SUPINE POSITION. PATIENT MUST BE ABLE TO UNDERSTAND AND GIVE AN INFORMED CONSENT. PATIENTS MUST BE ABLE TO TOLERATE LOCAL OR TOPICAL ANESTHESIA. PATIENTS WITH ELEVATED IOP SHOULD USE TOPICAL STEROIDS ONLY UNDER CLOSE MEDICAL SUPERVISION. CONTRAINDICATIONS: CORNEAL DISEASE THAT PRECLUDES APPLANATION OF THE CORNEA OR TRANSMISSION OF LASER LIGHT AT 1030 NM WAVELENGTH. DESCEMETOCELE WITH IMPENDING CORNEAL RUPTURE. PRESENCE OF BLOOD OR OTHER MATERIAL IN THE ANTERIOR CHAMBER. POORLY DILATING PUPIL, SUCH THAT THE IRIS IS NOT PERIPHERAL TO THE INTENDED DIAMETER FOR THE CAPSULOTOMY. CONDITIONS WHICH WOULD CAUSE INADEQUATE CLEARANCE BETWEEN THE INTENDED CAPSULOTOMY DEPTH AND THE ENDOTHELIUM (APPLICABLE TO CAPSULOTOMY ONLY). PREVIOUS CORNEAL INCISIONS THAT MIGHT PROVIDE A POTENTIAL SPACE INTO WHICH THE GAS PRODUCED BY THE PROCEDURE CAN ESCAPE. CORNEAL THICKNESS REQUIREMENTS THAT ARE BEYOND THE RANGE OF THE SYSTEM. CORNEAL OPACITY THAT WOULD INTERFERE WITH THE LASER BEAM. HYPOTONY OR THE PRESENCE OF A CORNEAL IMPLANT. RESIDUAL, RECURRENT, ACTIVE OCULAR OR EYELID DISEASE, INCLUDING ANY CORNEAL ABNORMALITY (FOR EXAMPLE, RECURRENT CORNEAL EROSION, SEVERE BASEMENT MEMBRANE DISEASE). HISTORY OF LENS OR ZONULAR INSTABILITY. ANY CONTRAINDICATION TO CATARACT OR KERATOPLASTY. THIS DEVICE IS NOT INTENDED FOR USE IN PEDIATRIC SURGERY. WARNINGS: THE LENSX® LASER SYSTEM SHOULD ONLY BE OPERATED BY A PHYSICIAN TRAINED IN ITS USE. THE LENSX® LASER DELIVERY SYSTEM EMPLOYS ONE STERILE DISPOSABLE LENSX® LASER PATIENT INTERFACE CONSISTING OF AN APPLANATION LENS AND SUCTION RING. THE PATIENT INTERFACE IS INTENDED FOR SINGLE USE ONLY. THE DISPOSABLES USED IN CONJUNCTION WITH ALCON® INSTRUMENT PRODUCTS CONSTITUTE A COMPLETE SURGICAL SYSTEM. USE OF DISPOSABLES OTHER THAN THOSE MANUFACTURED BY ALCON MAY AFFECT SYSTEM PERFORMANCE AND CREATE POTENTIAL HAZARDS. THE PHYSICIAN SHOULD BASE PATIENT SELECTION CRITERIA ON PROFESSIONAL EXPERIENCE, PUBLISHED LITERATURE, AND EDUCATIONAL COURSES. ADULT PATIENTS SHOULD BE SCHEDULED TO UNDERGO CATARACT EXTRACTION. PRECAUTIONS: DO NOT USE CELL PHONES OR PAGERS OF ANY KIND IN THE SAME ROOM AS THE LENSX® LASER. DISCARD USED PATIENT INTERFACES AS MEDICAL WASTE. AES/COMPLICATIONS: CAPSULOTOMY, PHACOFRAGMENTATION, OR CUT OR INCISION DECENTRATION. INCOMPLETE OR INTERRUPTED CAPSULOTOMY, FRAGMENTATION, OR CORNEAL INCISION PROCEDURE. CAPSULAR TEAR. CORNEAL ABRASION OR DEFECT. PAIN. INFECTION. BLEEDING. DAMAGE TO INTRAOCULAR STRUCTURES. ANTERIOR CHAMBER FLUID LEAKAGE, ANTERIOR CHAMBER COLLAPSE. ELEVATED PRESSURE TO THE EYE. ATTENTION: REFER TO THE LENSX® LASER OPERATOR'S MANUAL FOR A COMPLETE LISTING OF INDICATIONS, WARNINGS AND PRECAUTIONS. © 2014 Novartis 11/14 LSX14078JAD CMS clarifies policy A clarification of Centers for Medicare & Medicaid Services (CMS) rules for instrument sterilization at ophthalmic ambulatory surgery centers (ASCs) indicates that the majority of ophthalmic ASCs would be in compliance when using short-cycle steam sterilization, as long as they adhere to the manufac- turer's directions for use (DFUs). This comes after efforts by the American Society of Cataract & Refractive Surgery (ASCRS), American Academy of Ophthalmology (AAO), and the Outpatient Ophthalmic Surgery Society (OOSS), which twice met with CMS in an effort to shed light on why, or whether, there was a change in CMS' policy involving instrument sterilization procedures, said David F. Chang, MD, clinical professor of ophthalmology, Univer- sity of California, San Francisco, and a past president of ASCRS. "The CMS update to surveyors in late August stated that 'immediate use steam sterilization' (IUSS) was no longer acceptable for routine instrument sterilization," Dr. Chang said. "Unfortunately, this term and the wording of the memo were con- fusing and somewhat ambiguous to many of us in ophthalmology." Nomenclature issue Nick Mamalis, MD, professor of ophthalmology, John A. Moran Eye Center, Department of Ophthalmol- ogy, University of Utah, Salt Lake City, pointed out that the concern appeared to be over terminology. "One of the things that came out of these meetings that we had with CMS was exactly what they were talking about when they were talking about sterilization," Dr. Mamalis said, adding that he thinks there was some confusion over pre- cisely what was being done in most surgery centers versus what CMS thought was occurring. "Flash sterilization is a proce- dure where an ultra-short cycle is used to sterilize the instruments on an emergency basis, for example, if an instrument falls on the floor and needs to be cleaned emergently," Dr. Mamalis said. "But that is not the type of sterilization that is going on now in the vast majority of surgery centers in the United States—they are using complete short-cycle, steam sterilization." The fact is that as long as the manufacturer's directions for use are followed, then short-cycle steam sterilization is a very good, thorough way of sterilizing instruments for ophthalmic surgery, Dr. Mamalis stressed. To help support the ophthal- mic position, Dr. Chang noted that the 3 societies collaborated in Dec. 2014 to conduct a survey of facilities on their instrument sterilization practices. Results of this survey were then presented to CMS in late Jan. 2015. "It showed that approximate- ly half of all ophthalmic ASCs use short-cycle steam sterilization in between cases, as opposed to a much longer wrapped terminal cycle," Dr. Chang said, adding that virtually all of these ASCs are routinely follow- ing the manufacturer's DFUs for the approved sterilizers. In addition, the incidence of infectious endophthal- mitis was no different between the groups that were using short-cycle steam sterilization and those who were using the long-cycle terminal sterilization, and was extremely low overall, he said. "This supports our position that both methods are safe and appropri- ate," Dr. Chang said. "Following the manufacturer's directions for use for approved shorter sterilization cycles should be referred to as 'short-cycle steam sterilization' and this continues to be acceptable to CMS." – David F. Chang, MD

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