Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 3220 S E C T O R S P O T L I G H T OPHTHALMIC Members of AdvaMed’s Ophthalmic Devices Sector are focused on creating technologies that preserve, restore and improve healthy eyesight. The Sector meets quarterly to discuss key priorities and is committed to ensuring patient access to these vision-enhancing products. In 2015, the Sector met with FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, and the agency’s Office of Surveillance and Biometrics. They discussed how medical device reports of adverse events following laser-assisted in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) procedures can be updated and improved, and drafted a detailed follow-up document containing recommendations for the types of events that are reportable, in addition to alternative reporting methods and other considerations for LASIK procedures. ORTHOPEDIC Orthopedic devices help patients by restoring mobility, relieving pain and improving quality of life. In 2015, AdvaMed’s Orthopedic Sector continued to support development and maintenance of a single central im- plantable arthroplasty device component database avail- able to all arthroplasty registries. The Sector also approved participation by industry representatives in an initiative to explore creation of a single global hip and knee rating system to address ongoing concerns with the United King- dom’s Orthopedic Data Evaluation Panel rating system. The Orthopedic Reimbursement Work Group met with Center for Medicare and Medicaid Innovation (CMMI) Deputy Director Rahul Rajkumar to discuss how gainsharing financial incentives in the Bundled Payments for Care Improvement (BPCI) and Comprehensive Care for Joint Replacement (CJR) programs may compromise beneficiary access to the devices they need, in addition to reports that some BPCI providers are purchasing almost exclusively lower-utility devices without considering patients’ long-term needs. They also discussed CMMI’s plans to monitor patient care in bundled payment programs and the need for more transparency around BPCI implementation. The Sector’s Working Group on Unique Device Identifiers (UDIs) also worked to address issues related to UDI implementation. FDA confirmed that companies that distribute non-sterile devices in trays (e.g., spine, trauma and craniomaxillofacial devices) may use a “cross-reference” approach to meet the requirement to provide UDIs at the point of use. This cost-effective mechanism will enable companies to continue to use existing stock. In another cost-saving effort, FDA confirmed that devices consigned or loaned prior to their UDI implementation date are not subject to the UDI rule, thus preventing these products from being discarded or having to be reworked to be UDI compliant. SECTOR HEAD Michael Frazzette President Advanced Surgical Devices Division Smith & Nephew SECTOR HEAD Andy Stapars Director, Reimbursement and Market Access Abbott Medical Optics SECTOR HEAD Michael Pfleger Vice President External Affairs and Regulatory Policy Alcon Laboratories A D V A M E D 2 0 1 5 A N N U A L R E P O R T