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Background: Providing high-value care for urgent orthopaedic trauma patients requires effective and timely treatment. Herein, we describe the implementation of an innovative program utilizing the operating room (OR) capacity of a satellite campus to decrease stress on a pediatric tertiary care center without jeopardizing patient safety.Methods: In addition to the daily emergency surgical room on the main campus, a dedicated orthopaedic trauma surgery OR was established in a satellite hospital location for 3 days per week in the summer and for 2 days per week for the rest of the year. Nonemergency, non-multitrauma operative fracture cases presenting to our tertiary care facility emergency department or orthopaedic clinic were considered for satellite referral. Eligible patients required clearance for transfer via orthopaedic, emergency department, and anesthesia checklists. An opt-out policy was established for provider judgment or patient family concern to overrule transfer decisions. Selected patients were discharged home with satellite OR scheduling or approved for same-day satellite location admission. Short elective cases were performed when openings existed in the schedule.Results: From June 1, 2016, through June 30, 2017, 480 cases (372 trauma, 108 elective) were completed in our satellite OR. The most common trauma cases that were treated in the satellite OR were type-II supracondylar humeral fractures (n = 76). Summer months averaged 41.75 trauma cases and 11.25 elective cases per month, with 3.15 trauma cases and 0.85 elective cases per day. Nonsummer months averaged 22.78 trauma cases and 7.00 elective cases per month, with 2.93 trauma and 0.90 elective cases per day. Of the 17 postoperative issues, the greatest number (n = 7 [41%]) involved symptomatic hardware. The remaining complications were not surgeon or geographic-site-specific. There were no intraoperative complications, compartment syndrome episodes, or patients who required transfer back to our tertiary care facility for unexpected or serious medical issues.Conclusions: With the proper screening protocols in place for appropriate patient selection, the use of a dedicated satellite orthopaedic trauma OR can increase capacity without compromising patient safety. [ABSTRACT FROM AUTHOR]

The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation. [ABSTRACT FROM AUTHOR]

Growth estimates and demographic shifts of the population of the United States foreshadow a future heightened demand for musculoskeletal care. Although many articles have discussed this growing demand on the musculoskeletal workforce, few address the inevitable need for more musculoskeletal care providers. As we are unable to increase the number of orthopaedic surgeons because of restrictions on graduate medical education slots, physician assistants (PAs) and nurse practitioners (NPs) represent one potential solution to the impending musculoskeletal care supply shortage. This American Orthopaedic Association (AOA) symposium report investigates models for advanced practice provider integration, considers key issues affecting PAs and NPs, and proposes guidelines to help to assess the logistical and educational possibilities of further incorporating NPs and PAs into the orthopaedic workforce in order to address future musculoskeletal care needs. [ABSTRACT FROM AUTHOR]