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Objectives: This study aimed to characterize the processes of listing prostheses and medical devices in all insurance schemes., Methods: A literature review was performed, and in-depth interviews were conducted with the representatives of 6 insurance agencies. Civil Servant Medical Benefits Scheme (CSMBS), Social Security Scheme, Local Government Officer Scheme (LGOS), State Enterprise Scheme (SES), Universal Coverage Scheme (UCS), and Non-Thai Resident Scheme (NTRS)., Results: The outcomes of interest were structure details and the body of the working groups, listing processes, and key assessment criteria. Each insurance scheme's process can be summarized in 5 steps: (1) receiving the proposed topics of health technologies, (2) screening, (3) selection, (4) consideration, and (5) approval and publicization. Notably, the organizational structures and working group compositions vary across schemes, leading to differences in process activities and assessment criteria. LGOS and SES are exceptions because they follow the application process of CSMBS. UCS demonstrates the most transparent process, providing specific working groups that are competent in undertaking each activity. The processes of listing prostheses and medical devices vary across health insurance in Thailand, leading to varying numbers of health technologies covered by insurance schemes., Conclusions: This study characterizes prostheses and medical device listing processes in 6 Thai Universal Health Coverage insurance schemes (CSMBS, Social Security Scheme, UCS, LGOS, SES, and Non-Thai Resident Scheme). Variations in processes result in differing technology listings. It offers essential insights for healthcare professionals and policy makers., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: Clinical quality registries (CQRs) are intended to enhance quality, safety, and cost reduction using real-world data for a self-improving health system. Starting in 2001, Kaiser Permanente established several medical device CQRs as a quality improvement initiative. This report examines the contributions of these CQRs on improvement in health outcomes, changes in clinical practice, and cost-effectiveness over the past 20 years., Methods: Eight implant registries were instituted with standardized collection from the electronic health record and other institutional data sources of patient characteristics, medical comorbidities, implant attributes, procedure details, surgical techniques, and outcomes (including complications, revisions, reoperations, hospital readmissions, and other utilization measures). A rigorous quality control system is in place to improve and maintain the quality of data. Data from the Implant Registries form the basis for multiple quality improvement and patient safety initiatives to minimize variation in care, promote clinical best practices, facilitate recalls, perform benchmarking, identify patients at risk, and construct reports about individual surgeons., Results: Following the inception of the Implant Registries, there was an observed (1) reduction in opioid utilization following orthopedic procedures, (2) reduction in use of bone morphogenic protein during lumbar fusion allowing for cost savings, (3) reduction in allograft for anterior cruciate ligament reconstruction and subsequent decrease in organizationwide revision rates, (4) cost savings through expansion of same-day discharge programs for joint arthroplasty, (5) increase in the use of cement fixation in the hemiarthroplasty treatment of hip fracture, and (6) organizationwide discontinuation of an endograft device associated with a higher risk for adverse outcomes following endovascular aortic aneurysm repair., Conclusion: The use of Implant Registries within our health system, along with clinical leadership and organizational commitment to a learning health system, was associated with improved quality and safety outcomes and reduced costs. The exact mechanisms by which such registries affect health outcomes and costs require further study., (Copyright © 2024 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Background: To develop a novel 3D-printer-assisted method to fabricate patient-specific implants for cranioplasty and to demonstrate its feasibility and its use in 16 consecutive cases., Methods: We report on 16 consecutive patients who have undergone cranioplasty surgery for an extensive skull defect after decompressive surgery and in which the bone flap was not available. We present the workflow for the implant production using a 3D-printer-assisted molding technique. Preoperative, intraoperative, and postoperative data were analyzed/evaluated., Results: Eleven out of our 16 patients (68.7%) presented with extensive hemispheric bone defects. Indication for initial craniotomy were traumatic brain injury (4; 25%), acute subdural hematoma (4; 25%), ischemic stroke (3; 18.8%), tumor (3; 18.8%), and ruptured aneurysm (2; 12.5%). Median (range) operation time was 121 (89-206) minutes. Median (range) intraoperative blood loss was 300 (100-3300) mL. The mean (range) follow-up period is 6 (0-21) months. Complications occurred in 7 out of our 16 patients (43.8%), in 6 (37.5%) of which a reoperation was required to evacuate an extra-axial hematoma (3; 50%), for shunting of an epidural fluid collection (1; 16.7%), or for skin flap necrosis (1; 16.7%). One patient (16.7%) developed a chronic asymptomatic subdural fluid collection that was stable over the follow-up period., Conclusions: Our workflow to intraoperatively produce patient-specific implants in a timely manner to cover cranial defects proved to be feasible. The results are cosmetically appealing, and postoperative CT scans show well-fitting implants. As implantable printable substrates are already available, we aim to advance and certify 3D-printed patient-specific implants in the near future., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Health care costs are increasing in medicine and in orthopedics. Device choice in orthopedic cases can impact the cost of the procedure and thus result in cost savings. This study aims to determine whether orthopedic attendings and residents accurately estimate device costs they are implanting in trauma cases and whether costs would influence their surgical device selection., Design: Using nationally published average cost data for 13 implants, a survey was distributed at 6 US academic centers. Respondents were asked to select the correct cost from cost ranges. They also answered yes/no questions about their choices regarding published research outcomes for specific fractures. Residents' answers were compared with faculty answers using t tests for each cost estimate question, and chi-square tests for yes/no questions and frequencies., Results: A total of 51 faculty members and 76 residents responded. Attending estimates were closer to the actual cost for most devices. The average total error in cost estimate for all 13 implants was $11,288.36 for residents (35.6% difference) and $10,208.33 for faculty members (32.2% difference). Significantly more faculty members estimated costs within 10% versus residents. When asked if the literature showed differences in outcome when using different implants to treat 4 common fractures, most answered these questions correctly. Further, 71.1% of residents said their choice of implant would change if costs affected physician reimbursements versus 58% for faculty members., Conclusions: Our data indicate orthopedic physicians are not aware of true implant costs and nearly half of attendings would not consider cost as a factor in deciding between equivalent implants, even if this affected their reimbursement. Most notably, participants showed a poor ability to closely estimate the cost of more expensive implants (actual device cost greater than $2000). Our results suggest that medical cost containment should be stressed to the next generation of surgeons., (Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: Surgical costs are under scrutiny and surgeons are being held increasingly responsible for cost containment. In some instances, implants are the largest component of total procedure cost, yet previous studies reveal that surgeons' knowledge of implant prices is poor. Our study aims to (1) understand drivers behind implant selection and (2) assess whether educating surgeons about implant costs affects implant selection., Methods: We surveyed 226 orthopedic surgeons across 6 continents. The survey presented 8 clinical cases of upper extremity fractures with history, radiographs, and implant options. Surgeons were randomized to receive either a version with each implant's average selling price ("price-aware" group), or a version without prices ("price-naïve" group). Surgeons selected a surgical implant and ranked factors affecting implant choice. Descriptive statistics and univariate, multivariable, and subgroup analyses were performed., Results: For cases offering implants within the same class (eg, volar locking plates), price-awareness reduced implant cost by 9% to 11%. When offered different models of distal radius volar locking plates, 25% of price-naïve surgeons selected the most expensive plate compared with only 7% of price-aware surgeons. For cases offering different classes of implants (eg, plate vs external fixator), there was no difference in implant choice between price-aware and price-naïve surgeons. Familiarity with the implant was the most common reason for choosing an implant in both groups (35% vs 46%). Price-aware surgeons were more likely to rank cost as a factor (29% vs 21%)., Conclusions: Price awareness significantly influences surgeons' choice of a specific model within the same implant class. Merely including prices with a list of implants leads surgeons to select less expensive implants. This implies that an untapped opportunity exists to reduce surgical expenditures simply by enhancing surgeons' cost awareness., Type of Study/level of Evidence: Economic/Decision Analyses I., (Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.)

Objective: The scarcity of implants during the economic crisis partially has replaced decompression and instrumented fusion for the treatment of cervical spondylotic myelopathy with implant-less expansile cervical laminoplasty (ECL). The aim of the study was to compare the results obtained with instrumented anterior cervical corpectomy and fusion with implant-less ECL., Methods: Patients suffering from cervical spondylotic myelopathy Nurick 3-5 with preoperative tethering and postoperative untethering were included. Exclusion criterion was kyphosis more than 10°. Patients were assessed according to 30-meter walking track (30mWT), Nurick, and modified Japanese Orthopaedic Association scale scores. Kinematic magnetic resonance imaging 3-dimensional subaxial spinal cord reconstructions were 3 dimensionally modeled to confirm preoperative pincer clamping and follow-up unclamping to measure subaxial spinal cord length and pia envelope area (PEA)., Results: A total of 35 patients divided in the ECL (n = 19) and the anterior cervical corpectomy and fusion (n = 16) groups were selected from 534 patients operated on between September 1, 2008, and August 31, 2013 as the result of degenerative cervical disorders. Patients improved according to Nurick and modified Japanese Orthopaedic Association scores without differences between groups. Follow-up 30mWT analysis showed greater decrease in steps number and time in ECL group, creating the basis for further imaging analysis. Magnetic resonance imaging analysis showed that spinal cord length (mm) shortened more (4.47 ± 1.87 vs. 1.5 ± 2.5, t = -4.02; P = 0.0003) and PEA (mm 2 ) shrank more (95.58 ± 43.73 vs. 22.94 ± 33.11, t = -5.45, P < 0.0001) in the ECL group. Multivariate logistic analysis showed that Δ 30mWT-time and Δ PEA were a very predictive model when area under the receiver operating characteristic curve is 0.98., Conclusions: Our results created a nidus for further research of postdecompression spinal cord relaxation., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: U.S. health care is responding to significant regulation and meaningful incentives for higher quality care, patient safety, electronic documentation and data exchange. FDA's Unique Device Identification (UDI) Rule, a relatively new regulation aligned with these goals, requires standard labeling of medical devices by manufacturers. This lays the foundation for UDI scanning and documentation in the electronic health record, expected to change the landscape of medical device identification and postmarket surveillance., Methods: We developed national projections for time, cost and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA) using American Association of Hip and Knee Surgeons 2012 membership survey data, Nationwide Inpatient Sample 2011 data and THA/TKA demand projection data., Results: Our projections suggest that cumulative surgeon time spent identifying failed implants could reach 133,000 h in 2030, representing opportunity to perform over 500,000 15 min established patient office visits. Staff time could reach 220,000 h with a cost of $3.3m. Failed implants that cannot be identified may be greater than 50,000 preoperatively and 25,000 intraoperatively in 2030., Conclusion: Study projections indicate significant time, cost and inability to identify failed implants, supporting need for improvement of implant documentation. FDA's UDI Rule sets the foundation for UDI scanning and documentation in the electronic health record, a process poised to serve as the standard system for device documentation., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: At present, there is no cure for tinnitus. Neurostimulation techniques have shown great promise, but it is uncertain whether they will gain acceptance because of their invasive nature. We have previously demonstrated that pairing acoustic stimuli with vagus nerve stimulation (VNS) also has potential as a viable tinnitus treatment approach., Methods: We conducted a survey on tinnitus sufferers that emphasized questions related to a willingness to pay for the treatment of tinnitus, including VNS. Four hundred thirty-nine individuals responded to an Internet survey modeled after a recent study by Tyler., Results: The average age was about 47 years. Ninety-four percent reported that they had health insurance. Almost 40% had spent between $500 and $10,000 on tinnitus therapies. Almost three-fourths said that they would be willing to have a device implanted if it reduced tinnitus annoyance by half. About 70% of those with very loud tinnitus would be willing to have a temporary implant, and about 60% would be willing to have a permanent implant even if the device suppressed their tinnitus by only half of its annoyance. Only 10% of patients with SOFT tinnitus would be willing to have a permanent implant if the therapy suppressed their tinnitus by only half of its annoyance., Conclusions: We conclude that implanted devices, such as a VNS, will be an acceptable form of tinnitus treatment for many who suffer from tinnitus. The results of this survey indicate that VNS tone pairing would be an acceptable therapeutic solution for individuals with moderate to severe tinnitus and should be developed for the market., (© 2012 International Neuromodulation Society.)

Large skull bone defects resulting from craniotomies due to cerebral insults, trauma or tumours create functional and aesthetic disturbances to the patient. The reconstruction of large osseous defects is still challenging. A treatment algorithm is presented based on the close interaction of radiologists, computer engineers and cranio-maxillofacial surgeons. From 2004 until today twelve consecutive patients have been operated on successfully according to this treatment plan. Titanium and polyetheretherketone (PEEK) were used to manufacture the implants. The treatment algorithm is proved to be reliable. No corrections had to be performed either to the skull bone or to the implant. Short operations and hospitalization periods are essential prerequisites for treatment success and justify the high expenses., (Copyright © 2010 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.)

Objective: To assess the preference-based comparative effectiveness (human value gain) and the cost-utility (cost-effectiveness) of a telescope prosthesis (implantable miniature telescope) for the treatment of end-stage, age-related macular degeneration (AMD)., Design: A value-based medicine, second-eye model, cost-utility analysis was performed to quantify the comparative effectiveness and cost-effectiveness of therapy with the telescope prosthesis., Participants: Published, evidence-based data from the IMT002 Study Group clinical trial. Ophthalmic utilities were obtained from a validated cohort of >1000 patients with ocular diseases., Methods: Comparative effectiveness data were converted from visual acuity to utility (value-based) format. The incremental costs (Medicare) of therapy versus no therapy were integrated with the value gain conferred by the telescope prosthesis to assess its average cost-utility. The incremental value gains and incremental costs of therapy referent to (1) a fellow eye cohort and (2) a fellow eye cohort of those who underwent intra-study cataract surgery were integrated in incremental cost-utility analyses. All value outcomes and costs were discounted at a 3% annual rate, as per the Panel on Cost-Effectiveness in Health and Medicine., Main Outcome Measures: Comparative effectiveness was quantified using the (1) quality-adjusted life-year (QALY) gain and (2) percent human value gain (improvement in quality of life). The QALY gain was integrated with incremental costs into the cost-utility ratio ($/QALY, or US dollars expended per QALY gained)., Results: The mean, discounted QALY gain associated with use of the telescope prosthesis over 12 years was 0.7577. When the QALY loss of 0.0004 attributable to the adverse events was factored into the model, the final QALY gain was 0.7573. This resulted in a 12.5% quality of life gain for the average patient during the 12 years of the model. The average cost-utility versus no therapy for use of the telescope prosthesis was $14389/QALY. The incremental cost-utility referent to control fellow eyes was $14063/QALY, whereas the incremental cost-utility referent to fellow eyes that underwent intra-study cataract surgery was $11805/QALY., Conclusions: Therapy with the telescope prosthesis considerably improves quality of life and at the same time is cost-effective by conventional standards., (Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Objectives/background: In June 2003, detachable balloons were removed from the US market and were supplanted with coil embolization for parent artery sacrifice in difficult or nonsurgical aneurysms and other vascular pathologies. The current series examines the use of MicroNester pushable coils (Cook Medical, Bloomington, IN) as a low-cost and effective adjunct to detachable coils in the treatment of selected neurovascular pathologies., Methods: A retrospective analysis of all patients undergoing neurointerventional procedures from November 2003 through May 2008 was performed to identify patients in whom MicroNester coils were used as part of treatment. Analysis of coil type and number as well as pathology was performed., Results: MicroNesters were used in 26 cases, of which 21 were for arterial sacrifice--19 for the internal carotid artery and 2 for the vertebral artery. Fourteen were performed for intracranial aneurysms, 3 for pseudoaneurysms, 2 for carotid cavernous fistulae, 1 for a carotid blowout, and 1 for an arteriovenous malformation. Five additional procedures were transvenous, for treatment of dural arterial venous fistulae. The mean number of coils for artery sacrifice was 13, with an average of 10 MicroNesters. For transvenous embolizations, the means were 30 and 6, respectively., Conclusion: MicroNesters are not the coil of choice for most neurointerventional procedures because they are not retrievable. However, when parent artery sacrifice or transvenous occlusion of dural arteriovenous fistulas is the goal, MicroNesters are a relatively inexpensive and equally effective alternative to more expensive, detachable coils and can reduce the procedural costs by $3600 to $6000 for the current series., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Implantation of medical devices is becoming more prevalent, and as a result, a greater number of patients who fall accidentally are expected to have a medical implant. The Nationwide Inpatient Sample (NIS) was used to evaluate hospital admissions following accidental falls involving re-operation of existing medical implants (hip, knee, spine, and fracture fixation) from 1990 to 2005. From 1990 to 2005, hospitalisations due to accidental falls on level surfaces increased by 306%, and hospitalisations due to falls from stairs increased by 310%. Falls involving orthopaedic revision surgery (re-operation) are relatively rare, but the incidence has increased by approximately 35%. Hospital stays after falls on level surfaces involving re-operation were 1.0 day (median) longer and cost 50% (median) more than those that did not involve re-operation in 2005. After staircase falls, hospital stays for patients undergoing re-operations were 2.0 days (median) longer and cost 108% (median) more. The greater hospital costs and hospital stay for patients needing re-operations indicate that additional medical treatment was required.

Introduction: The cost-utility of vagus nerve stimulator (VNS) devices for medically refractory epilepsy has yet to be estimated., Methods: Using a meta-analysis of randomised controlled trials of VNS, we estimate that six people require implantation in order for one person to experience a 50% reduction in seizure frequency. Costs averted from improved epilepsy control were ascertained from published literature. Values for health states were obtained from a series of 42 seizure clinic attenders using time trade-off techniques and the EQ-5D health status instrument. The cost per quality adjusted life year gained was estimated and the values obtained were tested in a sensitivity analysis., Results: Improved epilepsy control averted, on average, 745 pounds sterling health care costs per annum. People with epilepsy had great difficulty performing the time trade-off experiment, but those who managed to complete the task valued a 50% reduction in their own seizure frequency at 0.285 units. For a programme of six implants, the baseline model estimated the cost per quality adjusted life year gained at 28,849 pounds sterling. The most favourable estimate was equal to 4785 pounds sterling per quality adjusted life year gained, assuming that the number needed to treat was similar to published series in which one response was obtained for every three implants. The least favourable estimate was equal to 63,000 pounds sterling per quality adjusted life year gained, when EQ-5D utility values were used. The cost per quality adjusted life year gained was not sensitive to changes in length of stay, nor complication rates, but was significantly influenced by cost of device and device battery life expectancy., Conclusion: There is not a strong economic argument against a programme of VNS implantation, although care should be taken to try and identify and treat those most likely to benefit.