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Background: The list of medical devices (MD) eligible for reimbursement under the Compulsory Health Insurance in Morocco is set by Ministerial Order comprising 869 items between life-support equipment, external prostheses, and implants. The objective of the present study is to analyze the nomenclature of implantable medical devices (IMD) appearing on this list and compare them with the global nomenclature of MD (GMDN) and the European nomenclature of MD (EMDN)., Methods: The study deals with (i) the mapping of the codes of the IMD list with 170 DM per cardinality and (ii) a metric identification by Sørensen-Dice coefficient of terminological similarity of the IMD with respect to the two databases., Results: The 170 IMD codes are mapped onto 493 terms in the GMDN and 344 terms in the EMDN. The 37.7% of implants are mapped to more than or equal to 2 terms of GMDN while 36.5% are mapped to more than or equal to 2 terms to the EMDN. The comparison of cardinality distributions has revealed no significant difference (P=0.430) between the two databases. The implants examined are divided into 11 categories whose strong similarity is given to active cardiovascular implants in the EMDN database with sim Dice =0.534., Conclusion: Healthcare authorities need to align with nomenclature standards to improve interoperability and rely on a more efficient and rational regulatory process., (Copyright © 2024 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Objective: Advances in surface architecture and technology have made interbody fusion devices more bioactive, with the hope of facilitating the fusion process more successfully. The advent of these increasingly bioactive implants may reduce reliance on more expensive biologics that have previously been used to achieve high fusion rates., Methods: A retrospective review of prospectively collected data (August 2018-December 2019) was conducted of consecutively performed anterior lumbar interbody fusions in which an acid-etched, nanosurface-modulated, titanium interbody device packed only with corticocancellous allograft chips and local blood was used. Minimum follow-up was 1 year, and inclusion required available imaging and outcome metrics preoperatively and at 1 year. Fusion and subsidence were assessed via CT scans and/or dynamic radiographs. Health-related quality-of-life measures (Oswestry Disability Index [ODI], visual analog scale [VAS] back/leg) were collected pre- and postoperatively., Results: In total, 55 patients met inclusion criteria (1 year of follow-up, available imaging, and outcome metrics). A total of 69 lumbar levels were treated in these 55 patients. The mean age was 67 ± 12.1 years, with 47% female patients. Roughly one-third (35%) had previous spine surgery, and approximately one-tenth (9.1%) had prior spinal fusion. A total of 20.6% were treated at multiple levels (mean levels per patient 1.2, minimum 1, maximum 3). The mean preoperative patient-reported outcomes were as follows: ODI 39.71 ± 18.15, VAS back 6.49 ± 2.19, and VAS leg 5.41 ± 2.71. One year after surgery, the mean improvements in patient-reported outcomes (vs preoperative scores) were as follows: ODI -22.9 ± 13.08 (p < 0.001), VAS back -3.75 ± 2.03 (p < 0.001), VAS leg -3.73 ± 2.32 (p < 0.001). All levels achieved fusion at 1 year postoperatively based on CT scans (65/69 levels) or dynamic radiographs (4/69 levels, change in score < 5% on flexion-extension radiographs). Four of the 65 levels were assigned to the grade 3 category according to a CT-based grading system, meaning cranial and caudal endplate bone apposition to the implant on both surfaces with no clear intervertebral bone connection through or around the implant. Sixty-one of 65 were found to have contiguous intervertebral bone bridging and thus were assigned to grade 1 (n = 54) or grade 2 (n = 7). Low-grade graft subsidence (Marchi grade 0 or I) occurred in 9 levels (13.0%) and high-grade subsidence (Marchi grade II or III) in 4 levels (5.8%). No patients required reoperation at the level of anterior lumbar interbody fusion and no radiographic or clinical evidence of pedicle screw loosening or failure was observed., Conclusions: The combination of advances in materials science and surface technology as demonstrated with a nanotechnology titanium cage resulted in the ability to obtain lumbar interbody fusion with allograft chips and local blood alone. Achieving high fusion rates with low-cost biologics/allograft provides for an attractive pathway toward reducing the cost of reconstructive spine care, and a potential incremental benefit for healthcare economics.

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.)

Computer-aided design (CAD) models can now be directly converted into products and structures. One technique to realize such approach is through Additive Manufacturing (AM). AM is relatively new manufacturing technology in which products are manufactured by layering various materials like rubber, metal, ceramic, composites, and polymers. However, the use of this technology requires consideration of its associated cost to ensure its competitiveness. In this paper, a simplified mathematical cost model is suggested. The model considers the main components of costs. The model formula utilizes expenses related to the pre-processing, main processing, and the post-processing operations. To validate the model, it is tested to estimate the cost of medical implants manufacturing using AM technique. In many cases, medical implants require unique or dedicated design for each patient. Hence cost estimation will help to assess and estimate the required financial resources for such operations. A case study is provided in this paper to estimate the manufacturing cost of a finger's phalanges bone, with metal implant using AM technique. The developed model may be described as Activity Based Costing (ABC). The model is introduced to estimate the cost of parts produced using AM technique. Although the model is developed to suit custom implant manufacturing using AM technique, its use may also be adapted to suit the manufacturing of many other parts and products. The developed model is aiming to achieve several tasks namely assigning cost drivers to each activity, estimating the cost of individual actions, allocating overhead expenses, calculating the overall production cost, and establishing an acceptable selling price. It assists companies in computing the cost of custom implants for customers, enhancing the accuracy of production cost estimates, and ultimately boosting profitability., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Neamah et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Patient-specific implants (PSIs) are accurate, efficient alternatives to traditional plate fixation. They are well-suited for use in procedures that require the utmost accuracy, stability, and efficiency. Although PSIs have demonstrated such qualities in craniomaxillofacial reconstruction, they have so far found limited utilization elsewhere., Case Presentation: We explored the departmental protocol for Lefort 1 PSI orthognathic surgery at a high-volume, tertiary referral center. Three cases were selected that matched predetermined criteria, which included treatment by the same surgical team, concurrent Lefort 1 osteotomy and bilateral sagittal split osteotomy, Angle's type 3 malocclusion, lack of interdental osteotomies, and American Society of Anesthesiologists classification 2 or less without metabolic or osseous diseases. The operative outcomes from these patients were then compared to similar cases also meeting the same criteria and conducted within the same time period., Conclusion: The use of PSI in Lefort 1 osteotomy is associated with anatomically sound designs that could contribute to postoperative stability of the jaws. They also have not shown increased rates of complications such as infection, dehiscence, or relapse at 6 weeks postoperatively but may in fact decrease the operative duration. These findings are consistent with the results gleaned from literature on the use of PSI in craniomaxillofacial reconstruction.

Aims: To report hospitalization costs of patients with non-valvular atrial fibrillation (AF) submitted to percutaneous left atrial appendage closure (LAAC) with the Watchman device., Methods: Pre- and post-procedural hospitalization AF-related costs were calculated using the DRG system (diagnosis-related groups) and compared., Results: Between 2012 and 2016, 677 non-valvular AF patients underwent LAAC. Median time from first cardiac hospitalization to LAAC was 5.9 years (IQR 1.6-9.1) and median follow-up after LAAC was 4.8 years (IQR 3.6-5.6). LAAC mortality was 1.3% and follow-up mortality 16.9%. Median pre-LAAC hospitalization cost was € 17,867 (IQR € 7512-35,08) and post-LAAC € 8772 (IQR € 1183-25,159) (p < 0.0001). Annualized cost pre-LAAC was 3773 € (IQR € 1644-8,493) and post-LAAC 2,001 € (IQR € 260-6913) (p < 0.0001). Follow-up survivors had significantly lower post-LAAC costs (p < 0.0001) and after a survival cut-off time of 4.6 years LAAC procedural and post-procedural hospitalization costs achieved parity with pre-LACC costs (AUC 0.64; p = 0.02). CHA2DS2-VASc score (B = 0.04; p = 0.02; 95% CI 0.006-0.08), and HAS-BLED score (B = 0.08; p = 0.004; 95% CI 0.02-0.14) were independent determinants for annualized hospitalization costs post-LAAC. At Cox-regression analysis the DRG mean clinical complexity level (CCL) was the only independent determinant for follow-up mortality (OR = 2.2; p < 0.0001; 95% CI 1.6-2.8) with a cut-off value of 2.25 to predict follow-up mortality (AUC 0.72; p < 0.0001; Spec. 70%; Sens. 70%)., Conclusion: Hospitalization costs pre-LAAC are consistent, and after LAAC, they are significantly reduced. Costs seem related to the patient's risk profile at the time of the procedure. With the increase in post-LAAC survival time, the procedure becomes economically more profitable., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Arthroplasty procedures are commonly performed and contribute to healthcare expenditures seen in the United States. Surgical team members may make selections among implants and materials without always knowing their relative cost. The current study reports on a survey aimed to investigate the perceptions of an academic group about the relative cost and value of commonly used operating room implants and materials related to joint arthroplasty cases using 10 matched pairs of items. Of the 124 persons eligible to take the survey, 102 responded (response rate of 82.3%) including attendings, fellows, residents, physician assistants (PAs), advanced practice registered nurses (APRNs) and registered nurses (RNs). On average for the ten pairs of items, the more expensive items were correctly selected by 90.2+/-13.9% (mean+/- standard deviation) of respondents with a range from 54.9% to 100%. Of note, the cost differences were significantly overestimated for 8/10 item pairs. The majority of respondents perceived the more expensive item as the item with the higher clinical value for 9/10 item pairs. Most arthroplasty attendings (91.3%) indicated willingness to use the less expensive item of two similar items. Nonetheless, 17.9% of fellows, residents, PAs, APRNs and RNs indicated that they would not feel comfortable suggesting using the less expensive item. Although attending arthroplasty surgeons stated a desire to consider costs, a knowledge deficit with regards to identifying the extent of cost differences was identified, and a significant portion of the surgical support team reported being hesitant to suggest less expensive options., Competing Interests: We have read the journal’s policy and the authors of this manuscript have the following competing interests: • Jonathan Grauer: financial support publishing role in North American Spine Society; editor-in-chief for North American Spine Surgery Journal; board member/committee appointments for North American Spine Society; board member/committee appointments for Lumbar Spine Research Society • Lee Rubin: paid consultant for DePuy Synthes; paid consultant for ConvaTEC; stock or stock options in 3D Surgical, Inc.; royalties, financial or material support from SLACK, Inc.; royalties, financial or material support from Johns Hopkins University Press; Medical/Orthopaedic publications editorial/governing board-Journal of Arthroplasty; Medical/Orthopaedic publications editorial/governing board-Arthroplasty Today; Medical/Orthopaedic publications editorial/governing board-Reconstructive Review; board member/committee appointments for AAOS; board member/committee appointments for AAHKS; board member/committee appointments for ABOS. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Introduction: Health benefits package (HBP) is regarded as one of the main dimensions of health financing strategy. Even with increasing demands for prosthetics and orthotics (P&O) services to approximately 0.5% of the world's population, only 15% of vulnerable groups have the chance to make use of such benefits. Inadequate coverage of P&O services in the HBP is accordingly one of the leading reasons for this situation in many countries, including Iran., Aims: The main objective of this study was to find and prioritize solutions in order to facilitate and promote P&O services in the Iranian HBP., Study Design: A mixed-methods (qualitative-quantitative) research design was employed in this study., Methods: This study was conducted in two phases. First, semi-structured interviews were undertaken to retrieve potential solutions. Then an analytic hierarchy process (AHP) reflecting on seven criteria of acceptability, effectiveness, time, cost, feasibility, burden of disease, and fairness was performed to prioritize them., Results: In total, 26 individuals participated in semi-structured interviews and several policy solutions were proposed. Following the AHP, preventive interventions, infant-specific interventions, inpatient interventions, interventions until 6 years of age, and emergency interventions gained the highest priority to incorporate in the Iranian HBP., Conclusion: A number of policy solutions were explored and prioritized for P&O services in the Iranian HBP. Our findings provide a framework for decision- and policy-makers in Iran and other countries aiming to curb the financial burdens of P&O users, especially in vulnerable groups., Competing Interests: The authors have declared that no competing interests exist.

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.)

Physicians offer unique contributions to the orthopaedic implant design process by providing creative ideas and insightful clinical expertise. This article provides a brief overview of the pertinent considerations of transforming a concept into an orthopaedic implant and bringing it to the market. Implant concept choice should consider medical or surgical necessity, regional variability, market characteristics, cost of goods sold, and average selling price. Implant development requires adherence to regulatory requirements and device classification. Implant production incorporates design specifications, mechanical testing, sterilization, packaging, and marketing and sales. Orthopaedic implant company agreements determine physician compensation through royalties and/or the purchase of intellectual property. After rollout, physicians participate in monitoring for device safety. Bringing an orthopaedic implant from a concept to the market can be lengthy and complicated, but innovation is essential for advancing patient care and well-being.

Craniofacial prostheses are commonly used to restore aesthetics for those suffering from malformed, damaged, or missing tissue. Traditional fabrication is costly, uncomfortable for the patient, and laborious; involving several hours of hand-crafting by a prosthetist, with the results highly dependent on their skill level. In this paper, we present an advanced manufacturing framework employing three-dimensional scanning, computer-aided design, and computer-aided manufacturing to efficiently fabricate patient-specific ear prostheses. Three-dimensional scans were taken of ears of six participants using a structured light scanner. These were processed using software to model the prostheses and 3-part negative moulds, which were fabricated on a low-cost desktop 3D printer, and cast with silicone to produce ear prostheses. The average cost was approximately $3 for consumables and $116 for 2 h of labour. An injection method with smoothed 3D printed ABS moulds was also developed at a cost of approximately $155 for consumables and labour. This contrasts with traditional hand-crafted prostheses which range from $2,000 to $7,000 and take around 14 to 15 h of labour. This advanced manufacturing framework provides potential for non-invasive, low cost, and high-accuracy alternative to current techniques, is easily translatable to other prostheses, and has potential for further cost reduction.

Treatment and management of sacroiliac joint pain is often non-surgical, involving packages of care that can include analgesics, physiotherapy, corticosteroid injections and radiofrequency ablation. Surgical intervention is considered when patients no longer respond to conservative management. The iFuse Implant System is placed across the sacroiliac joint using minimally invasive surgery, stabilising the joint and correcting any misalignment or weakness that can cause chronic pain. The iFuse system was evaluated in 2018 by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). Clinical evidence for iFuse suggests improved pain, Oswestry disability index (ODI) and quality of life compared to non-surgical management. The company (SI-Bone ® ) submitted two cost models indicating that iFuse was cost saving compared with open surgery and non-surgical management. Clinicians advised that non-surgical management was the most appropriate comparator and Cedar (a health technology research centre) made changes to the model to test the impact of higher acquisition and procedure costs. Cedar found iFuse to be cost incurring by approximately £560 per patient at 7 years. During the consultation period, the company reduced the cost of some iFuse consumables, and Cedar extended the time horizon to test the assumption that iFuse would become cost saving over time. These changes indicated that iFuse becomes cost saving at 8 years (approximately £129 per patient), after which the cost saving continues to increase. NICE published guidance in October 2018 recommending that the case for adoption of the iFuse system in the UK National Health Service (NHS) was supported by the evidence.

Objective: Options for the management of orbital floor fractures continue to evolve offering both potential advantages as well as higher costs. To date, the effect of implant choice on the cost associated with the repair of orbital floor fractures has not been studied., Methods: A retrospective review at a tertiary care, level I trauma center examining all adult, uncomplicated orbital floor fractures that underwent open reduction and internal fixation from 2013 to 2016. Patients with concurrent operative facial fractures were excluded. The main outcomes were overall cost of care from injury to last follow-up and operating room-related costs. Costs were determined using computerized records of charges as well as the hospital Charge Description Master. Kruksal-Wallis rank sum tests were used to analyze for differences between groups., Results: Twenty-eight patients fulfilled the inclusion criteria. Eight different stock, non-patient specific, implants were used for repair. The cost of individual types of implants ranged from $70.25 to $7 718.00. Total cost of care per patient across all implant types averaged $35 585.57 (range $25 586.26 to $49 985.74, P  = .34). Operation-related charges accounted for the vast majority (94.4%) of the total cost of care. One complication occurred requiring operative re-positioning of the implant with an additional $13 042.41 in charges., Conclusions: In the setting of uncomplicated orbital floor fractures, surgeons should select an implant that allows them to carry out the repair in a safe, timely fashion. Additional large-scale studies would help to further delineate cost differences.

Introduction: Implant wastage is an under-reported issue in orthopaedics, yet it has been shown to have a significant cost burden on healthcare budgets. In a background of a perilous financial climate in the UK health service, our aim was to define the frequency and costs of implant wastage in orthopaedic trauma., Materials and Methods: The trauma theatre's implant logbook was retrospectively analysed between April 2017 and April 2018. Wasted implants were identified by the study authors independently. Patient demographics, implant details and costs were among the data collected. Product codes of wasted implants were used to identify implant costs through the manufacturer., Results: Implant wastage occurred in 25.1% of trauma procedures during the study period. Most wasted implants (91%) were screws. The total cost of implant wastage was £8,377.25 during the 12-month period, accounting for 2% of the total implant budget. Wasted intramedullary nails accounted for almost 50% of the total cost. More than 51% of affected procedures involved a trainee as the primary operator., Discussion: We report the first study of implant wastage in orthopaedics from the UK. Total implant wastage was higher than reported in most of the published literature, although it represented a small portion of the budget. Implant wastage is attributable to surgeons or operating theatre staff in most cases and is compounded by surgeons' limited understanding of implant costs. Initiatives to reduce implant wastage should include raising awareness of costs and departmental wastage to surgeons and operating theatre staff as well as employing preoperative planning techniques.

Introduction: Treatment of congenital ptosis is exclusively surgical; the frontalis sling method is most appropriate when the ptosis is severe, with no upper eyelid levator function. This surgery typically utilizes various materials (autologous fascia lata, silicone, nylon, or polypropylene bands, etc.)., Materials and Methods: This was a retrospective descriptive study of 22 children under 16 years of age, treated for congenital ptosis by frontalis suspension of the levator muscle of the upper eyelid using the polypropylene technique, between January 1, 2014 and June 30, 2017 at the African Institute of Tropical Ophthalmology teaching hospital., Results: In our study, the surgical result (prior to correction of recurrences) was satisfactory in 81.82 % of cases, with a recurrence rate of 13.64 %. The mean follow-up was 14 months, ranging from 4 to 25 months., Discussion: The use of polypropylene provides encouraging results in ptosis surgery, while also offering the advantage of being low cost and more available. Its use in developing countries deserves special attention., (Copyright © 2019 Elsevier Masson SAS. All rights reserved.)

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations., Competing Interests: None

Purpose: Approximately 1.5% of the world's population (∼100 million people) need a prosthesis/orthosis. The objective of the study was to establish an overview of the literature that has examined prosthetic and orthotic interventions with a view to inform policy development. Methods: Fourteen databases were searched from 1995-2015. Studies reporting primary research on the effectiveness or cost-effectiveness of prosthetic and orthotic interventions were examined. Metadata and information on study characteristics were extracted from the included studies. Results: The searches resulted in a total of 28,958 articles, a focus on studies with the words "randomized" OR "randomized" OR "cost" OR "economic" in their citation reduced this total to 2644. Research has predominantly been conducted in Australia, Canada, Germany, Netherlands, UK and USA. A total of 346 randomized controlled trials were identified, with only four randomized controlled trials examining prosthetic interventions. The majority of research examined lower limb orthoses in the adult population and used a wide range of outcome measures. Conclusions: While various international organizations have highlighted the value of providing prosthetic and orthotic services, both to the user and society as a whole, the availability of scientific research to inform policy is limited. Future structured evaluation of prosthetic and orthotic interventions/services is warranted to inform future policy developments.Implications for rehabilitationResearch into prosthetic and orthotic interventions has grown substantially in the last 20 years, with most of this research conducted in a small number of countries and focusing on the use of lower limb orthotics in adult populations.Research to date has utilized an extensive range of outcome measures, the development of agreed standardized sets of outcomes would allow comparison and combination of results in future research.This study highlights the need for further research in this area, especially studies which examine the cost-effectiveness of prosthetic and orthotic provision.

Background: The COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) demonstrated that edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip resulted in reduced mortality and heart failure hospitalizations and improved quality of life compared with maximally tolerated guideline-directed medical therapy (GDMT) in patients with heart failure and 3 to 4+ secondary mitral regurgitation. Whether TMVr is cost-effective compared with GDMT in this population is unknown., Methods: We used data from the COAPT trial to perform a formal patient-level economic analysis of TMVr+GDMT versus GDMT alone for patients with heart failure and 3 to 4+ secondary mitral regurgitation from the perspective of the US healthcare system. Costs for the index TMVr hospitalization were assessed using a combination of resource-based accounting and hospital billing data (when available). Follow-up medical care costs were estimated on the basis of medical resource use collected during the COAPT trial. Health utilities were estimated for all patients at baseline and 1, 6, 12, and 24 months with the Short Form Six-Dimension Health Survey., Results: Initial costs for the TMVr procedure and index hospitalization were $35 755 and $48 198, respectively. Although follow-up costs were significantly lower with TMVr compared with GDMT ($26 654 versus $38 345; P =0.018), cumulative 2-year costs remained higher with TMVr because of the upfront cost of the index procedure ($73 416 versus $38 345; P <0.001). When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase life expectancy by 1.13 years and quality-adjusted life-years by 0.82 years at a cost of $45 648, yielding a lifetime incremental cost-effectiveness ratio of $40 361 per life-year gained and $55 600 per quality-adjusted life-year gained., Conclusions: For symptomatic patients with heart failure and 3 to 4+ secondary mitral regurgitation, TMVr increases life expectancy and quality-adjusted life expectancy compared with GDMT at an incremental cost per quality-adjusted life-year gained that represents acceptable economic value according to current US thresholds., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079.

Importance: Significant cost savings can be achieved from consolidating purchases of spinal implants with a single vendor. However, it is currently unknown whether sole-source contracting or vendor rationalization more broadly affects patient care., Objectives: To describe the single-vendor procurement of spinal implants, characterize the economic benefits of sole-source contracting, and gauge whether vendor rationalization is associated with a diminished quality of care., Design, Setting, and Participants: This retrospective cohort study assessed adult patients receiving single-level lumbar interbody fusions at a single institution from January 1, 2009, to July 31, 2017. Exclusion criteria included multilevel fusions and prior spinal fusions., Exposures: Patients were analyzed based on the number of vendors available to surgeons at the time of the patient's surgery. January 1, 2009, to December 31, 2010, was defined as the multivendor period (10 vendors); January 1, 2011, to December 31, 2014, was defined as the dual-vendor period; and January 1, 2015, to July 31, 2017, was defined as the single-vendor period., Main Outcomes and Measures: Rates of 12-month revision surgery, complications, 30-day readmissions, and postoperative patient-reported outcomes, as measured by 5-dimension European Quality of Life (EQ-5D) and Patient-Reported Outcomes Measurement Information System-Global Health (PROMIS-GH) utilities. Propensity score weighting was performed to control for confounding. The Holm method was used to correct for multiple testing. Annual cost savings associated with the dual-vendor and single-vendor periods were also reported., Results: A total of 1373 patients (mean [SD] age, 59.2 [12.6] years; 763 [55.6%] female; 1161 [84.6%] white) were analyzed. Rates of revisions after adjusting for confounding were 3.2% (95% CI, 1.5%-6.7%) for the multivendor period, 4.5% (95% CI, 3.1%-6.5%) for the dual-vendor period, and 3.0% (95% CI, 1.7%-5.0%) for the single-vendor period. Complication rates were 5.3% (95% CI, 2.7%-10.1%) for the multivendor period, 7.2% (95% CI, 5.4%-9.6%) for the dual-vendor period, and 6.4% (95% CI, 4.6%-8.8%) for the single-vendor period. Readmission rates were 14.2% (95% CI, 9.7%-20.2%) for the multivendor period, 12.6% (95% CI, 10.1%-15.5%) for the dual-vendor period, and 9.7% (95% CI, 7.4%-12.7%) for the single-vendor period. Revisions, complications, and patient-reported outcomes were statistically equivalent across all periods. Readmissions were not statistically equivalent but not statistically different. The savings attributable to vendor rationalization were 24% for the dual-vendor and 21% for the single-vendor periods., Conclusions and Relevance: The single-vendor procurement of spinal implants was associated with significant cost savings without evidence of an associated decline in the quality of care. Large hospital systems may consider sole-source purchasing as a viable cost reduction strategy.

Background: During an orthopedic or trauma surgery procedure, when an implantable medical device is unpackaged, not implanted and cannot be resterilized, it is considered "waste". The cost burden falls on the hospital. The French Social Security Code provides for add-on reimbursement for certain expensive or very specialized devices (supplementary list of costly implants). To allow its restocking without linking it to a patient or reimbursement request, the wasted implant is tracked in a computerized database. The economic impact of these wasted implants is not known in France. This led us to conduct a retrospective study: 1) to determine the percentage and number of wasted implants, 2) to identify elements related to the surgery that impact implant waste., Hypothesis: Various elements of the surgical environment (type of procedure, specialty, surgeon experience, time of year) can independently contribute to the non-implantation of a medical device., Methods: We carried out a retrospective observational study of data collected prospectively in the database of our teaching hospital in 2016. The primary outcome was the percentage of wasted implants. The secondary outcome was the mean cost of these wasted implants. These parameters were determined for all the implants used in orthopedics and trauma surgery and tracked in this department, then for each variable hypothesized to led to non-implantation. Our analysis was descriptive, then comparative., Results: In our database, 29,073 devices were tracked (€3,761,180), of which 1995 devices were wasted (6.9%). The total cost of the wasted implants was €179,193 (4.8% of the overall cost). The breakdown of the wasted implants was 430 (4.4%) from the add-on list (average cost of €293.10) versus 1565 implants associated with the hospital's diagnosis-related group payment system (average cost of €33.90). Trauma surgery procedures had significantly more wasted implants than orthopedic surgery (1135 vs. 860 (p<0.01)), although the individual cost was less (€59.20 vs. €130.10 (p<0.01)). Fracture fixation implants were more likely to be wasted than ligament reconstruction or arthroplasty implants, with a lower mean cost. More implants were wasted during hip arthroplasty than during other arthroplasty procedures. Less experienced surgeons wasted more implants than more experienced surgeons (1087 vs. 905 (p<0.01)) but these implants cost less (€69.20 vs. €114.80 (p<0.05)). The percentage of implants wasted was higher during the resident changeover period relative to the other months of the year (772 vs. 1223 (p<0.01))., Discussion: This study is the first attempt at quantifying the number and cost of wasted implants in the context of orthopedics and trauma surgery at a teaching hospital in France. While trauma surgery is associated with more wasted implants, the cost burden is higher in orthopedics. Surgeons, by virtue of their experience and teaching mandate, have a decisive role managing this cost burden., Type of Study: IV, Retrospective study., (Copyright © 2019. Published by Elsevier Masson SAS.)

Biofabrication holds great potential to revolutionize important industries in the health, food, and textile sectors, but its translation to market is still challenging. I analyze the current state of innovation and commercialization in biofabrication and try to assess its limitations, strengths, and future progress., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Time-varying magnetic field gradients involved in magnetic resonance examinations can damage implanted electronic systems. The quantity related to this side effect is the gradient slew rate, which is usually not directly available on magnetic resonance console. The present study proposes a low-cost approach in slew rate assessment, which is useful in risks versus benefits evaluation as well as in sequences optimization. The experimental method is based on an analog circuit, which senses the output voltage of the scanner waveform generator. This allows taking easy and reliable slew rate measurements, even during clinical examinations on patients. Whereas previous studies required managing a considerable amount of data, the present work addresses only the maximal slew rate of any clinical sequence. Experimental results show that the smooth gradient mode, selectable on the two scanners examined, is very effective in patient safety improvement. In particular, it reduces slew rate values in the range from 52.4 up to 132.4 T m -1 s -1 , i.e. far below the interval 216-346 T m -1 s -1 , indicated as slew rate tolerance limit of modern implanted electronic devices. Bioelectromagnetics. 2019;40:512-521. © 2019 Bioelectromagnetics Society., (© 2019 Bioelectromagnetics Society.)

Blepharoptosis or ptosis is a common and potentially debilitating clinical problem. Long-term surgical treatment for ptosis caused by progressive myopathies can be challenging due to potential recurrence and complications associated with facial muscle weakness. When surgical treatment is no longer effective, an eyelid crutch can be used as an alternative intervention. This report demonstrates how 3D printing was used to rapidly design, prototype, and manufacture new custom-fit eyelid crutches at a low cost.

Background: A corticosteroid-eluting sinus implant was recently approved by the FDA as a drug to treat adult patients with nasal polyps who have undergone previous endoscopic sinus surgery (ESS) of the ethmoid sinuses. ESS is performed in an operating room under general anesthesia, whereby diseased tissue and bone are removed to provide improved drainage. ESS typically involves dissection of 1 or more of the 4 paired sinus cavities (maxillary, ethmoid, sphenoid, or frontal). The implant, containing 1,350 mcg of mometasone furoate, is inserted by a physician in an office setting and offers controlled localized release of corticosteroid to the polypoid sinus tissue. The implant has demonstrated significant improvements in clinical testing; however, little research has been conducted on its economic impact., Objective: To evaluate and quantify the budget impact to a commercial payer of using this implant instead of ESS in patients with nasal polyps after a previous ESS. Since essentially all patients with recurrent nasal polyps after ESS are patients with chronic sinusitis (CS) diagnosis, this study also identified patients with CS with nasal polyposis (CSwNP) for consistency with the patient population studied in clinical trials evaluating the implant., Methods: A budget impact analysis was conducted from a U.S. commercial payer perspective over a 1-year time horizon with patients who received the implant or revision ESS. Primary outcomes of interest were annual total and per-member per-month (PMPM) direct health care costs. Costs were estimated using a decision analysis model, assuming 50% implant utilization as an alternative to revision ESS in eligible patients, with other levels (25%, 75%) also considered. The model utilized the results of a recently published analysis of 86,052 patients in the Blue Health Intelligence database, results from published clinical trials evaluating the implant, a literature review, and published Medicare national payment amounts., Results: A commercial health plan with 1 million members could anticipate 1,000 CSwNP patients as candidates for receiving the implant or revision ESS. Estimated direct treatment costs for refractory CSwNP using only revision ESS are $11.03 million ($0.92 PMPM). If the implant replaced surgery in 50% of cases and if 63% those patients received a second treatment with the implant during the year, the estimated total cost savings would be $2.56 million ($0.21 PMPM). Cost savings associated with using the implant changed to $0.11 PMPM and $0.32 PMPM with implant adoption of 25% and 75%, respectively., Conclusions: In a large commercially insured U.S. population, annual revision ESS costs are substantial. Using the implant instead of revision ESS could result in considerable cost savings for payers at various levels of adoption., Disclosures: This study was sponsored by Intersect ENT, which was involved in study design and manuscript review. Ernst and Imhoff are employed by CTI Clinical Trial and Consulting Services, which contracted with Intersect ENT to conduct this study. Ernst and Imhoff also report other financial support from Intersect ENT during the conduct of the study. DeConde reports personal fees from Intersect ENT during the conduct of the study, as well as personal fees from Optinose, Stryker Endoscopy, and Olympus, outside the submitted work. Manes reports grants from Intersect ENT during the conduct of the study, as well as grants from Optinose and Sanofi outside the submitted work.

Purpose: Severe corneal disease contributes significantly to the global burden of blindness. Corneal allograft surgery remains the most commonly used treatment, but does not succeed long term in every patient, and the odds of success fall with each repeated graft. The Boston keratoprosthesis type I has emerged as an alternative to repeat corneal allograft. However, cost limits its use in resource-poor settings, where most corneal blind individuals reside., Methods: All aspects of the Boston keratoprosthesis design process were examined to determine areas of potential modification and simplification, with dual goals to reduce cost and improve the cosmetic appearance of the device in situ., Results: Minor modifications in component design simplified keratoprosthesis manufacturing. Proportional machinist time could be further reduced by adopting a single axial length for aphakic eyes, and a single back plate diameter. The cosmetic appearance was improved by changing the shape of the back plate holes from round to radial, with a petaloid appearance, and by anodization of back plate titanium to impute a more natural color., Conclusions: We have developed a modified Boston keratoprosthesis type I, which we call the "Lucia." The Lucia retains the 2 piece design and ease of assembly of the predicate device, but would allow for manufacturing at a reduced cost. Its appearance should prove more acceptable to implanted patients. Successful keratoprosthesis outcomes require daily medications for the life of the patient and rigorous, frequent, postoperative care. Effective implementation of the device in resource-poor settings will require further innovations in eye care delivery.

Polymethyl methacrylate (PMMA), an easily moldable and economical synthetic resin, has been used since the 1940s. In addition, PMMA has good mechanical properties and is one of the most biocompatible alloplastic materials currently available. The PMMA can serve as a spacer and as a delivery vehicle for antibiotics. Prior studies have indicated that no significant differences in infection rates exist between autologous and acrylic cranioplasty. Although inexpensive, the free-hand cranioplasty technique often yields unsatisfactory cosmetic results. In the present study, the application of a recently developed, economic modality for the perioperative application, and molding of PMMA to ensure a precise fit in 16 patients using computer-aided design, computer-aided manufacturing, and rapid prototyping was described.The mean defect size was 102.0 ± 26.4 cm. The mean volume of PMMA required to perform the cranioplasty procedure was 51 mL. The cost of PMMA was approximately 6 Euro (&OV0556;) per mL. The costs of fabricating the implants varied from 119.8 &OV0556; to 1632.0 &OV0556; with a mean of 326.4 &OV0556; ± 371.6. None of the implants required removal during the follow-up period.

Background: Advanced heart failure (HF) can be treated conservatively or aggressively, with left ventricular assist devices (LVADs) and heart transplant (HT) being the most aggressive strategies., Objective: The goal of this review was to identify, describe, critique and summarize published cost-effectiveness analyses on LVADs for adults with HF., Methods: We conducted a literature search using PubMed and ProQuest DIALOG databases to identify English-language publications from 2006 to 2017 describing cost-effectiveness analyses of LVADs and reviewed them against inclusion criteria. Those that met criteria were obtained for full-text review and abstracted if they continued to meet study requirements., Results: A total of 12 cost-effectiveness studies (13 articles) were identified, all of which described models; they were almost evenly split between those examining LVADs as destination therapy (DT) or as bridge to transplant (BTT). Studies were Markov or semi-Markov models with one- or three-month cycles that followed patients until death. Inputs came from a variety of sources, with the REMATCH trial and INTERMACS registry common clinical data sources, although some publications also used data from studies at their own institutions. Costs were derived from standard sources in many studies but from individual hospital data in some. Inputs for health utilities, which were used in 11 of 12 studies, were generally derived from two studies. None of the studies reported a societal perspective, that is, included non-medical costs such as caregiving., Conclusions: No study found LVADs to be cost effective for DT or BTT with base case assumptions, although incremental cost-effectiveness ratios met thresholds for cost effectiveness in some probabilistic analyses. With constant improvements in LVADs and expanding indications, understanding and re-evaluating the cost effectiveness of their use will be critical to making treatment decisions.

Objectives: To evaluate the healthcare cost of amputation and prosthesis for management of upper and lower extremities in a single institute., Design: Retrospective cohort study conducted between 2000 and 2014., Participants: All patients who underwent upper (UEA) and lower extremities amputation (LEA) were identified retrospectively from the operating theatre database. Collected data included patient demographics, comorbidities, interventions, costs of amputations including hospitalisation expenses, length of hospital stay and mortality., Outcome Measures: Incidence, costs of amputation and hospitalisation according to the level of the amputation and cost per bed days, length of hospital stay and mortality., Results: A total of 871 patients underwent 1102 (major 357 and minor 745) UEA and LEA. The mean age of patients was 59.4±18.3, and 77.2% were males. Amputations were most frequent among elderly (51.1%). Two-third of patients (75.86%, 95% CI 72.91% to 78.59%) had diabetes mellitus. Females, Qatari nationals and non-diabetics were more likely to have higher mean amputation and hospital stay cost. The estimated total cost for major and minor amputations were US$3 797 930 and US$2 344 439, respectively. The cumulative direct healthcare cost comprised total cost of all amputations, bed days cost and prosthesis cost and was estimated to be US$52 126 496 and per patient direct healthcare procedure cost was found to be US$59 847. The total direct related therapeutic cost was estimated to be US$26 096 046 with per patient cost of US$29 961. Overall per patient cost for amputation was US$89 808., Conclusions: The economic burden associated with UEA and LEA-related hospitalisations is considerable. Diabetes mellitus, advanced age and sociodemographic factors influence the incidence of amputation and its associated healthcare cost. The findings will help to showcase the economic burden of amputation for better management strategies to reduce healthcare costs. Furthermore, larger prospective studies focused on cost-effectiveness of primary prevention strategies to minimise diabetic complication are warranted., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Study Design: Prospective case series of nine children with early-onset scoliosis (EOS) treated by a single surgeon with a novel implant, the magnet-driven growing rod (MdGR) in a publicly funded health care service accounting for "payer costs" (PC) incurred., Objective: The aim of this study was to compare the cost-effectiveness of MdGR versus conventional growing rods (CGRs) with respect to the PC incurred for treating EOS at 5 years., Summary of Background Data: Cost estimate and mathematical modeling study projections of MdGR have shown despite high insertional costs, it breaks even with CGR by 3 to 4 years. However, no clinical study to date exists either supporting or refuting this hypothesis., Methods: Nine patients with EOS secondary to idiopathic (two), congenital (one), syndromic (three), and neuromuscular (three) etiologies treated by submuscular insertion of MdGR against stringent inclusion criteria formed the study cohort. We collected costs incurred with all aspects of care over the lifetime of device (or at least 5 years) from payers' perspective to compute and report average PC incurred per patient. We performed this cost analysis by comparing the MdGR PC against literature reported PC for CGR at 5 years., Results: There were five single rod (SR) and two dual rod (DR) de novo MdGR insertions, while two patients had conversion of CGR to MdGR. MdGR alone accounted for at least 50% of overall budget. The MdGR was at least 40% more cost-effective in comparison to the CGR (£34,741 vs. £52,293) and there were seven MdGR graduates., Conclusion: The first study reporting direct PC incurred in EOS treated by MdGR that is devoid of any mathematical modeling and deterministic sensitivity analysis is presented. The true societal/human cost savings taking into consideration indirect costs are likely to be significantly higher. MdGR is a promising novel implant that may eventually become the "standard of care" for certain EOS etiologies., Level of Evidence: 4.

There is a paucity of available research on knowledge of orthopaedic implant costs and healthcare schemes among orthopaedic residents. With the rising healthcare costs in Singapore, it is imperative for residents, who are the future surgeons, to understand these issues in order to provide proper counselling and cost-effective management. This study aimed to quantify how accurately they understood these issues and determine if senior residents had better knowledge given their increased experience. An online survey was administered to all orthopaedic residents within a residency programme. There was poor knowledge of implant costs and healthcare schemes among residents. Junior residents fared better at healthcare schemes, while senior residents fared better at estimation of implant costs. Education on these issues should be incorporated into the residency programme to bring about more holistic and cost-conscious clinicians., (Copyright: © Singapore Medical Association.)

Health care costs in the United States continue to rise, and economic pressures influencing the care of the orthopedic trauma patient have never been greater. Value-based health care is vital to the survival of the current health care system, and the use of value-based implants is central to success. Value-based implants have similar clinical outcomes to conventional implants; however, multiple barriers exist. Despite biomechanical equivalence and significant cost savings, surgeons have difficultly changing implant use without financial incentive. The rise of physician-owned surgery centers, bundled payments, and gain sharing and comanagement agreements will likely drive this change., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Medical devices are estimated to account for 6 percent of health expenditures in the US and 7 percent in European Union (EU) countries. Cardiac implants are a large segment of the market, but little is known about their prices. Using 2006-14 data from a large hospital panel survey, this article provides a systematic comparison of prices of cardiac implants between the US and four EU countries. The data reveal that prices were two to six times higher in the US than in Germany, where cardiac implants were generally the cheapest. Prices also varied between EU countries. Prices of coronary stents and pacemakers were higher in France and Italy than in the UK, where prices were similar to those in Germany. The data also confirmed findings of prior studies that found significant price variation between hospitals within a given country. This study found that within- and between-country variations were similar in magnitude. While these findings can help assess whether technology-related policies effectively control the prices of cardiac devices, future research is necessary to establish a causal relationship between prices and several possible explanatory factors and help policy makers understand which mechanisms are available to control device prices.

Background: Despite the recognition that inguinal hernia (IH) repair is cost-effective, repair rates in low- and middle-income countries remain low. Estimated use of mesh in low- and middle-income countries also remains low despite publications about low-cost, noncommercial mesh. The purpose of our study was to assess the current state of IH repair in the northern and transitional zone of Ghana., Materials and Methods: A retrospective review of surgical case logs of IH repairs from 2013 to 2017 in 41 hospitals was performed. Multivariate logistic regression was used to determine predictors of mesh use., Results: Eight thousand eighty male patients underwent IH repair. The range of IH repair in each region was 96 to 295 (overall 123) per 100,000 population. Most cases were performed at district hospitals (84%) and repaired nonurgently (93%) by nonsurgeon physicians (66%). Suture repair was most common (85%) although mesh was used in 15%. The strongest predictor of mesh use was when a surgeon performed surgery (odds ratio [OR] 3.13, P <0.001), followed by surgery being performed in a teaching hospital (OR 2.31, P <0.001). Repair at a regional hospital was a negative predictor of mesh use (OR 0.08, P <0.001) as was the use of general anesthesia (OR 0.40, P = 0.001)., Conclusions: Most IH repairs are performed in district hospitals, by nonsurgeon physicians, and without mesh. Rates of repair and the use of mesh are higher than previous estimates in Ghana and Sub-Saharan Africa but not as high as high-income countries., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Traditional manufacturing methods and materials used to fabricate epidermal electronics for physiological monitoring, transdermal stimulation, and therapeutics are complex and expensive, preventing their adoption as single-use medical devices. This work describes the fabrication of epidermal, paper-based electronic devices (EPEDs) for wearable and implantable applications by combining the spray-based deposition of silanizing agents, highly conductive nanoparticles, and encapsulating polymers with laser micromachining. EPEDs are inexpensive, stretchable, easy to apply, and disposable by burning. The omniphobic character and fibrous structure of EPEDs make them breathable, mechanically stable upon stretching, and facilitate their use as electrophysiological sensors to record electrocardiograms, electromyograms, and electrooculograms, even under water. EPEDs can also be used to provide thermotherapeutic treatments to joints, map temperature spatially, and as wirelessly powered implantable devices for stimulation and therapeutics. This work makes epidermal electronic devices accessible to high-throughput manufacturing technologies and will enable the fabrication of a variety of wearable medical devices at a low cost.

Background: There are few studies of the economic value of orthotic and prosthetic services. A prior cohort study of orthotic and prosthetic Medicare beneficiaries based on Medicare Parts A and B claims from 2007 to 2010 concluded that patients who received timely orthotic or prosthetic care had comparable or lower total health care costs than a comparison group of untreated patients. This follow-up study reports on a parallel analysis based on Medicare claims from 2011 to 2014 and includes Part D in addition to Parts A and B services and expenditures. Its purpose is to validate earlier findings on the extent to which Medicare patients who received select orthotic and prosthetic services had less health care utilization, lower Medicare payments, and potentially fewer negative outcomes compared to matched patients not receiving these services., Methods: This is a retrospective cohort analysis of 78,707 matched pairs of Medicare beneficiaries with clinical need for orthotic and prosthetic services (N = 157,414) using 2011-2014 Medicare claims data. It uses propensity score matching techniques to control for observable selection bias. Economically, a cost-consequence evaluation over a four-year time horizon was performed., Results: Patients who received lower extremity orthotics had 18-month episode costs that were $1939 lower than comparable patients who did not receive orthotic treatment ($22,734 vs $24,673). Patients who received spinal orthotic treatment had 18-month episode costs that were $2094 lower than comparable non-treated patients ($23,560 vs $25,655). Study group beneficiaries receiving both types of orthotics had significantly lower Part D spending than those not receiving treatment (p < 0.05). Patients who received lower extremity prostheses had comparable 15-month episode payments to matched beneficiaries not receiving prostheses ($68,877 vs $68,893) despite the relatively high cost of the prosthesis., Conclusions: These results were consistent with those found in the prior study and suggest that orthotic and prosthetic services provide value to the Medicare program and to the patient.

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.)

This paper reports the novel design of a touch mode capacitive pressure sensor (TMCPS) system with a wireless approach for a full-range continuous monitoring of ventricular pressure. The system consists of two modules: an implantable set and an external reading device. The implantable set, restricted to a 2 × 2 cm² area, consists of a TMCPS array connected with a dual-layer coil, for making a reliable resonant circuit for communication with the external device. The capacitive array is modelled considering the small deflection regime for achieving a dynamic and full 5⁻300 mmHg pressure range. In this design, the two inductive-coupled modules are calculated considering proper electromagnetic alignment, based on two planar coils and considering the following: 13.56 MHz frequency to avoid tissue damage and three types of biological tissue as core (skin, fat and muscle). The system was validated with the Comsol Multiphysics and CoventorWare softwares; showing a 90% power transmission efficiency at a 3.5 cm distance between coils. The implantable module includes aluminum- and polyimide-based devices, which allows ergonomic, robust, reproducible, and technologically feasible integrated sensors. In addition, the module shows a simplified and low cost design approach based on PolyMEMS INAOE ® technology, featured by low-temperature processing.

This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.

Background: Studies have demonstrated that physicians are often unaware of prescription drug, laboratory, diagnostic, and surgical supply costs., Objective: To investigate the effects of increased physician awareness on infection incidence and surgical device cost containment., Methods: Within our institution, physicians were informed of individual, independently adjudicated, craniotomy and ventricular shunt infection incidence and rankings among peers, after which a protocol aimed at reducing skin bacterial burden was implemented for craniotomies. Physicians were also made aware of the costs for shunts and dural substitutes as well as available alternatives., Results: The combined craniotomy and ventricular shunt infection incidence significantly decreased by 37.5% from 3.2% over May 2011 to April 2015 (132 infections/4137 procedures) to 2.1% over May 2015 to April 2016 (26 infections/1250 procedures; P = .041). The average annual cost savings was $234 175 from preventing postoperative craniotomy infections and $121 125 from preventing postoperative ventricular shunt infections. Total supply costs of ventricular shunts significantly decreased by 26% from $2345 per procedure in fiscal year 2015 to $1747 per procedure in fiscal year 2016 (P < .001). Total supply cost of dural grafts significantly decreased by 54% from $191 per procedure in fiscal year 2015 to $88 per procedure in fiscal year 2016 (P < .001). In total, all initiatives in this study resulted in an estimated annual savings of $567 062., Conclusion: Physician awareness of outcomes and costs resulted in increasing the quality of care, while at the same time reducing the cost.

This document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.

Background: Assistive products are items which allow older people and people with disabilities to be able to live a healthy, productive and dignified life. It has been estimated that approximately 1.5% of the world's population need a prosthesis or orthosis., Objective: The objective of this study was to systematically identify and review the evidence from randomized controlled trials assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions., Methods: Literature searches, completed in September 2015, were carried out in fourteen databases between years 1995 and 2015. The search results were independently screened by two reviewers. For the purpose of this manuscript, only randomized controlled trials which examined interventions using orthotic or prosthetic devices were selected for data extraction and synthesis., Results: A total of 342 randomised controlled trials were identified (319 English language and 23 non-English language). Only 4 of these randomised controlled trials examined prosthetic interventions and the rest examined orthotic interventions. These orthotic interventions were categorised based on the medical conditions/injuries of the participants. From these studies, this review focused on the medical condition/injuries with the highest number of randomised controlled trials (osteoarthritis, fracture, stroke, carpal tunnel syndrome, plantar fasciitis, anterior cruciate ligament, diabetic foot, rheumatoid and juvenile idiopathic arthritis, ankle sprain, cerebral palsy, lateral epicondylitis and low back pain). The included articles were assessed for risk of bias using the Cochrane Risk of Bias tool. Details of the clinical population examined, the type of orthotic/prosthetic intervention, the comparator/s and the outcome measures were extracted. Effect sizes and odds ratios were calculated for all outcome measures, where possible., Conclusions: At present, for prosthetic and orthotic interventions, the scientific literature does not provide sufficient high quality research to allow strong conclusions on their effectiveness and cost-effectiveness.

Hammertoe deformities are one of the most common foot deformities, affecting up to one third of the general population. Fusion of the joint can be achieved with various devices, with the current focus on percutaneous Kirschner (K)-wire fixation or commercial intramedullary implant devices. The purpose of the present study was to determine whether surgical intervention with percutaneous K-wire fixation versus commercial intramedullary implant is more cost effective for proximal interphalangeal joint arthrodesis in hammertoe surgery. A formal cost-effectiveness analysis using a decision analytic tree model was conducted to investigate the healthcare costs and outcomes associated with either K-wire or commercial intramedullary implant fixation. The outcomes assessed included long-term costs, quality-adjusted life-years (QALYs), and incremental cost per QALY gained. Costs were evaluated from the healthcare system perspective and are expressed in U.S. dollars at a 2017 price base. Our results found that commercial implants were minimally more effective than K-wires but carried significantly higher costs. The total cost for treatment with percutaneous K-wire fixation was $5041 with an effectiveness of 0.82 QALY compared with a commercial implant cost of $6059 with an effectiveness of 0.83 QALY. The incremental cost-effectiveness ratio of commercial implants was $146,667. With an incremental cost-effectiveness ratio of >$50,000, commercial implants failed to justify their proposed benefits to outweigh their cost compared to percutaneous K-wire fixation. In conclusion, percutaneous K-wire fixation would be preferred for arthrodesis of the proximal interphalangeal joint for hammertoes from a healthcare system perspective., (Copyright © 2017 The American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.)

A recent Senate Inquiry investigated the Prostheses List (PL) which has been an integral part of the private health care system since its introduction in 1985. The PL sets the price of various prostheses products available for private health insurance patients. In recent years however, the PL has come under scrutiny due to the inflated prices of prostheses, lack of transparency from the list's creators and regulators, and increased premiums. This column critically analyses the recent Senate report, particularly as to whether it appropriately addressed the various concerns and issues raised in submissions and terms of reference of the inquiry and what ongoing role the PL should have in the Australian Healthcare System.

This study examines the burden of road traffic injuries (RTIs) among road crash victims in a tertiary hospital in Ibadan, Nigeria. The study adopted a purposive sampling method to obtain primary data. Interview was done with 266 RTI victims who were admitted to the University College Hospital, Ibadan and discharged between March and May, 2015, using a structured questionnaire. From the data obtained, the study carried out descriptive statistical analyses. The results showed that the average cost per patient for RTI treatment was ₦ 42,946 ($215.9); on average, the amount expended on surgery was the highest followed by wound dressing and drugs; and the prevalence of catastrophic out-of-pocket (OOP) expenditure was over 86%. It is recommended that given the high burden of OOP hospital expenditure associated with RTI, there is need to implement more effective financial protection mechanisms against the high OOP expenditure faced by crash victims.

Background: Although studies assessing the cost effectiveness of genotype-guided warfarin dosing for the management of atrial fibrillation, deep vein thrombosis, and pulmonary embolism have been reported, no publications have addressed genotype-guided warfarin therapy in mechanical heart valve replacement (MHVR) patients or genotype-guided warfarin therapy under the fee-for-service (FFS) insurance system., Objective: The aim of this study was to evaluate the cost effectiveness of genotype-guided warfarin dosing in patients with MHVR under the FFS system from the Korea healthcare sector perspective., Methods: A decision-analytic Markov model was developed to evaluate the cost effectiveness of genotype-guided warfarin dosing compared with standard dosing. Estimates of clinical adverse event rates and health state utilities were derived from the published literature. The outcome measure was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY). One-way and probabilistic sensitivity analyses were performed to explore the range of plausible results., Results: In a base-case analysis, genotype-guided warfarin dosing was associated with marginally higher QALYs than standard warfarin dosing (6.088 vs. 6.083, respectively), at a slightly higher cost (US$6.8) (year 2016 values). The ICER was US$1356.2 per QALY gained. In probabilistic sensitivity analysis, there was an 82.7% probability that genotype-guided dosing was dominant compared with standard dosing, and a 99.8% probability that it was cost effective at a willingness-to-pay threshold of US$50,000 per QALY gained., Conclusion: Compared with only standard warfarin therapy, genotype-guided warfarin dosing was cost effective in MHVR patients under the FFS insurance system.

Objectives: To present a method aimed to evaluate the economic impact associated with the use of medical devices (DM) not reimbursed in addition to diagnosis related groups (DRGs) tariffs using the example of biological meshes for parietal reinforcement., Methods: In this multicenter retrospective cohort study, we included all patients who received a biological mesh between January 2010-April 2014 (University hospitals of Saint-Étienne, France) or between January 2010-March 2015 (Lyon University hospitals, France). Measured costs associated with biologic meshes were compared to those of the "Étude nationale des coûts à méthodologie commune" (2012) to weigh the economic impact of biologic meshes with the French DRGs costs. We also compared these costs to the fares perceived by the hospital from the French sickness fund (GHS)., Results: Thirty-six patients received a biological mesh and were treated by a total of 38 biological meshes. Of these, the implant was Protexa ® , Permacol ® and Strattice ® in 66%, 29% and 5% of cases respectively. The hospitals incomes were 10,496±5562€ per stay. Meshes-related expenditures represented in average 28% of DRGs costs and 38% of GHS tariffs. The mean additional cost for biological meshes was 3793±2292 euros compared to the mean cost on implantable medical devices in the French DRGs., Conclusion: Given their currently restricted use, the hospital budget impact of biological meshes remains limited although the incremental cost per patient is substantial. Analytic costs data can be useful within the scope of decision-making related to DM not refunded by the French health system., (Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)