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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.)