[The issues of development and functioning of common market of medical equipment and articles within the framework of the Eurasian Economic Union].

The market of medical devices within the framework of the Eurasian Economic Union is regulated by special legislation that ensures formation of common market and compliance of products with all necessary requirements. This allows to ensure high level of quality of medical equipment and articles that contributes into improving safety and efficiency of medical procedures. The development of uniform requirements, considering world practices, is an important step, since it allows to guarantee high standards not only at level of single states, but also at level of the entire Union. This approach facilitates reinforcement of confidence to medical production of manufacturers from he Eurasian Economic Union countries. The article examines normative legal base regulating issues of formation and functioning of common market of medical equipment and articles within the framework of the Eurasian Economic Union. The analysis of normative legal base of the Russian Federation in section related to medical articles market was carried out. The analysis of the regulatory framework of the Russian Federation in terms of issues related to the market of medical devices was also carried out. The corresponding conclusions were made based on the study results.

Health system lessons from the global fund-supported procurement and supply chain investments in Zimbabwe: a mixed methods study.

BACKGROUND: The Global Fund partnered with the Zimbabwean government to provide end-to-end support to strengthen the procurement and supply chain within the health system. This was accomplished through a series of strategic investments that included infrastructure and fleet improvement, training of personnel, modern equipment acquisition and warehouse optimisation. This assessment sought to determine the effects of the project on the health system. METHODS: This study employed a mixed methods design combining quantitative and qualitative research methods. The quantitative part entailed a descriptive analysis of procurement and supply chain data from the Zimbabwe healthcare system covering 2018 - 2021. The qualitative part comprised key informant interviews using a structured interview guide. Informants included health system stakeholders privy to the Global Fund-supported initiatives in Zimbabwe. The data collected through the interviews were transcribed in full and subjected to thematic content analysis. RESULTS: Approximately 90% of public health facilities were covered by the procurement and distribution system. Timeliness of order fulfillment (within 90 days) at the facility level improved from an average of 42% to over 90% within the 4-year implementation period. Stockout rates for HIV drugs and test kits declined by 14% and 49% respectively. Population coverage for HIV treatment for both adults and children remained consistently high despite the increasing prevalence of people living with HIV. The value of expired commodities was reduced by 93% over the 4-year period. Majority of the system stakeholders interviewed agreed that support from Global Fund was instrumental in improving the country's procurement and supply chain capacity. Key areas include improved infrastructure and equipment, data and information systems, health workforce and financing. Many of the participants also cited the Global Fund-supported warehouse optimization as critical to improving inventory management practices. CONCLUSION: It is imperative for governments and donors keen to strengthen health systems to pay close attention to the procurement and distribution of medicines and health commodities. There is need to collaborate through joint planning and implementation to optimize the available resources. Organizational autonomy and sharing of best practices in management while strengthening accountability systems are fundamentally important in the efforts to build institutional capacity.

Industry Payments to Physicians Endorsing Drugs and Devices on a Social Media Platform.

This study evaluates adherence to industry and professional standards among physicians endorsing drugs and devices on a social media platform.

Addressing the need for economic evaluation of cardiovascular medical devices in India.

This article emphasizes the pivotal role of economic evaluation in the management of cardiovascular diseases (CVDs) within the Indian healthcare system. It explores the importance of economic evaluation methodologies such as cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis in guiding informed healthcare decisions related to CVD management. Additionally, it discusses the unique challenges and opportunities surrounding health technology assessment (HTA) and economic evaluation specific to India, providing insights into potential areas for improvement. By giving precedence to economic evaluation, India can optimize the allocation of resources, improve patient outcomes, and alleviate the economic burden associated with CVDs. The implementation of these recommendations has the potential to significantly enhance the efficiency and effectiveness of CVD management strategies in India, ultimately leading to improved healthcare outcomes for the population.

The Process of Listing Prostheses and Medical Devices in Thailand's Universal Health Coverage.

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.

Administración del consultorio odontológico en contextos inflacionarios / Dental clinic administration in inflationary contexts

La administración es una herramienta fundamental que permite planificar, desarrollar y organizar cualquier empresa, independientemente del tamaño de la misma. Tener una sana administración del consultorio odontológico es imprescindi- ble para la toma de decisiones, más aún en contextos de crisis y alta inflación (AU)

Administration is a fundamental tool that allows plan- ning, developing, and organizing any company, regardless of its size. Having a healthy administration of the dental clinic is essential for decision making, even more so in contexts of crisis and high inflation (AU)

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Examining the Impact of the Current Reimbursement Regulation on Patient Access to Innovative Medical Devices in Taiwan: Insights From 8 Years' Reimbursement Data.

OBJECTIVES: This study aimed to assess the impact of the reimbursement regulation of medical devices (Regulation), introduced by the National Health Insurance Administration (NHIA) in 2013, on patients' access to innovative medical devices in Taiwan. METHODS: Analysis of the amount of time needed from application for NHIA reimbursement for new medical devices to receiving the decision from NHIA was done using the nonreimbursement product list featured on the NHIA website. Additionally, Welch analysis of variance was used to compare the amount of time it took from application to NHIA with reimbursement decisions made by the NHIA for different nonreimbursement code categories. Further, related Pharmaceutical Benefit Reimbursement Scheme meeting minutes were analyzed to obtain more detailed information concerning medical devices' reimbursement or not. RESULTS: From December 2012 to June 2021, the overall reimbursement percentage was 56.7%, and the average amount of time between application and reimbursement was 856.7 ± 474.7 days. The mandatory reimbursement rate was about 45%. NHIA reimbursement decisions as special medical devices also take a longer amount of time, because the applicants need to agree to the decision (P < .05). The NHIA decision-making process for nonreimbursement medical devices requires a significantly longer amount of time than for general materials (eg, suture, etc) decisions. CONCLUSIONS: Although the Regulation resolves payment issues, it also increases the amount of time to reach reimbursement decisions, thus hindering patient access to innovative medical devices. The study suggests that the review process needs to be simplified concerning reimbursement notification, using local real-world data to support reimbursement decisions.

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

Design of Fuzzy Aided Cognition System for International Economic and Trade Information under Supply Chain Management.

The existing fuzzy assistant cognition system has the problem of imperfect retrieval function, which leads to long execution time. This paper designs a fuzzy assistant cognition system of international economic and trade information under supply chain management. Hardware Part. Optimize wireless sensor and connect power interface and related accessories. In the software part, the dynamic characteristics of international economic and trade information elements are extracted, the flexible operation model of supply chain management is constructed, the demand-oriented organizational structure is established, the output set is determined by the product reasoning, and the retrieval function of fuzzy assistant cognitive system is designed by using the fuzzy association algorithm. Experimental Results. The average execution time of the fuzzy assistant cognitive system and the other two systems is 123.593 s, 165.733 s, and 169.506 s, which proves that the cognitive system integrated with supply chain management has a higher practical application value.

Association between Industry Payments and Published Position on Use of Devices for the Treatment of Lower Urinary Tract Symptoms.

OBJECTIVE: To determine the impact of industry payments to authors of opinion articles on the Urolift and Rezum devices. We also examined the extent to which authors omitted acknowledgements of financial conflicts-of-interest. METHODS: We searched Google Scholar for all articles that cite either of the respective pivotal trials for these devices. 2 blinded urologists coded the articles as favorable or neutral. A separate blinded researcher recorded industry payments from the manufacturers using the Open Payments Program database. RESULTS: We identified 29 articles written by 27 unique authors from an initial screening list of 235 articles. Of these articles, 15 (52%) were coded as positive and 14 (48%) were coded as neutral. 20 (74%) authors have accepted payments from the manufacturer of the device. Since 2014, these authors have collectively received $270,000 from NeoTract and $314,000 from Boston Scientific. Of the 20 authors with payments, 9 (45%) received more than $10,000 from either manufacturer. Of authors with payments, 65% (13/20) contributed to only positive articles. Authors who received payments had more than 4 times the number of article contributions than did authors without payments (42 vs 10). Authors of at least one favorable article were more likely to have received payments from the device manufacturers than authors of neutral articles (P = .014, Chi-squared test). Most (80%, 16/20) authors with payments did not report a relevant conflict-of-interest within any of their articles. CONCLUSION: These data suggest a relationship between payments from a manufacturer and positive published position on that company's device. There may be a critical lack of published editorial pieces by authors without financial conflicts of interest.

[French national overview of the inclusion of environmental criteria in the public purchasing of health products (drugs and sterile medical devices)]. / Prise en compte des critères environnementaux dans la commande publique des produits de santé.

OBJECTIVES: Healthcare products (HP) have a significant carbon footprint that must be included by regulation in the facility's purchasing policy. A national overview of the inclusion of environmental criteria (EC) in the public procurement (PP) of HP in hospitals has been carried out. METHODS: Thirty EC were identified in the literature. Two questionnaires were proposed: (i) for buyers that analyze the level of "importance" and "ease of application" for public tenders (PT), and (ii) for suppliers that declare their commitments and evidence. RESULTS: Six regional buyers and 28 suppliers participated. Buyers recognize the "importance" of sustainable development (SD) but are more reticent about the "applicability" of EC in PT. The environmental rating remains low: on average 4.38 (0.25-10.00) % of the total rating. Only 12 EC are integrated within some PT. Suppliers report a high and diversified commitment to SD: 18 suppliers sent 474 evidence. Buyers and suppliers converge on the optimization of primary packaging and the establishment of a minimum order or delivery group. CONCLUSIONS: Since the efficiency of PP is inevitable, EC that combines SD and savings should be prioritized. The integration of additional EC, simple and easily documented, allowing cost containment for both suppliers and buyers, is possible to promote sustainable purchasing.

Bringing Your Idea to the Market: A Primer for Plastic Surgeons.

SUMMARY: The progress of biotechnology, medical instruments, and applied sciences contributes to a rapidly expanding space for the advancement of the medical field. Surgeons experience first-hand the limitations of current medical devices and thus have unique insight into problems that could be solved with new products. The process of turning an idea into a product capable of success in the marketplace, however, is often unfamiliar to surgeons. The authors seek to illuminate this process and provide an ordered list of tasks that can make bringing ideas to market more achievable for surgeons. The first step in this process is the generation and protection of a new idea. Next, the process of making an idea into a product is outlined. This phase involves team assembly, business planning, and product development. Market research and valuation are key to understanding how a product can be applied in the market, and meticulous research during this phase allows for informed decision-making that will help secure funding down the road. Finally, various options for financing are discussed and compared to help surgeon-entrepreneurs find an option that best fits their project, and steps to maximize leverage are described. The development of new products can be a complicated process for surgeons. Organized into four phases, with ordered instructional steps to advance through each phase, the process of bringing an idea to the market is clarified. Facilitating this process will possibly contribute to the continual improvement of medical and surgical abilities through the introduction of new devices and technologies.

An Implementation Research Approach to Re-orient Health Supply Chains Toward an Equity Agenda in the COVID-19 Era.

The Covid-19 pandemic has exposed critical inequities in global healthcare supply chains and the need for these systems to be analyzed and reoriented with an equity lens. Implementation research methodology can guide the use of evidence-based interventions to re-orient health supply chains towards equity and optimize health outcomes. Using this approach, private and public sector entities can adapt their strategies to focus not just on efficiency and cost savings but ensuring that vulnerable populations have access to essential medications, vaccines, and supplies. Findings can inform regulations that address supply chain inequities at the global level, strengthen existing systems to fill structural gaps at the national level, and address contextual challenges at the subnational level. This methodology can help account for historical practices from prior health initiatives, identify contemporary barriers and facilitators for positive change, and have applicability to the Covid-19 pandemic and ongoing vaccine distribution efforts. An implementation research approach is critical in equipping health supply chains with a path for more resilient and equitable distribution of necessary supplies, vaccines, and delivery of care.

Adapting health technology assessment for drugs, medical devices, and health programs: Methodological considerations from the Indian experience.

INTRODUCTION: Heterogeneity in methods of economic evaluation makes the use of health technology assessment (HTA) evidence difficult. Thereby, several countries including India have developed their own standard guidelines for conducting HTAs. However, diverse HTA studies involving drugs, medical devices, health programs, and platforms require an adaptation of the standard methods. AREAS COVERED: This review presents the specific characteristics of HTAs involving medical devices and health programs requiring adaptation of the standard guidelines. We use recent HTA studies in India to illustrate specific issues. These considerations involve the nature of decision-making problems, multiple scenarios in case of health programs, and specific attention to costing and the valuation of consequences. In case of medical devices, we discuss the issue of costing application of devices, multiple usage, learning curve for achieving effects, long causal path for health outcomes, and the issue of valuing false positives. EXPERT OPINION: While standard guidelines are essential, specific features of health programs and medical devices need to be considered while undertaking HTAs. Additionally, the context in which the HTA is being undertaken, characteristics of the health system, methods of financing healthcare, and demand-side characteristics of healthcare utilization should be reflected in the HTA for health programs and medical devices.