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.

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.

How the US Sanctions Are Affecting the Health Research System in Iran?

BACKGROUND: In November 2018, the United States withdrew from the Joint Comprehensive Plan of Action (JCPOA), known commonly as the Iran nuclear deal, and imposed severe sanctions on Iran. This study explores the impact of US sanctions in Iran's health research system. METHODS: This phenomenological study interviewed 24 Iranian health science scholars through purposeful sampling to learn about their experiences and thoughts regarding the impact of US sanctions on Iran's health research system. RESULTS: The impact of sanctions on Iran's health research system were classified into five categories: (a) financial issues, (b) difficulty in supplying laboratory materials and (c) equipment, (d) disruption in international research collaboration and activities, and (e) other issues (e.g., increased stress and workload). CONCLUSION: This study indicated that since research centers in Iran are highly dependent on governmental budgets, sanctions have greatly affected the health research system in Iran. Financial and economic problems, restrictions in transferring funds, and the disruption in political and international relations have created many challenges for supplying medical laboratory materials and equipment for medical and health research centers in Iran.

Neither protective nor harmonized: the crossborder regulation of medical devices in the EU.

To what extent does inadequate market regulation contribute to poor health outcomes? A series of prominent scandals involving harmful medical devices has made improving the regulation of these devices an urgent problem for the European Union (EU). This is, however, a specific example of a general phenomenon. The EU remains first and foremost a large and integrated market within which the EU institutions have considerable regulatory authority. Even if there is little EU commitment to a health or social policy agenda, its use of that regulatory authority shapes health care cost and quality and should be understood as health policy. We use data from EU-level and national policy documents to analyse the EU's current regulatory framework for medical devices and assess its likely future efficacy. Despite revising the medical devices directive to require more stringent pre-authorization requirements for high-risk medical devices and improvements in post-market surveillance, the key underlying problems of market fragmentation and patient safety persist. Without strong and consistent support for the implementation of the new directive, the likely result is the status quo, with significant consequences for health in Europe.

Barriers and facilitators to accessing insulin pump therapy by adults with type 1 diabetes mellitus: a qualitative study.

AIMS: Uptake of continuous subcutaneous insulin infusion (CSII) by people with diabetes (PwD) in Ireland is low and exhibits regional variation. This study explores barriers and facilitators to accessing CSII by adults with Type 1 diabetes mellitus. RESEARCH DESIGN AND METHODS: A qualitative study employing focus groups with adults with Type 1 diabetes mellitus (n = 26) and semi-structured interviews with health care professionals (HCP) and other key stakeholders (n = 21) was conducted. Reflexive thematic analysis was used to analyze data, using NVivo. RESULTS: Four main themes comprising barriers to or facilitators of CSII uptake were identified. These included: (1) awareness of CSII and its benefits, (2) the structure of diabetes services, (3) the capacity of the diabetes service to deliver the CSII service, and (4) the impact of individuals' attitudes and personal characteristics-both PwD, and HCP. Each of these themes was associated with a number of categories, of which 18 were identified and explored. If the structure of the health-service is insufficient and capacity is poor (e.g., under-resourced clinics), CSII uptake appears to be impacted by individuals': interest, attitude, willingness and motivation, which may intensify the regional inequality in accessing CSII. CONCLUSIONS: This study identified factors that contribute to gaps in the delivery of diabetes care that policy-makers may use to improve access to CSII for adult PwD.

Análise do processo de manutenção e de vida útil dos equipamentos médicos ecocardiógrafos: a experiência de um hospital de ensino / Analysis of the maintenance process and useful life of echocardiography equipment: An experience in a teaching hospital

Introdução: A ecocardiografia é uma ferramenta diagnóstica de crescente utilização na prática clínica, aplicada a diversos cenários médicos. Os cuidados e os processos de manutenção preventiva ou corretiva dos equipamentos são ainda pouco padronizados. O objetivo do presente estudo foi descrever o processo de manutenção atualmente aplicado a equipamentos ecocardiográficos em um laboratório. Descrever o processo inclui a caracterização de danos e aplicações de manutenção preventiva ou corretiva. Métodos: Estudo observacional descritivo e exploratório realizado em centro único. As informações de dados do processo de manutenção de equipamentos ecocardiográficos foram obtidas de arquivos eletrônicos do sistema de gestão de equipamentos de um laboratório de médio porte de um hospital público de nível terciário com características de ensino, no período de 2003 a 2018. Resultados: Foram identificados dez tipos de avarias mais comuns, como dano a programas (23,8%), peças (23,1%) e relacionadas à queda de energia e de acessórios (13,8%). Após a implementação do processo de manutenção preventiva, houve significativa redução dos custos de manutenções (US$ 44.472,10 versus US$ 25.807,59; p= 0,029). Mesmo após a manutenção preventiva, os custos de manutenção corretiva em equipamentos aplicados à ecocardiografia transesofágica (US$ 7.789,17) foram maiores que aqueles a equipamentos aplicados a outras modalidades (US$ 3.184,37 em ecocardiografia transtorácica e US$1.813,00 em estresse). Conclusão: O processo de manutenção de equipamentos ecocardiográficos foi descrito. Danos a equipamentos ecocardiográficos estão relacionados a altos custos, principalmente naqueles aplicados a modalidades especiais, como ecocardiografia transesofágica. As manutenções preventivas reduziram significativamente os custos de manutenção. (AU)

Introduction: Echocardiography is a diagnostic tool that is increasingly used in clinical practice in different medical scenarios; however, the preventive (PM) or corrective maintenance (CM) care and processes for this equipment are still poorly standardized. To describe the maintenance process currently implemented for echocardiographic equipment (ECHO) in a medium-sized laboratory in a tertiary-level public teaching hospital. The description of the process includes damage characterization and MP and MC implementation. Methods: This was a descriptive and exploratory single-center observational study. Data on the maintenance process of echocardiographic equipment were obtained from electronic files from the hospital's equipment management system between 2003 and 2018. Results: Together with the description of the equipment maintenance process, the ten most common types of malfunctions were identified, including software (23.8%), parts (23.1%), and power outage and accessory damage (13.8%). The implementation of the PM process significantly decreased the maintenance costs (USD 44,472.10 vs USD 25,807.59, p = 0.029). Even after the MP, the CM costs related to transesophageal echocardiography equipment (TEE) (USD 7,789.17) were higher than those with other equipment modalities (USD 3,184.37 for transthoracic echocardiography equipment (TTE) and USD 1,813.00 for stress testing). Conclusion: The maintenance process for ECHO equipment was described. ECHO equipment damage has high costs, especially in special modalities such as TEE. PM significantly reduced maintenance costs. (AU)

Dual-Channel Global Closed-Loop Supply Chain Network Optimization Based on Random Demand and Recovery Rate.

In the process of globalization, customer demand is usually difficult to predict, and product recycling is generally difficult to achieve accurately. It is also urgent to deal with increased inventory while avoiding shortages, with the purpose of reducing supply chain risks. This study analyzes the integrated supply chain decision-making problem in the random product demand and return environment. It proposes a multi-objective optimization model, which is an effective tool to solve the design and planning problems of the global closed-loop supply chain. It consists of a multi-period, single-product and multi-objective mixed integer linear programming model, which can solve some strategic decision problems, including the network structure, entity capacities, flow of products and components, and collection levels, as well as the inventory levels. From the perspective of economic, environmental and social benefits, three objective functions are defined, including maximizing the net present value (NPV) of the system, minimizing the total CO2e emissions of supply chain activities, and maximizing social sustainability indicators. Finally, a numerical example is provided to verify the advantages of this model, and sensitivity analysis results are provided. The results show that changes in product demand and return rate will have a great impact on economic and social performance.