Rescuing the Lost in Translation.

The translation of medically relevant academic inventions that could transform public health has been notoriously difficult, stemming largely from cultural differences been academia and industry. New initiatives to kindle academic entrepreneurship and establish stronger public/private partnerships are helping to align these differences and accelerating the translation of promising new therapies.

Credibility assessment of in silico clinical trials for medical devices.

In silico clinical trials (ISCTs) are an emerging method in modeling and simulation where medical interventions are evaluated using computational models of patients. ISCTs have the potential to provide cost-effective, time-efficient, and ethically favorable alternatives for evaluating the safety and effectiveness of medical devices. However, ensuring the credibility of ISCT results is a significant challenge. This paper aims to identify unique considerations for assessing the credibility of ISCTs and proposes an ISCT credibility assessment workflow based on recently published model assessment frameworks. First, we review various ISCTs described in the literature, carefully selected to showcase the range of methodological options available. These studies cover a wide variety of devices, reasons for conducting ISCTs, patient model generation approaches including subject-specific versus 'synthetic' virtual patients, complexity levels of devices and patient models, incorporation of clinician or clinical outcome models, and methods for integrating ISCT results with real-world clinical trials. We next discuss how verification, validation, and uncertainty quantification apply to ISCTs, considering the range of ISCT approaches identified. Based on our analysis, we then present a hierarchical workflow for assessing ISCT credibility, using a general credibility assessment framework recently published by the FDA's Center for Devices and Radiological Health. Overall, this work aims to promote standardization in ISCTs and contribute to the wider adoption and acceptance of ISCTs as a reliable tool for evaluating medical devices.

Resource sustainability and challenges in the supply chain: implications for infection prevention.

PURPOSE OF REVIEW: Infection prevention and control practices remain the bedrock of healthcare associated infection prevention and outbreak and epidemic control efforts. However, issues in supply chain management can hinder these efforts, as exemplified by various public health emergencies. This review explores the key role of supply chains in infection prevention and explores specific challenges. RECENT FINDINGS: In all of the critical components of infection prevention and control - hand hygiene, personal protective equipment, sterile supplies, environmental disinfection, and waste management - disruptions in supply chains have led to limited availability and dissemination. SUMMARY: Strategies to mitigate these resource constraints in the inter-epidemic period will also be highlighted. The infection prevention workforce is well poised to inform supply chain dynamics. Without robust and adequate supply chains, infection prevention and control efforts suffer which perpetuates healthcare-associated infections, clusters, and epidemics.

Medical device management reform, United Republic of Tanzania.

Health-care technology is central to boosting the productivity and quality of health-care systems. In many sub-Saharan African countries, however, medical device management systems are weak or absent. The aim of this article is to illustrate, using a case study, how policy reforms can help ensure policy on health-care technology is translated into everyday practice and how an integrated systems approach can enhance the operation of medical device management. Between 2011 and 2023, a plan to improve medical device management systems in the United Republic of Tanzania was developed and implemented through Swiss-Tanzanian cooperation within the Health Promotion and System Strengthening Project. The availability of biomedical engineers was increased through new training courses and the creation of permanent positions in government. Moreover, additional district and regional maintenance and repair workshops were built, and a National Centre for Calibration and Training was established to ensure the correct functioning of medical devices. The introduction of an electronic medical device management system provided health facilities and the health ministry with data on the operational status of medical devices and the need for repairs and spare parts. Every level of government was encouraged to allocate more human and financial resources to medical device management. Following this decade-long effort, the percentage of functioning equipment increased substantially, and costs were reduced by repairing rather than replacing equipment. The project also demonstrated the value of an integrated, system-strengthening approach that considered personnel, maintenance and repair facilities, documentation and management, and government policy and budgeting.

Les technologies jouent un rôle crucial dans le renforcement de la productivité et de la qualité des systèmes de santé. Pourtant, dans de nombreux pays d'Afrique subsaharienne, les systèmes de gestion des dispositifs médicaux sont limités, voire inexistants. Cet article a pour but d'illustrer, au moyen d'une étude de cas, comment les réformes peuvent contribuer à faire en sorte que les politiques en matière de technologies sanitaires soient appliquées au quotidien, et comment une approche intégrée peut améliorer la gestion des dispositifs médicaux. Entre 2011 et 2023, un plan visant à développer les systèmes de gestion des dispositifs médicaux en République-Unie de Tanzanie a été défini et mis en œuvre en collaboration avec la Suisse, dans le cadre du Projet de Promotion et de Renforcement du Système de Santé. De nouvelles formations et la création de postes permanents au sein du gouvernement ont permis d'accroître la disponibilité des ingénieurs biomédicaux. En outre, des ateliers supplémentaires d'entretien et de réparation ont été construits dans différentes régions et districts, tandis qu'un Centre National d'Étalonnage et de Formation a ouvert ses portes pour assurer le bon fonctionnement des dispositifs médicaux. L'introduction d'un système électronique de gestion des dispositifs médicaux a fourni aux établissements de soins de santé et au Ministère de la Santé des données concernant le statut opérationnel de ces dispositifs, ainsi que les réparations et pièces détachées requises. Chaque niveau de pouvoir a été encouragé à attribuer davantage de ressources humaines et financières à la gestion des dispositifs médicaux. Au terme de dix ans d'efforts, le pourcentage d'équipements en état de marche a considérablement augmenté et les coûts ont diminué grâce au recours à la réparation plutôt qu'au remplacement. Le projet a également démontré l'importance d'une approche intégrée, qui consiste à renforcer le système en tenant compte du personnel, de l'entretien et des installations de réparation, de la documentation et de la gestion, mais aussi de la politique gouvernementale et du budget.

La tecnología aplicada a la atención sanitaria es fundamental para impulsar la productividad y la calidad de los sistemas sanitarios. Sin embargo, en muchos países del África subsahariana los sistemas de gestión de los productos sanitarios son deficientes o inexistentes. El objetivo de este artículo es ilustrar, mediante un estudio de caso, cómo las reformas políticas pueden ayudar a garantizar que la política sobre tecnología de la atención sanitaria se convierta en una práctica cotidiana y cómo un enfoque de sistemas integrados puede mejorar el funcionamiento de la gestión de los productos sanitarios. Entre 2011 y 2023, se elaboró un plan para mejorar los sistemas de gestión de los productos sanitarios en la República Unida de Tanzania, que se implementó a través de la cooperación suizo-tanzana en el marco del Proyecto de Promoción de la Salud y Fortalecimiento del Sistema. Se aumentó la disponibilidad de ingenieros biomédicos mediante nuevos cursos de formación y la creación de puestos permanentes en el gobierno. Además, se construyeron talleres de mantenimiento y reparación adicionales de distrito y regionales, y se estableció un Centro Nacional de Calibración y Formación para garantizar el correcto funcionamiento de los productos sanitarios. La introducción de un sistema electrónico de gestión de productos sanitarios proporcionó a los centros sanitarios y al Ministerio de Sanidad datos sobre el estado operativo de los productos sanitarios y la necesidad de reparaciones y piezas de repuesto. Se animó a todos los niveles de gobierno a asignar más recursos humanos y financieros a la gestión de los productos sanitarios. Tras este esfuerzo de una década, el porcentaje de equipos en funcionamiento aumentó notablemente y los costes se redujeron al reparar los equipos en lugar de sustituirlos. El proyecto también demostró el valor de un enfoque integrado de refuerzo del sistema que tenía en cuenta el personal, las instalaciones de mantenimiento y reparación, la documentación y la gestión, y la política y los presupuestos gubernamentales.

Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two-stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace.

Evidence from clinical trials on high-risk medical devices in children: a scoping review.

BACKGROUND: Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. METHODS: Within the CORE-MD project, we performed a scoping review on evidence from clinical trials investigating high-risk paediatric medical devices used in paediatric cardiology, diabetology, orthopaedics and surgery, in patients aged 0-21 years. We searched Medline and Embase from 1st January 2017 to 9th November 2022. RESULTS: From 1692 records screened, 99 trials were included. Most were multicentre studies performed in North America and Europe that mainly had evaluated medical devices from the specialty of diabetology. Most had enrolled adolescents and 39% of trials included both children and adults. Randomized controlled trials accounted for 38% of the sample. Other frequently used designs were before-after studies (21%) and crossover trials (20%). Included trials were mainly small, with a sample size <100 participants in 64% of the studies. Most frequently assessed outcomes were efficacy and effectiveness as well as safety. CONCLUSION: Within the assessed sample, clinical trials on high-risk medical devices in children were of various designs, often lacked a concurrent control group, and recruited few infants and young children. IMPACT: In the assessed sample, clinical trials on high-risk medical devices in children were mainly small, with variable study designs (often without concurrent control), and they mostly enrolled adolescents. We provide a systematic summary of methodologies applied in clinical trials of medical devices in the paediatric population, reflecting obstacles in this research area that make it challenging to conduct adequately powered randomized controlled trials. In view of changing European regulations and related concerns about shortages of high-risk medical devices for children, our findings may assist competent authorities in setting realistic requirements for the evidence level to support device conformity certification.

Balancing pediatric device utility and harm: navigating the challenges for safer healthcare.

This article discusses the challenges in balancing the utility and harm associated with pediatric medical devices. Takashima et al. explored the prevalence and complications of invasive devices across three Australian pediatric tertiary hospitals and reported a high prevalence of complications, particularly with vascular access devices. We also highlight the need to pay attention to the use of these devices, particularly intravenous catheters, and the importance of a culture of patient safety in healthcare systems. We emphasize the need for a nuanced approach that carefully weighs the benefits against potential risks and encourages collaboration among stakeholders to establish robust regulatory frameworks and prioritize the safety and well-being of pediatric patients. Finally, we conclude by advocating the involvement of parents and families in gathering information about hospital safety incidents and fostering a culture of safety that supports reporting, flexibility, and learning. IMPACT: Reporting adverse events and their consequences is essential in the strategy to prevent them, allowing comparison with national or international standards, and identifying indicators to optimize and harbor the possibility of determining improvement measures that pursue a multifactorial approach and are cost-effective. Our comment advocates limiting the prevalence of medical invasive devices and their consequences by reviewing their epidemiology. Although advancements in medical technology have undoubtedly improved the diagnostic and therapeutic possibilities, the delicate balance between device utility and potential harm necessitates careful consideration.

Development of the headspace gas chromatography-tandem mass spectrometry method for ethylene oxide and ethylene chlorohydrin residue in medical devices.

RATIONALE: Ethylene oxide (EO) sterilization is commonly employed for the sterilization of medical devices and has a very high market share. However, EO and its metabolite ethylene chlorohydrin (ECH) are toxic to humans. In compliance with the classification and residue limits of medical devices defined by ISO 10993-7, our study established two extraction methods for the testing of EO and ECH. METHODS: The first method involves simulated-use extraction using water as the extraction solvent. While the second, exhaustive extraction, directly extracts sample through headspace sampling analysis. Gas chromatography-tandem mass spectrometry in multiple reaction monitoring mode was utilized, requiring only 16 min. Then, the developed method was applied to assess 10 commercially available medical devices sterilized by EO. RESULTS: In simulated-use extraction, calibration curves were evaluated in the range of 1-100 and 5-500 µg for EO and ECH, respectively (r > 0.999). Inter-day recoveries ranged from 85.0% to 95.2% and from 94.8% to 102.4%. In exhaustive extraction, calibration curves spanned 0.5-50 and 2-200 µg for EO and ECH, respectively (r > 0.999). Inter-day recoveries ranged from 101.6% to 102.1% for EO and from 98.1% to 102.2% for ECH. After analysis of the 10 commercially available medical devices, two cotton swabs were found to have ECH of 35.1 and 28.4 µg per device, and four medical devices were found to have EO with concentration below the limit of quantification. Meanwhile, we found that the EO internal standard (propylene oxide) recommended by ISO 10993-7 had interference problems with other similar substances and was not suitable as an internal standard for EO. CONCLUSIONS: This study offers a sensitive and straightforward analytical approach to EO and ECH residues in a variety of medical devices. In addition, the results show that the EO or ECH content of these types of medical devices in our study falls below the regulatory limits, therefore instilling confidence among consumers regarding their safe use.

Uneven primary healthcare supply of rural doctors and medical equipment in remote China: community impact and the moderating effect of policy intervention.

BACKGROUND: Unequal access to primary healthcare (PHC) has become a critical issue in global health inequalities, requiring governments to implement policies tailored to communities' needs and abilities. However, the place-based facility dimension of PHCs is oversimplified in current healthcare literature, and formulating the equity-oriented PHC spatial planning remains challenging without understanding the multiple impacts of community socio-spatial dynamics, particularly in remote areas. This study aims to push the boundary of PHC studies one step further by presenting a nuanced and dynamic understanding of the impact of community environments on the uneven primary healthcare supply. METHODS: Focusing on Shuicheng, a remote rural area in southwestern China, multiple data are included in this village-based study, i.e., the facility-level healthcare statistics data (2016-2019), the statistical yearbooks, WorldPop, and Chinese GDP's spatial distribution data. We evaluate villages' PHC service capacity using the number of doctors and essential equipment per capita, which are the major components of China's PHC delivery. The indicators describing community environments are selected based on extant literature and China's planning paradigms, including town- and village-level factors. Gini coefficients and local spatial autocorrelation analysis are used to present the divergences of PHC capacity, and multilevel regression model and (heterogeneous) difference in difference model are used to examine the driving role of community environments and the dynamics under the policy intervention. RESULTS: Despite the general improvement, PHC inequalities remain significant in remote rural areas. The village's location, aging, topography, ethnic autonomy, and economic conditions significantly influence village-level PHC capacity, while demographic characteristics and healthcare delivery at the town level are also important. Although it may improve the hardware setting in village clinics (coef. = 0.350), the recent equity-oriented policy attempts may accelerate the loss of rural doctors (coef. = - 0.517). Notably, the associations between PHC and community environments are affected inconsistently by this round of policy intervention. The town healthcare centers with higher inpatient service capacity (coef. = - 0.514) and more licensed doctors (coef. = - 0.587) and nurses (coef. = - 0.344) may indicate more detrimental policy effects that reduced the number of rural doctors, while the centers with more professional equipment (coef. = 0.504) and nurses (coef. = 0.184) are beneficial for the improvement of hardware setting in clinics. CONCLUSIONS: The findings suggest that the PHC inequalities are increasingly a result of joint social, economic, and institutional forces in recent years, underlining the increased complexity of the PHC resource allocation mechanism. Therefore, we claim the necessity to incorporate a broader understanding of community orientation in PHC delivery, particularly the interdisciplinary knowledge of the spatial lens of community, to support its sustainable development. Our findings also provide timely policy insights for ongoing primary healthcare reform in China.