[Exploration of Application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: Take Artificial Joint Products as Example].

Through the effective application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (EP), to continuously improve the corresponding management tools to ensure the safety and effectiveness of medical device in the quality management system, risk management system, evaluation of safety and effectiveness for the supervision departments and manufacturers. The current status of the application of EP and the application issues are analyzed in the study. Take artificial joint products for example, the idea of using EP in quality management system, risk management system and evaluation of safety and effectiveness is investigated, and several thoughts are proposed. Supervision departments should strengthen the unified understanding of EP, develop requirements according to the classification of medical device，and refine specific execution requirements.

Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models.

OBJECTIVES: Lack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of "lifecycle" and "lifecycle evaluation" as embodied within evaluation models/frameworks used for medical devices. METHODS: Drawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives. RESULTS: Fifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The "lifecycle" may represent a single stage, a series of stages, a cycle of innovation, or a system. "Lifecycle evaluation" focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase. CONCLUSIONS: Using a "lifecycle evaluation" approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.

Reporte de incidentes serios en productos sanitarios usados en cirugía intraocular. Proponiendo ideas / Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas

La entrada en vigor del reglamento sobre productos sanitarios obliga a los clínicos a identificar y reportar a las autoridades sanitarias los posibles incidentes serios derivados de su utilización. Dadas las dudas que pueden suscitarse sobre qué puede o no considerarse incidente serio, un grupo de trabajo, creado por miembros de la Sociedad Española de Retina y Vitreo (SERV) y el clúster de oftalmología y ciencias de la visión (Cluster4Eye), han elaborado un documento que pretende orientar a los oftalmólogos sobre algunos de los incidentes que, en la experiencia del equipo de trabajo, no son habituales o pueden causar un serio daño a la función del paciente. (AU)

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreous (SERV) and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function. (AU)

Medical device regulatory challenges in the UK are affecting innovation and its potential benefits.

The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.

Which value aspects are relevant for the evaluation of medical devices? Exploring stakeholders' views through a Web-Delphi process.

BACKGROUND: Implementation and uptake of health technology assessment for evaluating medical devices require including aspects that different stakeholders consider relevant, beyond cost and effectiveness. However, the involvement of stakeholders in sharing their views still needs to be improved. OBJECTIVE: This article explores the relevance of distinct value aspects for evaluating different types of medical devices according to stakeholders' views. METHODS: Thirty-four value aspects collected through literature review and expert validation were the input for a 2-round Web-Delphi process. In the Web-Delphi, a panel of participants from five stakeholders' groups (healthcare professionals, buyers and policymakers, academics, industry, and patients and citizens) judged the relevance of each aspect, by assigning a relevance-level ('Critical', 'Fundamental', 'Complementary', or 'Irrelevant'), for two types of medical devices separately: 'Implantable' and 'In vitro tests based on biomarkers'. Opinions were analysed at the panel and group level, and similarities across devices were identified. RESULTS: One hundred thirty-four participants completed the process. No aspects were considered 'Irrelevant', neither for the panel nor for stakeholder groups, in both types of devices. The panel considered effectiveness and safety-related aspects 'Critical' (e.g., 'Adverse events for the patient'), and costs-related aspects 'Fundamental' (e.g., 'Cost of the medical device'). Several additional aspects not included in existing frameworks' literature, e.g., related to environmental impact and devices' usage by the healthcare professional, were deemed as relevant by the panel. A moderate to substantial agreement across and within groups was observed. CONCLUSION: Different stakeholders agree on the relevance of including multiple aspects in medical devices' evaluation. This study produces key information to inform the development of frameworks for valuing medical devices, and to guide evidence collection.

Clinical evidence requirements according to the IVDR 2017/746: practical tools and references for underpinning clinical evidence of IVD-MDs.

In May 2022, the European Regulation 2017/746 (IVDR) came into force. It changes the approach of in vitro medical devices (IVD-MDs) for industry and institutions. It reinforces the clinical evidence requirements to improve performance, safety and transparency. Despite extended transition periods and existing guides, IVDR remains difficult to interpret and bringing devices into compliance requires efforts. The generation of clinical evidence is essential to demonstrate compliance with IVDR, and encompasses scientific validity, analytical performance and clinical performance. It is required to demonstrate, per intended use in the target population and clinical care pathway, IVD-MDs clinical performance (compared to a predefined clinical performance). Thus, there is a need for IVD-manufacturers and end-users in health care institutions, to obtain guidance on how to generate this clinical evidence. This article aims industrials and clinicians to identify key steps imposed by the IVDR for bringing IVD-MDs to the EU-market. We propose a general view of performance evaluation requirements for IVD-MDs and provide key references, including how to establish study design that will enable to document clinical performance of existing, refined or emerging medical tests. Finally, we propose a roadmap to address the relevant questions and studies in relation to the documents requested in the IVDR.

Functional quality assessment of whole-body vibration training devices based on instantaneous amplitude and frequency of photogrammetric vibration measurements.

The practical use of whole-body vibration training (WBVT) and such research may be negatively influenced by generated vibrations with amplitudes, frequencies, and/or patterns that deviate from preset adjustments on WBVT devices. This study examined whether prolonged regular use can generate respective deviations. Four WBVT devices, used for 19 months in a research project on the effects of WBVT, were analyzed using photogrammetry before start of the research project and after 19 months. Divergences between preset and measured amplitudes and frequencies were calculated for all measurements. To quantify how well the output of devices correlates with the target setting, the vibration characteristics were calculated. In particular, exact long-term measurements related to the vibration amplitude is conducted and analyzed for the first time, which has been found as an important measure of the device functional quality. One device had a significantly (p<0.01) larger machine run time than the other three. This one showed the most pronounced signs of functional impairments concerning instantaneous amplitudes, frequencies and the mode of vibration after prolonged use. These results based on photometric measurements underline again that prolonged use can result in divergences between preset and actual applied amplitudes, frequencies, mode of vibration and other accuracy measurement metrics.

Incompatibility of Some Prefilled Glass Syringes and Luer-Activated Needleless Valve Connectors.

Some needleless Luer-activated valve connectors with internal pins are not compatible with certain prefilled glass syringes. The internal pin can block the glass syringe tip and prevent drug administration.Nurses should be aware of this risk and assist in evaluating the Luer-activated valve connectors used in their organization.

Health State Assessment of Industrial Equipment Driven by the Fusion of Digital Twin Model and Intelligent Algorithm.

Equipment health state assessment is of great significance to improve the efficiency of industrial equipment maintenance support and realize accurate support. Using the method driven by the fusion of digital twin model and intelligent algorithm can make the equipment health state assessment more suitable for the "accuracy" requirement of equipment support. Taking the neural network algorithm as an example, this paper studies the method of unit level health state assessment of equipment driven by the fusion of digital twin model and intelligent algorithm. The principle and opportunity of equipment health state assessment based on digital twin model are analyzed, the equipment health state grade is redefined from the data-driven perspective, the selection principles of assessment parameters are established, and the unit level health state assessment model of equipment based on digital twin model and neural network algorithm is established. The proposed method is implemented by programming with Python, and the effectiveness of the method is verified by a case study. It provides support for further research of equipment-level health state assessment and the decision-making of equipment maintenance and provides reference for the study of the combination of digital twin model and other intelligent algorithms for health state assessment.

Do Health Technology Safety Issues Vary by Vendor?

There is a need to determine the relative similarity and differences in safety issues across specific types of software and medical devices in order to develop standardized solutions that can be used across these technologies. Over the past several years, health informatics researchers have identified differing types of technology-induced errors or safety issues. This work has led to a literature that has been effective in identifying varying technology-induced errors. Less effort has been made in attempting to understand if there are common types of safety issues and outcomes across vendors for specific types of technology such as electronic health records (EHRs). Our findings demonstrate that some safety issues are common across the same type of software. The findings suggest there is a need to develop standardized approaches to managing technology-induced errors.

Tool Condition Monitoring for High-Performance Machining Systems-A Review.

In the era of the "Industry 4.0" revolution, self-adjusting and unmanned machining systems have gained considerable interest in high-value manufacturing industries to cope with the growing demand for high productivity, standardized part quality, and reduced cost. Tool condition monitoring (TCM) systems pave the way for automated machining through monitoring the state of the cutting tool, including the occurrences of wear, cracks, chipping, and breakage, with the aim of improving the efficiency and economics of the machining process. This article reviews the state-of-the-art TCM system components, namely, means of sensing, data acquisition, signal conditioning and processing, and monitoring models, found in the recent open literature. Special attention is given to analyzing the advantages and limitations of current practices in developing wireless tool-embedded sensor nodes, which enable seamless implementation and Industrial Internet of Things (IIOT) readiness of TCM systems. Additionally, a comprehensive review of the selection of dimensionality reduction techniques is provided due to the lack of clear recommendations and shortcomings of various techniques developed in the literature. Recent attempts for TCM systems' generalization and enhancement are discussed, along with recommendations for possible future research avenues to improve TCM systems accuracy, reliability, functionality, and integration.

Eficacia y seguridad del uso de colchoneta, cojinete y rodete de gel polímero viscoelástico para mesa de sala de operaciones en pacientes de cualquier edad con indicación de cirugía cardiaca de alta complejidad / Efficacy and safety of the use of viscoelastic polymer gel mattress, bearing and impeller for operating room table in patients of any age with indication for highly complex cardiac surgery

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución del Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad del uso de colchoneta, cojinete y rodete de gel polímero viscoelástico para mesa de sala de operaciones, en pacientes de cualquier edad, que presentan indicación de cirugía cardiaca de alta complejidad. A través de la Nota N°548-DIR-INCOR-ESSALUD-2020, los médicos especialistas del Servicio de Anestesiología, del Instituto Nacional Cardiovascular (INCOR), a través de la gerencia de su dirección, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación para la posible incorporación de los dispositivos: 1) colchoneta de polímero para mesa de sala de operaciones, 2) cojinete para mesa de operaciones, y 3) rodete circular; los cuáles, según los especialistas, son tecnologías fabricadas con gel polímero viscoelástico. Asimismo, debido a que son tecnologías de uso concomitante, para efectos del presente dictamen preliminar se les denominará como: "Colchoneta, cojinete y rodete de gel polímero viscoelástico para mesa de sala de operaciones". ASPECTOS GENERALES: Las úlceras de presión son lesiones de la piel que ocurren debido a isquemia y necrosis en zonas de la piel que se encuentran sometidas a fricción o presión constante sobre una superficie. Por ello, son comunes en personas postradas debido a condiciones incapacitantes y que generan dificultades motrices (Zaidi S and Sharma S 2021). En el año 2019 se estimó que casi 850,000 personas a nivel mundial tenían al menos una úlcera de presión, lo que representa poco más del doble del número reportado en el año 1990 (420,000) (Zhang et al. 2021). Asimismo, la mayoría de los casos se identificaron en Norteamérica (221,138), Europa Occidental (168,939) y Centroamérica (61,804) (Zhang et al. 2021). Las personas con úlceras de presión suelen presentar desde molestias hasta dolor en la zona afectada, lo que puede afectar su calidad de vida. Del mismo modo, una úlcera de presión puede convertirse en la vía de ingreso para una infección, que eventualmente podría convertirse en una sepsis (Zaidi S and Sharma S 2021). Un grupo particularmente vulnerable a presentar esta complicación son los pacientes sometidos a cirugía cardiaca; pues se estima que casi un tercio de ellos presentará una úlcera de presión luego de la intervención (Feuchtinger, Halfens, and Dassen 2005). Esto se atribuye a la larga duración de este tipo de cirugías y, consecuentemente, al contacto prolongado de la piel del paciente sobre la mesa de operaciones, así como a las fuerzas de cizallamiento ocurridas durante el acto quirúrgico (Chen et al. 2017). METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia disponible sobre la eficacia y seguridad del uso de colchonetas, cojinetes y rodetes de gel polímero viscoelástico, en comparación con la colchoneta estándar de mesa de operaciones y campos de tela enrollados, en pacientes de todas las edades sometidos a cirugía cardiaca de alta complejidad. La búsqueda bibliográficasse realizó en las bases de datos de PubMed, Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan GPC y ETS, incluyendo el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), Agency for Healthcare Research and Quality (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de lncorporagáo de Tecnologías no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), y Haute Autorité de Santé (HAS). Además, se realizó una búsqueda de GPC en las páginas web de las principales sociedades o instituciones especializadas en cirugía cardiaca o en la prevención y/o tratamiento de las úlceras de presión, como: National Pressure lnjury Advisory Panel (NPIAP), European Pressure Ulcer Advisory Panel (EPUAP), Pan Pacific Pressure Injury Alliance (PPPIA), Japanese Society of Pressure Ulcers (JSPU), la American College of Cardiology (ACC), y la European Society of Cardiology (ESC). Por último, se realizó una búsqueda de estudios clínicos en ejecución o aún no terminados en ClinicalTrials.gov e International Clinical Trial Registry Platform (ICTRP). RESULTADOS: Luego de la búsqueda bibliográfica con fecha 16 de diciembre de 2021, se incluyeron para evaluación 2 GPC: NICE, y JSPU (Japanese Society of Pressure Ulcers 2016, National Institute for Health and Care Excellence 2018), y una ETS elaborada por la Medical Advisory Secretariat (MAS) de Ontario, en Canadá (Medical Advisory Secretariat 2009). CONCLUSIÓN: Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación no aprueba la incorporación de las tecnologías colchoneta, cojinete y rodete de gel polímero viscoelástico al petitorio de dispositivos de EsSalud, para su uso en pacientes de cualquier edad con indicación de cirugía cardiaca de alta complejidad. Asimismo, se sugiere a los especialistas, que, de existir otro tipo de superficies de redistribución de presión cuyo uso consideren podría ser de beneficio para la prevención de la incidencia de úlceras de presión o quemaduras por cizallamiento, en los pacientes con indicación de cirugía cardiaca de alta complejidad, envíen sus solicitudes debidamente justificadas para ser valorados en una nueva ETS.

Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.

Importance: Strengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of device safety and oversight that mandate attention. Objectives: To review the regulatory history and clinical evidence of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) and use the device recall as a case study of the challenges associated with clinical evaluation, transparency, and oversight of medical devices in the US. Evidence: Regulatory history and clinical evidence for the Penumbra medical devices were analyzed through a qualitative review of decision letters in the Access FDA database for medical devices and medical device reports in the Manufacturer and User Facility Device Experience database and a review of market data (eg, earnings calls, company communications) and clinical literature. Findings: The JET 7 device was subjected to a class I recall following more than 200 adverse event reports, 14 of which involved patient deaths. Regulatory analysis indicated that each of the Penumbra reperfusion catheters was cleared under the 510(k) pathway (which allows devices to be authorized with limited to no clinical evidence), with limited submission of either new clinical or animal data. Clinical evidence for Penumbra devices was generated from nonrandomized, single-arm trials with small sample sizes. The regulatory issues raised by JET 7 are reflective of broader challenges for medical device regulation. Opportunities for reform include strengthening premarket evidence requirements, requiring safety reporting with unique device identifiers, and mandating active methods of postmarket surveillance. Conclusions and Relevance: The case study of JET 7 highlights the long-standing gaps in medical device oversight and renews the impetus to build on the Institute of Medicine recommendations and reform FDA medical device regulation to protect public health.

US FDA best practices for initiating early feasibility studies for neurological devices in the United States.

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.

Management of central catheters in newborns and children hospitalized in intensive care units / Manejo de catéteres centrales en recién nacidos y niños hospitalizados en unidades de cuidados intensivos / Manejo de cateteres centrais em recém-nascidos e crianças internadas em unidades de terapia intensiva

Objective: to identify the care strategies adopted by nursing professionals in the handling of central catheters in children and newborns hospitalized in an Intensive Care Unit. Method: descriptive research, with quantitative approach, of the non-participant systematic observation type, in a tertiary public hospital in Rio de Janeiro. A structured checklist was applied to the professionals who assisted this clientele. The data were submitted to simple descriptive analysis and organized in graphs. Results: 80 observations were obtained, separated into three stages: moments of hand hygiene; manipulation of the deep catheter; equipment and connectors. Conclusion: the nursing team has satisfactory support to items considered essential in the care and prevention of bloodstream infections related to central catheters in children and newborns hospitalized in the Intensive Care Unit.

Objetivo: identificar las estrategias de cuidado adoptadas por los profesionales de enfermería en el manejo de catéteres centrales en niños y recién nacidos hospitalizados en una Unidad de Cuidados Intensivos. Método: investigación descriptiva, con enfoque cuantitativo, del tipo observación sistemática no participante, en un hospital público terciario de Río de Janeiro. Se aplicó una lista de verificación estructurada a los profesionales que asistieron a esta clientela. Los datos fueron sometidos a un análisis descriptivo simple y organizados en gráficos. Resultados: se obtuvieron 80 observaciones, separadas en tres etapas: momentos de higiene de manos; manipulación del catéter profundo; equipos y conectores. Conclusión: el equipo de enfermería cuenta con un apoyo satisfactorio a los ítems considerados esenciales en el cuidado y prevención de infecciones del torrente sanguíneo relacionadas con catéteres centrales en niños y recién nacidos hospitalizados en la Unidad de Cuidados Intensivos.

Objetivo: identificar as estratégias de cuidado adotadas pelos profissionais de enfermagem no manuseio dos cateteres centrais em crianças e recém-nascidos internados em Unidade de Terapia Intensiva. Método: pesquisa descritiva, com abordagem quantitativa, do tipo observação sistemática não participante, em um hospital público terciário do Rio de Janeiro. Foi aplicado um check-list estruturado aos profissionais que assistiram essa clientela. Os dados foram submetidos a análise descritiva simples e organizados em gráficos. Resultados: obteve-se 80 observações, separadas em três etapas: momentos da higienização das mãos; manipulação do cateter profundo; equipos e conectores. Conclusão: a equipe de enfermagem possui uma adesão satisfatória aos itens considerados essenciais no cuidado e na prevenção de infecções da corrente sanguínea relacionados a cateteres centrais em crianças e recém-nascidos internados em Unidade de Terapia Intensiva.