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Zhongguo Yi Liao Qi Xie Za Zhi ; 48(1): 85-87, 2024 Jan 30.
Artigo em Chinês | MEDLINE | ID: mdl-38384223


This study conducted statistics on the special review applications for Class Ⅱ innovative medical devices in Shanghai from April 2020 to April 2023. It summarized and analyzed common problems in the innovation review application stage, and gave suggestions for applicants and reviewers in order to further improve the quality of innovation application and improve the pass rate of innovation applications.

Equipamentos e Provisões , China , Invenções
J Zhejiang Univ Sci B ; 25(2): 153-167, 2024 Feb 15.
Artigo em Inglês, Chinês | MEDLINE | ID: mdl-38303498


Brain diseases affect millions of people and have a huge social and economic impact. The use of neural probes for studies in animals has been the main approach to increasing knowledge about neural network functioning. Ultimately, neuroscientists are trying to develop new and more effective therapeutic approaches to treating neurological disorders. The implementation of neural probes with multifunctionalities (electrical, optical, and fluidic interactions) has been increasing in the last few years, leading to the creation of devices with high temporal and spatial resolution. Increasing the applicability of, and elements integrated into, neural probes has also led to the necessity to create flexible interfaces, reducing neural tissue damage during probe implantation and increasing the quality of neural acquisition data. In this paper, we review the fabrication, characterization, and validation of several types of flexible neural probes, exploring the main advantages and drawbacks of these devices. Finally, future developments and applications are covered. Overall, this review aims to present the currently available flexible devices and future appropriate avenues for development as possible guidance for future engineered devices.

Equipamentos e Provisões , Doenças do Sistema Nervoso , Animais , Humanos , Doenças do Sistema Nervoso/diagnóstico
Int J Technol Assess Health Care ; 40(1): e2, 2024 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-38179661


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.

Equipamentos e Provisões , Formulação de Políticas , Equipamentos e Provisões/normas
Neuropsychopharmacology ; 49(1): 18-22, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37853093


Recent research and technological developments have led to an expanding number of novel and rapidly acting therapeutics being developed across a variety of neuropsychiatric disorders. Novel medical devices range from implantable and non-invasive brain stimulating and recording technologies to digital therapeutics. This perspective provides an overview of FDA regulatory oversight for medical devices, including a discussion of regulatory pathways and the review of neuromodulation devices for psychiatric disorders. We highlight the importance of early engagement with FDA and special programs that may be useful to device developers participating in interactions with the FDA that are solution focused. We explore current novel and rapid treatments for psychiatric disorders and those on the horizon. Lastly, we provide considerations for developers in navigating the regulatory landscape for neuromodulation devices intended for psychiatric disorders, including approaches to incorporating patient perspectives.

Equipamentos e Provisões , Regulamentação Governamental , Transtornos Mentais , United States Food and Drug Administration , Humanos , Transtornos Mentais/terapia
Arch. Soc. Esp. Oftalmol ; 98(12): 723-726, dic. 2023.
Artigo em Espanhol | IBECS | ID: ibc-228148


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)

Humanos , Procedimentos Cirúrgicos Oftalmológicos/efeitos adversos , Equipamentos e Provisões/normas , Consenso , Espanha
Int J Technol Assess Health Care ; 39(1): e69, 2023 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-37933611


OBJECTIVES: This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned. METHODS: Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members. Structured information was collected from organizations that confirmed having an HSS for medical devices. RESULTS: Sixteen initiatives could be identified, of which 11 are currently ongoing. The purposes of the HSS range from raising awareness of trends and new developments to managing informed decisions on innovative health services in hospitals. The time-horizon is most often 3 years up to a few months before market entry. Three models of identification of new technologies crystallized: a reactive (stakeholders outside HSS inform), a pro-active (actively searching multifold sources), and a hybrid model. Prioritization is often conducted by separate committees via scoring or debate. The outputs focus either on in-depth information of single technologies or on a class of technologies or on technologies in specific disease areas. CONCLUSIONS: The identified HSS share the common experience that horizon scanning (HS) for medical devices is a resource-intensive exercise that requires a dedicated and skilled team. Insights into the identified HSS and their experiences will be used in the continued work of the IHSI MDWG on its proposal for an IHSI HSS for medical devices.

Tecnologia Biomédica , Equipamentos e Provisões , Avaliação da Tecnologia Biomédica
JMIR Mhealth Uhealth ; 11: e46237, 2023 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-37966871


BACKGROUND: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app's effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses. OBJECTIVE: This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account for nonadherence and how appropriate are their methods? METHODS: We searched the Food and Drug Administration's registration database for registrations of repeated-use, patient-facing SaMD therapeutics. For each such registration, we searched, company websites, and MEDLINE for the corresponding clinical trial and study articles through March 2022. Adherence and engagement data were summarized for each of the 24 identified articles, corresponding to 10 SaMD therapeutics. Each article was analyzed with a framework developed using the Cochrane risk-of-bias questions to estimate the potential effects of imperfect adherence on SaMD effectiveness. This review, funded by the Richard King Mellon Foundation, is registered on the Open Science Framework. RESULTS: We found that although most articles (23/24, 96%) reported collecting information about SaMD therapeutic engagement, of the 20 articles for apps with prescribed use, only 9 (45%) reported adherence information across all aspects of prescribed use: 15 (75%) reported metrics for the initiation of therapeutic use, 16 (80%) reported metrics reporting adherence between the initiation and discontinuation of the therapeutic (implementation), and 4 (20%) reported the discontinuation of the therapeutic (persistence). The articles varied in the reported metrics. For trials that reported adherence or engagement, there were 4 definitions of initiation, 8 definitions of implementation, and 4 definitions of persistence. All articles studying a therapeutic with a prescribed use reported effectiveness estimates that might have been affected by nonadherence; only a few (2/20, 10%) used methods appropriate to evaluate efficacy. CONCLUSIONS: This review identifies 5 areas for improving future SaMD trials and studies: use consistent metrics for reporting adherence, use reliable adherence metrics, preregister analyses for observational studies, use less biased efficacy analysis methods, and fully report statistical methods and assumptions.

Aplicativos Móveis , Software , Estados Unidos , Equipamentos e Provisões , Ensaios Clínicos como Assunto
Arch Soc Esp Oftalmol (Engl Ed) ; 98(12): 723-726, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37865190


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 Vitreo 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.

Equipamentos e Provisões , Procedimentos Cirúrgicos Oftalmológicos , Oftalmologia , Humanos , Equipamentos e Provisões/efeitos adversos , Olho , Procedimentos Cirúrgicos Oftalmológicos/efeitos adversos , Regulamentação Governamental
Proc Inst Mech Eng H ; 237(11): 1243-1247, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37840272


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.

Equipamentos e Provisões , Legislação de Dispositivos Médicos , Reino Unido , Equipamentos e Provisões/normas , Invenções
Angiol. (Barcelona) ; 75(5): 309-320, Sept-Oct, 2023. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-226585


La ecografía Doppler es una modalidad diagnóstica dependiente de un operador indispensable por disponibilidad, eficacia y costes. además de conocimientos anatómicos y clínicos, exige un mínimo conocimiento de sus principios físicos y tecnológicos. Conocer, practicar, ajustar las funciones del eco Doppler de forma ordenada y en función del paciente y de la exploración indicada harán que nuestras exploraciones sean más sencillas, rápidas, seguras y precisas. este artículo de formación intenta repasar y esquematizar cómo ajustar las principales aplicaciones del equipo mediante los botones y controles del dispositivo ("knobology").(AU)

doppler ultrasound is an operator-dependent diagnostic modality, essential due to its availability, efficacy and addition to anatomical and clinical knowledge, it requires a minimum knowledge of its physical and technologicalprinciples. the knowledge, training, and set up the functions of the duplex scan in a properly way depending onthe patient and kind of exploration, will make our examinations easier, faster, safer, and more precise. this papertries to review and outline how to adjust the main applications of the equipment using the buttons and controlsof the device (knobology).(AU)

Humanos , Ultrassonografia Doppler/tendências , Tecnologia Biomédica/educação , Diagnóstico por Imagem/métodos , Ultrassonografia/métodos , Equipamentos para Diagnóstico , Equipamentos e Provisões , Ultrassonografia Doppler/métodos , Ultrassonografia Doppler/instrumentação , Diagnóstico por Imagem/tendências
Washington, D.C.; PAHO; 2023-10-12. (PAHO/IMT/RP/COVID-19/23-0002).
em Inglês | PAHO-IRIS | ID: phr-58314


Conducting market research and value chain analysis is crucial for defining a productive investment strategy. In this context, the Pan American Health ORganization contracted IQVIA Solutions do Brasil LTDA and Fundação Instituto de Administração (FIA) to conduct market and value chain studies for biological medicines, chemically synthesized medicines, medical devices, and personal protection equipment. This executive summary presents the context and key conclusions.

Produtos Biológicos , Equipamentos e Provisões , Equipamento de Proteção Individual , Medicamentos Sintéticos , Tecnologia Biomédica , América , Região do Caribe
JAMA ; 330(11): 1094-1096, 2023 09 19.
Artigo em Inglês | MEDLINE | ID: mdl-37589985


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.

Conflito de Interesses , Equipamentos e Provisões , Cobertura do Seguro , Medicare , Idoso , Humanos , Conflito de Interesses/economia , Equipamentos e Provisões/economia , Medicare/economia , Medicare/ética , Estados Unidos , Cobertura do Seguro/economia , Cobertura do Seguro/ética
Zhongguo Yi Liao Qi Xie Za Zhi ; 47(4): 428-432, 2023 Jul 30.
Artigo em Chinês | MEDLINE | ID: mdl-37580295


Animal study plays a key role to evaluate the safety and effectivity of medical devices. This study aims to share evaluated consideration on the role, general principles, necessity, study design and quality management system of animal study, in order to improve the quality of animal study and reduce unnecessary study.

Equipamentos e Provisões , Modelos Animais , Animais
Farm. hosp ; 47(4): 168-174, Julio - Agosto 2023. graf, tab
Artigo em Inglês, Espanhol | IBECS | ID: ibc-223574


El asma es una enfermedad respiratoria crónica con un alto impacto sanitario, social y económico, en particular, en el caso del asma grave no controlada (AGNC). Por ello, son especialmente necesarias nuevas estrategias para mejorar su abordaje, con un enfoque personalizado a cada paciente y desde una perspectiva multidisciplinar, además de integrar las nuevas prácticas de telemedicina y telefarmacia impulsadas a raíz de la pandemia de COVID-19. En este contexto se ha desarrollado el proyecto TEAM 2.0 («Trabajo en Equipos de Asma Multidisciplinares»), continuación del proyecto TEAM llevado a cabo en 2019, con el objetivo de actualizar y priorizar buenas prácticas de trabajo multidisciplinar en AGNC en un contexto post pandemia y analizar los avances conseguidos. Un grupo coordinador, constituido por 8 equipos multidisciplinares de farmacéuticos hospitalarios, neumólogos y alergólogos, llevó a cabo una revisión bibliográfica actualizada, puesta en común de buenas prácticas multidisciplinares y análisis de avances. A través de 5 reuniones regionales con otros expertos con experiencia en AGNC, se compartieron las buenas prácticas identificadas y fueron sometidas a debate, evaluación y priorización. En total, 23 buenas prácticas de trabajo multidisciplinar en AGNC, agrupadas en 5 ámbitos de trabajo: 1) organización del trabajo en equipos multidisciplinares, 2) educación al paciente, autoadministración y adherencia, 3) resultados en salud, seguimiento de datos y persistencia, 4) telefarmacia y experiencias implantadas durante la pandemia de COVID-19 y 5) formación e investigación, fueron evaluadas y priorizadas por 57 profesionales del ámbito de la farmacia hospitalaria, la neumología, la alergología y la enfermería. Este trabajo ha permitido actualizar la hoja de ruta de acciones prioritarias, para seguir avanzando en modelos óptimos de atención al paciente con AGNC en un contexto post-COVID-19. (AU)

Asthma is a chronic respiratory disease with a high health, social and economic impact, particularly in the case of Severe Uncontrolled Asthma (SUA). For this reason, new strategies are especially necessary to improve its approach, with a personalized approach to each patient and from a multidisciplinary perspective, in addition to integrating the new telemedicine and telepharmacy practices promoted as a result of the COVID-19 pandemic. In this context, the TEAM 2.0 project (“Work in Multidisciplinary Asthma Teams”) has been developed, following the TEAM project carried out in 2019, with the aim of updating and prioritizing good multidisciplinary work practices in SUA in a post pandemic context and analyze the progress made. A coordinating group, made up of eight multidisciplinary teams of hospital pharmacists, pulmonologists, and allergists, carried out an updated bibliographic review, sharing of good multidisciplinary practices, and analysis of advances. Through five regional meetings with other experts with experience in SUA, the good practices identified were shared and subjected to debate, evaluation and prioritization. In total, 23 good multidisciplinary work practices in SUA, grouped into five work areas: 1) Organization of work in multidisciplinary teams, 2) Patient education, self-management and adherence, 3) Health results, data monitoring and persistence, 4) Telepharmacy and experiences implemented during the COVID-19 pandemic and 5) Training and research, were evaluated and prioritized by 57 professionals from the field of Hospital Pharmacy, Pulmonology, Allergology and Nursing. This work has made it possible to update the roadmap of priority actions to continue advancing in optimal models of care for patients with AGNC in a post-COVID-19 context. (AU)

Humanos , Asma , Equipamentos e Provisões , Farmácia , Hospitais , Telemedicina , Serviço de Farmácia Hospitalar
Nutr. clín. diet. hosp ; 43(3): 12-19, Juli 26, 2023. tab
Artigo em Espanhol | IBECS | ID: ibc-223597


Introducción: Las Unidades Especiales (UE) son espacios físicos destinados a la preparación y distribución de fórmulas lácteas y enterales para proporcionar una alimentación artificial inocua acorde a las necesidades nutricionales del usuario. Objetivo: Diagnosticar las áreas de trabajo y el equipamiento en relación con las recomendaciones técnicas para UE de hospitales públicos y privados.Material y métodos: Estudio observacional, descriptivo y transversal en 13 UE de hospitales de la ciudad de Montevideo. Se aplicó una lista de cotejo para la verificación visual de las características estructurales y el equipamiento. Resultados: 11 de 13 hospitales disponen de un lugar físico de uso exclusivo de la UE instalado en zonas alejadas de focos de insalubridad y otros contaminantes; el acceso es únicamente para personal autorizado. La ubicación de las áreas de trabajo recepción, almacenamiento y preparación de alimentos están claramente definidas. La dotación de equipamiento evidencia un nivel de cumplimiento “adecuado” respecto a la calidad y cantidad. Discusión: Según la normativa de referencia para empresas alimentarias la ubicación de las instalaciones y las características estructurales son condición indispensable para los locales donde se elaboran alimentos para garantizar la inocuidad del producto final. Asimismo, los materiales de construcción del equipamiento de las áreas de trabajo son resistentes a los procesos de esterilización y/o sanitización ajustándose a la reglamentación. Conclusiones: En las instituciones hospitalarias estudiadas las UE presentan características estructurales calificadas “adecuadas” y “totalmente adecuadas” evidenciando un alto grado de cumplimiento respecto a la normativa con un comportamiento similar entre instituciones hospitalarias públicas o privadas.(AU)

Introduction: The socalled Special Units (SU) are physical spaces intended for the preparation and the distribution ofmilk and enteral formulas, in order to provide safe artificialfeeding, according to the user’s nutritional needs.Aim: To diagnose the work areas and the equipment in relation to the technical recommendations for Special Units inpublic and private hospitals. Equipment and Methods: Observational, descriptive andcross-sectional study in 13 hospital SU’s in the city ofMontevideo. A checklist was resorted to for visual verificationof the structural characteristics and the equipment.Results: 11 out of 13 hospitals have a physical place forthe exclusive use of the SU, installed in areas that stay awayfrom sources of unsanitary conditions and all kinds of contaminants. Moreover, access is granted to authorized personnel only. Work, reception, storage and food preparation areasare clearly defined. The provision of equipment shows an “adequate” level of compliance in terms of quality and quantity. Discussion: According to the reference standards forfood business, the location of the facilities and the structural characteristics are an indispensable condition forpremises where food is processed, in order to ensure theharmlessness of the final product. Furthermore, the building materials of the equipment in the work areas are resistant to sterilization and/or sanitization processes, pursuant to the regulations in force. Conclusions: In the hospital institutions studied, the SU’spresent structural characteristics that were qualified as “adequate” and “totally adequate”, what shows a high degree ofcompliance with the regulations in force in both public andprivate hospital institutions alike.(AU)

Humanos , Masculino , Feminino , Unidades Hospitalares , Hospitais Públicos , Hospitais Privados , Equipamentos e Provisões , Uruguai , Epidemiologia Descritiva , Estudos Transversais
J Med Econ ; 26(1): 781-792, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37300440


AIMS: Strategies focus on securing the competitiveness of medical device corporations by strengthening their organizational capabilities, which, in turn, ensure their continuous development. This study aims to investigate both management strategies and organizational culture, which may affect the performance of these companies, and analyzes the influence of education and training investment. MATERIALS AND METHODS: We used data from the 3rd to 6th Human Capital Corporate Panel surveys by the Korea Research Institute for Vocational Education and Training as well as data from the Korea Information Service and 6,112 workers and 260 companies were analyzed. For the analysis, management strategy and organizational culture were set as independent variables, and corporation performance was set as the dependent variable. Additionally, investment in education and training was set as a control variable between the independent and dependent variables. Corporate performance was analyzed by dividing into organizational satisfaction and organizational commitment. RESULTS: Differentiation strategy and innovative culture had a positive (+) effect on organizational satisfaction, while cost leadership strategy and hierarchical culture had a negative (-) effect. On the other hand, in the case of interaction with education and training investment, cost leadership strategy and hierarchical culture had a positive (+) effect, while differentiation strategy and innovation culture had a negative (-) effect. In organizational commitment, innovation culture had a positive (+) effect, and hierarchical culture had a negative (-) effect. In the case of interaction with investment in education and training, only the hierarchical culture had a positive (+) effect. CONCLUSIONS: The innovation culture positively influenced the performance of medical device companies. Furthermore, cost leadership strategy, hierarchical culture, education and training investment improved the corporate performance of these companies. To enhance corporate performance, these companies should create an innovation culture and invest in education and training in accordance with the organizational culture.

COVID-19 has proven the excellence of Korea's medical devices, and the medical device industry is expected to continue to grow due to the increase in chronic disease and non-face-to-face treatment. However, the current medical device industry is monopolized by global companies with capital and technological prowess. To overcome this, Korean medical device companies are developing innovative medical devices centered on start-ups, but now is the time to strategically respond to them in order to compete with global companies. In general, companies establish management strategies for survival and growth by analyzing threats and opportunities based on the market environment to maintain the optimal organization according to market competition, government policies, and changes in consumer needs. Strategies are often established based on the culture of the organizations that make up the company. When it comes to strategy establishment, the medical device industry has special characteristics compared to other industries. The medical device industry is based on advanced technology and puts patient safety first, requiring continuous product upgrades. Therefore, it is an essential industry for employees to invest in education and training. The analysis shows the effectiveness of investment in education and training according to the management strategy and organizational culture of medical device companies. It was confirmed that when medical device companies create an Innovation culture, their performance improves. It also shows that when medical device companies adopt a cost leadership strategy, they need to increase their investment in education and training to improve corporate performance.

Equipamentos e Provisões , Cultura Organizacional
BMC Health Serv Res ; 23(1): 593, 2023 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-37291513


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.

Equipamentos e Provisões , Avaliação da Tecnologia Biomédica , Equipamentos e Provisões/normas , Técnica Delfos , Avaliação da Tecnologia Biomédica/normas
Biomed Instrum Technol ; 57(2): 44-51, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37343068


Background: Cleaning is essential to ensuring the safe processing of reusable medical devices, and most manufacturers' instructions for use (IFUs) specify that clinical soil should not be allowed to dry on devices. If soil is allowed to dry, the cleaning challenge could be increased due to change in soil solubility. As a result, an additional step could be needed to reverse the chemical changes and return a device to a state where cleaning instructions are appropriate. Methods: Using a solubility test method and surrogate medical devices, the experiment described in this article challenged eight remediation conditions to which a reusable medical device might be exposed if soil is dried on a device. These conditions included soaking with water or neutral pH, enzymatic, or alkaline detergent cleaning agents, as well as conditioning with an enzymatic humectant foam spray. Results: The results demonstrated that only the alkaline cleaning agent was able to solubilize the extensively dried soil as effectively as the control, with a 15-minute soak being as effective as a 60-minute soak. Discussion: Although opinions vary, the overall data demonstrating the risk and chemical changes that occur when soil dries on medical devices are limited. Further, in cases in which soil is allowed to dry on devices for an extended time outside of the guidance from leading practices and manufacturers' IFUs, what additional steps or processes may be necessary to ensure that cleaning can be effective? Conclusion: This experiment demonstrated the effectiveness of a soaking step with an alkaline cleaning agent as an additional step if soil is dried on reusable medical devices, thus reversing the effect of an extended soil dry time.

Desinfecção , Reutilização de Equipamento , Equipamentos e Provisões