Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device / 中国医疗器械杂志

The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed. Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.

Approval Status and Suggestions on Supervision of Class II Innovative Medical Device / 中国医疗器械杂志

Based on the current situation of approval and publicity of class II innovative medical devices in various provinces and cities, especially after analyzing the problems found in the review of class II innovative medical devices in Shanghai and the factors affecting the listing process of innovative medical devices, this study puts forward some thoughts on supervision for reference in establishing and perfecting systems and regulations, changing the review and approval thinking, extending services to the development of innovative medical devices and the formulation of clinical trial schemes.

Status Analysis and Improvement Suggestions on Filing Review Trial Implementation of Shanghai's Class II Passive Medical Device Registration / 中国医疗器械杂志

This article collected the statistics of Shanghai's class II passive medical device registration filing review trial implementation. It summarized and analyzed the common issues in the filing review stage, and gave suggestions for registration applicants and reviewers in order to further improve the quality of application materials and improve the efficiency of review.

Study on the Medical Device Registration Submission Dossier Requirements in China / 中国医疗器械杂志

The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.

Mulheres na gestão de tecnologias e engenharia clínica: o caso dos ventiladores pulmonares na Covid-19 / Women in technology management and clinical engineering: the case of pulmonary ventilators at Covid-19

RESUMO O risco iminente de desabastecimento de ventiladores pulmonares nos serviços de saúde acarretou diversas frentes de trabalho para disponibilizar o maior número possível desses equipamentos para o tratamento dos pacientes acometidos. O agravamento da crise sanitária colapsou serviços de saúde com busca isocrônica por leitos. Em meio ao colapso, foi detectada nova variante da linhagem Sars-CoV-2 e confirmado o primeiro caso de reinfecção. Entre os pontos críticos, foi destaque a escassez caótica de oxigênio e taxas de ocupação de leitos acima de 90%. Pretende-se relatar a participação das autoras nas iniciativas para o enfrentamento da pandemia de relevância internacional. Destacar a participação de mulheres em atividades que são cruciais para responder, em tempo oportuno, às demandas oriundas de emergências sanitárias. Por meio de método de pesquisa de abordagem descritiva e exploratória, buscou-se verificar o perfil das mulheres atuantes na gestão de tecnologias no enfrentamento da pandemia. Destaca-se a pesquisa recente da Associação Brasileira de Engenharia Clínica que verificou que apenas 19% dos associados respondentes eram mulheres, enquanto 81% eram do sexo masculino. Assim, divulgar e dar amplo conhecimento das ações de mulheres nessa área pode colaborar para o alcance da igualdade de gênero e empoderar todas as mulheres e meninas.

ABSTRACT The imminent risk of shortage of pulmonary ventilators in health services has resulted in several work fronts to maintain and make available the largest possible number of equipment available for the treatment of patients. The worsening of the health crisis has collapsed health services with an isochronic search for beds. Amid the collapse, a new variant of the Sars-CoV-2 strain was detected and the first case of reinfection was confirmed. Among the critical points was the chaotic oxygen scarcity and bed occupancy rates above 90%. We intend to report the participation of the authors in the initiatives to face the pandemic; highlight the participation of women in activities that are crucial to respond, in a timely manner, to the demands arising from health emergencies. Through a research method with a descriptive and exploratory approach, we sought to verify the profile of women working in the management of technologies in facing the pandemic. The recent survey by the Brazilian Association of Clinical Engineering stands out, which found that only 19% of the respondent associates were women. Thus, disseminating and giving broad knowledge of women´s actions in this area can collaborate in achieving gender equality and empower all women and girls.

The Policy and Practice of Medical Device Emergency Approval at the Local Level under the Circumstance of COVID-19 Disease / 中国医疗器械杂志

This research analyzed Chinese emergency approval policies and practices of medical devices at the local level under the circumstance of COVID-19 disease. The legal basis and administrative system were clarified, the implementation and characteristics of emergency approval policies were investigated, the products information including total approved number, product type and license's validity period were counted. Advices as enhancing the standardization of emergency approval system, strengthening registration guidance and optimize information disclose and management were provided.

Research on Supervision System of Combination Product in FDA / 中国医疗器械杂志

On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.

Discussion of Enlightenment from the Reorganization of CDRH Regulatory for Medical Device / 中国医疗器械杂志

This study introduces the establishment and the situation before and after the reorganization of Center for Devices and Radiological Health (CDRH). Meanwhile, it sorted out the important changes in this reorganization of CDRH. CDRH optimizes regulatory decisions by integrating pre-marketing and post-marketing professionals for the total product lifecycle of medical devices, based on product line guidelines. Taking the sutatus of Chinese medical device supervision into consideration, this study put forward some thoughts on scientific supervision.

Desafios na inocrporação de tecnologias de alta complexidade: estudo do PET-CT na perspectiva do plano de expansão da radioterapia / Challenges in the incorporation of high complexity technologies: PET-CT study in the perspective of radiotherapy expansion plan

Após a decisão pela incorporação de tecnologias na tabela de procedimentos no Sistema Único de Saúde (SUS), uma série de eventos pode prejudicar o efetivo acesso da população a tecnologias de alta complexidade, realçando uma dificuldade do SUS de executar localmente as estratégias definidas em âmbito federal. O objetivo deste estudo foi analisar os aspectos organizacionais pós-incorporação de tecnologias de alta densidade, em especial o caso do PET-CT (Tomografia por Emissão de Pósitron-Tomógrafo Computadorizado), identificando os principais desafios na implementação dessa tecnologia e avaliar a viabilidade de uso de soluções integradas a partir da experiência do Plano de Expansão da Radioterapia no SUS. Foram realizadas pesquisas nos sistemas informatizados do Ministério da Saúde e base de dados da Plataforma + Brasil. Foram coletadas as informações com as áreas técnicas e finalísticas do Ministério da Saúde e dados de registros sanitários na ANVISA. Discutiu-se que a solução integrada, como o Plano de Expansão da Radioterapia, pode ser alternativa real para a efetiva incorporação de tecnologias de alta complexidade.

Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process / 中国医疗器械杂志

In order to strengthen the supervision and management of medical devices, China implements pre-market registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.

Preliminary Review of Relationship between Medical Device Evaluation and Quality Management System in Premarket Approval / 中国医疗器械杂志

This paper analyzed the current reform of review and approval mechanism for medical devices and discussed the method for technical review process extending to product quality controllable direction and found the measures and suggestions to strengthen technical review for quality management system with the help with complementary relationship between the technical review and the quality management system assessment of the pre-market registration. Nowadays, because of the demand of eRPS， MAH and the amendment of regulation, the integration of technical review and quality management system is more important, necessary and scientific. Scientific and systematic evaluation should be carried out to strengthen the pre-market approval of medical devices and ensure the safety and effectiveness of medical products.

Solution to Unify the Review of Domestic Second Class Medical Device / 中国医疗器械杂志

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.

Study on Regulations of Exemption in Medical Device Registration and Approval Process in the United States and China / 中国医疗器械杂志

Registration and approval is a necessary step in product marketing process of new medical devices to ensure their safety and efficiency.At present,many countries are relatively strict in the management of high risk medical devices,especially for class Ⅲ medical devices.Taking clinical trials as examples,they cost too many human,material resources.FDA has introduced a variety of regulations and policies to streamline the registration process to speed up the product marketing process.Based on the introduction of the relevant regulations on the exemption in parts of medical device registration and approval process in the United States,this paper compares and analyzes the simplified status of medical device approval in China.In the end,the significance of exemption in the registration and approval process is expounded,and some suggestions on how to optimize and approve the registration and approval process of medical devices in China are put forward.

Reference and Innovation: Research on the Construction of Medical Device Registrar System / 中国医疗器械杂志

In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.

Discussion on Administrative Innovation of Medical Device in China and U.S / 中国医疗器械杂志

This article refreshes the innovative review approach of medical device in China at first. It proposes reference through presenting a series of existing review and approval of innovative medical device in U.S. as well as new tools and methods for supporting scientific review.

Practice of Medical Device Clinical Evaluation / 中国医疗器械杂志

For medical device clinical evaluation activities, reference to international and domestic medical device regulations and guidance documents, this paper briefly introduces the implementation steps of clinical evaluation of medical devices, and focus on the evaluation report should be included in the content, provides reference for relevant personnel of medical devices registration and certification on medical device clinical evaluation practice.

Principles for evaluating the clinical implementation of novel digital healthcare devices

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, ‘digital exceptionalism’ (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

Research on the Management System of Medical Device Recognized Consensus Standards in USA / 中国医疗器械杂志

This paper gives a brief introduction on the development of recognized consensus standards, the recognition working procedure and the overview of medical devices recognized consensus standards in USA, and analyzes the experience of the recognition management system in USA, aiming at providing a reference for the improvement of the medical device standard management system in China.

Robotic Cholecystectomy Using the Newly Developed Korean Robotic Surgical System, Revo-i: A Preclinical Experiment in a Porcine Model

One Korean company recently successfully produced a robotic surgical system prototype called Revo-i (MSR-5000). We, therefore, conducted a preclinical study for robotic cholecystectomy using Revo-i, and this is a report of the first case of robotic cholecystectomy performed using the Revo-i system in a preclinical porcine model. Revo-i consists of a surgeon console (MSRC-5000), operation cart (MSRO-5000) and vision cart (MSRV-5000), and a 40 kg-healthy female porcine was prepared for robotic cholecystectomy with general anesthesia. The primary end point was the safe completion of these procedures using Revo-i: The total operation time was 88 minutes. The dissection time was defined as the time from the initial dissection of the Calot area to the time to complete gallbladder detachment from the liver bed: The dissection time required 14 minutes. The surgical console time was 45 minutes. There was no gallbladder perforation or significant bleeding noted during the procedure. The porcine survived for two weeks postoperatively without any complications. Like the da Vinci surgical system, the Revo-i provides a three-dimensional operative view and allows for angulated instrument motion (forceps, needle-holders, clip-appliers, scissors, bipolar energy, and hook monopolar energy), facilitating an effective laparoscopic procedure. Our experience suggests that robotic cholecystectomy can be safely completed in a porcine model using Revo-i.

Validação dos sistemas computadorizados empregados na determinação dos enantiômeros do nadolol e dos homólogos da ivermectina e da abamectina / Validation of the computer systems used in the determination of nadolol enantiomers and homologous of ivermectin and abamectin

O nadolol é um agente bloqueador de receptores ß-adrenérgicos empregado principalmente, na "angina pectoris", hipertensão, certas arritmias cardíacas e no tratamento do glaucoma (SING, 2006). A ivermectina e a abamectina são fármacos que apresentam ação antiparasitária (SHOOP, 1995). Na presente pesquisa, a cromatografia em fase líquida de alta eficiência foi uma das técnicas estudadas para a quantificação dos enantiômeros do nadolol e dos homólogos presentes na abamectina e ivermectina. A versatilidade desta técnica reside no grande número de fases estacionárias existentes, as quais possibilitam análises, separações e determinações quantitativas de uma ampla gama de compostos com alta eficiência (Aquino Neto e Nunes, 2003). Para identificação dos enantiômeros do nadolol foi utilizado o dicroísmo circular que permite a determinação da configuração absoluta de enantiômeros (LIMA, 1997). Para os enantiômeros do nadolol e dos homólogos presentes na abamectina e na ivermectina também foram realizados testes para desenvolvimento de uma metodologia de quantificação por meio de uma técnica relativamente recente chamada de eletroforese capilar (EC), a qual tem alcançado desde sua introdução um rápido desenvolvimento e ampla aplicação na análise de fármacos em medicamentos (SANTORO, 2000). Para a comprovação da qualidade e segurança dos sistemas computadorizados dos equipamentos de cromatografia em fase líquida de alta eficiência (CLAE) e de eletroforese capilar (EC) foram efetuadas, neste trabalho, as respectivas validações. Após esta validação, pode-se confirmar o correto funcionamento de um software, e suas interações com o hardware, onde devem ser levados em consideração, dentre outros, os aspectos relacionados à infra-estrutura, segurança e manutenção de dados (AGÊNCIA NACIONAL DE VIGILÂNIA SANITÁRIA, 2010). As metodologias analíticas desenvolvidas a para quantificação do nadolol, abamectina e ivermectina por cromatografia em fase líquida de alta eficiência foram validadas. A validação analítica deve garantir, por meio de estudos experimentais, que o método atenda às exigências das aplicações analíticas, assegurando a confiabilidade dos resultados. Para tanto, o método deve apresentar especificidade, linearidade, intervalo, precisão, sensibilidade, limite de quantificação e detecção, exatidão, adequados à análise (AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA, 2003). Portanto, o objetivo proposto nesta pesquisa é primeiramente a validação dos sistemas computadorizados dos equipamentos de cromatografia em fase líquida de alta eficiência (CLAE) e de eletroforese capilar (EC). Para isto, serão desenvolvidos e validados os métodos analíticos de separação, identificação e quantificação dos enantiômeros do nadolol e dos homólogos presentes na abamectina e na ivermectina, em medicamentos, empregando as técnicas analíticas selecionadas

Nadolol is a blocking agent with activity in the ß -adrenergic receptors. It is mainly used in angina, hypertension, certain heart arrhythmias and in the treatment of glaucoma (SING, 2006). Ivermectin and abamectin are drugs with antiparasitic activity (SHOOP, 1995). In the present research, high performance liquid chromatography is one of the techniques used in the quantification of the enantiomers of nadolol and homologues present in abamectin and ivermectin. The versatility of this technique and the large number of existing stationary phases, enables the separation and quantitative determination of a wide range of compounds with high efficiency (Aquino Neto e Nunes, 2003). For identification of the nadolol enantiomers, circular dichroism was used which allows the determination of the absolute configuration of the enantiomers (LIMA, 1997). Nadolol enantiomers and the homologues present in abamectin and ivermectin will be also quantified by capillary zone electrophoresis (CE), a separation technique relatively recent, which has achieved, since its introduction, a wide application in the analysis of drugs in pharmaceutical preparations (SANTORO, 2000). In order to assure the quality of the analytical results, the computer systems of the liquid chromatograph and capillary electrophoresis equipments, must be validated prior to the analytical methods validation. Computer systems validation is used to verify and confirm the proper operation of softwares, and their interactions with the hardwares, besides the infrastructure, safety and storage of data (AGÊNCIA NACIONAL DE VIGILÂNIA SANITÁRIA, 2010). The analytical methodologies developed for quantification of nadolol, abamectin, ivermectin by using high efficiency liquid chromatography and capillary electrophoresis were validated. The analytical methods validation should ensure, through experimental studies, that the method meets the requirements for analytical applications, ensuring the reliability of the results. Parameters like, specificity, linearity, range, accuracy, sensitivity, limits of detection and quantification and accuracy, must be determined (AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA, 2003). The objective of this study is to validate the computer systems of the high performance liquid chromatograph and capillary electrophoresis equipments and then to develop and validate analytical methods for separation, identification and quantification of nadolol enantiomers and the homologues of abamectin and ivermectin