Quality indicators for the processing of health products: A mixed-methods study / Indicadores de calidad para el procesamiento de productos para la salud: estudio de método mixto / Indicadores de qualidade para o processamento de produtos para saúde: estudo de método misto

Objective: to analyze the use of quality assessment indicators and their implementation to improve quality in the processing of health products. Method: a mixed-methods study with a multiple case approach using Structure, Process and Results indicators and elaboration of a plan using Appreciative Inquiry, carried out in four central sterile supply departments from hospital units. Results: the indicators for the Cleaning stage presented 47.8% compliance for Structure and 59.0% for Process: in addition 71.8% of the products were clean. In the Preparation operational stage, 50.0% of the Results indicators were in compliance for Structure and 66.7% for Process. In the Sterilization, Storage and Distribution stage, 43.5% compliance was obtained for Structure, 55.7% for Process and 78.6% for Packaging conservation. Appreciative planning proposed improvements to the physical structure, review of processes and protocols, promotion and appreciation of the work done and strengthening of teaching about processing and service management, highlighting the protagonism of the group and of the leaders. Conclusion: using indicators was positive in materializing reality; however, it was verified that the improvements proposed are related to people. The affirmative and constructive view of Appreciative Inquiry presented itself as a path to changes and quality improvements.

Objetivo: analizar el uso y la implementación de indicadores de evaluación de la calidad para mejorar la calidad del procesamiento de productos para la salud. Método: estudio mixto, con enfoque de casos múltiples que usa indicadores de estructura, proceso y resultado y la elaboración de una planificación mediante la investigación apreciativa, realizado en cuatro centros de material y esterilización de unidades hospitalarias. Resultados: los indicadores de la etapa de limpieza mostraron un 47,8% de conformidad en estructura, un 59,0% en proceso y el 71,8% de los productos estaban limpios. En la etapa operativa de la preparación, se registró conformidad en el 50,0% de los indicadores de resultados de estructura y en el 66,7% de proceso. En la etapa de esterilización, almacenamiento y distribución se obtuvo un 43,5% de conformidad en estructura, un 55,7% en proceso y un 78,6% en conservación de los envases. La planificación apreciativa propuso mejoras para la estructura física, revisión de procesos y protocolos, promoción y valoración del trabajo, fortalecimiento de la enseñanza sobre procesamiento y gestión de servicios, y destacó el protagonismo del grupo y del liderazgo. Conclusión: el uso de indicadores fue positivo para materializar la realidad, sin embargo, se observó que las mejoras propuestas tienen que ver con las personas. La visión afirmativa y constructiva de la investigación apreciativa demostró ser útil para cambiar y mejorar la calidad.

Objetivo: analisar o uso de indicadores de avaliação da qualidade e suas implementações para melhoria da qualidade do processamento de produtos para saúde. Método: estudo misto, com abordagem de casos múltiplos utilizando indicadores de estrutura, processo e resultado e a construção de um planejamento utilizando a investigação apreciativa, realizado em quatro centros de material e esterilização de unidades hospitalares. Resultados: os indicadores para a etapa da limpeza apresentaram 47,8% de conformidade para estrutura, 59,0% para processo e 71,8% de produtos estavam limpos. Na etapa operacional do preparo, 50,0% dos indicadores de resultados estiveram em conformidade para estrutura e 66,7%, para processo. Na etapa de esterilização, armazenamento e distribuição, obtiveram-se 43,5% de conformidade para estrutura, 55,7% para processo e 78,6% para conservação das embalagens. O planejamento apreciativo propôs melhorias para a estrutura física, revisão de processos e protocolos, promoção e valorização do trabalho, fortalecimento do ensino sobre processamento e a gerência do serviço, destacando o protagonismo do grupo e da liderança. Conclusão: o uso dos indicadores foi positivo na materialização da realidade, porém verificou-se que as melhorias propostas se relacionam às pessoas. A visão afirmativa e construtiva da investigação apreciativa apresentou-se como caminho para mudanças e melhorias da qualidade.

Trombocitopenia severa inducida por un oclusor para DAP: reporte de caso en tecnovigilancia

Introducción: El ductus arterioso persistente (DAP) es una cardiopatía congénita de especial interés. La oclusión intervencionista es el tratamiento de elección, no obstante, el dispositivo médico "oclusor para DAP", usado en este procedimiento, puede dar lugar a la aparición de eventos adversos de rara frecuencia como hemorragia, trombocitopenia, entre otros. Reporte de caso: Se presenta un caso de una paciente pediátrica con trombocitopenia severa posterior a la intervención. Durante su hospitalización, la paciente mantuvo niveles bajos de plaquetas hasta que logra su recuperación y sale de alta sin una nueva manifestación hematológica. El caso fue reportado como sospecha de incidente adverso asociada al oclusor para DAP. Conclusión: Al realizarse el análisis causa-raíz, se concluye que el tamaño del oclusor para DAP podría ser la principal causa de la trombocitopenia. El presente caso es una muestra que los dispositivos médicos pueden causar eventos adversos severos, por lo que, es necesaria la implementación de tecnovigilancia, principalmente a los dispositivos médicos de alto riesgo.

Introduction: Patent ductus arteriosus (PDA) is a congenital heart condition of special interest. Interventional occlusion is the treatment of choice; however, a PDA occlude, used in this procedure, is a medical device that rarely could lead to adverse events such as hemorrhage, thrombocytopenia, etc. Case report: We present a case of a pediatric patient with severe thrombocytopenia after surgery. During her hospitalization, platelet levels remained lower and, finally, she was fully recovered without any hematological manifestation. The case was reported as a suspected adverse incident related to PDA occlude. Conclusion: After performing a cause-root analysis, we concluded that the size of the PDA occlude may be the main cause of thrombocytopenia. This case demonstrates that medical devices could lead to adverse events. Thus, it is important for clinicians to implement medical device surveillance, mainly for high-risk medical devices.

Awareness and outlook of health-care professionals regarding materiovigilance in a tertiary care teaching hospital in South Rajasthan

Background: Post-marketing surveillance regulates the safety, quality, and performance of medical devices (MDs). Medical professionals play a key role in the monitoring and reporting of MD Adverse Events (AEs). Since the launch of Materiovigilance (MV) Programme of India, very few published studies were found regarding reporting of MDAE. Aim and Objective: This study aims to know about awareness and outlook of medical professionals regarding MV. Materials and Methods: A cross-sectional study done among medical professionals of various specialties in a tertiary care teaching hospital in South Rajasthan. A pre-validated questionnaire was circulated to 200 doctors containing questions related to knowledge, attitude and practice of MV. Results: About 58.6% of the doctors came to know about the term MV during this study. About 76.7% of participants knew that MD could lead to an AE, but only 11.2% of the participants had the correct knowledge of how to report an AE related to MD. About 66.8% of participants had positive attitude regarding reporting of AE, 23.7% reported the event and 66.6% did not report as they found them mild. Conclusion: Majority of doctors had the knowledge about reporting of AEs, but they were largely unaware of the term MV. Knowledge regarding where to report is very limited. Despite adequate level of knowledge, reporting practices are very limited. Hence, there is a need for regular sensitization and training programs to foster the habit of reporting AE related to MD even if they are mild.

Guía para la gestión de riesgos de los dispositivos médicos para el diagnóstico / Risk management guidance for diagnostic medical devices

Introducción: Los fabricantes de los dispositivos médicos no siempre disponen de experiencia para realizar un proceso de gestión de riesgos que cumpla con la norma ISO 14971:2019 e incluya los requisitos metrológicos necesarios; por tanto, para un mejor uso de estos equipos, especialmente los de diagnóstico, se debe implementar y mantener un proceso de gestión de riesgos basado en las normativas establecidas. Objetivo: Proponer una guía para la gestión de los riesgos indirectos en pacientes con diagnósticos incorrectos o retrasados. Métodos: Se revisaron las normas internacionales aplicables y se analizaron expedientes de gestión del riesgo de dispositivos médicos, entre ellos reactivos para el diagnóstico in vitro. Resultados: La guía ofrece elementos orientadores para cada etapa del proceso de gestión de riesgos en los dispositivos médicos para el diagnóstico: plan de gestión del riesgo, análisis, valoración y control del riesgo, evaluación del riesgo residual global, revisión de la gestión de riesgo y retroalimentación a partir de la información de producción o posproducción. Conclusiones: Esta guía es una herramienta útil para diseñadores, fabricantes, evaluadores de dispositivos médicos para el diagnóstico, asesores en temas de gestión de riesgos y la calidad de los dispositivos y personal médico(AU)

Introduction: Manufacturers of medical devices do not always have the expertise to perform a risk management process that complies with ISO 14971:2019 and includes the necessary metrological requirements; therefore, for better use of these devices, especially diagnostic devices, a risk management process based on established regulations should be implemented and maintained. Objective: To provide guidance for the management of indirect risks in patients with incorrect or delayed diagnoses. Methods: Applicable international standards were reviewed and risk management dossiers for medical devices, including in-vitro diagnostic reagents, were analyzed. Results: The guidance provides guiding elements for each step of the risk management process for diagnostic medical devices: risk management plan, risk analysis, risk assessment, risk evaluation and control, overall residual risk assessment, risk management review, and feedback from production or post-production information. Conclusions: This guide is a useful tool for designers, manufacturers, evaluators of diagnostic medical devices, risk management and device quality assessors, and medical personnel(AU)

Analysis for Key Points of Registration Applications and Difficulties of Process Control of 3D Printed Customized Dentures / 中国医疗器械杂志

With the highlighted advantages of 3D printing technology in the field of dental prosthodontics, there is increasing in the numbers of registration applications for additive manufacturing customized dentures. However, there is still a lack of unified analysis in the core elements of process control, the key points of registration and the safety production quality control. Based on the current research status of the industry, the study is intended to clarify confusion and difficulties, deeply analyse the mechanism of the product defects, sort the core elements of process control, then try to establish a systematic evaluation system from product performance research, key process verification, production quality control and the description of registration files, so that it can provide help for practitioners to clarify research direction, establishing quality management system, improving the efficiency of registration and ensuring product quality.

Roadmap of Medical Device for Implanted Brain-computer Interface / 中国医疗器械杂志

Implanted brain-computer interface (iBCI) is a system that establishes a direct communication channel between human brain and computer or an external devices by implanted neural electrode. Because of the good functional extensibility, iBCI devices as a platform technology have the potential to bring benefit to people with nervous system disease and progress rapidly from fundamental neuroscience discoveries to translational applications and market access. In this report, the industrialization process of implanted neural regulation medical devices is reviewed, and the translational pathway of iBCI in clinical application is proposed. However, the Food and Drug Administration (FDA) regulations and guidances for iBCI were expounded as a breakthrough medical device. Furthermore, several iBCI products in the process of applying for medical device registration certificate were briefly introduced and compared recently. Due to the complexity of iBCI in clinical application, the translational applications and industrialization of iBCI as a medical device need the closely cooperation between regulatory departments, companies, universities, institutes and hospitals in the future.

Changes in Registration Status of Identification Codes on PMDA’s Information Search Site of Pharmaceuticals for Prescription / 医薬品情報学

The identification code of a drug is defined as “a code for identifying tablets, etc.” and is described in the “Composition/Properties” section of the package insert. We investigated whether the Pharmaceuticals and Medical Devices Agency (PMDA) website, which allows users to search package insert information, can be used for drug identification using identification codes in 2019 before the new package insert guidelines were implemented, and in 2022, during the revision period. Approximately 30% of the investigated high-risk drugs were unidentifiable in both years. The most common reason was that images were used to register identification codes on the PMDA website, and character strings were not searchable. We then conducted a questionnaire survey of pharmaceutical companies, and only approximately half of the respondents opined that it would be preferable if the registration format for identification codes was established within the pharmaceutical industry. However, hospital pharmacists urged for more simplified identification of drugs on the PMDA website.

Investigation of Medical Device Program Defects Affecting Pharmacotherapy / 医薬品情報学

Objective:Medical device malfunctions can significantly impact pharmacotherapy. With advances in digital technology, smartphone applications for the treatment of nicotine addiction have recently been released in Japan. However, it cannot be denied that the malfunction of medical devices related to such programs may affect drug treatment. Therefore, we investigated malfunctioning medical devices related to the program.Methods: We investigated reports on malfunctions from FY 2006 to 2021, using the Pharmaceuticals and Medical Devices Agency database.Results: A total of 94 cases of program-related medical device failures were reported in Japan. The malfunction of medical devices (such as infusion pumps and dialysis machines) associated with drug treatment were confirmed. The events included a rapid infusion of the drug and an inability to ascertain the total dose, both of which were caused by bugs in the program. Although the specifics are unknown, there was a malfunction in the contrast medium injection device as well.Conclusion: When issues arise with the dosage setting of medical devices, it is necessary to consider both human errors by medical staff as well as program bugs. Additionally, to provide safe drug therapy to patients, pharmacists must inspect the medical devices used in drug therapy when visiting hospital wards and patients' homes.

Characteristic Analysis and Ethical Review Strategy of Medical Device Expanded Clinical Trials / 中国医学伦理学

Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.

Quality management and indicator system for clinical trials of medical devices / 中国临床药理学与治疗学

AIM: Exploring medical device clinical trial quality management indicator system to continuously improve medical device clinical trial quality system construction. METHODS: Through literature research and Delphi method, we summarized the risks of medical device clinical trials in various aspects such as quality management, clinical trial data, and clinical trial research personnel construction, analyzed the risks and proposed a clinical trial quality management index system, as well as corresponding quality improvement measures. RESULTS: To establish an appropriate medical device clinical trial quality evaluation management tool for quality risk monitoring and management, and to support and help the construction of a medical device clinical trial quality management system. CONCLUSION: To identify risks in various aspects of clinical trials and establish a preliminary assessment index system to provide a reference for the evaluation of the effectiveness of clinical trial quality management.

Analysis of Radio Frequency Identification Immunity Standard for Medical Equipment / 中国医疗器械杂志

Aiming at the increasing application of RFID technology in the medical environment, this study introduces the foreign requirements for RFID immunity test of medical devices, compares them with the current immunity test requirements of medical devices in China, and puts forward the necessity of establishing relevant test specifications in China.

Design and implementation of Internet of Things for emergency medical devices based on cloud-edge-device architecture / 生物医学工程学杂志

Internet of Things (IoT) technology plays an important role in smart healthcare. This paper discusses IoT solution for emergency medical devices in hospitals. Based on the cloud-edge-device architecture, different medical devices were connected; Streaming data were parsed, distributed, and computed at the edge nodes; Data were stored, analyzed and visualized in the cloud nodes. The IoT system has been working steadily for nearly 20 months since it run in the emergency department in January 2021. Through preliminary analysis with collected data, IoT performance testing and development of early warning model, the feasibility and reliability of the in-hospital emergency medical devices IoT was verified, which can collect data for a long time on a large scale and support the development and deployment of machine learning models. The paper ends with an outlook on medical device data exchange and wireless transmission in the IoT of emergency medical devices, the connection of emergency equipment inside and outside the hospital, and the next step of analyzing IoT data to develop emergency intelligent IoT applications.

A study of assessing knowledge, attitude, and practice of materiovigilance among medical surgeons of Gujarat

Background: Medical devices which are now employed in all areas of health care have played a crucial role in patient care. Although, their use is not without risk. Materiovigilance refers to close monitoring for any medical device-associated adverse events by a well-coordinated surveillance system of detection, collection, assessment, reporting, and prevention of adverse events. Aim and Objective: The aim of the study was to assess the knowledge, attitude, and practice (KAP) of materiovigilance among medical surgeons of Gujarat. Materials and Methods: This was an observational, cross-sectional, and questionnaire-based study, conducted among practicing medical surgeons of Gujarat, India. A structured self-administered Google form-based questionnaire in the English language was prepared to collect the relevant data of the study variables. The questionnaire contained a total of 17 questions related to KAP aspects of the materiovigilance. The questionnaire was distributed to the study participants through a digital web link using various social media platforms and their responses were collected. Results: A total of 156 participants responded. Nearly, 71.8% of the participants had an idea about various reporting systems in India to report medical device-induced adverse events, but only 31.4% of the participants were aware of India’s current program for monitoring adverse events. Very few (9%) participants had reported adverse events during their practice. Whereas, 77.6% of the participants were willing to report a medical deviceinduced adverse event in the future. Conclusion: Participants in our study were found to be lacking adequate knowledge and practice of materiovigilance. However, they showed a positive attitude toward materiovigilance. Various educational interventions and training are required to promote the reporting of medical device-induced adverse events.

Mapeamento dos bancos de dados em dispositivos médicos: revisão narrativa e o cenário brasileiro para avaliação com dados de mundo real (RWD) / Mapping of database in medical devices: review and the Brazilian scenario for evaluation with real world data (RWD)

Objetivo: Pretendeu-se mapear os bancos de dados governamentais em dispositivos médicos, na perspectiva pública com o intuito de contribuir como fonte para gerar dados de mundo real (RWD) e potencial para subsidiar estudos de Avaliação de Tecnologias em Saúde (ATS). Métodos: Realizada revisão narrativa na base de dados do Embase. Os critérios para inclusão de elegibilidade foram: i) dimensão ampla de RDW nos processos de gestão de tecnologias; e ii) aplicação de RDW em processos regulatórios, cobertura e ATS. Também foram consultados os sistemas do Ministério da Saúde e da Anvisa. Resultados: A busca retornou 1.185 resultados; após leitura dos resumos, foram selecionados 29 artigos, sendo 5 incluídos. Na consulta ao catálogo do Datasus, foram localizados 262 sistemas informatizados; após análise da descrição sumária e principais objetivos, foram selecionados 12 sistemas que geram dados sobre dispositivos médicos. A falta de interoperabilidade dos sistemas é recorrente e a ausência de uma nomenclatura padronizada é um desafio a mais. Conclusão: Há crescente discussão do uso de RWD para subsidiar ATS em todo o ciclo de vida tecnológico, desde regulação até monitoramento do uso, como também para subsidiar análises de custo-efetividade e benefícios clínicos. Assim como nos demais países, o Brasil sistematizou inicialmente os dados administrativos para atender às demandas comerciais e financeiras. Os sistemas não geram dados dos resultados clínicos. São disponibilizados dados das tecnologias dispensadas e dos valores repassados e não são coletadas as informações dos benefícios do uso dessas tecnologias. Com a evolução dos métodos de ATS, a utilização de RWD tornou-se relevante.

Objective: It was intended to map government databases on medical devices, in the public perspective, in order to contribute as a source to generate real world data (RWD) and potential to subsidize Health Technology Assessment (HTA) studies. Methods: A narrative review was carried out in the Embase database. The criteria for inclusion of eligibility were: i) broad dimension of RDW in technology management processes; and ii) application of RDW in regulatory processes, coverage and HTA. The systems of the Ministry of Health and Anvisa were also consulted. Results: Results: The search returned 1,185 results, after reading the abstracts, 29 articles were selected, 5 of which were included. The catalog of Datasus database were consulted, 262 summaries with the description and the main objectives were analyzed, 12 systems were selected systems that generate medical devices. The lack of interoperability of systems is recurrent and the absence of a standardized nomenclature is an additional challenge. Conclusion: There is a growing discussion about the use of RWD to subsidize HTA throughout the technological life cycle, from regulation to monitoring of use, as well as to subsidize the examination of cost-effectiveness and clinical benefits. As in other countries, Brazil has systematized administrative data for commercial and financial data demands. The systems do not generate data on clinical outcomes. Data provided are on dispensed technologies, on transferred values and are not collected on the benefits of using these technologies. With the evolution of HTA methods, the use of RWD has become relevant.

Medical devices associated adverse events under Materiovigilance Programme of India in a Tertiary Care Hospital of Tribal District of Odisha

Background: A materiovigilance program is a system that is used for the identification, collection, and reporting of possible adverse reactions resulting from the use of medical devices. This monitoring program ensures the safety of patients and aids the post-marketing surveillance process. The Materiovigilance Programme of India (MvPI) was launched on July 6, 2015. Aims and Objectives: The primary objective of the study was to generate evidence based data on the safety of the medical devices used in our institute and to analyze the risk benefit ratio of reported adverse events of medical devices and to communicate the safety information to the stake holders. The secondary objective was to educate and advocate the concept of MvPI and creating a culture of adverse events reporting among health workers. Materials and Methods: A retrospective study was conducted after receiving clearance from the Institutional Ethical Committee, Saheed Laxman Nayak Medical College and Hospital (SLN MCH), Koraput. Data about Medical Device-Associated Adverse Events (MDAEs) were collected from MDMC, SLN MCH, Koraput, for the period from October 2019 to February 2022. MDAE reports were collected by a materiovigilance associate during the period from October 2019 to February 2022. Events were reviewed to verify whether or not they were documented in patient’s electronic records and a database of devices was created, which included the events associated with each device. Device-related MDAEs were classified by patient characteristics and the medical devices used. Results: In the 15-month study period, a total of 56 cases of MDAE were reported to MDMC, SLN MCH, Koraput. Of these, 17.9% MDAEs (10 cases) were adverse events related to surgical gloves, 8.9% (five cases) were associated with pulse oximeters, 7.14% of cases (4 cases) were due to glucometer malfunctioning, and 7.1% were related to HIV diagnostic kits such as false positives and false negatives. Adverse events such as skin rashes, irritation on skin, itching, redness of eyes, and gum bleeding in patients with dental braces were reported. A majority of device defects involved inaccuracy in the data reported by the devices (seen in 10.7% of cases), while six cases were due to device malfunctioning. Conclusion: This study shows only the tip of iceberg of the reporting trends of MDME. There is inequality in reporting by different grades of health care workers and from different departments. It highlights the necessity of conducting awareness programs, training and workshops regularly. Device-related safety and reporting of device-related adverse events should be subject of attention and further research.

La investigación científica: un reto en electromedicina

RESUMEN En Cuba se fomenta el desarrollo de investigaciones en el campo de las ciencias médicas, con el fin de introducir sus resultados a favor del progreso económico y social. El objetivo de este trabajo fue reflexionar sobre el papel de la ciencia en la gestión de equipos médicos, su aplicación en los departamentos de electromedicina de las instituciones sanitarias, y su impacto social. Todo ello a partir de la presentación de los aspectos teóricos fundamentales de las relaciones entre ciencia, gestión de equipos médicos y función social de la electromedicina, a partir de su situación actual. La investigación científica en electromedicina, permitiría formular nuevas teorías o modificar las existentes e incrementar los conocimientos, lo que posibilitaría el enriquecimiento de las ciencias médicas. Resulta necesaria como proceso, a fin de obtener información relevante para la verificación, corrección y aplicación del conocimiento, en aras de solucionar los problemas de las tecnologías sanitarias y su impacto socioeconómico.

ABSTRACT In Cuba, the development of research in the field of the medical sciences is promoted in order to introduce its results to favor the social and economic progress. The aim of this work was to reflect on the role of science in the management of medical devices, its application in the electromedicine departments of health facilities, and its social impact, all this from the presentation of the main theoretical aspects of the relations between science, medical devices management and electromedicine social function in its current situation. Scientific research in electromedicine would allow to formulate new theories or to modify the existent ones and to increase knowledge, what would make possible the enrichment of the medical sciences. As a process, scientific research is necessary in order to obtain relevant information for the validation, correction and application of the knowledge, for the sake of solving the problems of health technologies and its socioeconomic impact.

Common issues and improvements on clinical trial data inspection of medical device / 中华医学科研管理杂志

Objective:The authenticity and accuracy of medical device related clinical trial data is crucial for the efficacy and safety of tested products. This article analyzed issues identified during previous data inspections of medical device clinical trials in our hospital, summarized experiences and findings, and proposed solutions.Methods:According to the " Medical Device Clinical Trial Inspection Points and Judgment Principles" , this study retrospectively analyzed the data inspection of medical device clinical trials in our hospital since 2016, summarized and analyzed the common issues identified.Results:A total number of six data inspections on medical device clinical trials were carried out in our hospital, during which 30 findings were identified. These findings include 4 items of pre-trial preparation, 2 items of patient rights protection, 7 items of trial processes, 12 items of records and reporting, as well as 5 items of experimental medical device management.Conclusions:The completeness, accuracy and consistency of clinical trial records in clinical trials of devices in our hospital have a lot space for improvement. And there is still room for improvement in the compliance to the protocol and the management of medical devices during the trial process. Based on the common findings, our drug clinical trial center will strengthen training and quality control, improve informatization and centralized management, and emphasize the importance of records. Through that the accuracy and authenticity of trial data for medical devices, and the credibility and objectiveness of trial results would be assured.

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.

Discussion on Ethical Review Elements of Clinical Research Regarding Artificial Intelligence Medical Devices / 中国医学伦理学

Clinical research of artificial intelligence (AI) medical devices is one of the most important links in the process of AI medical devices product development. This paper discusses the key elements of the ethical review of clinical research of artificial intelligence medical devices and the four aspects including strengthening the legislative construction and supervision, strengthening the capacity building of the ethics committee, improving the ethical review system and system construction, expanding platform construction and strengthening regional linkage that can improve the quality of ethical review in the future, protect the safety of subjects, and ensure the efficiency and quality of clinical research.