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.

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.

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.

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.

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.

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)

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.

Comparación de los desenlaces clínicos con cuatro técnicas de apendicetomía laparoscópica tras la implementación de políticas de reúso de dispositivos médicos / Comparison of clinical outcomes with four laparoscopic appendectomy techniques after implementation of medical devices reuse policy

Resumen Objetivo: En este estudio se comparan los desenlaces clínicos de cuatro técnicas de apendicectomía laparoscópica utilizadas en una institución colombiana para el manejo de la apendicitis aguda tras la adopción de políticas de reúso y reprocesamiento de dispositivos médicos para la Región de las Américas (2014). Materiales y Método: Mediante el análisis de varianza de una vía (ANOVA) y la prueba de Kruskal Wallis, se compararon las tasas de infección de sitio operatorio (ISO), reoperación no planeada, readmisión y mortalidad (en los primeros 30 días del postoperatorio) de las siguientes técnicas: Técnica 1: Ligadura del muñón apendicular con endonudo y disección del mesenterio apendicular con electrocoagulación bipolar convencional; Técnica 2: Clipaje del muñón con endoclip de polímero y disección del mesenterio con electrocoagulación bipolar convencional; Técnica 3: Clipaje del muñón con endoclip de polímero y disección del mesenterio con electrocoagulación monopolar; Técnica 4: Clipaje del muñón y disección roma y ligadura del mesenterio con endoclip de polímero. Resultados: Se incluyeron 551 pacientes. No se encontraron diferencias en los ANOVAs en cuanto a las características demográficas de los pacientes por cada técnica. Los desenlaces globales fueron: ISO (5,44%), reoperación no planeada (3,08%), readmisión (15,97%) y mortalidad (0,18%). Se encontraron diferencias significativas (p < 0,05) en estos desenlaces explicados por mayores tasas de ISO y reoperación con la Técnica-1. Conclusiones: Los desenlaces globales de la apendicectomía laparoscópica tras la adopción de políticas de reúso de dispositivos médicos se encuentran dentro de los aceptados globalmente cuando se utilizan las Técnicas 2-3-4 en poblaciones equivalentes de pacientes con apendicitis aguda. En este contexto, nuestros resultados invitan a utilizar con precaución la Técnica-1.

Aim: The present study sought to compare the clinical outcomes between four operative techniques for laparoscopic appendectomy in a Colombian institution, following the adoption of reuse and reprocessing policies for medical devices in the Region of Americas (2014). Materials and Methods: One-way analysis of variance (ANOVA) and Kruskal Wallis tests were used to compare the rates of Surgical Site Infection (SSI), unplanned reoperation, readmission and mortality (confined to 30 days after surgery) of these operative techniques: Technique 1: Ligature of appendiceal stump with endo stitch plus mesenteric dissection with conventional bipolar electrocoagulation; Technique 2: Clipping of stump with polymer endoclip plus mesenteric dissection with conventional bipolar electrocoagulation; Technique 3: Clipping of stump with polymer endoclip plus mesenteric dissection with monopolar electrocoagulation; Technique 4: Clipping of stump plus mesenteric dissection with polymer endoclip. Results: A total of 551 patients were included. No differences were found in the demographic characteristics of the patients between techniques during ANOVAs. The global outcomes were SSI (5.44%), unplanned reoperation (3.08%), readmission (15.97%) and mortality (0.18%). Significant differences were found (p < 0.05) in these outcomes explained by higher rates of SSI and unplanned reoperation with Technique 1. Conclusions: The overall outcomes of laparoscopic appendectomy, after the adoption of policies for the reuse and reprocessing of medical devices, are similar to those accepted globally when using operative techniques 2-3-4 in equivalent populations of patients with acute appendicitis. In this context, our results invite to use with caution technique-1.

Um Mapeamento Sistemático da Literatura no uso da IEC 62304 / A Systematic Literature Mapping in the use of IEC 62304 / Un Mapeo Sistemático de la Literatura en el uso de IEC 62304

A IEC 62304 fornece requisitos para os fabricantes de sistemas de saúde demonstrarem sua capacidade de fornecer softwares desenvolvidos com processos, atividades e tarefas, associadas aos riscos de segurança, que devem ser demonstrados para atendimento de fins regulatórios em diversos países. Este trabalho apresenta um mapeamento sistemático da literatura envolvendo os trabalhos que reportam utilizações, vantagens e dificuldades no uso da IEC 62304 em seus quase 15 anos de existência.

IEC 62304 provides requirements for manufacturers of healthcare systems to demonstrate their ability to provide software developed with processes, activities, and tasks, associated with safety risks, which must be demonstrated to meet regulatory purposes in several countries. This work presents a systematic literature mapping involving works that report uses, advantages and difficulties in the use of IEC 62304 in its almost 15 years of existence.

IEC 62304 proporciona requisitos para que los fabricantes de sistemas de atención médica demuestren su capacidad para proporcionar software desarrollado con procesos, actividades y tareas, asociadas con riesgos de seguridad, que deben demostrarse para cumplir con los propósitos regulatorios en varios países. Este trabajo presenta un mapeo sistemático de literatura que involucran trabajos que reportan usos, ventajas y dificultades en el uso de IEC 62304 en sus casi 15 años de existencia.

Analysis on Work Idea of Medical Device Classification Dynamic Adjustment Mechanism in the United States / 中国医疗器械杂志

OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.

Research on Current Situation of Quality Management of Artificial Intelligence Medical Device Enterprises / 中国医疗器械杂志

OBJECTIVE@#To understand the current situation of artificial intelligence production enterprise quality management system, so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device (AIMD) product quality management.@*METHODS@#Based on YY/T 0287-2017 Medical Device Quality Management System for Regulatory Requirements, Medical Equipment Production and the Quality Control Standard for Independent Software Appendix and Xavier GMLP report, the relevant factors were screened and the questionnaire was designed by combining expert consultation and literature review. Then, a total of 32 representative AIMD enterprises were invited to fill in the questionnaire. Descriptive statistical analysis was performed on the data results using Excel 2016.@*RESULTS@#Through in-depth analysis of the four themes in product planning and design, result output, product quality control and product change, it was found that it was necessary for enterprises participating in the survey to improve the quality management system of AIMD products to different degrees.@*CONCLUSIONS@#This study is the first time to systematically investigate the status quo of quality management of AIMD enterprises. The result will be useful for the establishment and continuous improvement of product quality management system. It will also provide a reference for the research of AIMD product quality management and the establishment of the standard.

Design and Implementation of Quality and Safety Traceability System for Reusable Medical Devices Disinfection Based on RFID Technology / 中国医疗器械杂志

Focusing on the requirements of visual traceability for reprocessing of reused medical devices under the background of deep integration of intelligent medical treatment, a quality and safety traceability system for disinfection of reused medical devices is developed. The multi-dimensional data of the reprocessing chain of reusable medical devices are acquired in real time by the RFID mobile terminal handset and stored temporarily. The data package is formatted based on LoRa protocol and uploaded to the management and control platform in multi-threaded transmission mode for in-depth analysis and traceability. The corresponding prototype system is developed. The first-line operation and maintenance test results show that the prototype system has strong cooperation, strong operation robustness, and obvious advantages in the identification rate and other layers of sterile equipment package.

Research and Thinking of International Coordination Documents for Medical Device Labeling / 中国医疗器械杂志

OBJECTIVE@#To further improve the regulation of medical device Introduction for Use (IFU) and improve the quality of medical device Introduction for Use (IFU).@*METHODS@#Summarize domestic regulatory experience and deficiencies through literature research, and introduce the international experience gathered from the IMDRF coordination document Principles of Labelling for Medical Devices and IVD Medical Devices.@*RESULTS@#The IMDRF international coordination document categorizes ten chapters to define and summarize the basic principles that medical device instructions and labels should contain.@*CONCLUSIONS@#According to the current status of medical device specification supervision and drawing on international supervision experience, improvement suggestions are proposed in terms of refining the IFU requires to improve the quality of the instructions, e.g. dynamic adjustment of IFU management requirements, strengthen the management of IFU for home used medical devices, and improving the standardization and rationality of medical device IFU content. We should continue to maintain effective management of medical device IFU.