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.

Knowledge of COVID-19, use of personal protective equipment and other safety practices of healthcare workers in southwest Nigeria

Background:Healthcare workers have a higher risk of SARS CoV2 infection with implications for transmission of infection and the safety of workers and patients. Objective: To assess knowledge on COVID-19 and the safety practices among selected healthcare workers in southwest Nigeria. Methods:A cross-sectional study of 210 workers providing direct care to patients during the COVID-19 pandemic was conducted. Respondents wererecruited through simple random sampling of members of online platforms of healthcare workers in Osun, Ondo and Ekiti States. Information on sociodemographic characteristics, knowledge of PPE and safety practices was obtained through a close-ended questionnaire. Results: The mean age of the respondents was 36.5±7.5 years. About 29% and 30% of respondents were from the State and Federal Government-owned Teaching Hospitals, respectively. A little above half (58.1%) had good knowledge of COVID-19, while 62.1%used PPE always when attending to suspected COVID19 cases. More than half (53.8%) had been trained on infection prevention and control (IPC), but only 34.3% adhered to good safety practices. Healthcare workers in State government-owned teaching hospitals had lower odds of good safety practices than those in Federal Teaching Hospitals (OR = 0.42, 95% CI = 0.19-0.93, p = 0.031).Conclusion: The knowledge of appropriate PPE and practice of safety precautions among healthcare workers is sub-optimal. This may predispose to increased COVID-19 transmission among healthcare workers, patients, and their families. Training and retraining healthcare workers, especially those from hospitals identified by the study as having poor safety practices, should be encouraged.

Research on Maintenance Management of Equipment of Magnetic Resonance Imaging Based on RAM / 中国医疗器械杂志

OBJECTIVE@#To optimize the maintenance quality management of MRI equipment and ensure the quality and safety of its clinical use.@*METHODS@#The data of failure time and repair time of a MRI equipment in three years were collected by magnetic resonance repair report system, and then the reliability, availability and maintainability(RAM) were studied and analyzed.@*RESULTS@#The results of reliability analysis showed that the communication module was the key subsystem of the MRI equipment. The results of usability analysis showed that RF module was a key subsystem of MRI equipment. Maintainability results showed that the proportion of the MRI equipment not fully utilized due to maintenance-related problems was 2.58%. In order to improve the availability of MRI equipment, the maintenance time of MRI equipment should be shortened.@*CONCLUSIONS@#RAM-based analysis of MRI equipment can help hospital equipment managers to carry out the work of operation optimization, maintenance strategy formulation and safety management of MRI equipment.

Enseñanzas de la actividad otorrinolaringológica durante el pico de la pandemia por COVID-19 en España / Lessons learned from ENT activity during the peak of the COVID-19 pandemic in Spain

Introducción: la infección por el coronavirus del síndrome respiratorio agudo grave de tipo 2 (SARS-CoV-2) tiene una elevada incidencia entre profesionales sanitarios, especialmente otorrinolaringólogos (ORL). El objetivo de este estudio fue recoger aspectos organizativos, de seguridad y de protección de los ORL durante el pico de la pandemia por la enfermedad por coronavirus de 2019 (COVID-19) en España. Material y métodos: estudio transversal con una encuesta por correo electrónico a los socios ORL de la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello (SEORL-CCC). Resultados: respondieron 408 profesionales. La atención a pacientes con COVID-19 representó más del 25 % de la actividad asistencial para el 24,4 % de los encuestados. 213 encuestados (52,6 %) respondieron que algún compañero había guardado cuarentena o dado positivo en la prueba. La cantidad de facultativos diagnosticados con COVID-19 o que guardó cuarentena por síntomas compatibles osciló entre 1 y 12 por hospital (media 2,2; mediana 2) y se encontró una mayor incidencia en las regiones con mayor incidencia de coronavirus (62,1 % frente a 41,8 %; p < 0,001), atención directa a pacientes con COVID-19 (81 % frente a 46,4 %; p = 0,001) y actividad de guardias (p = 0,01). El 61,5 % de los especialistas en hospitalización y el 40,4 % en consultas no contaron siempre con la protección personal aconsejada. Conclusiones: la pandemia por COVID-19 ha alterado la organización y la actividad asistencial de los servicios de otorrinolaringología. Importancia clínica: los especialistas ORL no han contado siempre con los equipos de protección aconsejados por los protocolos y una cantidad relevante se ha visto afectada por la COVID-19.

Introduction: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has a high incidence among healthcare professionals, especially otorhinolaryngologists (ENT). Study objective: The objective of this study was to collect organizational, safety and protection aspects of otorhinolaryngologists during the peak of the coronavirus disease 2019 (COVID-19) pandemic in Spain. Material and methods: Cross-sectional study with an e-mail survey to the ENT partners of the Spanish Society of Otorhinolaryngology and Head and Neck Surgery (SEORL-CCC). Results: 408 professionals completed the survey. Care of patients with COVID-19 represented more than 25% of healthcare activity for 24.4% of respondents. 213 respondents (52.6%) answered that a colleague tested positive or had been quarantined. The number of ENT surgeons diagnosed with COVID-19 or who were quarantined for compatible symptoms ranged between 1 and 12 per hospital (mean 2.2; median 2) and was related to regions with the highest incidence of coronavirus (62.1% vs. 41,8%; p <0.001), direct care for patients with COVID-19 (81% vs. 46.4%; p = 0.001) and on call activity (p = 0.01). 61.5% of the specialists attending inpatients and 40.4% attending outpatients did not always have the recommended personal protective equipment (PPE). Conclusions: The COVID-19 pandemic has altered the organization and care activity of the otorhinolaryngology departments. Clinical importance: ENT specialists have not always had the protective equipment recommended by the protocols and a significant number have been affected by COVID-19.

Lung Examination in Systemic Toxicitytest of Medical Devices / 中国医疗器械杂志

The lung is an important organ in systemic toxicity test of medical devices and is significant in safety evaluation. Based on the authors' understanding of medical devices, this study provides a brief analysis of the lung examination and common problems in systemic toxicity, so as to provide references for the pre-clinical safety evaluation of medical devices. It should be noted that a reasonable risk assessment should be made after comprehensive assessment for specific medical device products.

Comparison Study between the Second and First Editions of ISO/ TS 10974-Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device / 中国医疗器械杂志

ISO/TS 10974 is a general international technical specification (TS) which concentrates on the safety assessment of magnetic resonance imaging (MRI) for active implantable medical devices. ISO/TS 10974 Ed.2 was published in 2018 with substantial revision to Ed.1. To provide a guideline for adopting this recently revised TS in practice, this paper summarized the major changes and analyzed the technical improvements in Ed.2. Moreover, we also discussed current and emerging challenges to MRI safety evaluation remaining in Ed.2. The study revealed the consistency between these two editions with respect to classification of potential patient hazards and testing strategies, whereas Ed.2 has many methodological improvements over Ed.1 in testing methods for RF-induced heating, gradient-induced malfunction, and combined field testing, etc. However, it is still necessary to expand the scope of applicability and to adopt latest research findings into this TS to keep pace with the rapid developments in industry, making it a better guidance in the future.

Medical-device-related pressure injury on adults: an integrative review / Lesión por presión relacionada a dispositivos médicos en adultos: una revisión integradora / Lesão por pressão relacionada a dispositivo médico em adultos: revisão integrativa

ABSTRACT Objective: to identify factors associated with medical-device-related pressure injury. Method: an integrative review of published articles on the subject related to the adult population in the databases of PUBMED, Scopus, MEDLINE, Latin American and Caribbean Health Sciences Literature (Literatura Latino-Americana e do Caribe em Ciências da Saúde, LILACS), Web of Science and Nursing Database (Banco de Dados em Enfermagem, BDENF), between 2013 and 2018. Results: medical-device-related pressure injuries were common in adults, especially in the elderly, due to capillary fragility, among other changes. Other observed factors were length of stay, critically ill patients or those requiring any type of medical device. Numerous medical devices have been associated with skin lesions; among the most frequent were breathing, feeding, and orthopedic devices, tubes, oximeters, neck collars, patches and nasogastric tubes. Conclusion: the first step towards prevention is exploration in terms of identifying the types of injury-causing devices and evidence-based interventions, and disseminating information to the entire multidisciplinary team.

RESUMEN Objetivo: identificar factores asociados con las lesiones por presión relacionadas a dispositivos médicos. Método: revisión integradora de artículos publicados sobre el tema relacionado a la población adultas en las siguientes bases de datos: PUBMED, Scopus, MEDLINE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Web of Science y Banco de Dados em Enfermagem (BDENF), entre 2013 y 2018. Resultados: las lesiones por presión relacionadas con dispositivos médicos fueron comunes en adultos, principalmente en ancianos, debido a la fragilidad capilar, entre otras alteraciones. También se observaron otros factores como tiempo de permanencia, pacientes críticos o que necesitaban cualquier tipo de dispositivo médico. Se asoció un sinnúmero de dispositivos médicos a las lesiones de piel; entre los más frecuentes se pueden mencionar los dispositivos respiratorios, de alimentación y ortopédicos, los tubos, los oxímetros, los collares cervicales, los adhesivos y las sondas nasogástricas. Conclusión: el primer paso para la prevención es la exploración, en términos de identificar los tipos de dispositivos que causan la lesión y las intervenciones basadas en evidencias científicas, además de divulgar la información a todo el equipo multiprofesional.

RESUMO Objetivo: identificar fatores associados à lesão por pressão relacionada a dispositivo médico. Método: revisão integrativa de artigos publicados sobre o tema relacionado à população adulta nas bases de dados da PUBMED, Scopus, MEDLINE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Web of Science e Banco de Dados em Enfermagem (BDENF), entre 2013 e 2018. Resultados: lesões por pressão relacionadas a dispositivo médico foram comuns em adultos, principalmente em idosos, devido à fragilidade capilar, entre outras alterações. Outros fatores observados foram tempo de permanência, pacientes críticos ou que necessitassem de qualquer tipo de dispositivo médico. Inúmeros dispositivos médicos foram associados às lesões de pele; entre os mais frequentes estiveram dispositivos respiratórios, de alimentação, ortopédicos, tubos, oxímetros, colares cervicais, adesivos e sondas nasogástricas. Conclusão: o primeiro passo para a prevenção é a exploração, em termos de identificação dos tipos de dispositivos que causam a lesão e intervenções baseadas em evidências científicas, além da divulgação das informações para toda a equipe multiprofissional.

Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

Statistics and Analysis of 136 Cases of Adverse Events of International Medical Devices / 中国医疗器械杂志

To explore the law and characteristics of adverse events of medical devices and to provide research methods and basis for reducing the recurrence of similar adverse events, we collect medical devices safety information from five representative countries in the world, and make statistics and analysis on the types of events, the types of management and the causes of events. The results show that among 136 serious adverse events, the top three causes of recall are product design factors, software factors, and component defects. In order to reduce the application risk of medical devices, it is suggested that product designers, operating users and medical institutions should correctly implement the monitoring and evaluation system of medical devices.

Study on Testing Methods of Pen-injector's Dosing Accuracy / 中国医疗器械杂志

OBJECTIVE@#An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests.@*METHODS@#According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed.@*RESULTS@#After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested.@*CONCLUSIONS@#Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

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.

Medical Device-Related Pressure Injuries: an integrative literature review / Lesiones por Presión Relacionadas a Dispositivos Médicos: revisión integrativa de la literatura / Lesões por Pressão Relacionadas a Dispositivos Médicos: revisão integrativa da literatura

ABSTRACT Objetives: To identify and analyze the scientific evidence regarding the occurrence of Medical Device-Related Pressure Injuries, considering the development sites; and to describe the devices of risk and the measures of prevention and treatment. Method: Integrative, search-based review: CINAHL, PubMed, Wiley InterScience, Scopus, and Web Of Science. The terms "pressure ulcer" and "medical devices" were used, including original articles and case studies published between 2010 and 2015. Nine studies were selected. Results: Posterior cervical region and nose had the highest injury frequencies, respectively, 66.0% and 40.0%. Eleven risk devices were identified, with emphasis on Non-Invasive Ventilation masks and orotracheal tube. For prevention and treatment emerged recommendations specific to the device employed and general measures. Conclusion: Medical Device-Related Pressure Injuries are frequent problems, however, they can be prevented and treated based on the recommendations of the articles raised in this review.

RESUMEN Objetivo: Identificar y analizar las pruebas científicas sobre la ocurrencia de lesiones por presión relacionadas con dispositivos médicos, considerando los sitios de desarrollo; y describir los dispositivos de riesgo y las medidas de prevención y tratamiento. Método: Revisión Integrativa, con búsqueda en las bases: CINAHL, PubMed, Wiley Interscience, Scopus y Web of Science. Se utilizaron los términos "pressure ulcer" y "medical devices", incluidos los artículos originales y los estudios de caso, publicados entre 2010 y 2015. Se seleccionaron nueve estudios. Resultados: La región y la nariz cervicales posteriores obtuvieron las frecuencias más altas de lesiones, respectivamente, 66,0% y 40,0%. Se identificaron once dispositivos de riesgo, destacando las máscaras de ventilación no invasiva y el tubo orotraqueal. Para la prevención y el tratamiento surgieron recomendaciones específicas para el dispositivo empleado y las medidas generales. Conclusión: Las Lesiones por Presión Relacionadas a Dispositivos Médicos son problemas frecuentes, sin embargo, pueden ser prevenidas y tratadas con base en las recomendaciones de los artículos levantados en esta revisión.

RESUMO Objetivo: Identificar e analisar as evidências científicas quanto à ocorrência de Lesões por Pressão Relacionadas a Dispositivos Médicos, considerando os locais de desenvolvimento; e descrever os dispositivos de risco e as medidas de prevenção e tratamento. Método: Revisão integrativa, com busca nas bases: CINAHL, PubMed, Wiley InterScience, Scopus e Web Of Science. Utilizou-se os termos "pressure ulcer" e "medical devices", sendo incluídos artigos originais e estudos de caso, publicados entre 2010 e 2015. Foram selecionados nove estudos. Resultados: Região cervical posterior e o nariz obtiveram as frequências mais elevadas de lesões, respectivamente, 66,0% e 40,0%. Identificaram-se onze dispositivos de risco, destacando-se as máscaras de Ventilação Não Invasiva e o tubo orotraqueal. Para prevenção e tratamento emergiram recomendações específicas ao dispositivo empregado e medidas gerais. Conclusão: As Lesões por Pressão Relacionadas a Dispositivos Médicos são problemas frequentes, todavia, podem ser prevenidas e tratadas com base nas recomendações dos artigos levantados nesta revisão.

Routine use of v-lock® suture for bariatric anastomosis is safe: comparative results from consecutive case series / Uso rotineiro da sutura v-lock® para anastomoses em obesidade é seguro: resultados de estudo clínico comparativo

ABSTRACT Background: In high-income countries, morbid obesity is a growing health problem that has already reached epidemic proportions. When performing a laparoscopic gastric bypass several operative methods exist. Aim: To describe the institutional experience using a knotless unidirectional barbed suture (V-Loc 180/Covidien, Mansfield, MA) to create a hand-sewn gastrojejunostomy (GJ) and jejunojejunostomy (JJ) during bariatric surgery. Methods: Evaluation of a case series of 87 morbidly obese patients who underwent laparoscopic gastric bypass with a hand-sewn gastrojejunostomy (GJA) and jejunojejunostomy (JJA) between 01/2015 and 06/2017. The patients were divided into two groups: in group I, GJA und JJA sutures were performed using the knotless unidirectional barbed suture; in group II, GJA and JJA were sutured with resorbable multifilament thread (Vicryl® 3/0 Ethicon, Livingstone, UK). The recorded data on gender, age, BMI, ASA score, operative time, postoperative morbidity, length of hospital stay, and reoperation, were analyzed and compared. Results: All procedures were completed laparoscopically with no mortality. The mean operative time was 123.23 (±30.631) in group I and 127.57 (±42.772) in group II (p<0.05). The postoperative complications did not differ significantly between the two groups. Early complications were observed for two patients (0.9%) in the barbed suture group and for one patient (0.42%) in the multifilament suture group (p<0.05). In group I two patients (0.9%) required reoperation: on the basis of jejunojejunal stenosis in one patient, and local abscess near the gastrojejunostomy, without a leakage, in the other. In group II one patient (0.42%) required reoperation due to stenosis of the GJA. The duration of hospital admission was similar for both groups: 3.36 (±0.743) days in group I vs. 3.38 (±1.058) days in group II (p<0.05). Conclusion: The novel anastomotic technique is a safe and effective method and can be applied to gastrojejunal anastomosis and jejunojejunal anastomosis in laparoscopic gastric bypass.

RESUMO Racional : Em países de alta renda, a obesidade mórbida é um problema crescente de saúde que já atingiu proporções epidêmicas. Ao realizar um bypass gástrico laparoscópico, existem vários métodos operatórios. Objetivo: Descrever a experiência institucional utilizando uma sutura farpada unidirecional sem nós (V-Loc 180/Covidien, Mansfield, MA) para criar gastrojejunostomia (JJ) e jejunojejunostomia (JJ) costuradas à mão durante a cirurgia bariátrica. Métodos: Avaliação de uma série de casos com 87 pacientes obesos mórbidos submetidos ao bypass gástrico por videolaparoscopia com gastrojejunostomia (JJA) e jejunojejunostomia (JJA) suturados à mão entre 01/2015 e 06/2017. Os pacientes foram divididos em dois grupos; no grupo I, GJA e JJA as suturas foram realizadas com a sutura farpada unidirecional sem nós e, no grupo II, com sutura multifilamentar reabsorvível (Vicryl® 3/0 Ethicon, Livingstone, UK). Foram analisados ​​e comparados os dados registrados sobre gênero, idade, IMC, escore ASA, tempo operatório, morbidade pós-operatória, tempo de internação hospitalar e reoperação. Resultados: Todos os procedimentos foram concluídos por laparoscopia sem mortalidade. O tempo cirúrgico médio foi 123,23 (±30,631) no grupo I e 127,57 (±42,772) no grupo II (p<0,05). As complicações pós-operatórias não diferiram significativamente entre os dois grupos. Complicações precoces foram observadas em dois pacientes (0,9%) no grupo de sutura farpada e um (0,42%) no de sutura multifilamentar (p<0,05). No grupo I, dois pacientes (0,9%) necessitaram de reoperação; um devido à estenose jejunojejunal e abscesso local próximo à gastrojejunostomia, sem vazamento, no outro. No grupo II, um paciente (0,42%) necessitou de reoperação por estenose da GJA. O tempo de internação hospitalar foi semelhante nos dois grupos: 3,36 (±0,743) dias no grupo I vs. 3,38 (±1,058) dias no grupo II (p<0,05). Conclusão: A nova técnica de anastomose é método seguro e eficaz e pode ser aplicado nas anastomoses gastrojejunal e jejunojejunal no bypass gástrico laparoscópico.

Medical device adverse effects

This study aimed to describe adverse effects or reactions by medical devices. There may be unexpected effects caused by medical devices that can often be harmful to the patient. This is defined as a medical device adverse event or adverse effect (MDAE). We should prevent the recurrence of MDAEs by reporting them to regulatory authorities and device manufacturers. This reporting requires that manufacturers check the manufacturing process and update the medical device. However, it is difficult for both patients and medical persons to recognize and report MDAEs because adverse effects can be ambiguous to them in many cases. In addition, many medical persons lack an understanding of the role of this reporting. In Korea, the Ministry of Health and Welfare enacted laws and regulations for MDAE reporting in 2005. However, the number of MDAEs reported was still very small. The Ministry of Food and Drug Safety started the Medical Device Safety Monitoring Center project in 2011, with the purpose of promoting MDAE reporting. Since the Medical Device Safety Monitoring Center project began, the number of reported MDAEs rapidly increased from 137 in 2010 to 6,078 in 2017. Medical persons and device manufacturers should be encouraged to voluntarily report MDAEs and provide useful information. Korea is an important member of the International Medical Device Regulators Forum and leader of the Asia-Pacific Economic Cooperation Regulatory Committee. There should be medical device vigilance with global cooperation.

Analysis on Re-classifcation Management Procedure of Medical Devices in the United States / 中国医疗器械杂志

A detailed analysis on re-classification procedure of medical devices from Food and Drug Administration.The experience on classification procedures,the work-flow of risk reanalysis and regulatory categories reassessment of listed products,as well as launching a comprehensive evaluation and downgrading of listed high-risk products were explored in recent years.Based on the analysis on classification procedures and supervision of medical device products in the USA,and combined with the current situation of classification of medical devices in China,some suggestions were put forward on the current classification mode of medical devices so as to improve the quality and efficiency of classified management of medical devices in China.

Analysis and Some Thoughts on Safety Evaluation of Hearing Aids / 中国医疗器械杂志

Based on analysis of the domestic and foreign laws and regulations for hearing aids,some suggestions of safety evaluation about standards,premarket technical review and regulation are presented in this article.It is hoped to be helpful for registration and regulation of hearing aids.

Exploration of Domestic Medical Electrical Equipment Reliability Promotion Method / 中国医疗器械杂志

The reliability of domestic medical equipment is one of the main factors that restrict the competitiveness of domestic medical devices. It is also an important factor that endangers the safety of patients and a blind spot in safety risk management. By analyzing the core elements of reliability and the situation of domestic medical device industry, this paper sorts out and analyzes the problems existing in the reliability of medical device industry, and puts forward the key points and problems to be solved to improve the reliability of domestic medical equipment products.

Analysis of Variety Selection for Medical Device Supervision and Inspection / 中国医疗器械杂志

This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and diagnostic reagents.

Risk Point Analysis of Product Quality and Safety in Sample Inspection of National Medical Device Supervision / 中国医疗器械杂志

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.