Medical Device Supervision Research Articles

The Problems and Difficulties of Medical Devices in Chongqing in Response to Public Health Incidents in 2022

Background and Aim: In the face of emergencies such as large-scale infectious diseases, some medical device manufacturers either do not have enough practical research and development experience in related epidemic prevention medical devices or use cheaper raw materials to reduce product quality in the research and development stage to save costs and increase profits. purpose, and even use various channels and means to bypass market supervision and produce problematic medical devices from the very beginning. Or, to take advantage of the public's panic about unknown infectious diseases, some unscrupulous merchants falsely advertise products that do not meet medical requirements, confusing the masses without certain professional cognitive ability, blindly believing and following them, and causing sudden large-scale infectious diseases. It cannot effectively reduce and contain the spread of diseases or other public health events. Infectious diseases spread rapidly in various cities. This is the problem with the quality supervision of medical devices under public health emergencies. From this new crown pneumonia epidemic, it can be found that the existing system is still unable to meet the needs of emergencies such as public health. It is necessary to do a good job of system reserves for the accessibility of drugs and medical devices from the level of laws and regulations. This needs to be sorted out to achieve accessibility. The existing regulations and systems should be improved to meet the needs of medical device use in public health and other emergencies. Materials and Methods: Safety testing of medical devices used in 26 public health events using Chinese national standards Results: The histogram of sample scores in the operation link reveals a complex landscape with an increased sample size. This data accentuates the intricate scoring dynamics and intricate qualification rates within the operation link, showcasing variations even among identical products from the same manufacturer. The case of "LFR20B" and "LFR30B" infrared forehead thermometers exemplifies how subtle factors, such as the weighting of specific performance indicators, contribute to scoring distinctions. Despite the "LFR20B" model achieving a higher score, it falls short of the category's passing threshold, underscoring the intricate nature of sample evaluations. However, it is noteworthy that 58% of the samples successfully meet national standards and pass the inspection, indicating a substantial portion complying with regulatory requirements. Conclusion: Laws and regulations need to be improved, there are hidden dangers in regulation, the ability of regulatory teams needs to be improved, medical device enterprises have problems, medical devices should strictly follow national standards, and the public should actively participate in medical device regulation.

Consideration of Supervision of Mesotherapy Needles for Cosmetic Injection

With the development of medical aesthetics industry in China, sodium hyaluronic is injected into the facial dermis with multi needles to relieve wrinkles, thick pores, skin relaxation and other aging problems, is more and more popular nowadays. The wide application of mesotherapy for cosmetic injection and the subsequent adverse events are widely reported. This study attempts to explore the adverse events and countermeasures for the application of mesotherapy from the perspective of medical device supervision.

The Enlightenment of the Management of EU Notified Bodies to China's Introduction of Third-Party Institutions for Medical Device Supervision

Objective: By introducing the pilot situation of post-market supervision of medical devices purchased by third-party institutions in Jiangsu Province, China, the problems exposed by them were analyzed. At the same time, it draws on relevant advanced experience in the management of EU notified bodies to provide suggestions for optimizing China's follow-up practices and promoting social co-governance supervision.
 Method: Conduct on-the-spot investigations in Jiangsu Provincial Food and Drug Administration, China, conduct interviews with regulators on the progress of the project, and conduct in-depth communication. A large number of inquiries about the relevant research literature of the EU notified body and the laws and regulations promulgated by the EU, and systematic analysis.
 Results: In the introduction of third-party agencies to assist post-market supervision of medical devices, the Chinese government still has problems such as lack of relevant laws and regulations, imperfect access mechanisms for third-party agencies, imperfect supervision mechanisms, and backward regulatory informatization construction.
 Conclusion: Introducing third-party agencies to assist in the supervision of medical devices can effectively ease the pressure on supervision and supplement supervision resources. It is suggested that the Chinese government learn from the management experience of the EU notified bodies, improve the regulatory legal system, introduce relevant regulations, improve the access mechanism of third-party institutions, improve the supervision mechanism, strengthen the construction of supervision informatization, and build a unified supervision platform.

Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.

Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020

This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device. This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020. The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance. It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.

Analysis on the Characteristics of Quality Variation of National Medical Device Supervision and Inspection in 2020

This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.

Research advances of real world study in the field of chronic wound

In recent years, as a powerful supplement to the randomized controlled trial (RCT), real world study (RWS) has received more and more attention. However, in the field of chronic wounds, most of the patients have complex condition, and the strict inclusion and exclusion criteria of RCT were lack of practical application values. The RWS provides data closer to the real medical environment in clinical medical practice, drug and medical device supervision, and health technology evaluation. However, RWS has some problems that need to be resolved, such as inconsistent diagnostic criteria and unclear research endpoints. In addition, RWS in chronic wound research in China seems to have not really started yet, and institutions at all levels need to work together to promote the development of RWS.

The Status of Industry and Supervision of Medical Devices for Human Assisted Reproductive Technology in China

This study summarizes the status of domestic industries of medical devices for assisted reproductive technology, product category, the status of product classification management, the status of technical review, the progress of quality evaluation technology, and the progress of standardization. The domestic industry of medical devices for assisted reproductive technology in my country has begun to take shape, and a solid foundation has been laid for standardization and supervision technology. These will become an important driving force and guarantee for the subsequent development of medical devices for assisted reproductive technology. Under the guidance of the new development concept and the trend of accelerating the construction of the main body of the domestic cycle, my country's independent and controllable assisted reproductive medical device industry is gaining momentum.

Consideration of Application Supervision of Reuse of Disposable High-pressure Contrast Injector

With the popularization of angiography and enhanced scanning in China, high pressure contrast injector is widely used in CT, MRI, DSI and so on, the authors team try to explore and consider the harmfulness and countermeasures of the reuse of the disposable high-pressure contrast injector from the perspective of medical device supervision. Hope that it's helpful to this registration and technical evaluation.

Analysis of Quality Status of National Medical Device Supervision and Inspection in 2019

Summarize the quality status and variety quality change characteristics of the sampling products through the Summary and analysis, according to the results of the national medical device supervision and inspection in 2019. Put forward suggestions on the development of the medical device industry and supervisory measures. Thereby, further improve the level of the medical device and ensure the safety use of medical device.

Consideration of the Evaluation of Catheter Rupture and Supervision

With the vigorous development of medical device manufacturing industry in China, anesthetic puncture bag has been completely localization. The extensive application of anesthesia technology and the subsequent adverse events of anesthesia catheter rupture have been reported frequently. This paper attempts to explore and think about the harm and countermeasures of epidural anesthesia catheter fracture from the point of view of medical device supervision.

Discussion of Enlightenment from the Reorganization of CDRH Regulatory for Medical Device

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

Consideration and Practice of Introducing Third-party Certification Institutions to Participate in Post-marketing Supervision of Medical Devices

After years of international regulatory practice, the third party certification bodies have become an important social force in the field of medical devices supervision. It is broadly discussed how to introduce social resources to play an active role in the supervision of medical devices under the regulatory system of medical devices in China. Shanghai Medical Products Administration has carried out research and preliminary practice on the participation of third-party institutions in post-marketing supervision of medical devices. The article mainly focuses on purpose, entry point, inspection criteria and result disposal of introducing the participation of third-party institutions in the post-marketing supervision, meanwhile, discusses the next work direction at the same time.

Study on Feasibility and Countermeasures of Social Third-party EMC Testing for Medical Device Registration

In view of the background that the regulation of medical device supervision and management is about to cancel the registration and inspection, this paper analyses the risk of electromagnetic compatibility of medical devices, combs the current situation of electromagnetic compatibility testing, discusses the factors to be considered in the approval of third-party testing reports, and gives relevant solutions suitable for China's national conditions.

Evidence-based clinical engineering: Machine learning algorithms for prediction of defibrillator performance

Poorly regulated and insufficiently supervised medical devices (MDs) carry high risk of performance accuracy and safety deviations effecting the clinical accuracy and efficiency of patient diagnosis and treatments. Even with the increase of technological sophistication of devices, incidents involving defibrillator malfunction are unfortunately not rare.To address this, we have developed an automated system based on machine learning algorithms that can predict performance of defibrillators and possible performance failures of the device which can affect performance. To develop an automated system, with high accuracy, overall dataset containing safety and performance measurements data was acquired from periodical safety and performance inspections of 1221 defibrillator. These inspections were carried out in period 2015–2017 in private and public healthcare institutions in Bosnia and Herzegovina by ISO 17,020 accredited laboratory. Out of overall number of samples, 974 of them were used during system development and 247 samples were used for subsequent validation of system performance. During system development, 5 different machine learning algorithms were used, and resulting systems were compared by obtained performance.The results of this study demonstrate that clinical engineering and health technology management benefit from application of machine learning in terms of cost optimization and medical device management. Automated systems, based on machine learning algorithms, can predict defibrillator performance with high accuracy. Systems based on Random Forest classifier with Genetic Algorithm feature selection yielded highest accuracy among other machine learning systems. Adoption of such systems will help in overcoming challenges of adapting maintenance and medical device supervision mechanism protocols to rapid technological development of these devices. Due to increased complexity of healthcare institution environment and increased technological complexity of medical devices, performing maintenance strategies in traditional manner is causing a lot of difficulties.

Analysis of Variety Selection for Medical Device Supervision and Inspection

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 in vitro diagnostic reagents.

Risk Point Analysis of Product Quality and Safety in Sample Inspection of National Medical Device Supervision

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.

Consideration of Application of Insulin Pen Needles and Supervision

With the increasing incidence of diabetes mellitus in China, hypodermic injection of artificial insulin to control blood sugar has been popularized. Insulin pen needles are widely used in hospitals, communities and families. This article attempts to explore and think about the harm and countermeasures brought about by the reuse of insulin pen needles from the perspective of medical device supervision.

Risk Management to Shanghai Medical Device Registrants

In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.

Simple Suggestion of Adapting Requirements of Medical Devices New Supervision Regulation System for Medical Device Manufacturers

Since the releasing of Order 650 in 2014, China Food and Drug Administration (CFDA) organized professionals to intensively formulate and revise regulations based on the original medical device supervision regulations system. Up to now, China medical device supervision new regulation system has been formed basically and has profound active implications on the whole medical device industry. The article analyzed the change of requirements of medical device supervision new regulation system from manufacture's point of view and tried to provide some simple suggestions of adapting them.