The objective of inspection, testing and supervision of medical devices is to ensure the effectiveness and safety of medical devices in use. Leachables are substances that are leached from medical devices or materials during their clinical use. Leachables are important factors for the safety risks of medical devices. The analysis, detection, and safety evaluation of leachables are important parts of the safety evaluation of medical devices. The allowable limits for leachable substances which are established on the toxicological research provide a scientific basis for the judgment of qualitative and quantitative analysis results. Obtaining more detailed, rigorous and sufficient toxicological research data is of great significance to set highly enforceable product technical indicators. For the establishment of allowable limits for leachable substances, its role in the safety evaluation of medical devices is summarized, and the relevant standards and their implementation status in the testing of medical devices are introduced.
Equipment and Supplies/standards* ; Equipment Safety

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.
Equipment and Supplies ; Industry ; Reference Standards

The construction of county and district medical community is an important measure for high-quality medical resources to "double sink and improve". In this study, we have initially constructed a medical equipment quality control system for members of the regional medical community. The current situation of lack of professional medical equipment management personnel and quality control equipment in primary medical institutions has been alleviated, the quality control level of medical equipment in primary medical institutions has been improved, and a new management model for quality control of primary medical equipment has been explored.
Equipment and Supplies, Hospital/standards* ; Materials Management, Hospital/organization & administration* ; Quality Control

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic ; Equipment and Supplies/standards* ; Indicators and Reagents/standards* ; Reproducibility of Results ; Research Design/standards*

OBJECTIVE: By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China. METHODS: The MDR system and the related inspection system in the US were systematically analyzed. RESULTS: The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system. CONCLUSIONS By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.
China ; Equipment and Supplies/standards* ; Product Surveillance, Postmarketing

In order to evaluate the quality of different brands of magnetic resonance imaging system, optimize the quality of equipment repair and maintenance, and ensure the quality and safety of the equipment in clinical use. Meanwhile build the reliability evaluation model of magnetic resonance imaging equipment based on the large failure data collected by magnetic resonance repair system. In this paper, using the fault data of a certain brand of magnetic resonance in the past two years, applying the statistical judgment criterion, selecting the appropriate statistical distribution model, and finally fitting the equipment reliability evaluation model based on the non-homogeneous Poisson process, and then obtaining the magnetic resonance imaging equipment. Reliability evaluation indicators such as cumulative fault strength function, magnetic resonance imaging equipment fault density function, and mean time between failures. According to the calculated reliability index, on the one hand, it can evaluate the system reliability quality of a certain brand of magnetic resonance imaging equipment, and then evaluate the quality of different brands of magnetic resonance imaging equipment, on the other hand, it can help hospital equipment managers to carry out operational optimization, maintenance strategy development and safety management of magnetic resonance imaging equipment.
Equipment and Supplies, Hospital/standards* ; Magnetic Resonance Imaging/instrumentation* ; Reproducibility of Results

The information-based management of medical device standards is of great significance for promoting the development of the medical device standardization. Here we analyzed the important role of the information-based management of medical device standards in the delicacy management of the whole process of establishing and modifying medical device standards, introduced its present situation and upgrade of information-based management system of medical device standards, and put forward work ideas and suggestions for it.
Equipment and Supplies ; standards ; Information Management ; standards ; trends ; Reference Standards

Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.
Equipment and Supplies ; standards ; Government Regulation ; Licensure

The threshold of toxicological concern (TTC), a risk estimation method based on compound structurally-related toxicity data, has been widely used by many countries and regions for the safety risk assessment of food packaging materials and additives etc. Toxicological risk estimation is of importance in the biological evaluation of medical devices. Application of the TTC approach to leachable from medical devices may reduce or replace some unnecessary biocompatibility tests, but consideration should be taken for contact duration and route differences, which could affect the applicability of TTC. We herein focused on analyzing the eligibility of TTC for its further application in biological evaluation of medical devices.
Equipment and Supplies ; standards ; Food Packaging ; standards ; Risk Assessment ; Toxicological Phenomena

In order to improve the accuracy of the pacemaker's parameter adjustment and to avoid the surgical replacement of the pacemaker when the battery is exhausted, this paper designs a novel single-chamber pacemaker circuit based on low-power single-chip microcomputer. The circuit uses digital control to accurately control the amplitude, pulse width and frequency of the pacing pulse. The circuit is also designed with wireless charging function, and wireless communication with the programmer can wirelessly charge the pacemaker and know the charging information in real time. Wireless charging function can reduce the number of times the patient replaces the pacemaker or even completely avoid it.
Electric Power Supplies ; Equipment Design ; Humans ; Pacemaker, Artificial ; standards ; trends