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

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.
Radio Frequency Identification Device ; Electromagnetic Fields ; Radio Waves ; Equipment Safety ; Technology

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.
Equipment Safety ; Equipment and Supplies, Hospital ; Magnetic Resonance Imaging ; Reproducibility of Results ; Safety Management

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.
Equipment Safety ; Humans ; Lung ; Risk Assessment

IMDRF revised the
Equipment Safety ; Equipment and Supplies

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.
Equipment Safety ; Humans ; Magnetic Resonance Imaging ; Prostheses and Implants

Betacoronavirus ; Coronavirus ; Coronavirus Infections ; epidemiology ; prevention & control ; Disease Transmission, Infectious ; prevention & control ; Guidelines as Topic ; Humans ; Infection Control ; organization & administration ; Pandemics ; prevention & control ; Personal Protective Equipment ; standards ; Pneumonia, Viral ; epidemiology ; prevention & control ; Primary Prevention ; methods ; standards ; Safety ; standards ; Safety Management

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.
Device Approval ; Equipment Safety ; Research Design

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.
Disposable Equipment/standards* ; Equipment Safety ; Injections, Intradermal/instrumentation* ; Syringes

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.
Equipment Safety ; Equipment and Supplies/adverse effects* ; Product Surveillance, Postmarketing ; Software