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

The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel. Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9, 3.7, 2.5 mg/(kg.d), and the second stage doses of 1.2, 0.25 mg/(kg.d) by the intravenous route. The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d) for SD rats, and the result was verified by subchronic systemic toxicity test of nickel alloy. The threshold of toxicological concern (TTC) of nickel is 150 μg/d (based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.
Animals ; Equipment and Supplies/adverse effects* ; Nickel/toxicity* ; No-Observed-Adverse-Effect Level ; Rats ; Rats, Sprague-Dawley ; Risk Assessment

DEHP is largely used in soft PVC products as the plasticizer, which is also widely applied in medical devices. Due to its potential and widespread toxicity and medical devices' specific use, the safety of DEHP's application in medical devices has received extensive attention. In this paper, a comprehensive review of the application and potential toxicity of DEHP in PVC medical devices is made on the basis of the research results all over the world. Besides, the safety evaluation in medical devices is discussed and some possible coping strategies are explored.
Diethylhexyl Phthalate ; adverse effects ; Equipment Safety ; Equipment and Supplies ; adverse effects ; Plasticizers ; adverse effects ; Polyvinyl Chloride

As we all know, DEHP is seriously harmful to human health and consequently has been acquired critical attention. DEHP is able to migrate from PVC medical devices for the non-chemically bound to PVC, thus contact with user and patient. The DEHP migration is influenced by various parameters. In order to assess the security of PVC-tubes medical devices scientifically of DEHP migration, we develop an experimental model by analyzing the parameters comprehensively and systematically, taking into account the clinical practices. For example, assessing the security of DEHP migration from infusion sets by utilizing this model.
Diethylhexyl Phthalate ; adverse effects ; Equipment and Supplies ; Humans ; Models, Theoretical ; Plasticizers ; adverse effects ; Polyvinyl Chloride

OBJECTIVESTo increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.

METHODSBased on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results.

RESULTSBuilding a classification monitoring model of medical device adverse events based on risk management.

CONCLUSIONSThe classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.

OBJECTIVES: To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system. METHODS: Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices. RESULTS: The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc. CONCLUSIONS The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.
Equipment Safety ; Equipment and Supplies ; adverse effects ; Product Surveillance, Postmarketing ; Surveys and Questionnaires

Based on the analysis of risk management to Chinese medical device situation and deficiencies, provide some guidance for the application of risk management to medical device.
Equipment and Supplies ; adverse effects ; standards ; Risk Management

To discuss IC50 application in cytotoxicity tests of medical devices, we firstly investigated the vibrating condition and endpoint of MTT method specified in ISO 10993-5: 2009. Furthermore, we demonstrated the application of IC50 in the result evaluation of MTT method. The experimental results show that usage of IC50 in quantitative evaluation of MTT method is feasible.
Equipment and Supplies ; adverse effects ; standards ; Inhibitory Concentration 50 ; Toxicity Tests ; methods

On the basis of real working practices in data normalization, the case reports from the monitoring system were studied, non-standard reports were summarized and the reasons were analyzed, the methods of data normalization and improving the reporting quality were discussed. The standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of new cases.
Databases, Factual ; Equipment and Supplies ; adverse effects ; standards ; Quality Control

The overseas and domestic application status and research progress of genotoxicity evaluation of medical devices is briefly introduced. The trend of future development is analyzed.
Equipment and Supplies ; adverse effects ; Mutagenicity Tests