This article discusses about the definition of usability of medical devices and introduces the related international standards. It describes the significance of usability and the relationship with the risk analysis. Some advices are given to improve the usability and reduce the risk of medical devices by explaining the standards.
Equipment Design ; standards ; Risk Assessment

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

Biological evaluation of medical devices before clinical usage has become one of the necessary procedure. But many of medical devices which have already passed a series of biological safety evaluation do not mean that they are absolutely safe and harmless. And there are still application risks in these medical devices, because of the deficient knowledge about the interaction of biomedical materials and human tissue, limitation of the existent technology level, the indefiniteness of the evaluation system, the imperfections of present standards and so on. This essay is trying to analyze the relationship between the biological evaluation of medical devices and their application risks, and to discuss how to make a risk analysis related to biological evaluation in order to acquire a better and exact understanding of biological evaluation for medical devices.
Device Approval ; standards ; Equipment Safety ; standards ; Equipment and Supplies ; standards ; Humans ; Materials Testing ; Reference Standards ; Risk Management ; Technology Assessment, Biomedical ; methods ; standards ; Toxicity Tests

This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as well.
Government Regulation ; Renal Dialysis ; instrumentation ; standards ; Research Design ; Risk Assessment ; Risk Management

Acupuncture ; standards ; Acupuncture Therapy ; standards ; China ; Complementary Therapies ; standards ; Guideline Adherence ; Herpes Zoster ; diagnosis ; therapy ; Humans ; Male ; Practice Guidelines as Topic ; standards ; Risk Assessment ; Severity of Illness Index

The aim of this study was to revise the provisions for aluminum-containing food additives in GB 2760-2011 (The National Food Safety Standard for Use of Food Additives), in order to reduce aluminum exposure among the Chinese population. According to the latest risk assessment results of JECFA and China on aluminum and the actual use of aluminum-containing food additives in certain products, the aluminum-containing food additive-related provisions in GB 2760-2011 were revised. Those revisions included narrowing down the applicable food categories and adjusting the maximum use level of aluminum potassium sulfate and aluminum ammonium sulfate, repealing nine aluminum-containing food additives in puffed food and repealing the use of sodium aluminum phosphate, sodium aluminosilicate and starch aluminum octenylsuccinate in all food. After revision of the use of aluminum food additive provisions, the weekly dietary intake of aluminum in the Chinese population can be reduced to a safe level.
Aluminum ; analysis ; China ; Environmental Exposure ; prevention & control ; standards ; Food Additives ; analysis ; standards ; Food Contamination ; analysis ; Humans ; Risk Assessment

A new risk analysis method based upon reliability theory was introduced in this paper for the quality risk management of Chinese medicine injection manufacturing plants. The risk events including both cause and effect ones were derived in the framework as nodes with a Bayesian network analysis approach. It thus transforms the risk analysis results from failure mode and effect analysis (FMEA) into a Bayesian network platform. With its structure and parameters determined, the network can be used to evaluate the system reliability quantitatively with probabilistic analytical appraoches. Using network analysis tools such as GeNie and AgenaRisk, we are able to find the nodes that are most critical to influence the system reliability. The importance of each node to the system can be quantitatively evaluated by calculating the effect of the node on the overall risk, and minimization plan can be determined accordingly to reduce their influences and improve the system reliability. Using the Shengmai injection manufacturing plant of SZYY Ltd as a user case, we analyzed the quality risk with both static FMEA analysis and dynamic Bayesian Network analysis. The potential risk factors for the quality of Shengmai injection manufacturing were identified with the network analysis platform. Quality assurance actions were further defined to reduce the risk and improve the product quality.
Drugs, Chinese Herbal ; administration & dosage ; chemistry ; standards ; Medicine, Chinese Traditional ; standards ; Quality Control ; Reproducibility of Results ; Risk Assessment

Health outcomes evaluation seeks to compare a new treatment or novel programme with the current standard of care, or to identify variation of outcomes across different healthcare providers. In the real world, it is not always possible to conduct randomised controlled trials to address the issue of comparator groups being different with respect to baseline risk factors for the outcomes. Therefore, risk adjustment is required to address patient factors that may lead to biases in estimates of treatment effects. It is essential when conducting outcomes evaluation of more than trivial significance. Risk adjustment begins by asking 4 questions: what outcome, what time frame, what population, and what purpose. Next, design issues are considered. This involves choosing the data source, planning data collection, defining the sample required, and selecting the variables carefully. Finally, analytical issues are considered. Regression modelling is central to every analytic strategy. Other methods that may augment regression include restriction, stratification, propensity scores, instrumental variables, and difference-in-differences. The construction of risk adjustment models is an iterative process requiring both art and science. Derived models should be validated. Limitations of risk adjustment include reliance on data availability and quality, imperfect method, ineffectiveness when comparators are very different, and sensitivity to different methods used. Thoughtful application of risk adjustment can improve the validity of comparisons between different treatments, programmes and providers. The extent of risk adjustment should be guided by its purpose. Finally, its methodology should be made explicit, so that informed readers can judge the robustness of results obtained.
Health Services Research ; Outcome Assessment (Health Care) ; Regression Analysis ; Risk Adjustment ; standards

This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
Equipment and Supplies ; standards ; Risk Assessment ; United States ; United States Food and Drug Administration

To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.
China ; Drug Contamination ; Drugs, Chinese Herbal ; analysis ; standards ; Metals, Heavy ; analysis ; Risk Assessment