Objective To learn the current status, publication standards, formats, and contents of medical advertisements published in journals in China, and to discuss the possibility of evidence-based evaluation and standards for advertisement publication. Methods We handsearched Issue One, 2008 of 222 core medical journals indexed by A Guide to the Core Journals of China (2004 version) and the most important databases to index top 20% academic journals to identify basic journal information and the content of their advertisements. The general and trade name of the drugs, and the advertisements and production license number of the drugs and devices were collected. We used EXCEL software for data input and SPSS 13.0 for statistical analyses. Results Two-hundred and eighteen journals were handsearched and evaluated. The other 4 journals were excluded because the print version could not be found. A total of 1,201 advertisements were published in 159 (72.9%) of the journals, with the average of 5.5 (range of 1-37) for each journal. Of the advertisements, 910 (75.8%) were related to medical drugs or devices, including 598 (49.8%) drug and 312 (26.0%) medical device advertisements. Most of them were published in clinical and special medical journals. There were 518 (86.6%) drug advertisements which had both advertisement license and production license number, but only 116 (36.1%) medical device advertisements stated the advertisement license and production license number. Conclusion The medical drug advertisements published in core medical journals in China lack sufficient publication standards, and medical device advertisements are even worse. We cannot conclude the efficacy, safety, and cost-effectiveness of advertisement production according to the current limited, unclear, and highly-commercialized advertisements.
With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.
Objective To study the USA government’s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA’s administrative system about medical device standards as well as many standards can be referenced.
In recent years, real-world evidence data (RWD) and real-world evidence (RWE) have gained substantial attentions from healthcare practitioners and health authorities worldwide. In particular, the needs from regulatory bodies have promoted the production and use of real-world evidence. In the context of drug and device evaluation and regulation decisions, the pattern for using real world evidence may differ. This article aimed to discuss the potential uses of RWE for pre-approval clinical evaluation, post-approval monitoring and evaluation, and associated regulatory decisions, which may ultimately improve the production and use of RWE for regulatory decisions.
Theory of risk control was introduced to medical instruments quality control management in West China Hospital. A quality control system for the whole life cycle management of instruments has been established, which includes evaluation before instrument purchase, policy and management of bidding, operation training, safe maintenance, maintenance management and waste disposal. Medical instrument quality system was introduced to provide information for medical instrument risk control and quality management in a large, general Chinese hospital.
Additive manufacturing (AM) is a collection of technologies based on the layer-by-layer manufacturing. Characterized by its direct manufacturing and rapidity, it has been regarded by the Economist Journal as one of the key techniques which will trigger the third industry reformation. The present article, beginning with a brief introduction of the history of AM and the process of its major technologies, focuses on the advantages and disadvantages and medical applications of the technique.
Real-world data is been increasingly valued nowadays. This paper combined with related requirements of clinical evaluation of medical devices in China, studied the role of real-world evidence in pre-marketing clinical evaluation of medical devices in terms of technical evaluation, in aim of providing reference for the future application of China's real-world evidence in pre-marketing clinical evaluation.
Electrocardiogram (ECG) signals are easily disturbed by internal and external noise, and its morphological characteristics show significant variations for different patients. Even for the same patient, its characteristics are variable under different temporal and physical conditions. Therefore, ECG signal detection and recognition for the heart disease real-time monitoring and diagnosis are still difficult. Based on this, a wavelet self-adaptive threshold denoising combined with deep residual convolutional neural network algorithm was proposed for multiclass arrhythmias recognition. ECG signal filtering was implemented using wavelet adaptive threshold technology. A 20-layer convolutional neural network (CNN) containing multiple residual blocks, namely deep residual convolutional neural network (DR-CNN), was designed for recognition of five types of arrhythmia signals. The DR-CNN constructed by residual block local neural network units alleviated the difficulty of deep network convergence, the difficulty in tuning and so on. It also overcame the degradation problem of the traditional CNN when the network depth was increasing. Furthermore, the batch normalization of each convolution layer improved its convergence. Following the recommendations of the Association for the Advancements of Medical Instrumentation (AAMI), experimental results based on 94 091 2-lead heart beats from the MIT-BIH arrhythmia benchmark database demonstrated that our proposed method achieved the average detection accuracy of 99.034 9%, 99.498 0% and 99.334 7% for multiclass classification, ventricular ectopic beat (Veb) and supra-Veb (Sveb) recognition, respectively. Using the same platform and database, experimental results showed that under the comparable network complexity, our proposed method significantly improved the recognition accuracy, sensitivity and specificity compared to the traditional deep learning networks, such as deep Multilayer Perceptron (MLP), CNN, etc. The DR-CNN algorithm improves the accuracy of the arrhythmia intelligent diagnosis. If it is combined with wearable equipment, internet of things and wireless communication technology, the prevention, monitoring and diagnosis of heart disease can be extended to out-of-hospital scenarios, such as families and nursing homes. Therefore, it will improve the cure rate, and effectively save the medical resources.