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.
Regulatory science of medical devices serves the scientific research and regulatory activities for supervision of medical devices. Principles of science and transparency and conduction of evidence-based study, which is advocated in Evidence-based science(EBS), also apply to regulatory science of medical devices, including using evidence-based scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and cost-effectiveness of total life cycle of medical products, target customers, and scope. EBS provides both new methods and tools for regulatory science for medical devices, and provides a new basis for further scientific regulatory decisions.
ObjectiveTo analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about.MethodsBased on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed.ResultsWith the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards.ConclusionConsidering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-L-guluronic acid to β-D-mannuronic acid of alginate, and impurity content.
The emergence of new-generation artificial intelligence technology has brought numerous innovations to the healthcare field, including telemedicine and intelligent care. However, the artificial intelligent medical device sector still faces significant challenges, such as data privacy protection and algorithm reliability. This study, based on invention patent analysis, revealed the technological innovation trends in the field of artificial intelligent medical devices from aspects such as patent application time trends, hot topics, regional distribution, and innovation players. The results showed that global invention patent applications had remained active, with technological innovations primarily focused on medical image processing, physiological signal processing, surgical robots, brain-computer interfaces, and intelligent physiological parameter monitoring technologies. The United States and China led the world in the number of invention patent applications. Major international medical device giants, such as Philips, Siemens, General Electric, and Medtronic, were at the forefront of global technological innovation, with significant advantages in patent application volumes and international market presence. Chinese universities and research institutes, such as Zhejiang University, Tianjin University, and the Shenzhen Institute of Advanced Technology, had demonstrated notable technological innovation, with a relatively high number of patent applications. However, their overseas market expansion remained limited. This study provides a comprehensive overview of the technological innovation trends in the artificial intelligent medical device field and offers valuable information support for industry development from an informatics perspective.
To design a new suit of instruments for meniscal suture with tondon, and then authenticate their feasibil ity and the therapeutic effect of the new technique. Methods Instruments were developed, including new ones and others which was improved according to the current instruments. From October 2005 to December 2006, 45 patients with meniscal injury were treated by meniscal suture with tendon. There were 29 males and 16 females, aged 17-40 years (mean 28 years). Injury was caused by sports in 33 cases, by traffic accident in 5 cases, by fall ing in 3 case and others in 4 cases. The disease course was 3 days to 6 months (mean 2 months). There were 23 cases accompanying with anterior cruciate l igament injury and 6 cases accompanying with posterior cruciate l igament injury. E-MRI showed 2 cases of degree II and 43 cases of degree III. Arthroscope showed that injury was at medial meniscus in 39 cases and at lateral meniscus in 6 cases. The pre-operationalLysholm score was 53.0 ± 10.3. Autogeneic or xenogenic tendon was made into suture l ine guided by stitch at the two ends. Thetherapeutic effect of the new technique was authenticated by cl inical results, including the change of symptoms and phy sical signs, and by comparing the pre-operational Lysholm score with the post one. Results Nineteen pieces of instruments weredeveloped. All the operation were successful, with no harm to nerves and vessels. The follow-up was 6 months to 24 mo nths (mean15 months). At the last follow-up, all the symptoms disappeared, including pain, swell ing and locking, etc. The Lysholm sc oreafter 6 months of operation was 87.8 ± 9.2, showing statistically significant difference when compared with per-operati on ( P lt; 0.01). Conclusion It is feasible to suture injured menisci with the new instruments and technique. It is an effective way to repair menisci with tendon according to the short-term results.
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
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 (RWD) in clinical research on specific categories of medical devices can generate sufficient quality evidence which will be used in decision making. This paper discusses the limitations of traditional randomized controlled trials in clinical research of medical devices, summarizes and analyses the applicable conditions of real-world evidence (RWE) for medical devices, interprets the new FDA guidance document on the characteristics of RWD for medical devices, in order to provide evidence for the use of RWE in medical devices in our country.
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.