Medical device-related pressure injury (MDRPI) is a kind of pressure injury that occurs in the course of diagnosis and treatment, and its appearance is similar to that of medical device. Neonatal intensive care unit (NICU) infants are more likely to develop MDRPI than children and adults because of the physiological characteristics of skin and the influence of disease. At present, the occurrence of MDRPI in NICU infants is attracting worldwide attention. Its treatment and nursing consume a large amount of medical resources, which not only affect the outcome of the disease, but also increase the economic burden of the family and society. This article summarizes the MDRPI from three aspects: summary, influencing factors, and evaluation tools. It is expected that NICU nurses will carry out large sample clinical investigation of MDRPI in the future, so as to provide a reference for risk prediction model and risk assessment tools to identify high-risk infants and take effective measures in advance to reduce the incidence of MDRPI.
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.
ObjectiveTo analyze the current situation and international research focuses on the study of medical device risk management. MethodsTo retrieve medical device risk management literature information cited from 2002 to 2011 in PubMed such as high-frequency MeSH; analyze current situation and research focuses of medical device risk management by using bibliometrics, bibliographic item co-occurrence matrix builder (BICOMB), and graphical clustering toolkit (gCluto) for quantitative analysis, high-frequency MeSH term papers cluster visualization analysis. ResultsA total of 7 073 published studies were retrieved, basically suggesting a gradually increasing trend of the number of published papers. The top 3 numbers of first authors' papers referred to three countries: the United States, Britain and Germany, while China ranked twelfth. The top 3 numbers of journal articles referred to the United States, Britain and Holland, while China ranked twenty-second. Twenty journals published more than 50 papers, and all these journals were clinical journals. Thirty-three authors published no less than 5 papers, with the maximum of 18 articles. Totally, there were 124 highfrequency MeSHs. The high-frequency MeSHs were classified into 6 categories by using double cluster analysis: kinds 0 to 4 included risk report, risk analysis, risk assessment and methodology of heart valve prosthesis, coronary stents, peripheral vascular stents, implantable defibrillators and other life support device, surgical repair surgical flaps and minimal invasion surgical device such as laparoscopy; kind 5 focused on safety management, risk control, organization and implementation and other related research based on prevention and control of medical device adverse reaction, medical errors, occupation exposure, and equipment failure. ConclusionThe analysis on international literature on medical device risk management basically shows a gradually increasing trend; most studies published in the clinical medicine journals; research focus on risk assessment, safety management and quality improvement in the application such as angioplasty, artificial prosthesis replacement, plastic surgery, minimally invasive surgery and critical care medicine, and radiology diagnosis and treatment; implantable, life-supported invasive and radiological devices as the main research subject; and characteristics include closely combination between medical device risk management and the application of safe and effective, quality improvement systems for clinical diagnosis and treatment.
The objective of this study is to map the global scientific competitive landscape in the field of artificial intelligence (AI) medical devices using scientific data. A bibliometric analysis was conducted using the Web of Science Core Collection to examine global research trends in AI-based medical devices. As of the end of 2023, a total of 55 147 relevant publications were identified worldwide, with 76.6% published between 2018 and 2024. Research in this field has primarily focused on AI-assisted medical image and physiological signal analysis. At the national level, China (17 991 publications) and the United States (14 032 publications) lead in output. China has shown a rapid increase in publication volume, with its 2023 output exceeding twice that of the U.S.; however, the U.S. maintains a higher average citation per paper (China: 16.29; U.S.: 35.99). At the institutional level, seven Chinese institutions and three U.S. institutions rank among the global top ten in terms of publication volume. At the researcher level, prominent contributors include Acharya U Rajendra, Rueckert Daniel and Tian Jie, who have extensively explored AI-assisted medical imaging. Some researchers have specialized in specific imaging applications, such as Yang Xiaofeng (AI-assisted precision radiotherapy for tumors) and Shen Dinggang (brain imaging analysis). Others, including Gao Xiaorong and Ming Dong, focus on AI-assisted physiological signal analysis. The results confirm the rapid global development of AI in the medical device field, with “AI + imaging” emerging as the most mature direction. China and the U.S. maintain absolute leadership in this area—China slightly leads in publication volume, while the U.S., having started earlier, demonstrates higher research quality. Both countries host a large number of active research teams in this domain.
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.
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.
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.
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 2019, the national government issued the document "Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Area", which allowed the use of innovative drugs and medical devices in medical institution of Boao Lecheng. These medical products had been designed to meet urgent clinical requirements and had been approved by regulatory authorities overseas. Through the use of these medical products, real-world data were generated in the routine clinical practice, based on which real-world evidence might be produced for regulatory decision-making by using scientific and rigorous methods. In March 2020, the first medical device product using domestic real-world data was approved, suggesting that the real-world data initiative in Boao Lecheng achieved initial success. This work also provided important experience for promoting the practice of medical device regulatory decision-making based on real-world evidence in China. Here, we shared the preliminary experiences from the study on the first approved medical device product and discussed the issues on developing a real-world data research framework in Boao Lecheng in attempt to offer insights for future studies.