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.
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.
Objective To introduce the basic information about mad cow disease and the current status of safety control of medical devices derived from mammalian animal tissues. Methods Literature concernedwas reviewed intensively. Results Mad cow disease, also knownas bovine spongiform encephacitis (BSE)， is generally considered from the samesource of Scrapie, and they are caused by the same kind of sponginess brain tissue pathological changes. Mad cow disease is caused by the misfolding of a small protein called Prion. This disease has the character of slowly breaking down the central neuron system of animals. Conclusion Further researches can provide evaluation for safety considerations of medical devices deriving from animal.
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.
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.
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.
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.
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.