Based on GB/T16886.4-2003 Standard, the coagulation effects of 5 cardiovascular system external communicating devices made consist of metal and polymer were assessed using the partial thromboplastin time (PTT) and Lee-White coagulation time (CT) tests. The results indicate that PTT test is a stable and valuble method for evaluating the coagulating pathway disturbance of the devices. In line with GB/T 16886.4-2003 Standard, PTT test is a recommendable method for evaluating the external communicating devices Based on GB/T14233.2-2005 Standard, CT test is a method more liable to variation, compared with PTT test. This is due to the complex relativity in the test itself, due to all the factors of coagulating cascade, and due to the individual difference of animal. The question of how to select proper negative control for coagulation evaluation of the Cardiovascular System External Communicating Devices in clinical setting for CT test should be addressed and studied.
Blood Coagulation ; Blood Coagulation Tests ; Cardiology ; instrumentation ; Equipment Safety ; Humans ; Metals ; adverse effects ; Partial Thromboplastin Time ; Polymers ; adverse effects ; Preoperative Care

Hyaluronan acid sodium gels are used in ophthalmic surgery, orthopedic treatment and cosmetic surgery. In 2009,there were 12 domestic manufacturers in China producing 33 kinds of products. 23 kinds of imported products were allowed by SFDA to sale in the meantime. Since manufacturers use different production processes, product performances are quite different. According to the GB/T 16886. 1-2001, we designed a pilot program to evaluate the sodium hyaluronate gel products comprehensively in this paper. The results showed that, except chromosome aberration test of gel A and subchronic systemic toxicity of gel C appeared positive, the remaining samples of the test results were negative. This article provides a reference to write standard of cross-linked hyaluronic sodium gel and the revision of standard YY0308-2004.
Animals ; Biocompatible Materials ; standards ; Cross-Linking Reagents ; chemistry ; Gels ; Hyaluronic Acid ; standards ; Mice ; Pilot Projects ; Quality Control ; Rabbits ; Rats ; Rats, Sprague-Dawley ; Toxicity Tests ; methods

OBJECTIVEA simple and effective therapy for single side constricted ear.

METHODSTransplanting normal side free composite auricular grafts to constricted ear (15 patients and 15 sides), then lengthening the helix, exposing the scapha, correcting deformity.

RESULTSThe 15 patients composite grafts all survived. The helix has been lengthened, the scapha exposed, the normal ear reduced, the constricted ear augmented and two sides ear have become symmetry.

CONCLUSIONThis method is simple and results are satisfied.

Adolescent ; Child ; Ear, External ; abnormalities ; surgery ; Female ; Humans ; Male ; Reconstructive Surgical Procedures ; methods ; Transplants ; Treatment Outcome

OBJECTIVETo investigate the changes on carotid artery of patients with acute ischemic stroke by dual source computed tomographic angiography (DS-CTA) .

METHODSFrom March 2009 to August 2010, 71 patients with acute ischemic stroke (IS group) underwent magnetic resonance imaging, which showed high signals on diffusion-weighted images. The location of atherosclerotic plaques in carotid artery, the nature of plaques, and the grade of stenosis were analyzed by DS-CTA, and the results were further compared with 45 patients with non-ischemic stroke (control group) .

RESULTSIn the IS group, 196 atherosclerotic plaques in the carotid artery were detected in 51 patients; the commonest locations included carotid artery bifurcation (52.0%) and trunk (20.4%) . Most plaques were combined plaques [52.0% (102/196) ] and soft plaques [27.0% (53/196) ] . Moderate and severe stenosis accounted for 86.3% in these 54 patients. The positive rate, nature, and location of plaques and the stenosis degree of artery were significantly different between IS group and control group (allP<0.05) .

CONCLUSIONThe commonest plaques in the carotid artery of patients with acute ischemic stroke are combined plaques and soft plaques, which often cause moderate and severe stenosis.

Adult ; Aged ; Aged, 80 and over ; Angiography ; methods ; Brain Ischemia ; diagnostic imaging ; Carotid Arteries ; diagnostic imaging ; Female ; Humans ; Male ; Middle Aged ; Plaque, Atherosclerotic ; diagnostic imaging ; Stroke ; diagnostic imaging ; Tomography, X-Ray Computed ; methods

Dual-magnetic circuit beads and scattering nephelometry dual channel semiautomatic coagulometers are used for the coagulational evaluation of the 5 blood contact medical devices which consist of metals and polymers. The partial thromboplastin time(PTT) and prothrombin time(PT) tests are made based on the GB/T 16886.4-2003 standard. The results indicate that the coefficient of variation in the two groups is in the identical order of magnitude. In the PTT tests, they give the similar evaluational results. With the smaller numerical values of the PT tests, the different coagulometers give the high consilience results. So, both of dual-magnetic circuit beads and scattering nephelometry coagulometers are acceptable in the medical devices' coagulational evaluations. But the interpretation and analysis of the results of the small numerical value tests, PT tests for example, should be noticed.
Blood Coagulation Tests ; instrumentation ; methods ; Magnetics ; instrumentation ; Nephelometry and Turbidimetry ; instrumentation

BACKGROUND: Due to the complexity of tissue induced biomaterials, the current biosafety evaluation standard is not available. For years, to choose an effective evaluation strategy and practice in tissue induced materials has been always a hot topic, but still with no conclusion. The existence of this problem results in numerous issues for manufactures when conducting the biosafety evaluation of tissue induced medical devices. OBJECTIVE: To formulate the biosafety evaluation strategy that should be followed by the material samples at the research and development stage and to provides some ideas and lessons for the selection of the product biology experimental items to be listed and registered. METHODS: In 2016, a statistical analysis was carried out for biological test items of tissue induced biomaterials. Cytotoxicity, irritation and sensitization tests were the most commonly used tests for biomaterials and medical devices. A biosafety evaluation only via the above three tests had been applied in 58 kinds of materials with 81 batches of samples. In this study, immune toxicity tests were performed in 17 kinds of materials and biodegradation tests were done in some samples. RESULTS AND CONCLUSION: It had been found that different test programs or evaluation strategies may be adopted in the product development or listing registration stage. At early stage of development, cytotoxicity, irritation and sensitization tests are suitable for sample screening. In the later stage of research and development, more in-depth tests, such as subchronic toxicity, degradation and immunity toxicity, should be employed to meet the safety evaluation requirements.

Objective: To determine the lead bioactive compound in kernel extract of Mangifera pajang and its anti-cancer activity against human breast cancer cell lines with positive estrogen receptor (MCF-7). Methods: The methanolic extract of dried powder kernel of Mangifera pajang was exposed to column chromatography for isolation. The structural elucidation of the isolated compound was characterized using infrared, nuclear magnetic resonance, mass spectrometry. Furthermore, cytotoxicity, morphological changes, flow cytometry and cell cycle arrest analyses were performed to examine the mechanism of anti-proliferation and apoptosis induced by methyl gallate against MCF-7. Results: One compound was isolated from the methanolic extract of Mangifera pajang kernel and identified as methyl gallate. The flow cytometric results demonstrated induction of apoptosis in MCF-7 cells by three concentrations of methyl gallate. The cell cycle arrest showed a significant (P<0.05) decrease in cell progression at G 2/M phase of MCF-7 after treatment with 100 μM of methyl gallate. The cell percentage of early and late apoptosis was significant at 10 and 100 μM of methyl gallate. Also, methyl gallate treatment induced up-regulation of reactive oxygen species levels in MCF-7 cells with a reduction in superoxide dismutase levels. Conclusions: These findings indicate that isolated methyl gallate from Mangifera pajang kernel extracts induces growth inhibition and apoptosis in MCF-7 cells via up-regulating oxidative stress pathway.

New biodegradable intravascular stent can reduce risk of foreign bodies retained, thus, it is widely concerned and some of the products have been introduced into the clinic. However, the characteristic of biodegradable may lead to more safety concerns associated with thrombosis. To ensure the safety, the thrombus formation experiment needs to be carefully designed and evaluated based on GB/T 16886.4 standard, but current standard do not provide explicit testing and evaluating methods. Establishing animal model with experimental pigs, the study compares biodegradable coronary stents and metal stents by simulating clinical implantation on the thrombus formation in the implanting process, and after the short-term and long-term implantation. The evaluation methods include gross observation, digital subtraction angiography intraoperative analysis, optical coherence tomography analysis, scanning electron microscopy and so on. The results show that combining these methods could comprehensively evaluate the whole process of the thrombus formation from the beginning of implantation to the end of preclinical animal experiments, so that, it may better predict the clinical thrombosis risk, and the selection of the control was very important. The study tries to use the comparison examples of thrombosis on the new medical instrument to provide the clue for thrombosis evaluation on similar instruments and show the methodology on the preclinical evaluation.
Absorbable Implants ; adverse effects ; Animals ; Drug-Eluting Stents ; adverse effects ; Polymers ; Swine ; Thrombosis ; etiology ; Tomography, Optical Coherence ; Treatment Outcome

Occupational therapists have a significant role in driving rehabilitation by helping clients with disabilities to return to driving. To date, the services for driving rehabilitation are still limited in Malaysia. Furthermore, the current practice of driving rehabilitation in Malaysia is still underreported. Therefore, this study aims to assess occupational therapists’ challenges, attitudes, and skills towards driving rehabilitation, the sociodemographic differences, and associations between the developed constructs. A cross-sectional study was conducted from June to September 2020. A convenience sampling method was used to recruit 177 occupational therapists with at least one year of working experience in Malaysia. The questionnaire consists of three constructs: the challenges, attitudes, and skills related to driving rehabilitation. The content validity of the questionnaire was good (S-CVI/Ave= 0.992; S-CVI/UA= 0.950; modified kappa= 0.812 to 1.000). Based on the Exploratory Factor Analysis (EFA), three items had been deleted due to low communalities. The Cronbach’s alpha for all constructs was acceptable (Cronbach’s alpha > 0.7). Experience in practicing driving rehabilitation, workplace settings, and educational level had significant differences in at least one of the constructs. Age and years graduated had a significant positive correlation with skills. This questionnaire proved to be a tool with good content validity and reliability to assess occupational therapists’ challenges, attitudes, and skills related to driving rehabilitation. In the future, qualitative studies are recommended to better understand the occupational therapists towards driving rehabilitation, especially from their personal experience.