顶空气相色谱法测定医用透明质酸钠凝胶中乙醇残留量

用顶空气相色谱法,测定医用透明质酸钠凝胶中乙醇残留量.采用HP-5毛细管柱;柱温:100℃;进样口温度:200℃;检测器温度:250℃;气体流速:N210ml/min,H240ml/min,Air375ml/min.结果表明:线性试验与精密度良好,回收率为96%～105%,RSD为5.6%,检出限为0.1μg/g.采用顶空气相色谱法,测定医用透明质酸钠凝胶中乙醇残留量,简便、准确.     

我国医疗器械数字化技术发展中存在的主要问题及原因

本文提出了我国医疗器械产业中数字化技术发展中存在的主要问题，并分析了问题产生的原因。     

带手套穿刺对留置套管针一次成功率的影响

为探讨戴手套与不戴手套穿刺对留置静脉套管针一次成功率的影响 ,为护理人员的自身防护提供科学依据 ,选取冠状动脉搭桥术病人 12 0例 ,随机分为实验组和对照组 ,实验组采用戴手套穿刺法 ,对照组采用常规洗手后不戴手套穿刺法。结果两组一次穿刺成功率经χ2 检验 ,无统计学意义( χ2 =0 .5 6 3,P >0 .0 5 )。说明戴手套留置套管针并不影响一次穿刺成功率。     

Cannabis and driving: A new perspective

Cannabis and driving is an emerging injury‐prevention concern. The incidence of driving while affected by cannabis is rising in parallel with increased cannabis use in the community. Younger drivers are at particular risk. Improvements in research methodology, technology and laboratory testing methods have occurred in the last 10 years. These cast doubt on earlier results and conclusions. Studies now show that cannabis has a significant impairing effect on driving when used alone and that this effect is exaggerated when combined with alcohol. Of particular concern is the presence of cannabis as the sole psychoactive drug in an increasing number of road fatalities and the lack of any structural response to this problem. A review of testing methods, laboratory and real driving studies, and recent epidemiological studies is presented. Suggestions for methods of further data collection and future public policy are made.     

环糊精在鼻腔给药系统中的应用

综述了环糊精作为鼻腔给药系统赋形剂的应用及安全性.     

便携式负压吸引装置的设计及材料学特点

对负压吸引装置便携方式的研究一直是急救医学追求的目标之一，因为它能够极大地促进急救成功率。文章基于这种需要，研制了一套便携式负压吸引装置，并根据实际应用效果，选择优化的制造材料。研制的便携式负压吸引装置主要由特殊设计的储液罐及罐盖、负压产生装置、过渡接头等部分组成，关键部件采用特殊材料制作，体积小，质量轻，操作简单，易于携带，完全能满足临床抢救及治疗的需要。作为一种急救中必不可少的器械，便携式负压吸引装置在急救伤病员运输、转运，家庭急救，及无动力源环境等情况下，对于抢救患者及提高救治效果，具有极大的竞争优势和应用前景。     

FDA’S Perspectives on Cardiovascular Devices

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.     

Cost and workforce implications of subjecting all physicians to aviation industry work hour restrictions: A response

In recent years, the surgical profession has attempted to incorporate into clinical practice certain techniques that the airline industry has used to improve safety. These mechanisms have proven to be valuable components of our efforts to ensure that surgical patients receive safe, high-quality care. However, as the authors of “Cost and workforce implications of subjecting all physicians to aviation industry work hour restrictions” note, it would be a mistake to extend aviation's work-hour restrictions to medicine, particularly to resident training programs.