我国首项自主知识产权的“乳腺计算机辅助检测系统”通过国家认证

由沈阳东软医疗系统公司研制生产的“MamoCAD2．0型乳腺计算机辅助检测系统”经辽宁省食品药品监督管理局（国家授权认证机构）审查,符合我国现行的《医疗器械注册管理办法》的规定准许注册（辽食药监械（准）字2008第200001号）。     

植入类医疗器械医疗机构的法律责任探讨

植入类医疗器械的法律责任属于医疗产品损害责任,既有医疗损害责任的特点,又有产品责任的特点。就产品责任而言,医疗机构一般承担无过错责任,即无论医疗机构是否有过错,患方均可向医疗机构追责。且如医疗机构不能指明缺陷产品的生产者,也不能指明缺陷产品的供货者,还应当承担最终责任。在植入类医疗器械的管理使用过程中,医疗机构应从严把采购关,完善购销记录,加强告知及培训,以及医疗器械不良事件报告和监测等几个方面来规避法律责任。     

浅析PLM系统在医疗器械行业的实施应用

阐述了PLM的基本概念、原理、行业研究和应用现状基础。针对医疗器械行业产品研发和产品监管的特点,结合企业的实际现状,详细分析了该医疗器械企业的PLM应用需求。该文还结合企业PLM系统项目开展的实际过程给出了设计、实施方案,并对实施效果进行了评估。     

Polymer Designs to Control Biofilm Growth on Medical Devices

Indwelling and temporary medical delivery devices (i.e. catheters) are increasingly used in hospital settings, providing clinicians with useful tools to administer nutrients, draw blood samples and deliver drugs. However, they can often put patients at risk for local or systemic infections, including bloodstream infections and endocarditis. Microorganisms readily adhere to the surfaces and colonize them by forming a slimy layer of biofilm. Bacteria growing in biofilms exhibit an increased antibiotic resistance in comparison with planktonic cells. Consequently the antibiotic treatment of these medical device-associated infections frequently fails. Detechment resulting in the formation of microemboli is a further biofilm related complication. Since infections often involve increased morbidity and morality, prolonged hospitalization and additional medical costs, various strategies to prevent biofilm formation on implanted medical devices have been developed over the last two decades. In this paper we review and discuss the most significant experimental approaches to inhibit bacterial adhesion and growth on these devices.     

Image Quality Characteristics of Handheld Display Devices for Medical Imaging

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10⁻⁵ mm² at 1 mm⁻¹, while handheld displays have values lower than 3.7×10⁻⁶ mm². Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices.     

碱性与中性含酶清洗剂清洗医疗器械效果比较

目的：探讨碱性含酶清洗剂与中性含酶清洗剂清洗医疗器械的效果。方法：随机抽取污染医疗器械420件,分成观察组与对照组,每组210件,观察组器械浸泡于1：200的碱性含酶清洗剂中,对照组器械浸泡于1：200的中性含酶清洗剂中,5min后分别取出在流动水下彻底冲洗,观察并比较两组器械洁净度以及潜血阳性率。结果：观察组洁净度明显优于对照组,差异有统计学意义（P〈0．05）;潜血阳性率显著低于对照组,差异有显著统计学意义（P〈0．01）。结论：碱性含酶清洗剂清洗医疗器械的效果明显优于中性含酶清洗剂,适合推广应用。     

Recall of associated memories

A mechanism of serial association in the brain is discussed. The passage from one state to another is assumed to be effected by a control operated by the thalamus on the cortex. Memory failure mechanisms are discussed, such as insufficient imprint, as well as Freudian failure phenomena.     

健康医疗可穿戴设备数据隐私相关问题研究

归纳、总结健康医疗可穿戴设备采集的数据内容,重点绘制健康医疗可穿戴设备的数据流动环节,并将数据流动划分为采集、上传、集成交互以及信息反馈等主要环节,并分析各主要环节中以及其他方面存在及潜在的数据安全与隐私问题,希望能为健康医疗可穿戴设备的数据隐私保护机制提供不同角度的理论参考。