“两个规范”与ISO9001：2008及ISO／IEC17025：2005质量管理体系的融合

将《血站质量管理规范》、《血站实验室质量管理规范》与ISO9001：2008、ISO／1EC17025：2005质量管理体系进行融合,在兼顾各条款要素的同时,以要求较高的要素为主,建立了一体化的血站质量管理体系。     

ISO9001质量管理体系在精神科封闭式管理医院感染控制中的应用研究

目的 探讨ISO9001质量管理体系对精神科封闭式管理医院感染控制的作用.方法 调查潍坊市精神卫生中心ISO9001质量管理体系（ISO9001-QMS）认证前2年与认证后运行6年期间所有封闭式病房出院病历,对医院感染率、感染相关因素等进行分析.结果 （1）与ISO9001-QMS认证前2年相比,认证后2年、4年、6年医院感染率比较差异均有统计学意义（P＜0.01）.（2） ISO9001-QMS认证前2年医院感染的相关因素为年龄、性别、病程、住院时间、疾病种类、季节（P＜0.05）,ISO9001-QMS认证后6年医院感染的相关因素为年龄、病程、住院时间及疾病种类（P＜0.05）.结论 实施ISO9001质量管理体系能有效降低精神科封闭式管理医院的院内感染率.     

基于有限元方法的全髋关节假体个体化选型分析

目的 研究ISO 7206标准对全髋关节置换术临床应用的指导意义。方法 建立肌骨数值模型,对正常行走步态进行仿真,以获得下肢的运动学和动力学参数;建立对应的全髋关节假体有限元模型,应用步态载荷进行计算,并对比ISO标准的有限元模型计算结果。结果 正常行走步态下,髋关节力分别在20%和54%步态周期出现峰值,以此作为有限元计算的步态载荷,得到20%步态周期时假体应力最大;松动模型中假体柄上最大应力大于无松动模型中假体柄上最大应力,且应力分布趋势存在差异;分析对比ISO测试和不同体重人体步态载荷下的假体最大应力,得到ISO测试中最大应力水平对应108~142 kg体重载荷下的假体最大应力。结论ISO测试中合格的假体可满足100 kg体重人体正常步态下的强度要求。     

Focus on Fluorides: Update on the Use of Fluoride for the Prevention of Dental Caries

Improving the efficacy of fluoride therapies reduces dental caries and lowers fluoride exposure.BackgroundFluoride is delivered to the teeth systemically or topically to aid in the prevention of dental caries. Systemic fluoride from ingested sources is in blood serum and can be deposited only in teeth that are forming in children. Topical fluoride is from sources such as community water, processed foods, beverages, toothpastes, mouthrinses, gels, foams, and varnishes. The United States Centers for Disease Control and Prevention (CDC) and the American Dental Association (ADA) have proposed changes in their long standing recommendations for the amount of fluoride in community drinking water in response to concerns about an increasing incidence of dental fluorosis in children. Current research is focused on the development of strategies to improve fluoride efficacy. The purpose of this update is to inform the reader about new research and policies related to the use of fluoride for the prevention of dental caries.MethodsReviews of the current research and recent evidence based systematic reviews on the topics of fluoride are presented. Topics discussed include: updates on community water fluoridation research and policies; available fluoride in dentifrices; fluoride varnish compositions, use, and recommendations; and other fluoride containing dental products. This update provides insights into current research and discusses proposed policy changes for the use of fluoride for the prevention of dental caries.ConclusionsThe dental profession is adjusting their recommendations for fluoride use based on current observations of the halo effect and subsequent outcomes. The research community is focused on improving the efficacy of fluoride therapies thus reducing dental caries and lowering the amount of fluoride required for efficacy.     

意大利辅助用具免费供给残疾人体系(英文)

Aids are only one of the instruments with which the disabled person can often reach a good level of autonomy,he can improve his conditions of life and prevent the aggravating of his situation.Aids serve also to facilitate care on the part of the family.The rights confirmed by Law 104 can also be achieved through the use of aids.The Italian state has planned a system of care with regards to aids so that some of them can be purchased with different tax concessions but essential aids,those necessary for the reaching of autonomy goals and prevention defined by an individual rehabilitative project,are supplied free of charge.In Italy essential aids are part therefore of a rehabilitation plan that is identified for each person with disabilities by a team made up of different professionals.     

Blood Glucose Monitor Performance: A Review of Standards and Statistics Used to Describe Blood Glucose Monitor Performance

Glucose performance is reviewed in the context of total error, which includes error from all sources, not just analytical. Many standards require less than 100% of results to be within specific tolerance limits. Analytical error represents the difference between tested glucose and reference method glucose. Medical errors include analytical errors whose magnitude is great enough to likely result in patient harm. The 95% requirements of International Organization for Standardization 15197 and others make little sense, as up to 5% of results can be medically unacceptable. The current American Diabetes Association standard lacks a specification for user error. Error grids can meaningfully specify allowable glucose error. Infrequently, glucose meters do not provide a glucose result; such an occurrence can be devastating when associated with a life-threatening event. Nonreporting failures are ignored by standards. Estimates of analytical error can be classified into the four following categories: imprecision, random patient interferences, protocol-independent bias, and protocol-dependent bias. Methods to estimate total error are parametric, nonparametric, modeling, or direct. The Westgard method underestimates total error by failing to account for random patient interferences. Lawton''s method is a more complete model. Bland–Altman, mountain plots, and error grids are direct methods and are easier to use as they do not require modeling. Three types of protocols can be used to estimate glucose errors: method comparison, special studies and risk management, and monitoring performance of meters in the field. Current standards for glucose meter performance are inadequate. The level of performance required in regulatory standards should be based on clinical needs but can only deal with currently achievable performance. Clinical standards state what is needed, whether it can be achieved or not. Rational regulatory decisions about glucose monitors should be based on robust statistical analyses of performance.     

Gentamicin and leucine inhalable powder: What about antipseudomonal activity and permeation through cystic fibrosis mucus?

The aim of this study was to evaluate the permeation properties of gentamicin (G) in a novel dry powder form for inhalation through an artificial mucus model. Moreover, since respiratory infections sustained by Pseudomonas are a major cause of sickness and death in CF patients, the susceptibility of P. aeruginosa to engineered G powders was investigated.     

Cadmium, lead, and thallium in smoke particulate from counterfeit cigarettes compared to authentic US brands.

Smoking remains the leading cause of preventable disease in the United States. Exposure to tobacco smoke leads to cancer, heart and lung disease, and addiction. The origin of the tobacco and cigarette manufacturing practices of counterfeit cigarettes are unknown. Because toxic metals are incorporated into the tobacco lamina during cultivation, the ambient metal content of the soil could produce significant differences in metal levels in both the tobacco and smoke of counterfeit cigarettes. We compared mainstream smoke cadmium, thallium, and lead deliveries from counterfeit and authentic brands. Mainstream smoke levels of all three metals were far greater for counterfeit than the authentic brands, in some cases by an order of magnitude. Significant differences still existed even after normalizing mainstream smoke metal levels with nicotine delivery; the counterfeits typically delivered much higher levels of all three analytes. Our findings, based on 21 different counterfeit samples, suggest that counterfeit cigarettes potentially result in a markedly greater exposure to toxic heavy metals than authentic brands, even after correcting for differences in nicotine intake. In view of the unknown health risks associated with inhaling higher levels of toxic metals, it is prudent to minimize exposure to toxic substances whenever possible.