器械与药物结合——医疗器械发展另辟蹊径

每个以技术为基础的公司都在寻求具有发展价值的创新产品，对于医疗器械公司而言，完成这种创新十分困难，然而．近年来的一个突破引起了广泛关注，这就是复合产品的出现。之所以称其为复合产品．是因为它是由两种不同类型的受管制产品构成的．通常是药物与器械组合或生物制品与器械组合。     

重组C因子细菌内毒素检测法应用于医疗器械的建议

细菌内毒素是药品、生物制品和医疗器械等产品重要控制指标之一，文章分析了经典方法（鲎试剂法）检测细菌内毒素面临的困难，并对新方法（重组C因子检测法）的必要性以及国内外对此方法的研究进展进行了综述，进一步结合医疗器械产品内毒素的控制指标，提出重组C因子法应用于医疗器械内毒素检测的建议。     

医疗器械产品市场准入审查新规定

医疗器械产品市场准入审查新规定日前，国家医药管理局发布关于“医疗器械产品市场准入审查规定”，对国内外医疗器械（医械）产品进入中国市场的审查做出新的规定：自１９９６年１月８日起，进入中国市场的任何一种医械产品须由产品生产者或其委托代理人向中国政府医械行...     

医疗器械产品实行安全认证制度

<正>为了保障我国医疗器械产品的安全、有效和产品质量,我国对医疗器械产品将实行安全认证制度.经国家技术监督局批准,中国医疗器械产品认证委员会于1994年12月21日成立.它标志着我国医疗器械的行政监督已步人与国际惯例接轨和法制管理的轨道.医疗器械作为一种特殊产品,在世界各国均被列为严格管理的范围内.新成立的中国医疗器械产品认证委员会代表国家对医疗器械产品作出科学、公正、客观的认证,经过认证的产品,国家行政管理部门实施强制性的监督管理.在认证期内,如发现产品质量达不到认证标准,委员会将发出限期整改的通知书,并停止使用认证标志.     

医疗器械产品标签及使用说明书有新规定

医疗器械产品标签及使用说明书有新规定国家医药管理局最近发出通知，对医疗器械产品的标签及使用说明书作出规定。规定要求医疗器械产品标签及使用说明书内容应根据国家有关标准和医药行业标准，而产品说明书除执行国家有关标准外，还应对以下的内容作出特殊说明：生产者...     

医疗器械的情感化设计

目前，国内外关于医疗器械产品的情感化设计方面的研究比较少，有～些研究是基于医疗器械产品的人性化设计的基础上，进行的泛泛或简单的论述没有形成系统的研究方法和途径。人性化设计是指以人为核心，全面考虑人的精神、物质需求的一种设计价值观。情感化设计是人性化设计中针对人的精神方面的设计。本文旨在前人关于产品情感化设计研究的基础上，将其与现代医疗器械的特征进行有机结合，对医疗器械的情感化设计进行探讨，希望对我国医疗器械的设计有一定帮助。     

设计类医疗器械软件分类管理探讨

当前设计类医疗器械软件主要用于辅助制定手术计划、设计医疗器械等，有多种重要用途，是一种比较特殊的软件，在监管工作中需要首先依据当前的相关法规明确此类产品管理属性。文章分析了设计类医疗器械软件产品的特点、目前产品的发展现状，结合我国和美国、欧盟的监管政策情况，根据《医疗器械分类目录》等法规并结合产品的使用风险，详细分析了对该类软件产品按照术前规划和生产加工两个不同的应用领域进行属性界定和管理类别划分的技术要求，并对应用新技术的该类软件的分类界定进行了探讨，从而为此类产品的监管工作提供技术参考。     

我国医疗器械工业也有了自己的质量技术咨询队伍

医疗器械产品和药品一样,与人类的生命攸关,有它独特的质量要求。医疗器械工业又是一种技术密集型的工业。要生产高水平、高标准、高质量的医疗器械产品,是会有一定难度的。但这一目标又是我们每个医疗器械工业战线上的职工必须追求的,必须     

欧盟的医疗器械市场准入与第三方认证的区别

由于医疗器械是与人民的健康和生命安全密切相关的产品，因此在发达国家对它的监管与对药品的监管一样，都是由政府主管部门制定专门的法律法规，实行统一管理。但是，有些人认为，欧盟与其它发达国家不一样，医疗器械的市场准入管理不是由政府统一施行，而是由第三方认证机构实行认证管理一只要认证了，就可以进入市场销售。这是一种误解，是有失偏颇的。下面简要介绍—下欧盟的医疗器械市场准入方式。     

我院新生物制品科技开发的现状与问题及其对策

我院新生物制品科技开发的现状与问题及其对策李安丽在市场经济条件下，医学科研成果的转化是科技发展的出发点和归宿，而医学生物高技术成果实现商品化主要是产生生物工程药物。因此，新生物制品的研究开发与报批是科研管理工作中成果推广的一项重要内容，是一项系统工程...     

Special report. New products that improve officer performance, safety

The need for products that improve performance of security officers is counterbalanced these days by budgetary constraints. While this may limit major investments in security systems and personnel, less costly improvements or innovations might be worth considering. In this report, we will discuss four advances that may be valuable not only in hospital security, but in other industries as well. One of them, a smoke filter, was originally developed for the hotel industry. Another, a drug detection device, may replace the use of undercover agents or drug-sniffing' dogs in certain circumstances. The third new product is an economical patrol vehicle for parking facilities which might replace more costly vehicles such as golf carts or cars. The fourth product, a roving CCTV camera, is actually being tested at a Midwest medical center and may allow you to monitor areas of parking garages with cameras instead of officers on patrol.     

医疗器械注册产品标准编制要求和注意事项简

目的：规范医疗器械注册产品标准的编制要求,提高编制水平。方法：依据《国家医疗器械注册管理办法》、《医疗器械标准管理办法》、《注册产品标准编写规范》等法规探讨对注册产品标准的编制要求、执行现状和常见错误。结果与结论：注册产品标准的编制存在较多不规范之处,应加强医疗器械标准化管理工作,特别是对试验方法验证工作的管理。     

Metoprolol succinate extended release/hydrochlorothiazide combination tablets

Lowering elevated blood pressure (BP) with drug therapy reduces the risk for catastrophic fatal and nonfatal cardiovascular events such as stroke and myocardial infarction. Given the heterogeneity of hypertension as a disease, the marked variability in an individual patient's BP response, and low response rates with monotherapy, expert groups such as the Joint National Committee (JNC) emphasize the value of combination antihypertensive regimens, noting that combinations, usually of different classes, have additive antihypertensive effects. Metoprolol succinate extended-release tablet is a beta-1 (cardio-selective) adrenoceptor-blocking agent formulated to provide controlled and predictable release of metoprolol. Hydrochlorothiazide (HCT) is a well-established diuretic and antihypertensive agent, which promotes natruresis by acting on the distal renal tubule. The pharmacokinetics, efficacy, and safety/tolerability of the antihypertensive combination tablet, metoprolol extended release hydrochlorothiazide, essentially reflect the well-described independent characteristics of each of the component agents. Not only is the combination product more effective than monotherapy with the individual components but the combination product allows a low-dose multidrug regimen as an alternative to high-dose monotherapy, thereby, minimizing the likelihood of dose-related side-effects.     

制订医疗器械产品标准的见解

本文就医疗器械产品标准具体制订中的一些问题,进行了思考、分析和总结,提出了一些经验和意见,为规范、有效的制订医疗器械产品标准提供合理化的建议和见解。     

药品费用过高的原因分析与控制策略研究

药品费用的过度上涨是医药各方利用药品的二重性、委托代理消费、信息不对称等经济学特征在不合理的政策设计和制度安排所预留出的较大空间内全面互动的结果。对药品费用的控制主要从完善医院补偿机制、调整药品生产经营结构、规范药品流通秩序和行为及改革价格管理办法四个方面入手     

对2005—2006年美国FDA召回的医疗器械产品分析

目的分析美国FDA医疗器械召回信息的特点．探讨医疗器械安全性问题。方法对每份报告记录了召回级别、产品名称、产品类别和召回原因．并进行了归类分析。结果分析了3093份召回报告．Ⅰ、Ⅱ、Ⅲ级召回原因类别具有显著差异：材料类召回原因主要是包装问题（39％）、设计缺陷《19％）;器械类主要是设计缺陷（27％）、包装问题（26％）,设备类主要是设计缺陷（45％）和系统故障（39％）;软件召回109例。高风险医疗器械召回主要原因是设计缺陷．其Ⅰ级召回比例2006年比2005年有所下降。结论应加强对医疗器械召回信息的监测和利用．总结医疗器械安全性问题的客观规律．为更好地开展我国医疗器械监测提供参考。     

医疗器械注册产品标准的现状分析与发展对策探究

本文回顾了医疗器械注册产品标准的产生与发展历程，同时进一步分析了注册产品标准目前存在和面临的问题以及最新发展动态，提出了下一步改进和完善注册产品标准管理的思路和建议。     

Recommendations on health-related quality of life research to support labeling and promotional claims in the United States

Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers. This revised version was published online in June 2006 with corrections to the Cover Date.     

Information transfer in the medical device industry.

This presentation provides an overview of the process of information transfer in a typical area of the medical device industry, that of medical imaging. The medical device industry must translate technological trends into ideas for new methods for diagnosis and treatment. The feasibility of such ideas has to be evaluated carefully, inasmuch as large amounts of money are sometimes invested in product development. Moreover, the knowhow obtained from research must be protected long enough to enable the industry to complete development and market the product.     

Evaluation of Measurement Tools for Tobacco Product Displays: Is there an App for that?

Tobacco product displays are a pervasive presence in convenience stores, supermarkets, pharmacies, and other retailers nationwide. The influence that tobacco product displays have on purchases and tobacco product initiation, particularly on young people and other vulnerable populations, is well known. An objective measurement tool that is valid, reliable, and feasible to use is needed to assess product displays in the retail setting. This study reports on the relative accuracy of various tools that measure area and/or distance in photos and thus could be applied to product displays. We compare results of repeated trials using five tools. Three tools are smartphone apps that measure objects in photos taken on the device; these are narrowed down from a list of 284 candidate apps. Another tool uses photos taken with any device and calculates relative area via a built-in function in the Microsoft Office Suite. The fifth uses photos taken with the Narrative Clip, a “life-logging” wearable camera. To evaluate validity and reliability, we assess each instrument''s measurements and calculate intra-class correlation coefficients. Mean differences between observed measurements (via tape measure) and those from the five tools range from just over one square foot to just over two square feet. Most instruments produce reliable estimates though some are sensitive to the size of the display. Results of this study indicate need for future research to test innovative measurement tools. This paper also solicits further discussion on how best to transform anecdotal knowledge of product displays as targeted and disproportionate marketing tactics into a scientific evidence base for public policy change.