为完成好国家药监局赋予的医疗器械检测任务做好服务保障工作

北京市医疗器械检验所（国家食品药品监督管理局北京医疗器械质量监督检验中心）承担着授权范围内医疗器械产品监督抽验检验、注册检验、认证检验、进出口商品检验、计量器具新品定型鉴定检验、科技成果鉴定检验以及委托检验、仲裁检验等检测任务。所内业务水平不仅关系到医疗器械公司产品的上市销售，对我国医疗卫生行业的发展，起着至关重要的作用。北京市医疗器械检验所办公室的工作，直接服务于各项检测工作。因此做好服务工作，将对更好地完成国家药监局交办的各项检测任务，是非常重要的。     

北京市医疗器械检验所

北京市医疗器械检验所(以下简称"北京市器检所",英文简称"BIMT")是经国家相关部门认可授权的综合性医疗器械检验机构。目前,北京市器检所经国家相关部门授权的检验项目达1280项,范围涵盖医疗器械电气安全、电磁安全、生物安全性评价、医用电气性能评价、医用材料性能评价、体外诊断系统检测等各专业领域,承担着全国和北京地区医疗器械产品监督抽验检验。     

北京市医疗器械检验所

北京市医疗器械检验所(以下简称“北京市器检所”,英文简称“BIMT”)是经CNCA、CNAS等部门认可授权的综合性医疗器械检验机构。目前,北京市器检所经国家相关部门授权的检验项目达1280项,范围涵盖医疗器械电气安全、电磁安全、生物安全性评价、医用电气性能评价、医用材料性能评价、体外诊断系统检测等各专业领域,承担着全国和北京地区医疗器械产品监督抽验检验、注册检验、进出口商品检验、委托检验等检验任务,承检能力保持全国同行业领先地位。该所还先后获得德国TüV、美国UL等国际认证机构的认可,为国内医疗器械产品走向国际市场提供便捷的检测技术服务。     

北京市医疗器械检验所

北京市医疗器械检验所(以下简称"北京市器检所",英文简称"BIMT")是经CNCA、CNAS、CFDA等部门认可授权的综合性医疗器械检验机构,是北京市药品监督管理局的直属单位。目前,北京市器检所经国家相关部门授权的检验项目达1294项,范围涵盖医疗器械电气安全、电磁安全、生物安全性评价、医用电气性能评价、医用材料性能评价、体外诊断系统检测等各专业领域,承担着全国和北京地区医疗器械产品监督抽验检验、注册检验、进出口商品检验、委托检验等检验任务,承检能力保持全国同行业领先地位。该所还先后获得德国TUV、美国UL等国际认证机构的认可,为国内医疗器械产品走向国际市场提供便捷的检测技术服务。     

北京市医疗器械检验所简介

北京市医疗器械检验所(国家食品药品监督管理局北京医疗器械质量监督检验中心,以下简称"器检所")是中国合格评定国家认可委员会(CNAS)、中国国家认证认可监督管理委员会(CNCA)、国家食品药品监督管理局(SFDA)等国家权威部门认可授权,并获得TUV PS、UL等国际权威认证机构认可的一所综合性医疗器械产品检测机构,是目前国内开展检验业务专业最全面的医疗器械检验机构。其中,经CNAS授权的检验范围涵盖医用电子、医用射线、核医学、电声学、体外诊断系统、一次性医疗产品、医用防护用品、医用橡胶制品、口腔     

天然胶乳橡胶避孕套检验分析及标准探讨

天然胶乳橡胶避孕套是有效避孕及预防性传播疾病的特殊产品,本文通过分析检验中遇到的问题,对该产品其他重要项目进行了探讨,就完善标准,规范产品作出了思考和建议。     

中国医疗器械检验机构现状与发展

该文介绍了我国医疗器械检验机构现状,全国有医疗器械检验机构53家,其中国家级医疗器械检验机构10家。医疗器械检验机构服务于政府对医疗器械的监管,在医疗器械上市前注册和上市后监督过程中发挥着技术支持作用。同时,其也是我国的医疗器械标准化工作重要的践行者。最后,提出了检验机构目前存在的问题与解决对策,以利于我国医疗器械的持续发展。     

上海国家医疗器械质量监督检验中心通过质量体系认可审查

上海国家医疗器械质量监督检验中心通过质量体系认可审查１９９５年１月中旬由国家技术监督局组织的专家评审小组，按ＩＳＯ／ＩＥＣ导则２５─１９９０“标准和检验实验室资格的通用要求”和ＩＳＯ９０００．２对国家医疗器械质量监督检验中心（上海医疗器械产品认证检测...     

天然胶乳橡胶避孕套产品比较研究及风险管理建议

目的：为我国完善天然胶乳橡胶避孕套产品的管理提供风险管理建议。方法：采用比较研究方法,研究我国与世界卫生组织、FDA对避孕套产品技术要求;同时采用文献研究方法,总结我国避孕套产品监督抽验中发现的主要问题。结果：产品风险主要体现在技术要求不完善、监督抽验质量不合格、原材料和工艺自身风险以及市场流通风险四个方面。结论：建议重点从避孕套产品生命周期的生产、注册、上市后监管三个环节加强管理,降低产品风险,以确保其安全、有效地使用。     

医药部门对医疗器械检验作出规定

医药部门对医疗器械检验作出规定国家医药管理局近日发出通知，对医疗器械产品的检验作出规定：医疗器械产品检验依据是国家标准、行业标准或国家有关规定。对于没有相应的国际或行业标准的产品的检验依据是经备案的企业产品标准；医械产品的检验包括两种出厂检验和型式检...     

Barriers to condom purchasing: Effects of product positioning on reactions to condoms

Correct and consistent condom use has been promoted as a method to prevent sexually transmitted infections including HIV. Yet research has repeatedly shown that people fail to use condoms consistently. One influence on the pervasive lack of condom use that has received relatively little attention is the context in which consumers are exposed to condoms (i.e., how condoms are displayed in retail settings). In this paper we present two studies explored variations in condom shelf placement and its effects on people's condom attitudes and acquisition. Study 1 explored the shelf placement of condoms in 59 retail outlets in Connecticut, USA and found that condoms were typically located in areas of high visibility (e.g., next to the pharmacy counter) and on shelves adjacent to feminine hygiene and disease treatment products. In Study 2, 120 heterosexual undergraduate students at the University of Connecticut were randomly assigned to evaluate condoms adjacent to sensual, positive, neutral, or negative products and found that overall men reported more positive attitudes and acquired more condoms when exposed to condoms in a sensual context compared to women in the same condition. Among women, condom attitudes were more positive in the context of neutral products; condom acquisition was strongest for women exposed to condoms in the positive aisles. These results suggest a gender-specific approach to condom promotion. Implications of these studies for HIV prevention, public health, and condom marketing strategies are discussed.     

Acceptability evaluation of a natural rubber latex, a polyurethane, and a new non-latex condom

After more than a century of reliance on latex condoms, male condoms fabricated from new materials are finally becoming commercially available to consumers. This study was an open label acceptability study that compared three lubricated condom products during vaginal intercourse: a natural rubber latex condom, a polyurethane condom, and a new non-latex (styrene ethylene butylene styrene, SEBS) condom. Fifty-four couples who were using condoms for birth control were enrolled in this three-way crossover study. Each couple tested three condoms of each type in a randomized sequence. Couples reported condom performance after each use and rated condom acceptability after use of three condoms of each type. At the completion of the study, participants selected their preferred condom type for overall acceptability, sensitivity, ease of use, appearance, and comfort. All three condom types had low clinical breakage and slippage rates (≤ 3.3%) although the polyurethane condom did not perform as well in other measures of performance including unrolling, discomfort, stretching, bunching, and sliding along the penis during intercourse. None of the condom types were statistically preferred overall [males: natural rubber latex 37%, polyurethane 24%, new non-latex (SEBS) 37%, no preference 2%; females: natural rubber latex 33%, polyurethane 27%, new non-latex 37%, no preference 2%]. A statistically higher proportion of couples preferred both the natural rubber latex condom and the new non-latex condom above the polyurethane condom for ease of unrolling, and the natural rubber latex condom above the other condom types for perceived safety. Approximately two-thirds of both male and female participants preferred one of the two condoms made of synthetic materials suggesting that consumers will appreciate the availability of these products.     

Improving the effectiveness of condom advertising: a research note

A limited number of studies have examined ways that health promotion messages about condoms can be improved, leading to increased purchase and use. This study tests alternative message structures as a potential avenue to improving condom advertising. As hypothesized, two-sided messages (positive and negative information about the product category) result in more positive attitudes toward the advertisement and the brand than do one-sided messages (positive information only about the product category). The study's implications for health care marketers interested in developing more effective advertising for condoms and other health care products are discussed.     

Toxicological evaluation of nitrosamines in condoms.

Volatile N-nitrosamines have been found in rubber products including gloves, balloons, toys, baby bottle teats, soothers, and condoms. N-Nitrosamines are potent carcinogens, and therefore, European legislation has limited the release of N-nitrosamines and N-nitrosatable compounds in teats and soothers to 0.01-0.1 mg/kg rubber, respectively. Previously, endogenous nitrosamine formation in the vagina has been suggested as a cause of cervical cancer. It was speculated that exogenous N-nitrosamines and N-nitrosatable compounds from condoms may also lead to genital cancer. Therefore, we reviewed the literature and calculated the risk for the induction of tumors by nitrosamines from condoms. In vitro Biaudet et al. (1997) found up to 88 ng nitrosatable compounds migrating from condoms to cervical mucous within 24 hrs. During sexual intercourse about 0.6 ng may migrate in the female genital mucous membranes because of the short contact to the condom, e.g. 10 min. Comparable amounts of nitrosamines may also migrate in the penile skin. Estimating 1500 contacts to condoms during lifetime (50 condoms/year for 30 years) this may result in the adsorption of up to 0.9 microgram nitrosamines in total. Animal studies in Syrian hamsters showed the induction of local and/or systemic tumors, in particular liver tumors, after topical application of nitrosamines to the skin or mucous membrane at a total dose of about 1 g. This dose exceeds the dose to be expected from contact with condoms by more than 1 million. Also, epidemiological studies do not support a role for condoms in the induction of cancer. The incidence of cervical cancer and liver tumors is high in developing countries, where condoms are seldom used. In addition, humans are regularly exposed to nitrosamines from food and tobacco smoke at a dose which is 1,000 to 10,000 fold higher than expected from condom use. In summary, the risk for the induction of tumors from nitrosamines in condoms is very low.     

Female condom technology: new products and regulatory issues

Like male condoms, female condoms (FCs) provide protection against unplanned pregnancy and most sexually transmitted infections including HIV. The first FC made by the Female Health Company was approved by the US Food and Drug Administration (USFDA) in 1993. Since 2000, several different types of FCs have become available or are in development to lower the cost and/or improve acceptability. Although similar in function, new FCs often differ in design and materials. Classified as Class III medical devices by the USFDA, FCs have a regulatory process that is more complex than that for male condoms. This, coupled with the lack of an international standard to verify the quality of new devices, has hindered new products gaining regulatory approvals and entering the market. We review the existing regulatory pathway for FCs, the progress made in developing standards specifically for FCs and the FCs available now or in development, including their current status regarding approval.     

A study of the relationship between tensile testing of condoms and breakage in use

The ability of the condom wall to maintain its integrity throughout sexual intercourse is critical to its role in halting the spread of major sexually transmissible pathogens including the human immunodeficiency virus. There are three principal in vitro performance tests applied to condoms: a test for freedom from holes, an inflation test, and tensile testing. In this study we subjected condoms that had broken in use to tensile tests in order to determine any correlation between their in vivo and in vitro performance. Condoms which had broken in use showed similar tensile properties to those which had not. All passed all tensile test criteria. Thus, the inclusion of tensile testing in National Standards for condoms is not sufficient to insure strong products.     

Knowledge of,attitudes toward,and stage of change for female and male condoms among denver inner-city women

Despite availability for a decade and documented acceptability among some groups of women for the method, female condom use is still rare. We surveyed 198 young women (15–25 years old) living in the inner city of Denver about their knowledge of, attitudes toward, and practices regarding female and male condoms. Most (75%) women had ever considered using male condoms; 32% had ever considered using female condoms; and use of either was sporadic. We examined predictors for being in either precontemplation or a later stage along the change continuum at both the bivariate and multivariate levels. Our findings suggest that African Americans and younger women are more likely to contemplate using female condoms. Both lack of knowledge and positive attitudes toward female condoms in this sample suggest that programs designed to raise awareness and knowledge of female condoms while improving their image are needed. This project was carried out in part under a cooperative agreement with the Association of Teachers of Preventive Medicine (TS310-1615) and the Division of Reproductive Health at the Centers for Disease Control and Prevention. The content of this publication does not necessarily reflect the views or policies of the Association or the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government.     

AIDS and the marketing of condoms.

The condom market has undergone unprecedented change in the 1980's and will continue to see its markets, advertising strategies, and sales grow and change in ways never before imagined. In the past, condoms were viewed as unmentionable products that were marketed only at men between 18 and 35 and sold only in gas station restrooms and bus stations. But today women account for and estimated 40-50% of condom sales and after a Supreme Court ruling in 1977, condoms are now sold in front of the counter, not behind it. Further, the AIDS epidemic which has afflicted 40,000 U.S. citizens between 19811 and 1988 has served as an impetus to growth and diversification of the condom market. The new legitimacy of the condom combined with new entries into the market by other manufacturers has resulted in growth and segmentation in the condom market.     

上海市大学生校内免费安全套使用意愿及影响因素

  目的  了解上海市在校大学生校内免费安全套使用意愿及影响因素,为优化相关公共医卫服务提供依据,预防大学生性病传播以保障生育人口生殖健康。  方法  对上海市62所专科及本科院校共14 612名在校大学生进行横断面调查,调查校内提供的免费安全套使用现状和个人看法,运用多因素logistic回归分析模型分析大学生校内免费安全套的使用意愿及影响因素。  结果  3 594例有过性行为的在校大学生校内免费安全套的使用意愿率为27.30%(981例),其中3 538例有效样本的使用率为9.04%(320例);性别、安全套使用经验、校内免费安全套使用经验、安全套日常负担成本、免费安全套评价与校内免费安全套的使用意愿差异均有统计学意义(均有P＜0.001),男性(OR=1.412,95% CI: 1.001~1.189)、使用过校内免费安全套的(OR=2.079,95% CI: 1.114~1.522)、对校内免费安全套评价较好的及认为安全套日常负担成本较低的使用意愿较高。保证产品质量占比86.22%、加大宣传占比61.42%,这两项是提高免费安全套吸引力的主要措施。  结论  上海市大学生的校内免费安全套使用率较低、使用意愿不强。应改进免费安全套品质、完善校内免费安全套发放渠道、提高免费安全套认可度和接受度、实现高校免费药具服务的有效供给。     

Will microbicide trials yield unbiased estimates of microbicide efficacy?

OBJECTIVE: To evaluate the effect of adherence and condom use on apparent efficacy of microbicides. DESIGN: Hypothetical trial designs and scenarios. METHODS: Mathematical calculations of effectiveness. RESULTS: In a randomized trial of a candidate microbicide and a placebo, nonuse of the microbicide will result in underestimation of microbicide efficacy, with the magnitude of this difference between effectiveness and efficacy increasing directly with the level of microbicide nonuse. Adding condoms to the trial will not change this expected result as long as use of condoms and microbicide is independent, and microbicide use is the same in the trials with and without condoms. However, if microbicide use is lower in the trial with condoms, then effectiveness will be lower than in the trial without condoms, with the magnitude of the difference between effectiveness and efficacy being even greater. Moreover, condom and microbicide use may not be independent. If participants tend to use condoms rather than nothing, the trial result will more closely approximate microbicide efficacy. If, however, participants substitute condom use for microbicide use, then the expected estimate of effectiveness will less closely approximate microbicide efficacy and could be closer to or further away from the expected estimate of effectiveness than in the trial without condoms. In another trial design, where there is either simultaneous use of microbicide and condoms or no use of either (guaranteed when condoms are packaged with either a microbicidal or a placebo gel), expected effectiveness will fall short of microbicide efficacy. If nonuse is the same in a trial without condoms and a trial with microbicidally lubricated condoms, then the trial with condoms will produce an estimate of effectiveness that less closely approximates microbicide efficacy than would the trial without condoms. If there is less nonuse in the trial with condoms, then the expected estimate of effectiveness will more closely approximate microbicide efficacy and could be closer to or further away from the expected estimate of effectiveness than in the trial without condoms. CONCLUSIONS: Nonuse of a microbicide and use of condoms may seriously impair our ability to identify an effective microbicide.