基于技术审评的一次性使用导尿管研究

目的：从技术审评角度,研究一次性使用导尿管产品的安全性和有效性。方法：基于各国行业标准和指南文件,对一次性使用导尿管的结构组成、作用机理、技术要求、风险分析、临床要求五个方面进行了分析研究,尤其是较为忽视的化学性能要求和涂层要求。结论：从技术审评角度,为保证导尿管产品的安全性和有效性,应加强对导尿管产品材料化学性能要求和生物学评价,增加对导尿管涂层的技术要求。     

一次性使用内窥镜注射针注册技术审评关注点

从医疗器械注册技术审评角度,简述内窥镜注射针申报文件风险管理资料、产品技术要求、研究资料、毒性物质残留、生物相容性评价、临床评价资料等章节的关注点。规定了技术要求常见条款,风险管理、研究资料列举了针对产品特性的项目要求,以便准确判断产品质量,提高审评和监管效率,推动行业发展。     

医用内窥镜产品技术审评要求

医用内窥镜发展已有100多年的历史,作为一种成熟产品,技术并不复杂,风险也不高.技术审评的重点是对注册申请资料的完整性和规范性进行审查.本文结合技术审评工作实际,从注册申请表、注册单元、产品名称和标准等方面总结了医用内窥镜类产品技术审评的一般要求.     

过敏原检测试剂上市前技术审查要求探讨

该研究从技术审评的角度梳理对比了中国、美国、欧盟等对过敏原检测试剂的上市前监管要求,结合上市后不良事件监测情况、可参考的标准和国内外法规依据文件,分析了该产品的监管风险和性能要求。针对该产品国内临床试验难、具有可比性的对比试剂难找、缺乏临床诊断金标准等“卡脖子”问题进行了探讨并给出监管建议,以期为该领域的产品研发生产和审评审批监管提供技术参考。     

基于注册技术审评的输液泵研究

目的：从注册技术审评角度，研究输液泵产品的安全性和有效性。方法：基于现行有效的国家标准、行业标准和指南文件，对输液泵产品的结构组成、技术要求、风险分析、临床要求和常见不良事件5个方面进行分析研究。     

酶电极生物传感器血糖检测仪注册技术审评探讨

酶电极生物传感器血糖检测仪是一种新型的快速血糖测定方法,国内外无相应的产品标准和行业标准可供参考,性能研究和临床评价方面缺乏相应的借鉴经验。本研究从医疗器械技术审评角度对酶电极生物传感器血糖检测仪的安全性、有效性进行探讨,期望能给医疗器械注册技术审评人员和注册申报企业提供一定的借鉴。     

空氧混合器注册技术审评要点分析

基于现行相关法规、标准、指导原则的要求，从注册审评的角度出发，对空氧混合器产品的注册情况、综述资料、研究资料、产品技术要求、产品说明书等方面进行要点分析，以期对该类产品注册申请人及审评相关人员有所帮助。     

微生物质谱鉴定仪安全有效性评价

微生物质谱鉴定仪运用的基质辅助激光解吸电离飞行时间质谱(MALDI-TOF-MS)技术应用于临床微生物鉴定操作,极大地提高了临床微生物的鉴定效率.文章从医疗器械技术审评角度对微生物质谱鉴定仪安全有效性进行评价.在综述资料、研究资料、临床评价、说明书方面提出审评关注点,以期对该类产品注册申报和技术审评有所帮助.     

专栏——医用光学医疗器械的质量控制(二)

编者按:医用光学医疗器械,包括诸如内窥镜、眼科光学仪器、医用手术及诊断用显微设备、医用激光器、植入体内或长期接触体内的眼科光学器具等,是临床不可或缺的诊断和治疗器械。此类产品的质量控制一直是研究的热点。国家食品药品监督管理总局医疗器械技术审评中心是我国医疗器械技术审评最高机构,负责所有进口医疗器械和国产高风险第III类医疗     

一次性使用内窥镜用注射针产品的评价与标准

介绍一次性使用内窥镜用注射针产品的应用发展及基于临床需求的设计要点，探讨一次性使用内窥镜用注射针的评价要点及国内外标准情况，并在此基础上提出制定一次性使用内窥镜用注射针产品标准的建议。     

Cleaning, disinfection, and sterilization of gastrointestinal endoscopes: approaches in the office

Bacterial contaimination of endoscopes can be clinically significant. While current data suggest that flexible sigmoidoscopy may entail fewer risks than upper endoscopy, these data are too incomplete to draw this conclusion. Careful cleaning and disinfection after each procedure are recommended. Gas sterilization of the endoscope and gas or heat sterilization of accessory equipment may be necessary in certain clinical situations. It must be remembered that hundreds of thousands of endoscopic procedures were performed in the 1970s using cleaning only without substantial health risk. The processes do not have to be complicated or difficult. Staff must be well trained and must understand the potential risks of working with disinfecting agents such as alkaline glutaraldehyde. It is recommended that the clinician fully understand the cleaning and disinfection steps and be able to perform them. It is important that office procedures be based on efficacy, not convenience. The procedures developed to date are not ideal and the ideal disinfectant has yet to be found. Cleaning and disinfecting machines have been developed, but they are expensive and their efficacy and safety are no better than hand-performed methods. An alternative approach to reducing transmission of infections by endoscopes may be to seek less adherent plastic substances for the endoscope sheath. The introduction of immersible endoscopes has helped with cleaning, but their use may also give rise to a false sense of security. Diligent attention to cleaning and disinfection is still necessary.(ABSTRACT TRUNCATED AT 250 WORDS)     

内窥镜防交叉感染安全保护套的研制

目的：改善目前内窥镜消毒欠佳的状况,研制内窥镜防交叉感染安全保护套。方法：选用无毒、无害、无味、透明、有弹性的医用橡胶,加工成圆管状或圆筒状,其大小与内窥镜前部的镜身相吻合。前后端开口处设置内藏加厚圈。每只以保护套的中线为轴心搓卷成卷桶状,消毒灭菌后装袋备用。结果：保护套结构简洁流畅,能够经内窥镜的末端顺利退卷并套上内窥镜镜身且紧密贴附。结论：内窥镜防交叉感染保护套能够有效地避免内窥镜镜身沾染受检者的血液黏液以及可能存在的病原微生物,降低医源性交叉感染的风险。     

内镜直视下气囊扩张术治疗贲门失弛缓症的随访研究

目的观察评价贲门失弛缓症的内镜直视下气囊扩张术的疗效。方法选择92例贲门失弛缓症并经过内镜下气囊扩张术治疗的患者,术后6个月、1年、2年定期随访,详细询问病史,并经内镜和钡餐检查对原有的吞咽困难等症状缓解程度进行评估。结果92例患者吞咽困难症状均有显著改善。1次扩张有效率达86.9%,2次有效率可达100%。术中可见贲门黏膜撕裂、渗血,未见致命性出血及穿孔等并发症。结论内镜下气囊扩张术治疗贲门失弛缓症可获得良好的近期和远期疗效,具有安全、简便、价廉的特点,是治疗贲门失弛缓症的首选方法。     

软式消化内镜干燥方法的研究进展

干燥通常作为软式消化内镜再处理环节中最后一个关键步骤,在医院感染控制中,干燥与软式消化内镜的清洗、消毒或灭菌有着同等重要的地位,但现有的干燥方法尚不能完全保证达到安全要求。本文总结软式消化内镜干燥的研究现状,分析归纳影响软式消化内镜干燥效果的因素,有利于软式消化内镜干燥的储存方法,以及干燥效果的评价方法,以期为临床现有实践和未来研究提供一定的循证依据。     

冠心病介入治疗术后拔除鞘管的护理配合

目的:探讨冠心病介入治疗术后拔除血管鞘的护理经验.方法:回顾分析44例冠心病介入治疗术后患者拔鞘方法,拔鞘前后护士密切观察病情和心理护理、伤口护理等.结果:44例患者均成功拔鞘.通过拔鞘前准备,拔鞘后护理,提高拔鞘的成功率,减少并发症.结论:拔鞘前充分的准备,拔鞘时积极的配合,拔鞘后的精心护理是保证冠心病患者介入治疗术后成功拔鞘的关键.     

便携式半软鞘颅腔镜系统的研制

目的：为微创神经外科研制轻便的半软鞘颅腔镜。方法：研究者创意、生产商参照WCM—II便携式电子内视镜（华芯数字技术有限公司,中国杭州）定制便携式EDA—H电子内视镜,以其视屏图像观察切开的新鲜石榴,在其视屏图像引导下进行SD大鼠大脑中动脉阻断术、家兔和人类尸头模拟开颅探查术。结果：EDA—H电子内视镜的视屏图像清晰、逼真、有立体感且与实际操作同步,在其引导下进行手术操作,手术过程平稳、操作准确,术中可随意变换和保持观察角度,止血方便、彻底。结论：可制备适合颅腔手术用的便携式半软鞘内视镜。     

EndoSheath endoscopic system

To address the problems inherent in reprocessing endoscopes--the time required (about an hour per use), the difficulty of the process, and the adverse consequences of endoscope contamination--Vision Sciences Inc. introduced the EndoSheath endoscopic system. It consists of a disposable sheath that fits over a specially designed reusable fiberoptic endoscope. When an endoscopic procedure is completed, the sheath is discarded, and the endoscope is wiped with alcohol and reused. We evaluated one of the EndoSheath products--a sheathed sigmoidoscope--for its suitability in an endoscopy suite. We examined the unit and surveyed a number of users. We found that, although it would considerably shorten the time between endoscopic procedures, the unit was not well suited for an endoscopy suite because it provided no more protection than would be afforded by a carefully followed reprocessing protocol. However, users informed us that the sigmoidoscope and one other product--a nasopharyngo-laryngoscope--would likely be useful in a doctor's office or a hospital clinic.     

内窥镜临床使用安全管理

内窥镜是一种精密医疗器械,目前广泛应用于临床检查、治疗。内窥镜主要分为软性镜、硬性镜、胶囊内窥镜三种。本文主要就软性镜、硬性镜的镜体、主机、摄像头、手术器械的临床使用安全进行探讨,包括常见误操作、清洗保养、消毒灭菌等。     

Current Evidence and Possible Future Applications of Creatine Supplementation for Older Adults

Sarcopenia, defined as age-related reduction in muscle mass, strength, and physical performance, is associated with other age-related health conditions such as osteoporosis, osteosarcopenia, sarcopenic obesity, physical frailty, and cachexia. From a healthy aging perspective, lifestyle interventions that may help overcome characteristics and associated comorbidities of sarcopenia are clinically important. One possible intervention is creatine supplementation (CR). Accumulating research over the past few decades shows that CR, primarily when combined with resistance training (RT), has favourable effects on aging muscle, bone and fat mass, muscle and bone strength, and tasks of physical performance in healthy older adults. However, research is very limited regarding the efficacy of CR in older adults with sarcopenia or osteoporosis and no research exists in older adults with osteosarcopenia, sarcopenic obesity, physical frailty, or cachexia. Therefore, the purpose of this narrative review is (1) to evaluate and summarize current research involving CR, with and without RT, on properties of muscle and bone in older adults and (2) to provide a rationale and justification for future research involving CR in older adults with osteosarcopenia, sarcopenic obesity, physical frailty, or cachexia.     

Surgical video systems

A surgical video system (SVS) is an integration of components used to perform minimally invasive surgery (MIS). In the operating room, an SVS consists of an endoscope, an attached video camera, a light source, a video processor, and one or more video displays. A single SVS can generally be used in any type of MIS procedure (e.g., general, orthopedic, urologic), provided that it is equipped with the appropriate type of endoscope. In this Evaluation, we tested seven systems from six manufacturers. We found that, on average, three-chip systems provide better overall image quality than one-chip systems. Three systems were judged as providing image quality slightly superior to that of all the other systems; however, the level of subjectivity involved in judging performance suggests that users should perform in-house trials before purchase. All the evaluated systems performed relatively well in performance testing, but most systems were rated Fair or Poor in several human factors and safety tests. In fact, only two systems did not receive any Poor ratings in the Light Source Safety Features tests. Although users bear much of the responsibility for ensuring that light sources are used safely, most manufacturers have not made simple design changes that would make unintentional misuse less likely. We would be more likely to rate systems that still exhibit these safety issues in the future as Not Recommended or Unacceptable.