必赢亚娱乐官网(中国)有限公司

您当前位置:奥咨达医疗器械服务集团 >> 资讯中心 >> 行业信息 >> 浏览文章

【奥译言】医疗器械与患者安全

阅读: 2017年05月08日

【奥译言】医疗器械与患者安全


如果医学影像设备由于维护不当而发生故障,将导致诊断错误、治疗延迟、患者可能会出现严重的损伤甚至死亡。如果X射线影像设备由于校准不当而导致模糊,将可能影响骨折位置的判断。如果电子计算机断层扫描(CT)出现故障,车祸伤者可能需要等待几个小时才能进行扫描。如果磁共振成像(MRI)器械的部件有问题,将可能导致爆炸或令患者窒息。如果任何电子器械密封不良,将可能导致病患或医护人员遭受触电。


这些问题,正是大家需要避免的。


此外,医学影像设备的制造商除了负责创新,设计,制造,包装,标签,组装和升级医疗器械外,还需要为已安装的医学影像设备提供服务活动,包括他们自身制造和由其他企业制造的医学影像设备。


原始器械制造商(OEMs)提供的服务,受到美国食品和药物管理局(FDA)监管。但对于非OEMs(例如第三方制造商)所提供的服务,则不受FDA的监管,以及不会遵循质量一致性、安全性和法规的监管要求。此外,目前这些第三方服务机构甚至不需要在FDA登记注册,这会在医疗器械这个重要的监管领域产生巨大的盲区,最终将迫使这些第三方服务商进行整改。


飞利浦医疗保健系统解决方案副总裁,及医学影像与技术联盟(MITA)董事会主席Joe Robinson向能源和商业卫生小组委员会作证时表示,对所有医疗器械服务商都应该有适当的监督,并遵循质量的一致性,安全性和监管要求。这就是上周医学影像行业强烈支撑由Ryan Costello和Scott Peters先容的H.R. 2118“通过负责任的医疗器械维修确保患者安全”的原因。两党法案在完善医学影像器械服务监管的一致性方面,迈出重要的一步,要求所有第三方医疗器械制造商必须在FDA上登记注册、提交不良事件报告,并通过投诉处理系统保障医疗器械的安全性。


患者希翼医学影像设备以安全有效的方式运作。无论哪一方对医疗器械进行维护,患者都希翼医疗器械受到同样的监督管理。事实上,MITA最近发表的一项民意调查显示,90%的美国人认为,无论是哪一方生产医疗器械,所有的医疗器械都应该受到法规的监管。同时74%的美国人认为,第三方服务商应该像OEMs一样,受到FDA的严格监管。


许多第三方服务商,以及他们生产的设备已经正在以安全有效的方式运作。但与OEMs遵循质量的一致性,安全性和监管要求不同,第三方服务商则强迫病人相信还需要维修的医疗器械。。这是病患不应该尝试承担的风险。


Costello和Peters的法案是一种合理和常规的解决方案,将为依赖医疗器械技术的安全性,有效性和可靠性的患者提供保护,并且不会对第三方服务机构或其他任何人造成昂贵或负担。


Joe Robinson还表示,正敦促国会迅速通过这一两党立法。作为医学影像设备制造商的代表,Joe Robinson期待与国会,FDA和其他利益相关者合作共同制定政策,通过安全有效的医疗器械维修来保护患者。



英语原文  


Protecting patients with consistent service for medical devices

If a medical imaging device malfunctions due to improper servicing, a diagnosis could be missed, care could be delayed, or the patient could be severely injured or even killed. If an X-Ray is fuzzy due to poor calibration, a fracture could be missed. If a CT scanner is out of operation, a car accident victim might have to wait hours to get scanned. If an MRI machine has the wrong parts, it could explode or suffocate the patient. If any electrical device is improperly sealed, the patient or healthcare provider could get a severe electric shock.


It is exactly these kinds of problems we want to avoid.


In addition to being responsible for innovating, designing, manufacturing, packaging, labeling, assembling and upgrading medical devices, imaging manufactures also often provide servicing activities for installed devices – both their own and those originally manufactured by other companies.


Service provided by original equipment manufacturers (OEMs) is regulated by the U.S. Food and Drug Administration (FDA). But service activities performed by non-OEM entities (i.e., third parties) do not have the same oversight and are not held to the same quality, safety, and regulatory requirements. Further, these third-party servicers are currently not even required to register with the FDA, creating an enormous blind spot in this very important industry, which leads to some of the rigged-up repairs OEMs have finally been called upon to rectify. 


As I testified to the Energy and Commerce Health Subcommittee, all entities that service a medical device should have appropriate oversight and be held to consistent quality, safety, and regulatory requirements. That’s why the medical imaging industry strongly supports H.R. 2118, “Ensuring Patient Safety through Accountable Medical Device Servicing,” introduced by Reps. Ryan Costello (R-Pa.) and Scott Peters (D-Calif.) last week.  The bipartisan bill takes an important step toward ensuring consistency in regulation for the proper servicing of medical devices by requiring third-party servicers to step out of the dark and register with the FDA, submit adverse event reports, and hold themselves accountable by maintaining a complaint handling system.


Patients expect that medical imaging devices operate in a safe and effective manner. They also expect that medical devices are covered by the same regulations – no matter who services the device. In fact, in a recent public opinion survey published by the Medical Imaging & Technology Alliance, 90 percent of Americans agree that all medical devices should be covered by regulations, regardless of who performs the service, and 74 percent of Americans think that, like OEMs, third-party servicers should be strictly regulated under FDA requirements.


Many third-party servicers do operate safely and effectively, as do the devices they service. But by not operating under the same quality, safety, and regulatory requirements as OEMs, third-party servicers are forcing patients to take a leap of faith about the upkeep of the device. That’s a risk patients shouldn’t have to take.


Costello and Peters’ bill is a reasonable and common-sense solution that will protect patients who rely on the safety, effectiveness and reliability of our technologies and will not be costly or burdensome to third-party servicers or anyone else.


I urge Congress to move quickly to pass this bipartisan legislation. On behalf of imaging device manufacturers, our industry looks forward to working with the Congress, the FDA, and other stakeholders to develop policies that protect patients through safe and effective medical device servicing.




内容来自: THE HILL

整理翻译:奥咨达


奥咨达翻译服务

奥咨达翻译团队根植于中国,面向全球,专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等,译稿已涵盖医疗器械领域的所有类型。


奥咨达翻译组联系方式:

邮箱:trans@osmundacn.com




(编辑:佚名 来源:本站原创)
分享按钮:
上一篇:中国原创新一代介入心脏瓣膜获准上市
下一篇:美国力求规模化生产3D打印器官

常用查询

    评审进度查询       |         医疗器械标准目录库       |         临床试验机构目录库       |         检测中心承检目录库

    医疗器械分类目录      |       医疗器械检测中心受检目录      |      国产必赢亚娱乐官网查询      |       进口必赢亚娱乐官网查询

更多>>

专家解读

奥咨达服务项目流程

临床试验
体外诊断试剂
进口注册
中国注册
质量管理体系
医械咨询
欧盟CE认证
美国FDA注册
海外注册
  • 经验丰富

    3000+医械客户,标准服务

  • 安全保障

    签订业务合同,资料专人管理

  • 合作无忧

    200+专业顾问,保质完成服务

  • 信誉卓著

    高新技术企业,信誉保障

  • 必赢亚娱乐官网|必赢亚娱乐官网

    XML 地图 | Sitemap 地图