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【medical-news】FDA试图寻找减少医疗差错的途径

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FDA investigates use of identifier system for medical devices

The Food and Drug Administration (FDA) is seeking information on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting.
A notice will appear in Friday's Federal Register (www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm). The agency is seeking public comment for the next 90 days. A public meeting is planned in the fall; FDA will provide details when they become available. The comments will be used to help the agency determine what next steps the agency should take related to a unique device identifier (UDI) system for medical devices.

"Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency."

The number and complexity of medical devices is growing. It is important for FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.

Over the past year, FDA met with various stakeholders and found that most supported the development of a UDI system as a way to improve patient safety. FDA also learned from the meetings that stakeholders recognize that such a system could provide supportive benefits, such as better management of the purchase, distribution and use of medical devices.

FDA also commissioned two reports from outside experts on automatic and unique identification of medical devices. The reports identified several potential benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions. In addition, FDA has been working with the Agency for Healthcare Research and Quality (AHRQ) in the U.S. Department of Health and Human Services (HHS) and with other federal partners to better understand the issues with the development, implementation and use of a UDI system.

"It is essential that we monitor the performance of medical products after they are approved and make sure that we quickly discover any potential problems that might arise," said Andrew C. von Eschenbach, M.D., Acting Commissioner, FDA. "To improve our postmarket data collection at FDA, we are using a total product lifecycle approach to how we look at medical devices and focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved."

During the comment period, FDA wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. A list of questions as well as what a UDI could look like, are included in the Federal Register notice.

http://www.fda.gov

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2006-08-16 23:22 浏览 : 666 回复 : 2

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2006-08-17 15:09

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FDA研究医疗设备鉴别系统的使用

食品药品管理局（FDA）正在寻找关于如何使特别医疗设备鉴别系统减少医疗事故，方便设备召回以及改善医疗设备的不良事件报告。一项公告将会报道在星期五的联邦登记簿上（www.accessdata.fda.gov/scripts/oc/ ohrms /advdisplay.cfm）。代理处会在未来90天内寻求意见。公开会议计划在秋天召开；FDA将会在可能的时机提供其细节内容。意见将会被用于帮助代理处决定对于医疗设备的特别设备鉴别系统（UDI）下一步的安排。

“类似于用于药物和生物产品的条形码，UDI会有很多潜在的优点使对病人的治疗效果有所改善。”FDA设备和放射健康中心主任 Daniel Schultz, M.D.说。“特别医疗鉴别系统能够在减少医疗事故、方便设备召回、改善医疗设备不良事件报告及在改善传递和供应链效率中鼓励花费的有效性方面有广泛的应用。”

医疗设备的数量和复杂性在增加。快速鉴别工业上新的危机以及与工业和设备使用者合作来适当处理这些危机对于FDA是很重要的。一套UDI系统可以被用于鉴别设备和其生命周期中相关的信息。例如，一套UDI系统可以鉴别设备的兼容性，如安全的用于磁力共振成像系统（MRI）的输入设备。

过去几年中，FDA遇到很多风险投资者，发现大多数都支持发展UDI系统作为改善病人安全的一种途径。FDA也从会议中了解到风险投资者认识到了这样的系统能够提供好处，如更好的管理购买、分配和医疗设备的使用。

FDA也委托了来自自动化和特别鉴别医疗系统外部专家的两份报告。报告确定了UDI系统的几个潜在的好处，包括鉴别设备或者潜在过敏反应的不相容性。另外，FDA已经与美国健康研究品质代理处、健康和人类服务处和其他联邦部门一同工作来更好的理解UDI系统的发展、执行和使用问题。

“我们有必要在保证能够快速发现可能出现的潜在问题后得心应手的操纵医疗产品，” FDA行动委员Andrew C. von Eschenbach, M.D.说，“为了加强我们在FDA的数据收集，我们正使用一个整体产品生命周期法用于如何看待医疗设备以及更多的关注我们需要的系统种类和进程来操纵许可后的产品。”

在提评论期间，FDA想了解发展和应用UDI系统对于医疗设备的可行性、有效性及花费。另外，代理处想学习各种自动鉴别技术，如条码和放射频，以用于UDI系统。一系列问题以及UDI可能的外观问题也包括在联邦登记簿公告中。

2006-08-18 13:55

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