9月20日,FDA正式出台了举世瞩目的医疗器械监管规则,要求相关产品须标注唯一识别码(UDI)。UDI规则实施后,器械产品将更容易被跟踪、监控,及加快召回。

UDI系统具有提高医疗器械不良事件报告的信息质量潜力,这将有助于FDA更快捷的找出产品问题、更好的定向回应以及提高病人的安全。FDA与医疗行业、临床社区、病人和大众消费群体都有紧密的合作。

医学、法学博士Jeffrey Shuren(FDA器械和辐射健康中心主任)表示:“UDI是提高病人安全的标志,让我们的医疗设备监控系统更加现代化,同时更促进了医疗设备的创新步伐”。

UDI系统包括两个核心部分。第一部分是器械的唯一识别编号,由GHTF(全球协调组)进行全球唯一赋码。这些编号包括了批号、型号、生产日期、有效期等信息,以号码、可扫描的条形码及英文文本的形式出现,由器械制造商管理。第二部分是可公开查询的数据库,里面可检索除病人信息外的其他数据,由FDA管理。

一旦该新规则全面实施,市场上流通的产品将可被快速、高效地识别。这意味着两个方面:

1.患者的电子病历上将显示使用了哪一个设备。这将提高不良反应事件的报告质量,加快产品召回,保障病人安全。这也有助于医疗保险的结算。

2.器械产品的分销网络将纳入数据库。出现问题后,库存产品亦可迅速召回。另一方面,也可防止假冒伪劣产品流入市场。FDA表示,分销网络的数据将是全球性的。

2007版的《联邦食品药品化妆品法》修正案当中,已明确将UDI纳入监管日程。因会导致部分厂家的合规成本惊人,政商两方展开了多年的拉锯,于2012年7月份发布了120天征求意见稿,而后继续推迟。

FDA在最终版规则中作出了一定的让步。大多数高风险植入设备将首先开展UDI监管,如心脏起搏器和除颤器。低风险的产品将免除部分或全部UDI,如绷带等大包装产品将共同使用一个UDI编码。(详细规则请点击https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system)

UDI实施后,医疗器械监管将进入信息化、溯源化的新时代。国家药监局CFDA将于2015年全面实施的药品电子监管,与UDI规则有异曲同工之处。不同之处在于一个是药品,一个是更为复杂的医疗器械,且UDI系统可公开查询。

英文信息:

Today, the U.S. Food and Drug Administration announced a final rule2 for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
  The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule. 
  “UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
  The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
  The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.
  The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
  Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.  
  “A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Shuren.
  The FDA issued the proposed rule3 requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.
  The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System4 proposed in September 2012.
  In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act. 

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FDA旷世瞩目医疗器械监管规则发布 将给行业产生巨大影响

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