这唯一的设备标识（UDI）程序是由美国食品药品监督管理局（FDA）在2013 as a central, globally harmonized tracking system for medical devices. A primary data repository called the全局唯一设备标识数据库（GUDID）是存储与程序有关的所有信息。数据库本身只能由政府雇员和授权官员访问和更新AccessGUDIDis available for public access to individual records.
这篇文章将探讨该计划给该计划带来的4个主要好处医疗保健行业。每个UDI代码都包含一个设备标识符和其他生产标识符，使得在整个生命周期内都可以轻松跟踪任何单个设备的历史记录。这UDI program is tightly controlled by 3 agenciesthat have aligned their standards and practices with the FDA recommendations. These agencies areGS1， 这国际血液银行自动化委员会（ICCBBA），和卫生行业商业传播委员会（HIBCC）。这success of the UDI program relies on close coordination between these governing bodies and the many manufacturers, distributors, and healthcare professionals that use medical devices.
1. Supply Chain Security
One of the main benefits of the UDI system is a more保护医疗设备的全球供应链。鉴于这些设备的高度专业化，要了解不同供应商模型之间性能和功能的差异是一个主要挑战。中央数据库允许对类似技术进行分类，在全球健康危机或特定医疗设备短缺的情况下，这可能是主要资源。
Additional supply chain benefits of the UDI system include improved inventory accuracy and reduced counterfeit devices found in the market. The high degree of supply chain traceability also streamlines the approval process for new devices, providing the FDA a faster route for authorizing use for novel applications that can have a benefit for patients.
2. Post-Market Safety
医疗的devices are prone to production errors and other issues that could impact their use. As a result, product recalls are a natural part of the medical device lifecycle and are often coordinated under the direction of the FDA. The UDI system gives the FDA a complete picture of thenumber of medical devices in existence和他们所在的地方。这可以大大reduce the amount of time needed to prepare and launch notifications in the event of a recall or safety advisory. In addition to adverse event reporting, the UDI system also supports safety investigations and the ability for manufacturers and agencies to prepare responses in the event of audits or other regulatory needs.
3. Informed Patient Treatment
UDI带来实时医疗设备信息directly to healthcare providers, allowing them to ensure quality care with each patient visit. This can help reduce medical errors or the improper use of devices by giving immediate access to the latest documentation and product safety information. UDI information may also be helpful for individual patients who have an implanted device, such as a stint. These patients could carry UDI information with them and share it with medical professionals at any time in the event of a medical issue or office visit. With the improvements being made in healthcare data sharing and security, there will be excellent opportunities in the future for further empowering healthcare professionals and patients.
4.质量控制
对于管理医疗产品和服务的公司而言，质量控制（QC）是极其重要的功能。bob电竞网址UDI系统通过定义UDI标记本身的详细规范来帮助保护医疗设备可追溯性。某些设备经常进行消毒或洗涤，必须获得直接标记而不是标签。其他设备可以使用合适的材料和设计标签，包括兼容GS-128或GS1数据矩阵代码and properly formatted identifying text.
Metalphoto®光敏阳极氧铝由于其出色的耐用性，是UDI标记的理想基板。阳极氧化铝提供的非孔表面不会含有细菌，真菌或霉菌。MetalPhoto光敏阳极氧铝，符合2007年的FDA修正案，以建立独特的设备识别（UDI）系统以及其他标准和规格，通过产生无机的地下图像，即使经过数千个灭菌周期后，也可以抵抗褪色和腐蚀，从而进一步迈出一步。
这些markings help streamline the quality control monitoring process并使更换零件和订购单个项目变得更容易。在某些应用中，这些标记还用于促进程序内的仪器跟踪，从而为操作员提供了每个设备的性能的实时视图。
UDI系统仍然是FDA，医疗设备制造商和全球医疗保健提供商的关键资源。由于这种复杂的标准化和创建一个简单而健壮的系统，也已经实现了许多好处。医疗设备识别将仍然是医疗保健行业的重要因素，以保持准确可靠的数据收集。遵守这些要求为医疗设备供应商提供了跟踪设备并随着时间的推移响应产品请求的绝佳方法。
