FDA建议使用医疗设备追踪系统

根据7月3日美国食品药品管理局(FDA)发布的一项声明，在美国销售的大部分医疗设备均应包含一个识别标签，以便于识别和解决与之相关的问题。

独特的设备标识(UDI)是一个唯一的数字或数字+文字编码，“可提高医疗设备不良事件报告的信息质量，有助于FDA更快地识别产品问题，更好地进行目标产品召回和保证患者安全”。

普通设备标识(UDI)的示例类似医疗设备标签。这个标签中包含产品名称、有限期限、参照和批号、生产商信息、条形码、设备详述和设备图示等信息。

根据FDA的建议，标签中将包含设备图示、产品名称、有效期限、参照和批号、生产商信息以及条形码等信息。

声明中说，2007年美国国会通过的法案中要求建立UDI系统，指导机构拟定明确这一系统的法规，机构与企业、临床团体以及患者和消费者团体密切合作，已进行了4项关于拟定建议规则的初步研究。

规则的实施将分步进行，首先对风险最高的医疗设备进行标识。低风险设备将被免除部分或全部要求，对于非处方设备将完全免除要求，因为这些设备通常有通用的产品编码。

除提高设备相关不良事件报告的准确性外，预期这一系统还可加速设备相关问题的解决。该系统还将涉及仿冒产品和医疗应急准备。

爱思唯尔  版权所有

By: ELIZABETH MECHCATIE, Cardiology News Digital Network

Most medical devices distributed in the United States should carry an identification label to help identify and resolve problems associated with them, according to a statement issued the Food and Drug Administration on July 3.

The unique device identifier (UDI), an exclusive numeric or alphanumeric code, "has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety," according to the statement.

Example of what a universal device identifier (UDI) would look like on a medical device label. The label contains information about the product name, its expiration date, reference and lot numbers, manufacturer information, bar code, details about the item, and an illustration of the item.
 
In the proposed rule, the label will include an illustration of the device, the product name, its expiration date, reference and lot numbers, manufacturer information, as well as a bar code.

The UDI system is required by legislation passed by Congress in 2007 directing the agency to develop regulations establishing such a system, and the agency worked closely with industry, clinical groups, as well as patient and consumer groups, and has conducted four pilot studies in developing the proposed rule, according to the statement.

Implementation will be phased in, with the highest-risk medical devices labeled first. Low-risk devices will be exempt from some or all of the requirements and over-the-counter devices will be exempt, since they usually have a universal product code.

In addition to improving the accuracy of device-related adverse event reporting, the system is expected to expedite the resolution of device-related problems. The system also will address counterfeit products and medical emergency preparation.