The traceability management and supervision of medical devices, especially high-risk medical devices, is a global challenge. In order to eliminate hidden dangers, from the perspective of patient safety, it becomes necessary to track and trace medical devices with globally standardized medical device naming and unique marking. The definition of Unique Device Identification (UDI) for medical devices is a code that is numeric or alphanumeric according to an international or equivalent converted national item code standard system. This code is composed in accordance with the requirements of medical device traceability, within the global scope, is a unique identification of a specific medical device, used to identify post-market medical device products that need to be traced, and can be used as a key to enter the relevant database, access to the specific medical device information associated with it.UDI is currently coordinated by various countries around the world as a solution to the effective traceability of specific post-market medical devices and to protect the interests of patients. Effective way. In order to actively promote UDI, GHTF established a special working group on UDI (AdHoc Working Group UDI, AHWG) in May 2008 and issued a related coordination guidance document.
In July 2012, the FDA proposed to adopt a UDI system for most medical devices in the U.S. The FDA believes that the safety of medical devices is its highest priority, and that a UDI system would improve the efficiency of adverse event reporting for medical devices by enabling the FDA to more quickly identify problems with a product and more effectively address medical device recalls to protect patient safety. The FDA has already conducted a number of advance studies on the proposal and is working closely with industry, clinical organizations, patients and consumer groups to ensure its successful adoption.
In FDA's proposal, a UDI should include:
* A device identifier, which is a numeric or alphabetic code unique to a particular device module;
* A product identifier, which, for a particular device, includes current product information.
The UDI contains basic identifying information about the device, such as the manufacturer's name, the category of the device, and may also provide other specific information such as expiration date and lot number. The information will be maintained in a publicly accessible UDI database, but the database does not include identifiable patient information.
The FDA proposes that the UDI system should be based on risk management and progressive in its implementation steps, gradually expanding from high-risk to low-risk medical devices. At the same time, the FDA also proposes exemptions for retail over-the-counter devices, which typically have UPC (Uniform Product Code) codes. To reduce costs to industry and implement the system quickly and efficiently, the UDI would build on existing standards as well as systems already in use by some companies.
The FDA believes that the UDI system will provide a number of benefits, including:
* Accurate reporting, evaluation, and analysis of adverse event reports, so that problematic devices can be identified and corrected more quickly;
* Reduced incidence of medical errors by enabling health care professionals to more quickly and accurately identify devices and obtain important information about device characteristics;
* Reduced incidence of medical errors by enabling health care professionals to more quickly and accurately identify devices and obtain important information about device characteristics. )
* Provides a uniform pathway for information entry into electronic medical health records and clinical information systems for devices.
* Provides a standardized identifier for manufacturers, distributors and healthcare professionals to more effectively manage medical device recalls;
* Provides the foundation for a secure global distribution chain for medical devices.