Traceability management and supervision of medical devices, especially high-risk medical devices, is a global issue. In order to eliminate hidden dangers and consider the safety of patients, it is necessary to track and trace medical devices with global unified medical device naming and unique identification. The definition of unique equipment identification (UDI) of medical devices refers to the code expressed by numbers or alphanumeric characters according to the international or equivalent national article coding standard system. The code is constructed according to the requirements of traceability of medical devices, and it is the unique identification of specific medical devices in the world. It is used to identify the medical device products that need to be traced after listing, and can be used as the key to enter the relevant database to obtain relevant specific medical device information. UDI is an effective way to solve the problem of effective traceability of specific medical devices after listing and protect the interests of patients through the coordination of countries around the world. In order to actively promote UDI, in May 2008, GHTF established the UDI(AHWG) Ad Hoc Working Group and issued relevant coordination guidance documents.

On July 20 12, FDA proposed that most medical devices in the United States adopt UDI system. FDA considers the safety of medical devices as its primary task. UDI system can improve the reporting efficiency of medical device adverse events, enable FDA to find product problems more quickly and solve medical device recall problems more pertinently, thus protecting the safety of patients. At present, the FDA has conducted some preliminary studies on this proposal, and is working closely with the industry, clinical institutions, patients and consumer groups to ensure that the proposal can be passed smoothly.

In the FDA proposal, UDI should include:

* the identification code of the instrument, which is the unique numeric or alphabetic code of a specific instrument module;

* product identification code, including the current product information of the instrument.

UDI contains basic identification information of equipment, such as manufacturer's name and equipment category, and may also provide other specific information, such as expiration date and batch number. This information will be stored in the UDI database for public access, but the database does not include identifiable patient information.

FDA proposed that UDI system should be based on risk management, and the implementation steps should be gradually progressive, and the scope should be gradually expanded from high-risk medical devices to low-risk medical devices. At the same time, FDA also proposed to exempt retail OTC devices, which usually have UPC (Uniform Product Code) codes. In order to reduce the industry cost and implement the system quickly and effectively, UDI will be based on the existing standards and systems already used by some companies.

The FDA believes that the UDI system will bring many benefits, including:

* Report, evaluate and analyze adverse event reports more accurately, so as to identify and correct the problem equipment more quickly;

* Reduce the occurrence of medical accidents by enabling health care professionals to identify equipment more quickly and accurately and obtain important information about equipment characteristics;

* Provide a unified information input method for the clinical information system of electronic medical health records and equipment.

* Provide standardized identification codes to facilitate manufacturers, distributors and medical staff to manage medical device recalls more effectively;

* It provides the basis for the global safe sales chain of medical devices.