The medical device industry, along with the pharmaceuticals, is one of the most important and key to the healthcare sector. As in every field, some threats such as fraud and lack of follow-up endanger the medical device industry. Of course, the necessary institutions have taken action for such an important issue for ensuring public health and preventing the economic loss caused by the lack of storage and recording system. As many of you will remember, Unique Device Identification (UDI) is the most popular traceability solution action taken by the FDA for the security of medical devices.
In 2013, The FDA established a unique device identification (UDI) system which is aimed to provide single, globally harmonized identification of medical devices through distribution and use. The label of devices to bear a globally unique device identifier is in both Automatic Identification and Data Capture (AIDC) and, if applicable, Human Readable Interpretation (HRI) form.
According to the guidance document on UDI developed by the International Medical Device Regulators Forum (IMDRF) in 2013, there are mainly three requirements of UDI:
- UDIs should be based on global standards,
- UDIs should be applied to the label and associated packaging of a medical device,
- Medical device-related information should be submitted to a UDI database for data sharing between regulators and other health stakeholders. Device labelers are required to submit information to the FDA-administered Global Unique Device Identification Database (GUDID).
UDIs consists of two following:
Device Identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device. PI includes device manufacturing units such as serial number, batch/batch number, manufacture, and/or expiry date. DI can be used alone to serve as an identifier for the product. The PI is a dynamic number that will change whenever a new lot or lot of the device is made.
GUDID includes a standard set of basic identifying elements for each device with a UDI and contains ONLY the device identifier (DI), which serves as the key to obtaining device information in the database. GUDID does not include the production identifier (PI).
Advantages of Using UDI System
- Allows more accurate reporting, review, and analysis of adverse events so device-related security issues can be identified and fixed more quickly
- Reduces medical errors by enabling healthcare professionals to quickly and precisely identify a device
- Supports the data collection by providing a standardized way to document device use in electronic health records, clinical information systems, claims data sources, and registries
- Allows patients to monitor their own devices
- Allows manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls due to the use of a standard identifier
- Helps to detect counterfeiting and diversion of medical devices
- Supports avoiding the informal economy
- Provides an environment to comply with national and international regulations
- Allows being able to make recalls for withdrawal from the market or repair, control, adjustment operations.
Traceability in All Medical Devices
The medical device industry has a wide variety of products such as pacemakers, stents, sutures, defibrillators, syringes. Considering human health, legal requirements and brand reliability, VISIOTT develops its solutions regardless of the variety of medical devices. It enables you to carry out your operations smoothly with hardware and software solutions produced under a single roof. Don’t forget to contact us for more detailed information!