By 2020, virtually all medical devices on the U.S. market will be required to carry a unique device identifier (UDI) label as part of the FDA's unique device identification rule. A UDI is a distinct two-part numeric or alphanumeric bar code that includes a device identifier (DI), which is specific to the device model, and a production identifier (PI), which includes the production information for the specific device (lot/batch number, serial number and/or expiration date). The purpose of the system is to improve patient safety, discourage counterfeiting, and strengthen postmarket surveillance efforts like adverse event reporting. An enterprise quality management system (EQMS) can help you more easily manage the data, process and system changes UDI requires.
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Congress directed the FDA to develop a global unique device identification system as part of the FDA Amendments Act of 2007. The UDI final rule was released in 2013. It mandates that labels and packaging of Class I, II and III medical devices include a unique device identifier in both human- and machine-readable formats. (Exceptions and special conditions are outlined on the FDA website.) Device manufacturers are also required to load the data on each device into the FDA's publicly accessible Global Unique Database (GUDID). Manufacturers that do not adhere to this regulation are subject to strict regulatory sanctions.
The FDA's proposed rollout of unique device identifiers is based on the risk. Class I includes devices with the lowest risk. Therefore, manufacturers of Class I devices will have more time to implement a UDI system. Compliance dates are listed on the FDA website. While the FDA is the first regulatory body to require a global unique device identification system, other countries are expected to follow. The European Commission, for example, has recommended that a UDI framework be implemented for devices sold in the European Union (EU).
Because the Unique Device Identification rule impacts every facet of a manufacturers quality processes (documentation, training, adverse event reporting) and operations (R&D, quality assurance, packaging), device makers should avoid implementing UDI in a silo, independent of existing business systems and workflows. This will only add cost and complexity to an already complicated endeavor.
Conversely, managing UDI within the quality system, with the help of an EQMS, allows manufacturers to avoid the piecemeal approach to compliance that standalone solutions create. Other ways in which an EQMS helps facilitate compliance are:
An EQMS can jumpstart your unique device identification system implementation efforts; however, not all enterprise systems are created equal. Few provide all of the tools and advanced features (e.g., document control, electronic signatures, tracking and trending analytics and adverse event reporting) necessary to manage your device from the point of manufacture, through the point of use, and beyond. MasterControl's EQMS connects all quality and other processes throughout the product's lifecycle under one scalable platform. Other attributes that set our company and solutions apart are:
To learn more about how MasterControl can help you address your UDI needs contact a MasterControl representative.