Patient Safety—Identification and Interoperability
The healthcare industry is working to improve patient safety and fight skyrocketing costs. All the while, organizations are addressing major legislation aimed at illuminating chain of custody of medical device and pharmaceutical supply chains, from point of manufacturer through the supply chain through to the patient.
The U.S. FDA UDI Rule establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device. UDIs will be presented on device labels in both a human-readable format and a machine-readable format (e.g., a barcode). Re-usable devices that need to be “reprocessed” before reuse will also be directly marked with a UDI. In addition, device labelers will submit device information to a U.S. FDA database called the Global Unique Device Identification Database (GUDID).*
*For information about the rule, see the U.S. FDA Unique Device Identification System
Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.
GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.
View the GS1 Standards Resources for U.S. FDA UDI Implementation Support webpage >
The Drug Supply Chain Security Act (DSCSA)** aims to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. It can be viewed as a three-phase implementation over 10 years. Phase 1 involves supply chain participants sharing lot-level, chain-of-ownership data starting in 2015. Phase 2 involves item-level identification and marking starting in 2017. And Phase 3 involves the electronic exchange of chain-of-ownership data to support serialized item traceability back to the product origin starting in 2023.
** For information about the act, see the 2013 Drug Supply Chain Security Act
View the Assessing Current Implication of DSCSA Serialization Requirements White Paper web page>
Working collaboratively as members of the GS1 Healthcare US® Initiative, leading healthcare organizations are driving the use of open, global standards to deliver the highest levels of patient care and safety while lowering costs, increasing efficiencies, and adapting to new legislation, reform, and regulations.
View our case study web pages: Mercy > and CentraState >