For quality assurance and safety, the Medical Device Industry has established a standard issued by the Food and Drug Administration (FDA) of the United States that requires all items to be marked with a Unique Device Identifier, or UDI. This new identification standard affects Class I, II and III medical devices in addition to combination products licensed through the Public Health Services Act (PHS). Each required marking includes sensitive information that aids in the tracking and maintenance of medical devices as well as coding and verification in production processes.

Barcode markings include an item’s origins, expiration data and past locations among other data. Additionally, barcodes ensure that items are tamper-proof, original and efficiently identified/verified with proper markings.

The Medical Device Industry upholds strict safety requirements, thus it is an industry that requires stringent rules to ensure each item meets current standards. The latest standard from the FDA requires suppliers to implement new processes that include easily verifiable coding; fortunately, those within this industry can upgrade existing equipment and technologies with approved software and hardware available from ID Integration.

Suppliers are poised to become more efficient with ID Integration’s UDI coding solutions that can be integrated into existing processes. A unique device identifier can be produced and verified using the following software and equipment available from ID Integration:

2D data matrix label software
2D data matrix label hardware
Hand-held 2D data matrix scanners
Fixed station 2D data matrix verification systems

ID Integration can provide more information for suppliers of the Medical Device Industry and recommendations for changes to current processes to comply with current standards enforced by the FDA.