Are You Ready for Unique Device Identification System (UID)?

Guest Post by:
Nicholas R. Lukianov, AVNET

September of 2007 the FDA Amendments act of 2007 was signed in to law. This legislation specified the establishment of a Unique Device Identification System, known as a ‘UID’. This system will require each device and sub-component to be labeled with a unique identifier capable of tracking the item throughout the supply chain and distribution channel by lot and serial number. Discussion is underway throughout the medical OEM community as to what will the actual implementation of an industry wide and enterprise level UID system look like. The FDA along with key healthcare industry partners and consortiums are analyzing how the implementation of such a system will address security and efficiency issues in the healthcare supply chain; to minimize medication errors, eliminate counterfeiting and effectively manage product recalls. The effort is focused on the development and adoption of an open global standard. February of 2009 a public workshop sponsored by the FDA addressed UID specifics; standards, placement and technology, database structure, implementation and adoption.

For many involved in the medical device product life cycle process from concept through end of life, it is critical to remain cognizant of the developments associated with the implementation of an industry wide UID standard. Numerous critical issues come to mind. What type of UID technology will be mandated? Will it be Class 1, Class 2, Class 3 specific? What will be the ability to withstand a variety of sterilization methodologies? What will be the compliance and certification requirements? Will devices, disposables, and pharmaceuticals share similar technology footprints or will specific product families require certain technologies albeit with a UID common denominator? How receptive will the supply chain be to the adoption of a UID system and the obvious cost issues involved? What will the end user requirements be, for example a local hospital or clinic. What are the enterprise level, domestic and global integration issues? Then there is the issue of reimbursement; who’s going to pay for it. And last but by no means least, what are the privacy issues?

Optimistically these are all daunting issues that will be resolved in the establishment of a mandate that will define an operational, efficient, and cost effective system. A similar program has been implemented by the DOD and has proved an effective deployment and usage model for the FDA in the development of a UID system for the medical device community.

Key technologies being considered for the implementation of the FDA mandated UID system are Bar codes, RFID, OCR and DPM (Direct Part Mark). RFID has a particularly unique capability in the fact that it is considered to be ‘intelligent’ based on it’s one-time and multiple programmability capability. A UID is already embedded during the manufacturing process in the RFID IC along with a number of security and data management features available that address cloning, multiple use, shelf life, patient / device data information and pre-loaded device parameters. Numerous applications and systems have benefited from the integration of a robust closed loop embedded and enterprise level systems based on the ISO15693 ‘vicinity read ’ 13.56MHz standard utilizing readily available passive RFID smart tag technology. Specific device manufacturing methodologies exist that withstand a variety of sterilization techniques. Packaging technology exists to facilitate post production / sterilization programming requirements. Custom inlays to fit specific form factors along with extensive adhesive and label conversion services accommodate a variety of solutions to provide a true ‘smart tag’ RFID solution. Avnet continues to work closely with our suppliers and value added service providers to assist the medical OEM with their unique RFID based medical device requirements throughout all the phases of the product lifecycle including the design, development, prototyping and production manufacturing.