CAMBRIDGE, Mass. — A conference to prepare the healthcare industry for the Food and Drug Administration’s (FDA) unique device identifier (UDI) regulation is scheduled for Nov. 30-Dec. 1, 2011 at the Hyatt Regency in Cambridge, Mass.
The UDI rule will require many organizations to implement new or improved systems and processes to efficiently mark or tag equipment, scan device information at various points in its lifecycle, and transmit that data to the UDI database and other software systems.
The FDA intends to issue a proposed rule on the UDI system by the end of 2011, with the final rule slated for release in 2012. The system will provide for early detection of defective devices and facilitate device recalls to ultimately enhance patient safety and reduce medical errors.
The Clarion Group Inc. produces and manages The 2011 UDI Conference, which aims to help medical device manufacturers, distributors and hospitals prepare for implementing the FDA’s UDI system. The FDA plans for its UDI system to transform disparate medical identification methods into a single device identification system that is consistent, unambiguous, standardized, and globally harmonized.
Led by the FDA and industry experts, the UDI conference will update attendees on the current status of the UDI rule. Additionally, participants will receive information to understand the fundamentals of an automated identification system, create their own plans, and guide their organizations through the rule. Professionals that may benefit from attending include medical device manufacturers, health care distributors, group purchasing organizations, health care industry professionals, and hospitals and health care providers.
The FDA Amendments Act (Section 226) of 2007 directed the FDA to issue regulations establishing a UDI system for medical devices to provide early detection of defective devices and facilitate device recalls to enhance patient safety and reduce medical errors. The law states: The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.
Jay Crowley, FDA’s senior advisor for patient safety, center for devices and radiological health, presents the conference’s opening keynote address: Industry Momentum & Progress. He will discuss what progress and activities have taken place in the last year that continue to move the UDI initiative forward, and the many activities and workgroups that are evolving UDI in the United States as well as gaining global traction. Crowley will speak to the vision of what is coming and how companies can embrace UDI practices to ensure day-to-day value and ultimate outcomes and gains.
Representatives from the FDA, industry associations and the medical device industry will lead seminars on topics including Following UDI Transactions: An Overview of the Technology Behind UDI; Exploring UDI Connections Between Manufacturers and Hospitals in Recall Processing; Practical Clinical Use Cases for UDI; UDI Step-by-Step: Implementation Best Practices for Medical Device Manufacturers; The UDI Database: How Manufacturers Need to Develop & Maintain Master Data; Transforming UDI Data into Knowledge; Achieving Perfect Order: Shifting the Healthcare Supply Chain Paradigm; The Use of UDI in Clinical Information Systems; and UDI Challenges.
The event also includes a networking reception and an exhibit hall with vendors such as CodeSource Inc., GHX, Loftware Inc., Microscan, Miyachi Unitek Corp., Seagull Scientific and Technifor Inc