Tips for Implementing FDA UDI without Derailing Production

Tips for Implementing FDA UDI without Derailing Production

Experts from the FDA and GS1 Share Advice on Improving Patient Safety with Unique Device Identification without Throwing Your Organization Off Track

For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. Currently there is no single global regulation for uniquely identifying medical devices in the supply chain. This means recalling devices is less efficient and more complex than it could and should be, negatively impacting patient safety and confidence. The FDA’s directive for UDI (Unique Device Identification) for medical devices offers a way of presenting information in a standard format or barcode, making trade, distribution and usage more secure. Compliance, however, can prove to be a time-consuming process, and if done incorrectly, can expose your company to serious setbacks. Aligning yourself with the FDA UDI regulations will impact many areas within your organization and will involve possible changes to current products and procedures.

In this 60-minute, information-packed session, PRISYM ID brings together industry experts Jay Crowley, FDA, and Siobhan O’Bara, GS1 US Office, to give you an in-depth look into what to consider when implementing your UDI strategy.

Benefits of Viewing:

  • Gain an understanding of UDI in practical terms  
  • Walk through the planned timeline for proposed FDA UDI regulations
  • Evaluate the benefits of implementing bar-coding using GS1 standards
  • Understand how labeling systems can remove the perceived complexities of FDA UDI regulations  
  • Learn how to implement UDI with minimal impact on your organization

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Jay Crowley, FDA

Jay Crowley is a Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held a variety of positions over his 20 years at the FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.

Siobhan O’Bara, GS1 Healthcare

Siobhan O’Bara is the VP, Healthcare at GS1 US. Siobhan started her career in healthcare at Cardinal Health — the James W. Daly division in 1990, where she held numerous positions in marketing, purchasing and logistics operations for Cardinal’s Pharmaceutical and Medical/Surgical business in the New England market. She joined Covidien in 1996 as the Customer Service Manager for the Kendall Medical division. During her fifteen years with Covidien, she has been in corporate roles leading customer services and operations, supply chain management and information systems. Additionally, Siobhan has led the supply chain functions at multiple Covidien divisions including: Kendall Confab Retail Group, Mallinckrodt Imaging and Pharmaceutical Sector and Nellcor Puritan Bennett Respiratory Monitoring Solutions. She has been responsible for customer services, transportation, planning, global replenishment, distribution operations and supply chain systems with expertise in acquisitions, integrations and business process development. Most recently, Siobhan joins the Industry Engagement team at GS1 US, leading the healthcare team on data standards’ development and adoption.