Complying with FDA's Unique Device Identification Rule Agenda

10:00 a.m. – 10:10 a.m.

Introduction to the Virtual Conference
Chairperson, Janice Kite, Director Healthcare Traceability, GS1 Global

10:10 a.m. – 10:55 a.m.

UDI- FDA’s Update and Vision for the Future
Jay Crowley, CDRH, FDA

When the Food and Drug Administration publishes their proposed rule for mandatory unique device identification, device manufacturers will have 1-5 years depending on device class to implement this system. While monitoring and tracking of devices will now be easier, compliance can prove to be more challenging. Join Jay Crowley, CDRH, FDA as he discusses the FDA’s perspective on the regulation, required elements and standards and how to implement a UDI system compliantly.

Attendees will learn:

  • First hand updates on the guidance and an understanding of the new rules
  • Required elements of a UDI system
  • Learn how to implement a compliant UDI system within your organization

10:55 a.m. – 11:40 a.m.

Case Study: Unique Device Identification Requirements and Implementation
Dennis Black, Director of e-business, Becton Dickinson

Implementing a Unique Device Identification system has the potential to improve the efficiency and effectiveness of the medical device supply chain. While it has been said that the benefits of implementing a UDI system will outweigh the initial start up costs, what companies really want to know is when they will begin to see these benefits and what steps the industry needs to take to realize these benefits?

Hear one manufacturer’s experience and learn about industry-wide UDI challenges, potential areas of concern, ways to avoid and overcome pitfalls and a glimpse into the future benefits.

11:40 a.m. – 11:50 a.m.

Break

11:50 a.m. – 12:10 p.m.

GS1 Standards
Janice Kite, Director Healthcare Traceability, GS1 Global Office

Referred to as a “go-to” reference point for UDI, this presentation will provide an overview of the GS1 standards. In this overview, you will learn background information on the standards, what they are and how to use them to best aid your organization.

12:10 p.m. – 1:10 p.m.

Lunch

1:10 p.m. – 1:55 p.m.

The Database- The Driving Force Behind UDI
MJ Wylie, Director of Global Data Standards, GHX

Unique device identification will aid manufacturers and healthcare providers tremendously, however the information included in a UDI is useless without a database to store the information. It is crucial to the UDI process that device manufacturers develop and maintain the master data from their devices to put into the UDI database, and create a database that allows for expansion as UDI continues to evolve.

Attendees will learn:

  • The key elements of a UDI system database
  • How to develop and maintain a process for storing master data
  • An implementation strategy for a UDI database
  • How to ensure your database can grow with UDI evolution

1:55 p.m. – 2:40 p.m.

HL7 Standards for UDI Across the World
Jackie Rae Elkin, Global Process Owner, Medtronic
Databases will serve as the key to successful UDI implementation. However, if with many different styles of data maintenance, databases could become confusing and sloppy. Health Level Seven International (HL7) has addressed this issue by creating a set of standards that must be used to pass data into the UDI database.

Attendees will learn:

  • How data entry and exchange are being harmonized across the world
  • The global standards required for data entry and exchange
  • The four standards set by HL7 and the interrelationship between them
  • How to use these standards to implement a system for data entry into the UDI database

2:40 p.m. – 3:25 p.m.

UDI in the Medical Facilities
Rosalind Parkinson, The Ohio State University Medical Center

When UDI rules are published healthcare providers will be challenged to incorporate device identification into information systems and operational processes reaching from the warehouse to the bedside. Medical device tracking is traditionally seen as less important than drug tracking since most medical accidents were historically related to drug errors. However, as medical device options proliferate and more devices are used in invasive procedures, risks for patient safety using faulty devices increase. Implementation of UDI will allow providers to know the unique identity and location of any device in their systems and successfully remove them before they are used in patient care.

Attendees will learn:

  • Clinical information system changes needed to accommodate the UDI
  • Business system changes needed between providers and suppliers
  • Internal business system processes needed
  • Major operational challenges facing hospitals with UDI implementation

3:25 p.m. – 3:40 p.m.

Break

3:40 p.m. – 4:25 p.m.

Developing a UDI Traceability Strategy Throughout the Supply Chain
Janice Kite, Director Healthcare Traceability, GS1 Global Office

The FDA is getting closer to publishing their guidance on unique device identification for medical devices. Medical device manufacturers are going to have a short amount of time to figure out how implementation of UDI on medical devices relate to traceability, patient safety and product recalls in and across the global healthcare supply chain and how to use it to their benefit. This presentation will show the relationships and how traceability, patient safety and recalls could be achieved.

Attendees will learn:

  • How UDI will make traceability of devices and recalls more efficient
  • How UDI will increase patient safety
  • How to achieve the maximum benefit from UDI for your company

4:25 p.m. – 4:40 p.m.

Closing Comments and Adjournment
Chairperson, Janice Kite, Director Healthcare Traceability, GS1 Global


 
How does this virtual conference work?

The Complying with FDA’s Unique Device Identification Rule takes all the best elements of the best live conference you’ve attended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.

All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.

Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.

What are the top benefits of a virtual conference?

Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.

Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.

Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.

Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions that most pertain to their responsibilities.

Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.

Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.

Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.

Comprehensive: You’ll hear from six industry experts all in the course of one day.