We are providing available copies of the presentations from the 2017 Baltimore UDI Conference.
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Your Morning Dose of UDI Fundamentals (CPE 1.25)
The Healthcare Committee of AIM North America (NA) will present a full spectrum overview of major aspects of UDI compliance. Representatives from industry and members of AIM NA will discuss requirements associated with compliance. The manufacturer’s perspective will be examined by a senior UDI compliance expert from a medical device company. Industry experts will discuss the AIDC implications of both the creation of the mark, and its reading by current linear and 2D readers. Part marking, inspection and grading of barcodes, and RFID will also be addressed. Discussion will then move toward the consumption of the UDI by healthcare providers, and an examination of associated challenges from the perspective of point of care, electronic health records, and back office systems.
Opening Keynote Address: UDI: Marching Forward (CPE 0.5)
Ms. Sigg will provide a summary of the recent activities surrounding the UDI initiative to highlight how UDI is making a difference; not only through UDI implementation efforts to date, but through the impact UDI is having across the multi-faceted spectrum of medical device information. You will also understand the adoption and implementation momentum and the dedication to data quality and data management for the GUDID.
UDI: Generating Value Beyond Compliance (CPE 1.0)
As the U.S. FDA UDI rule moves into its fourth year and healthcare providers face regulations requiring their use of UDIs, some manufacturers are recognizing the value of doing more than just what is required by the regulation. Manufacturer benefits include better customer relationships, more credible market positioning and improved operational efficiencies, while providers can rely on more real world evidence upon which to make sourcing decisions. But what does it take to achieve these benefits and why should manufacturers and providers care?
Luncheon and Exhibits
Learning UDI Community: Getting to Good Data in the GUDID (CPE 1.25)
With 3 of the 4 major UDI compliance dates behind us, the focus for the UDI is ‘Moving beyond Compliance’. We must, if we expect to recognize the potential and fully realize the benefits of the UDI across the healthcare eco-system; from point of manufacture, to point of consumption, downstream to the clinical registries.
The GUDID, as the source of truth for the Device Identifier, must be accurate in order for it to be useful. Five work groups of the Learning UDI Community (LUC) have come together to focus their efforts around GUDID data quality to ensure the usefulness and accuracy of the data within the GUDID.
This session will share the work of the LUC work groups and discuss their Best Recommended Practices as we seek to provide a neutral platform for open dialogue for broader stakeholders (across the manufacturer and provider communities) to further assess, revise, and finalize these practices.
Collaborating with AHRMM, organizations including Advamed, HMMC, HIDA, as well individual manufacturing representatives, will review the information gathered, refine, and publish the data as a White Paper report with the goal of influencing adoption of the proposed data quality practices.
Life After The Submission Deadline: Ongoing GUDID Maintenance and Downstream Value (CPE 0.75)
Unique Device Identification (UDI) requirements and responsibilities are not complete once you have fulfilled your initial submission to the GUDID, in fact, it is just the beginning. Hear from industry subject matter experts regarding ongoing GUDID requirements, and their approach to ensure ongoing compliance and accuracy. Additionally, learn how organizations are leveraging their UDI data to gain value and efficiencies in downstream processes, post-GUDID submission.
How to improve Data Quality at the Source (CPE 1.0)
One of the most challenging areas related to implementation of the UDI regulation is the Master Data Management and Governance. Master Data Management and Governance (MDM&G) refers to a series of processes and protocols that should exist within an organization to create, enrich, maintain and publish product information within and outside the enterprise. Equally important is “data quality management,” which is a complementary cycle of activities aimed to ensure that the subject information meets high standards of quality and reliability. In short, the data created by the product’s Brand Owner must meet the requirements of the intended use case. Medical device data which has to comply with UDI regulation is no exception.
Completeness and accuracy of product data is the responsibility of the Brand Owner (i,e. Labeler). Each Brand Owner should have an internal process to manage the data required by the regulator. This includes:
This session will share the experience of leading manufacturers from whom data quality is as important as the product they manufacture. You will receive a roadmap for achieving data quality as well as additional resources to help you achieve data quality.
Networking Gathering in Lobby Bar (Cash Bar)
Exhibits, Networking & Coffee – Make the most of your time by visiting with the UDI Exhibitors and networking! Exhibit Hall open 8:15am – 2:45pm
UDI as a Standard: UDI in Use (CPE 1.0)
FDA UDI adoption efforts seek to establish UDI as a healthcare standard that is recognized and used by all stakeholders and in all data sources to clearly identify a device through distribution and use. UDI will become a valued and accepted standard through a focus on continuous quality improvement affecting four key areas: building system and policy infrastructure; testing the infrastructure through demonstration projects; evaluating and analyzing demonstration project results; and leveraging lessons learned and best practices to take action to improve the infrastructure. Ensuring that UDI provides the benefits anticipated – in the UDI regulation and by early adopters – requires public-private collaboration.
Mr. Black and Ms. Weiker will share information on a successful cross-stakeholder effort that resulted in actionable steps toward using UDI to replace the existing “NDC” and NHRIC numbers on medical devices in the pharmaceutical supply chain. These numbers are utilized to order, prescribe, adjudicate, dispense, reimburse, manage, and pay for a specific set of medical devices. To avoid supply chain confusion and possible patient care disruptions, pharmacies, retailers and device manufacturers came together to identify which products are impacted and collaborate on the changes needed to improve the transition to UDI adoption.
This session will highlight the role FDA plays in UDI adoption and the commitment by cross-stakeholder groups to ensure that expected UDI benefits are achieved.
Data Quality Issues and Impacts (CPE 0.75)
The FDA will share actual issues they are seeing, the impacts those issues are having on the GUDID, and how we need to work together to ensure complete and correct data.
Exhibits & Coffee Break
Session brought to you by AHRMM – RAPID (Registry Assessment of Peripheral Interventional Devices) (CPE 1.0)
This session will highlight the efforts of the RAPID VQI efforts to develop a minimum core dataset for total product life cycle device evaluation across multiple data sources: a step toward establishing a National Evaluation System for Health Technology for peripheral intervention devices.
Session brought to you by AHRMM – Providers Taking UDI from the Supply Chain through the Electronic Health Record and Beyond (CPE 0.5)
Providers are sitting up and taking notice of the benefits of automatic product identification, data capture, store, and transmitting from an individual, object, image or sound without manual data entry. Sharing the data in an automated fashion ensures accuracy and speed to respond. Imagine as a Healthcare provider that you no longer have to manually input information to the numerous registries, that you now have an automated way to transmit the information upon closing a case. Imagine claims handled accurately, completely and automatically. This presentation will provide the descriptions of the process and electronic means used to make what we imagine a reality.
Exhibits & Luncheon/Networking
UDI Pilots that are Using AccessGUDID (CPE 1.0)
This session will provide an overview on MDEpiNet – a Public-Private Partnership that brings together leadership, expertise, and resources from health care professionals, industry, patient groups, payers, academia, and government to build and operate a national medical device evaluation system. Details on their key pilot projects will be shared to include current status, outcomes, impacts, and findings.
Global Update: The Next Step on the Road to a Globally Harmonized UDI: The EU MDR And IVDR Unique Device Identification Requirements (CPE 0.75)
The new European Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR) introduce many new requirements for device manufacturers – including the implementation of a UDI System that is similar to (but not the same as) the US FDA’s UDI regulation. Moreover, the MDR and IVDR require the use of UDI in many different documents and systems – as well as imposing obligations for its verification and use by downstream stakeholders. The panel will discuss all of these requirements, outstanding issues, as well as the differences and similarities with the US UDI System.
Session brought to you by AHRMM – Benefits of the UDI (CPE 0.75)
The goal of this session is to begin preliminary dialogue with the manufacturing community to identify the cost benefits of the UDI from a manufacturer’s perspective. This work would mirror the work of the LUC around the cost benefits to providers. Combined, these would provide a revolutionary report of the end to end ROI for the UDI.
Conference Wrap-Up and Planned Roadmap Ahead
Prize Give-Away (MUST be present to win).