August is prime time for UDI

July 22, 2018

It’s August, which means it’s time for AHRMM18, the annual conference and exhibition of the Association for Health Care Resource & Materials Management (AHRMM). For those interested in what’s happening in the industry around the adoption and use of unique device identifiers (UDIs), there’s plenty on the agenda.

Monday, August 13

Defective Product Recalls are Now Overwhelming – the Potential Impact of UDI

11:00 a.m. to 12:00 p.m. — The Government Accounting Office reports an increase in serious (Class I) device recalls. Learn how UDI can improve how recall notices are issued and tracked compared to current practices.

Everyone has a stake in a successful UDI implementation

1:30 p.m. to 2:30 p.m. — Panel discussion with representatives from electronic health record (EHR) and enterprise resource planning (ERP) vendors, a manufacturer and the U.S. FDA on the importance of a multi-disciplinary and multi-organizational approach to UDI adoption.

Tuesday, August 14

Manufacturers are from Jupiter; Providers from Saturn: Understanding each other’s world to make UDI work

1:00 p.m. to 2:00 p.m. — Often providers and manufacturers don’t fully understand the implications of global UDI regulations on each other’s respective systems and processes. This session focuses on how manufacturers assign device identifiers to their products and the downstream implications.

Tracking UDI on Hospital-Sterilized and Manufacturer-Packaged Implants During Surgery

2:30 p.m. to 3:30 p.m. — A case study on the effectiveness of a universal operating room UDI data collection system, including goals, lessons learned and the process used during surgery to collect medical device information accurately without slowing the pace of surgery.

Forward Deployed Inventory

4:00 p.m. to 5:00 p.m. — Learn how a hospital, large manufacturer and distributor are utilizing RFID to capture and track device utilization and then positioning product in warehouses closer to the point of use, resulting in lower transportation and purchase order costs for implantable devices and increased traceability.

Wednesday, August 15

UDI: Finding Value in the Real World

8:00 a.m. to 9:00 a.m. — Learn how to realize value from the capture of UDIs and related clinical and supply chain attributes in electronic health records to calculate total costs for procedures, ensure complete charge capture, and evaluate the performance of products in routine clinical practice.

Where Do I Begin? Building a UDI Implementation Roadmap

9:30 a.m. to 10:30 a.m. — Providers are required to capture and share UDIs for implantable devices as part of the Common Clinical Data Set. Learn how a Wisconsin Health System is capturing all of the required elements to enhance the clinical documentation process to improve revenue capture and patient safety.

AHRMM Learning UDI Community (www.ahrmm.org/luc)

Whether or not you can make the show, AHRMM has additional resources available through the AHRMM Learning UDI Community (LUC). The LUC is open to anyone interested in advancing the ability to realize value from UDI. The LUC is an example of a collaborative community, where a variety of stakeholders from the public and private sectors can come together to help solve shared problems. Recently, the FDA Center for Devices and Radiological Health (CDRH) listed the creation of collaborative communities as one of its strategic priorities, specifically calling out the accomplishments of the LUC.

Here’s a quick overview of some of what the LUC has to offer:

A new white paper on the linkage between the AHRMM Cost-Quality-Outcomes (CQO) Movement and the UDI rule documents the importance of accurately capturing data on devices used in patient care to understand total costs of procedures and the performance of devices in routine clinical care to improve product sourcing and utilization.

In addition, the LUC provides free access to the completed resources from seven work groups and information on four additional work groups still in progress.

Completed work

  • UDI Capture – Case studies from 8 providers on how they capture and utilize UDI data in their supply chain and clinical systems.
  • Unit of Use – 3 webcasts and downloadable presentations on FDA requirements, clinical applications, and potential use cases for this required field in the Global UDI Database (GUDID).
  • Catalog Number – Report on the business case and value for requiring manufacturers to publish catalog numbers in the GUDID.
  • Low Unit of Measure – Best practices for UDI labeling for products that are distributed and intended to be stored in a package with like products until use, taking into consideration impacts of distributor LUM and JIT programs.
  • Benefits of UDI – Workflows identifying the value of using UDI in inventory management for consumable and specialty (trunk stock) products, transfer of device usage info from EHRs to registries, adverse event reporting and recall notifications.
  • Human Cellular Tissue Product – Educational document on using UDIs to track donor information on products of human origin covered by the UDI regulation.
  • Clinically Relevant Size – Recommendations on how to improve completeness and usability of clinically relevant size data in the GUDID.

Work in progress

  • Multiple Device Identifiers – Exploration of issues related to the practice of assigning multiple device identifiers to devices.
  • High risk Implants – Developing user friendly search criteria to identify implants in the GUDID to enable documentation of implants, including for automating the billing process.
  • Bar Code at the Point of Care – Improving the process by which clinicians and other stakeholders can identify and scan the correct barcode to capture the UDI.
  • Device Categorization – Reviewing the pros and cons of the use of the GMDN and SNOMED terminologies for categorizing devices.
About the Author

Karen Conway | CEO, Value Works

Karen Conway, CEO, ValueWorks

Karen Conway applies her knowledge of supply chain operations and systems thinking to align data and processes to improve health outcomes and the performance of organizations upon which an effective healthcare system depends.  After retiring in 2024 from GHX, where she served as Vice President of Healthcare Value, Conway established ValueWorks to advance the role of supply chain to achieve a value-based healthcare system that optimizes the cost and quality of care, while improving both equity and sustainability in care delivery. Conway is former national chair of AHRMM, the supply chain association for the American Hospital Association, and an honorary member of the Health Care Supplies Association in the UK.