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A UDI Capture Work Group Case Study at the Beaver Dam Community Hospitals, Inc.

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: James Phillips, Consulting Manager, DSI, the Office of Data Standards and Interoperability, Franciscan Missionaries of Our Lady Health System (FMOLHS) CASE STUDY ORGANIZATION:

WORK GROUP TITLE: UDI Capture Work Group CASE STUDY PARTICIPANTS: Jim Booker, Manager of Master Data Management, Supply Chain, Stanford Health Care CASE STUDY ORGANIZATION:

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Medical device manufacturers have been working hard to comply with the new Unique Device Identification (UDI) regulations from the FDA that are aimed at bolstering the safety of medical devices. The UDI system, which the agency says will be phased in over several years, is intended to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. The FDA program leverages human and machine-readable UDI labeling for identifying medical devices, and device labelers must submit information about each device to the FDA’s Global UDI Database.

This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.

Increasingly, the hospital and health care delivery system executives are viewing the supply chain as a strategic asset that can be leveraged to meet operational, clinical, and financial performance imperatives. This has not always been the case. For years, the supply chain was seen as little more than a necessary but ancillary function – to buy and deliver products as needed – with the primary supply chain improvement strategy focused on buying those products at the lowest price possible.

The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:

On November 21, 2013, AHRMM submitted electronically