HSCA Weighs-in with Formal Commments on UDI to FDA

Last week, the HSCA weighed-in with its formal comments to the FDA in support of a swifter UDI implementation. No difficult to hit curve balls, just a lot of well-documented common sense nicely summarized by Curtis Rooney, HSCA’s president. What follows is a concluding excerpt taken from Mr. Rooney’s and the HSCA’s 24 page letter:

HSCA is committed to the UDI system and improving patient safety. HSCA believes that the FDA should maximize the efficiency and effectiveness of the UDI system by adopting the GS1 System as a model, establishing a GTIN-based UDI, a GUDID synchronized with publication of attribute data to the GDSN, and incorporating the UNSPSC standard for classification of products. HSCA also urges the FDA to shorten the proposed seven-year phase-in to three years to maximize the benefits to patients. All labelers should undertake to begin labeling their devices, with data published to the GUDID, starting with their highest device class. This allows labelers to meet the statutory requirements for Class III and implantable, life-saving, and life sustaining devices, at the end of Year One, and it ensures that all devices be in compliance at the end of Year Three.

HSCA believes the FDA should require all devices to be labeled at the packaging level (the level closest to the device), and all implantable or multi-use devices and stand-alone software that is a “device” which can feasibly be direct marked to also be direct marked. The FDA should eliminate proposed labeling exceptions to ensure that all devices in the United States healthcare supply chain are labeled with UDIs published in the GUDID. If a device can be labeled, it should be labeled. If a device subject to direct marking can be marked, it should be marked. Where it is not feasible to mark such a device, its immediate wrapper should be labeled. To create a robust and effective UDI system, every device should have a UDI associated with it either by label or by mark.

HSCA urges the FDA to ensure swift implementation by aligning data submission requirements to the GUDID with data submission requirements under the GS1 system, and allowing labelers to publish data to GUDID through synchronization with GDSN. FDA should require submission of UDI data to the GUDID at the same time that devices are labeled with UDIs to ensure that UDIs are tied to the relevant data about the device to which they refer. Finally, patients and other stakeholders will only realize the full benefit of the UDI system when providers use the UDIs. Therefore, HSCA urges policies that provide incentives for hospital and healthcare provider participation to integrate UDIs into patient health records. Scanning UDI barcodes into patient EHRs in the clinical setting will significantly enhance the usefulness of health information technology.

Hat’s off to the HSCA for showing the leadership the UDI opportunity deserves.

—Tom Finn


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