Amerinet Submits Comment to FDA in Support of Unique Device Identification Rule

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A Unique Identification System aligned with GS1 standards will improve patient safety and drive costs out of the supply chain.

Amerinet Inc., a leading national healthcare solutions organization, today announced that on November 7 it submitted a comment to the Food and Drug Administration (FDA) regarding the proposed rule to establish a Unique Device Identification (UDI) system for medical devices.

“Our decision to support a UDI system is yet another great example of Amerinet’s commitment to reducing healthcare costs and improving healthcare quality,” said Todd Ebert, president and CEO of Amerinet. “As a member of the GDSN Early Adoption Group facilitated by GS1 Healthcare US and as a participant in discussions which led to the development of the Healthcare Supply Chain Association’s (HSCA) comment to the FDA, Amerinet believes that a UDI system – properly aligned with GS1 standards – will improve patient safety and drive costs out of the supply chain.”

Amerinet encourages the FDA to base the UDI system on GS1 standards to minimize the costs associated with full implementation of that system. The healthcare industry has already expended significant sums in implementing GS1 standards on a voluntary basis, and adopting different standards for a UDI system would cause stakeholders to incur additional costs. Moving forward with GS1 standards will support quicker uptake by all stakeholders, including hospitals and other healthcare providers.

In addition to emphasizing the importance of a single standard based on GS1 be established, Amerinet supports key components of the HSCA comments, including:

  • The proposed seven-year phase-in be shortened to three years.
  • The policy should be that if a device can be labeled, then it must be labeled. If it cannot be labeled, then (if appropriate) it should be direct marked. If it cannot be labeled or cannot be direct marked, then its immediate wrapper should be labeled.
  • All devices in a convenience kit should be required to be labeled.
  • Barcodes should be required as the mandatory Automatic Identification and Data Capture (AIDC) technology.
  • The ISO standard should be adopted for the date format on device labels.
  • The date for data submission should be aligned with the date the label of the device must bear a UDI. Data submission requirements to the Global Unique Device Identification Database (GUDID) should be aligned with data submission requirements under the GS1 system. This would allow labelers to publish data to the GUDID through synchronization with the Global Data Synchronization Network (GDSN).
  • Submission of UDI data to the GUDID should be required at the same time that devices must be labeled with UDIs.
  • Incentives should be supported for hospitals and healthcare providers to integrate UDIs into patient health records, including electronic heath records.
  • Costs already incurred by labelers as they prepare to comply with the market’s demand for GS1 compliance and the 2012 GTIN sunrise should be excluded when determining the burdens imposed on labelers by the proposed UDI system.

“The recent McKinsey & Company report did an exceptional job at summarizing the voice of 80 thought leaders in the healthcare industry and highlighting the numerous benefits of one single global standard,” noted Curtis Miller, chief information officer at Amerinet. “In particular the report addressed how global standards could supplement electronic medical records and support the management of the complexity associated with personalized medicine and customized medical devices.”

About Amerinet
As a leading national healthcare solutions organization, Amerinet collaborates with acute and non-acute care providers to create and deliver unique solutions through performance improvement resources, guidance and ongoing support. With better product standardization and utilization, new financial tools beyond contracting and alliances that help lower costs, raise revenue and champion quality, Amerinet enriches healthcare delivery for its members and the communities they serve. To learn more about how Amerinet can help you successfully navigate the future of healthcare reform, visit

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