In its comment, Amerinet expressed support for a UDI system, and one aligned with GS1 standards.
“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, in the release. “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 comment to 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 supports other components of the HSCA comments, including the following:
- 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 technology.
- The ISO standard should be adopted for the date format on device labels.
- Incentives should be supported for hospitals and healthcare providers to integrate UDIs into patient health records, including electronic heath records.
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