Dear Administrator Verma and Commissioner Gottlieb:
The following organizations strongly support the implementation of the Unique Device Identifier
(UDI) through electronic health records (EHRs) and clinical registries in order to achieve the
congressional intent of promoting patient safety by ensuring all patients and their healthcare
providers as well as public health officials and researchers have accurate and complete
information on medical devices, in a timely manner. In light of the limited resources (including
funding and human resources) to effectively implement the UDI, we are also opposed to the
recommendation to add the Device Identifier (DI) portion of a medical device’s UDI to health
insurance administrative claims forms. This would impose additional costly administrative
burdens on health care providers and would provide no clearly identifiable benefit to patient
safety or the health care system.
Our organizations are strong proponents of efforts to enhance medical device safety. We support
a system that effectively integrates the UDI into clinical practice so that physicians and their
patients are well-positioned over time to have ready access to the full UDI when safety issues
arise. In addition, we strongly support strategies that enable earlier detection of patterns
suggestive of safety concerns. It is for these reasons we strongly support the inclusion of the full
UDI information in a patient’s EHR, which when coupled with a more robust data analysis
architecture, would facilitate more accurate reporting, as well as review and analysis of medical
device performance over time. Unlike the addition of DI to an administrative claim, including
the UDI in the EHR would place the identifier in the context of the clinical information
necessary for a complete understanding and evaluation of device performance. The portability of
a patient’s EHR with this information would serve as a more effective post-market surveillance
tool than using administrative claims and can improve coordination among physicians and
supports medical decision-making. (In contrast, when patients change insurance companies
during the annual election period or when they change employers, for example, the link between
patients and payer claims is broken.) The process to include the UDI in EHRs has already begun
and the certified EHR is required to include UDI in the next update.
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