The ambitious unique device identification initiative aims to create tracking capabilities for medical devices via a code that identifies an individual device and contains information about the particular device’s manufacturer, model, expiration date and other information. UDI implementation is underway. Innovative, high-risk devices are already supposed to contain UDI labels. The stakeholders’ comments to the Office of the National Coordinator for Health IT and Centers for Medicare & Medicaid Services show that the focus of UDI proponents is slowly shifting toward making sure the healthcare industry actually uses the data, or else industry’s efforts at compliance will amount to wasted money, and the expected benefits will not be achieved.
“Incorporating UDIs into electronic health records (EHRs) will help hospitals, clinicians and patients identify individuals implanted with recalled devices; support care coordination for patients that see multiple clinicians; provide patients and physicians with accurate information on products implanted; and improve analyses of device performance,” wrote a group of 9 organizations led by The Pew Charitable Trusts in their comment, which they shared with FierceMedicalDevices. They support provisions that allow EHRs to capture and transmit a device’s UDI, like a separate field for the UDI of implanted devices and integration with the FDA’s Global Unique Device Identifier Database.
However, the stakeholders requested a change to the proposed rule that would discourage manual errors among physicians when inputting UDIs. The FDA requires device-makers to display the UDI code in both a human readable and automatic identification and data capture format (such as a bar code), but the proposed rule regarding EHRs “does not require any form of automatic identification and data capture (AIDC) capabilities to record the UDI,” the stakeholders wrote. “There is potential for UDIs to be several dozen digits in length; failure to support some form of AIDC capabilities will require providers to manually enter the information, increasing the chances of an error and discouraging clinicians from documenting the devices implanted in the patient. In harmony with FDA’s requirement that medical device labels include at least one form of AIDC capability, ONC should require EHRs to also support at least one form of automated UDI capture,” the comment says.
A comment from the Healthcare Transformation Group, consisting of 5 healthcare systems, such as Kaiser Permanente, expressed similar concerns. A parallel effort is underway to encourage the integration of UDI into insurance claims. Unlike EHRs, insurance claims forms can track the same patient across different hospitals. But federal healthcare insurer CMS hasn’t been as supportive of those efforts, citing cost concerns and technical challenges, to the chagrin of UDI proponents.
REFERENCE: Fierce Medical Devices; 01 JUN 2015; Varun Saxena