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Related Experiment Video

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3D Planning and Printing of Patient Specific Implants for Reconstruction of Bony Defects

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Published on: August 4, 2020

UDI2Claims: Planning a Pilot Project to Transmit Identifiers for Implanted Devices to the Insurance Claim.

Yasmin A Zerhouni, Dan C Krupka¹, Jove Graham²

¹Twin Peaks Group, LLC, Lexington, Massachusetts.

Journal of Patient Safety

|November 28, 2018

Summary

Integrating unique device identifiers (UDIs) into insurance claims significantly enhances postmarket surveillance for implanted medical devices. This method provides more comprehensive adverse event data than electronic health records alone.

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Area of Science:

Medical Device Surveillance
Health Informatics
Public Health

Background:

Current postmarket surveillance of medical devices faces challenges.
The U.S. Food and Drug Administration mandated unique device identifiers (UDIs) for improved tracking.
Integrating UDIs into insurance claims offers potential for enhanced monitoring but faces implementation hurdles.

Purpose of the Study:

To demonstrate the benefits of including device identifiers (DIs) in insurance claims for monitoring implanted devices.
To explore the operational aspects of transmitting DIs from the point of care to insurance claims.

Main Methods:

Compared 90-day adverse event rates using electronic health records (EHR) versus EHR combined with claims data.
Conducted a pilot project to transmit DIs from point of care to claims at two provider/payer sites.
Identified and resolved five key operational challenges in DI transmission and data analysis.

Main Results:

Estimated adverse event rates were up to 3.75 times higher when including claims data alongside EHR.
Successfully captured, transmitted, and analyzed DIs on claim forms.
Overcame challenges related to DI capture at point of care, claim form integration, transmission, and data quality verification.

Conclusions:

Including DIs on insurance claims enables more complete adverse event data capture for implanted devices compared to EHR data alone.
Successful DI transmission to claims was achieved through careful planning and multistakeholder collaboration.