Results Summary

What was the project about?

Medical devices, such as pacemakers or stents, can help diagnose, treat, or prevent health problems. Companies that make medical devices label them with unique device identifiers, or UDIs. UDIs contain data about a device, such as the make, model, and expiration date. Healthcare providers can scan UDIs when they use the devices and record UDI data in patients’ health records.

Right now, UDI data can only be accessed by the health systems that use the devices. Having the UDI data in insurance claim forms, instead of only in patients’ health records, would mean that researchers could look at data over time and across health systems. They could then use these data to help monitor devices for safety or study questions like how well devices are working.

In this study, the research team created ways to send UDI data from health systems to insurance claims forms.

What did the research team do?

The research team worked with two health systems and insurers to make processes and software to send UDI data to insurance claims. To do this, the team

  • Created and tested processes in each health system to use barcode scanners to capture UDI data
  • Found places on insurance claims forms to report UDI data
  • Created software to send UDI data to claims forms
  • Created a method to help insurers analyze the UDI data in the claims forms

The research team manually reviewed insurance claims data to see if the software sent the right data to the insurance claims forms.

Patients with medical devices, healthcare providers, health technology professionals, and insurers helped design the study.

What were the results?

In both health systems, the processes and software were successful in merging the UDI data in insurance claims.

What were the limits of the project?

The study included only two large health systems. Small health systems with limited resources, such as old technology, may need more work to send UDI data to insurance claims.

Future research could look at how to transmit UDI data from health systems to insurers on a national level.

How can people use the results?

Researchers, health systems, and insurers can use the processes and software to help monitor medical device safety using UDI data.

Final Research Report

View this project's final research report.

More About This Research

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • One of the reviewers did not feel that the researchers made a compelling case for the significance and potential impact on patients of having a system to transfer information about unique device identifiers from providers to payers. The reviewer added that it was not clear how the researchers incorporated information from patients into planning and conducting the study. The researchers replied that the study included patient focus groups and benefited from the study team’s experience as patients. However, the primary stakeholders in this study were the people involved in working on tracking universal device identifiers and making policy decisions about them.
  • The reviewers expressed concern that the two health systems used in the analyses created a heterogeneous data set that reduced methodological rigor. The researchers disagreed, stating that although they did not initially know that the two health systems used different information systems to track unique device identifiers, they felt that the differences would make their findings more generalizable. The researchers went on to explain that in a nationwide implementation of their methods many different information systems would need to be adapted.

Conflict of Interest Disclosures

View the COI disclosures form.

Project Information

Joel S. Weissman, PhD
Brigham and Women's Hospital
$1,023,934
10.25302/ME.151132960

Key Dates

51 months
July 2016
February 2021
2016
2021

Study Registration Information

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Last updated: November 24, 2021