UDIs, Device Registries Can Help Measure Effectiveness, Safety

December 22, 2014 in News

Unique device identifiers and medical device registries can be used to effectively collect standardized post-market data and track the safety of medical devices, according to a series of research articles published in the Journal of Bone Joint Surgery, Healthcare IT News reports.

Study Details

For the articles, researchers from Kaiser Permanente and Weill Cornell Medical College analyzed data from seven registries in the International Consortium of Orthopedic Registries that included information on the safety and reliability of knee and hip devices.

The registries included two U.S. registries — Kaiser and Health East — as well as registries in:

  • Australia;
  • Italy
  • Norway;
  • Spain; and
  • Sweden.

The research was sponsored by FDA (Miliard, Healthcare IT News, 12/19).

Study Findings

Researchers found that the ICOR registries allowed them to:

  • Compile “real-world” data on the performance of devices across all settings and all demographics;
  • Identify data on the devices; and
  • Provide patients and surgeons with information to help decide on the best knee and hip implants for patients (Healthcare IT News, 12/19).

Thomas Barber, associate physician-in-chief of The Permanente Medical Group, in a statement said, “Having robust registries at the national and international level furthers our understanding of how to optimize outcomes for patients” (Bresnick, Health IT Analytics, 12/19).

Liz Paxton, director of Kaiser’s Surgical Outcomes and Analysis Unit of Clinical Analysis, added that ICOR’s “ability to create an international, distributed research network in the field of medical devices opens a new door for evidence development and device-safety investigations” (Healthcare IT News, 12/19).

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