The Mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system

Healthc (Amst). 2016 Jun;4(2):116-9. doi: 10.1016/j.hjdsi.2015.07.002. Epub 2015 Jul 16.

Abstract

Mercy, a 4 state health system, conducted an FDA-sponsored demonstration whereby prototype unique device identifiers (UDIs) of coronary stents were implemented in its electronic information systems for safety surveillance and research. To accomplish this, a multi-disciplinary team implemented a point of use barcode scanning inventory management system in all 5 Mercy cardiac catheterization laboratories. The system's potential for improving inventory management and tracking Cath Lab supplies was felt to be sufficiently compelling for system deployment outside of the context of the demonstration. Further, it was felt to be useful for all Cath Lab renewable supplies and not just coronary stents. Benefits included preventing procedure delays, lowering costs, and increasing revenue. Finally, the system is extensible to all implanted medical devices and generalizable to most hospitals.

Keywords: Device identification; Process improvement; Safety surveillance.

MeSH terms

  • Electronic Data Processing / statistics & numerical data
  • Electronic Health Records
  • Equipment Safety / standards*
  • Equipment and Supplies / standards
  • Government Programs
  • Humans
  • Inventories, Hospital*
  • Product Surveillance, Postmarketing / economics
  • Product Surveillance, Postmarketing / methods*
  • United States
  • United States Food and Drug Administration