Open AccessAdvancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers
Author(s) -
Natalia Wilson,
James E. Tcheng,
Jove Graham,
Joseph P. Drozda
Publication year - 2022
Publication title -
medical devices
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.482
H-Index - 30
ISSN - 1179-1470
DOI - 10.2147/mder.s364539
Subject(s) - identifier , patient safety , medical device , medical emergency , medicine , computer science , health care , biomedical engineering , computer network , political science , law
The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs. To assess the current state, we studied representative health system UDI implementation experiences, including barriers and the strategies to overcome them, and identified next steps to advance UDI adoption.