In September, the Food and Drug Administration's unique device identification system for medical devices took effect, marking a turning point in patient safety and medical-device management.
The UDI initiative also creates a huge opportunity for hospitals to improve business processes that can improve patient safety, lower medical-device costs, and some day generate the data that will inform better patient care.
Hospitals are not required to use the UDI format, but what is the alternative? Every year, hospitals collectively lose up to $5 billion and jeopardize patient safety because of the limitations of their manual record-keeping systems to accurately track their medical-device implants.
The system is a powerful tool, but the benefits will materialize only when hospitals use the data as the foundation for comprehensive medical-device management. This is a new concept for hospitals, but already, medical-device management systems are in the market and available for use because of UDI.
The benefits to hospitals are clear and the time to act is now. In this first phase, all Class III life-sustaining and life-supporting devices must carry UDI bar-code labels.
