In a new paper co-authored by myself along with Research Associate Ellyn McMullin, we look at UDI, or Unique Device Identification and its impact on the heathcare system.
The value of UDI goes well beyond the requirement to include a unique ID number; it is more than another Track & Trace metric; it is a plan calling for optimizing meaningful data collection and analysis. UDI will allow a patient to be notified when a Medical Device issue needs to be addressed and the ability of healthcare providers to take appropriate and better focused corrective and preventive actions.
The implementation of Unique Device Identification (UDI) is having a profound effect on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient. The 7-year compliance timeline reached its second milestone on October 24, 2015. As of that date the labels and packages of implantable, life-supporting and life-sustaining devices must bear a UDI and date. Furthermore, software that is classified a life-supporting or life-sustaining device must include a UDI.
In addition, FDA’s new report: “Coordinated Registry Networks to Bridge Clinical Care and Research” calls for the adoption of UDI in patient identification across the entire device life cycle.
A primary objective of the Coordinated Registry Network is to promote operational elements supporting analytic methodologies. This would include:
- Implementation of UDI
- Implement standardized, structured minimum core data sets and outcome definitions
- Enhance data poolability across heterogeneous data sources
Once personal data has been stripped from electronic health records, data collected can be further associated with the UDI via data aggregation. As a result, modeling and statistical analysis can be used to identify and predict trends in medical data and optimize treatment.
Could UDI be a key that unlocks the potential of personalized medicine for the masses?
To request a copy of UDI IMPLEMENTATION – The Key To Unlock Personalized Medicine? paper, please click here.