LAUSR

Abstract Background Most countries have different registration and tracking system, but unique device identification based approach was recently introduced in the USA. In 2013, FDA and EU released regulations about unique device identification system. In literature, there is not any study that compares the UDI legislations on the basis of the requirements. In addition to the legal requirements, establishing a UDI system in digital environment is very challenging. Methods This is a theory based study that includes information from healthcare industries and key points from UDI related legislations which are discussed. To visualize the design of the proposed system, the Dia program that contains the Unified Modeling Language (UML) components was used. Results Implementation of the UDI based tracking system is very difficult due to two reasons. First, the relevant legislations do not give detailed information on how UDI system will be implemented. Second, each type of medical device has difficulties due to UDI labeling. We have observed that the stakeholders in the medical devices sector in Turkey, especially the manufacturers, are not yet ready for UDI-based tracking. The current registry system is not effective to track medical devices and share data. Conclusions To overcome compliance problems, UDI requirements should be perfectly determined and subsequently related legislation should be established. Regarding these requirements, every country should introduce an action plan and include all sector stakeholders in that action plan. We suggest a model for medical device tracking to be able to use instead of the current registry system in Turkey.