The FDA’s initiative to phase in a unique device identification (UDI) system in the medical industry is underway. The changes will standardize tracking with labels that feature human- and machine-readable codes. The system is designed to make individual devices easier to identify and create efficiencies throughout the field.
Once integrated, manufacturers, distributors, hospitals, doctors, and patients will all gain access to data that allows them to recognize trends and meet long term demands.
Transformations in Healthcare
One of the most promising aspects of this development is public access to information through a search database that will enable increased transparency and understanding of medical devices. Patient safety will also improve with more exact tracking methods before, during, and after use. The system will also fill a major gap in the industry, as there is currently no system that allows for effective device recalls or improvements. Event reporting is lacking as well, making for slow corrections and difficulty establishing a shared knowledge base of common device issues and solutions.
The device supply chain is also currently disjointed, creating opportunities for counterfeiting and diversion. These disconnections can make communicating new uses, patient feedback, and device characteristics challenging. An integrated UDI system would eradicate these problems and create more secure distribution, post market surveillance, and simplified premarket clearances for device innovations and improvements.
Medical professionals will also enjoy an easier experience finding important information about device models and characteristics, without relying heavily upon personal experience at each stage of case management. The early stages of UDI are expected to shed light on unique practices and irregular, inventive applications for many devices. Visibility surrounding the importance of dedicated technicians and increased public knowledge will also influence the structure of the industry over time.
Predictions and Outcomes
The FDA hopes that actionable insights will be generated from post market surveillance. Advancements in medical devices is expected through the national knowledge and tracking system. The potential for a robust database to evolve from UDI will also allow manufacturers to identify demand for new devices, surgeons to consider new use cases, and patients to receive more successful treatment.
Knowledge of popular devices, use cases, durability, trends, and changes will enable technicians, surgeons, manufacturers, and distributors to provide more streamlined services. Safety for patients and improved focus, time management, and satisfaction are also expected to increase, as the system eliminates a lot of the administration and tracking work handled by healthcare professionals.
In addition to internal processes and device management, integration with health insurance, simplified billing, and specific claims will enhance efficiencies for patients and hospital employees. If executed correctly, the UDI system has the potential to make a national and global impact. Over time, the practice could become a model for healthcare systems around the world.
The shift is taking place with gradual implementation over several years. While there is still time before the full changes are in effect, medical professionals are taking steps to make the new system a reality and suppliers are making operational changes to remain relevant and prepared for future changes.
Pilot projects have already been launched with strong results. One of the first was conducted with Mercy in their cardiac catheterization laboratories. The results were promising, with major progress in inventory accuracy. They pinpointed process issues, data tracking errors, and other areas of improvement to account for during UDI implementation. Exact product valuation helped illuminated inefficiencies for the hospital and its manufacturers and distributors. The new information provided opportunities to reduce costs and increase organization when ordering and utilizing devices.
As more trials occur, improvements will be made to address challenges faced by different sectors of the healthcare industry. The pilots are designed to amend the most difficult parts of the transition and identify new issues.
Overcoming UDI Challenges
While the benefits are great, challenges will present themselves throughout the industry. The first hurdle will be implementation. Coordination at every stage and across the country will involve a unified effort by all parties.
The technology may also take some getting used to; especially for companies that are running on older legacy systems. In addition to integration with existing inventory tracking and EHR systems, codes like NHRIC or NDC numbers will need to be phased out. Replacing outdated technology or adapting these older systems to the new model will take time and dedicated training.
Difficult decision making processes will be necessary to address the influx and scale of important and sensitive information. Establishing data ownership and collection practices that offer value and real-time results for all areas of the industry will be critical for success. Providing adequate access without compromising patient privacy will be top priority as the system develops and grows.
Adaptation and troubleshooting in internal and external processes is inevitable. All areas of the medical field and each stage of distribution will need to comply with the nationwide changes. Foresight and planning are essential from beginning to end of the healthcare delivery system to create a system that is seamless and effective. Partnering with advanced clients and collaborators to leverage technology today will help facilitate the transition.
Finding Partners for Success
Lean systems and focus on efficiency, patient care, and innovation helps organizations optimize their processes at every stage of the healthcare device lifecycle. Staying connected to industry trends ensures long term business goals are relevant and achievable. Tailored systems also ensure organizations can adapt and tackle developments like UDI systems with ease.
Meeting the challenges and taking advantage of change is easier with planning and experience. SimplOR is rethinking the way devices are distributed and accounted for at every stage of the product lifecycle. Partnering with manufacturers, distributors, and hospitals ensures the most suitable device gets where it needs to be, in the hands of trained technicians. Comprehensive inventory tracking, up-to-date technology, and a forward-thinking, integrated approach saves expenses at every stage of case management. Learn more about how this reimagined approach to case management can support organizational goals and improve patient treatment.