In September of 2016, the FDA issued its third installment of compliance rules in an endeavor to establish a UDI system that will recognize medical devices throughout the product’s lifecycle. The full incorporation of UDI into electronic health information is targeted for 2020, and with full implementation the value of UDI will be seen from patients, physicians and the companies looking to drive innovation in healthcare devices with an even higher level of quality and safety.
Bringing comfort to patients and improving outcomes
Any healthcare product, from drugs to devices, begins with how it will impact patients. The same is true in the full implementation of UDI, which will benefit patients by notifying them when a medical device has an issue that needs to be addressed. For healthcare providers, UDI will allow them to take appropriate corrective and preventive actions quickly. In an Axendia brief, it’s noted that UDI will help providers and medical device companies provide better patient engagement strategies and more importantly, UDI will be thought of as a standardized identifier which can more effectively manage medical device recalls. This means that patients would receive more timely notifications of device issues and be made immediately aware of any needs to replace products in an effort to avoid potential life-threatening complications. Lastly, full UDI implementation will improve consistency with internal patient registries which will help reduce billing errors.
Additionally, UDI allows for the delivery of healthcare to be more precise, as a result, there is even an opportunity for UDI to empower precision medicine. Recently, the FDA launched a Precision Medicine Initiative which aims to identify appropriate treatments for individual patients. For providers to build a precise treatment plan for a patient, a piece of the puzzle will include leveraging data from UDIs to help understand trends with population cohorts that will help optimize treatments. For example, UDI can be used to identify specific device usages and where they occur globally. As a result, the data can be pulled to correlate and show patterns of specific diseases or treatments.
Keeping track of issues associated with multiple devices spread across the globe is a seemingly insurmountable task, but UDI provides for a streamlined approach for easy and efficient device tracking. In addition, there are several implications for improved innovation with this newfound simplicity including:
- Transforming end user feedback on device(s) thereby facilitating new product improvements based upon end user comments
- Shortened development cycles through reduced time spent on medical errors
- More better targeted device technologies
- Flexibility in making rapid design improvement changes and configurations to existing products
Employing an enterprise platform that links post-market, quality related information like adverse events with upstream development processes will allow manufacturers to drive continuous closed-loop quality improvements. In addition, once UDI is fully implemented, real-time dash boards can provide the ability to quickly obtain status updates on devices and ultimately track device type, patient, location, noted observation(s), and manufacturing site(s), which will allow the FDA to receive adverse event report notifications in a timely manner and manufacturers can avoid potential warning citations due to delays. Simply put, it provides manufacturers with the ability to more effectively manage and proactively monitor the products that are sold in different countries. Think of UDI as the next evolution in product identification systems.
In a recent article featured in Health Data Management, Dassault Systèmes Vice President of Life Sciences Jean Colombel argued, “A major component to improving the quality and safety of the healthcare industry is the ability to exchange information more effectively.” This recent round of UDI compliance is expected to have the greatest impact. This is primarily because it affects both class II and class III medical devices, which most devices fall under (approximately 800 unique devices).
The FDA is intent on significantly improving device evaluation and decision-making through the adoption of UDI across the device ecosystem. The value of UDI resides in the ability to optimize meaningful data collection and analysis. Once UDI is fully implemented as part of a company’s global business operation, opportunities for improving quality, streamlining regulatory reporting, accelerating notifications of device issues to registered owners to avert potential patient complications and driving innovations forward are finally possible.
To learn more about how to leverage UDI to accelerate product quality and patient safety, register for a webinar featuring FDA, Axendia and Dassault Systèmes experts.
Daniel R. Matlis, Founder and President, Axendia
Terrie Reed, Sr. Advisor, UDI Adoption, FDA
Arieh Halpern, Business Consultant Director, Dassault Systèmes