Ashlea Souffrou, Founder and President of SxanPro01.26.24
An impending FDA mandate will require medical device manufacturers to include unique device identifier (UDI) information within their recalled device communications—a much-needed and long-overdue advance when it comes to improving patient safety and supplier-provider communications. Given the growing urgency and concern around the handling of medical product recalls in healthcare, manufacturers shouldn’t wait to implement this important safety enhancement.
The UDI system is a key player in enhancing patient safety and operational efficiency in healthcare. With FDA implementation starting in 2017, UDI isn't just a technological advancement; it's a pivotal change in how the healthcare system handles medical devices. The UDI system was created to and has made significant strides in ensuring patient safety, accuracy in device tracking, and efficiency in medical procedures.
With an annual implementation cost of $55.2 million for domestic medical device labelers, it's crucial to leverage the UDI system to its fullest potential. The healthcare industry must bridge the communication gap between medical device suppliers and healthcare provider organizations. This can be achieved by implementing a digital system that facilitates direct, real-time communications and helps manage a variety of medical device supply disruptions, with a focus on recalls.
This issue is already receiving increased attention. Just this month, the U.S. Government Accountability Office (GAO) announced an inquiry into the FDA's oversight of medical device recalls. This pivotal move, initiated by Senators Richard Blumenthal and Richard Durbin (who has also proposed legislation to mandate the FDA to establish a more robust communication system for recalls) underscores a critical but often overlooked aspect of patient safety: the effective communication of medical device recalls.
As Guillermo Ramas, Founder and CEO of NotiSphere, notes, “This inquiry by the GAO isn't just a news headline; it's a catalyst for change. It's an opportunity for stakeholders in the healthcare sector to come together.”
The current recall alert communication process is insufficient for the modern healthcare industry. For years, it has failed to keep pace with technological advances and growing patient needs. It’s time for that to change. Today’s manufacturers can either wait to be handed their mandate—or they can lead the way into a safer, more-efficient future for all parties.
In collaboration with NotiSphere, we identified 431 recalled products still on hospital shelves just last month. More than a quarter (28 percent) of the recalled items were class 1 recalls—in other words, recalls with a high probability of causing patient harm if not addressed.
These findings highlight the importance of technology and UDI in managing healthcare facility inventories, especially in areas typically overlooked in standard supply chain processes. Healthcare supply disruptions pose a serious threat to hospital operations, clinical performance, and, most importantly, patient safety. The UDI is a key tool that can be leveraged to improve this situation.
The lack of technology-driven visibility is a major challenge in locating recalled devices on hospital shelves, and managing product recalls in hospitals is often a manual and inefficient process. Items found in hospitals we inventoried this year are still sitting on shelves after recall checks, posing significant risks to patients.
The threat to patients posed by recalled products still on hospital shelves is real. And the pressure is on to solve this issue.
While an FDA mandate will further empower efforts to help hospitals manage recalls more efficiently, the initiative from manufacturers to include UDI in recall notifications can start making a difference now. This proactive approach, combined with the right technologies, aligns with the FDA's vision for UDI implementation, aiming to use technology to enhance patient safety.
Ashlea Souffrou, is a 17-year veteran of the medical device industry with a passion and dedication to uncovering sustainable and cost-saving solutions within healthcare. She founded SxanPro in 2019, building a technology company that digitizes inventory processes throughout the hospital supply chain. As CEO of SxanPro, Ashlea continues to drive the advancements of the company’s product line while fostering strategic partnerships with companies and healthcare systems across the industry.
The UDI system is a key player in enhancing patient safety and operational efficiency in healthcare. With FDA implementation starting in 2017, UDI isn't just a technological advancement; it's a pivotal change in how the healthcare system handles medical devices. The UDI system was created to and has made significant strides in ensuring patient safety, accuracy in device tracking, and efficiency in medical procedures.
With an annual implementation cost of $55.2 million for domestic medical device labelers, it's crucial to leverage the UDI system to its fullest potential. The healthcare industry must bridge the communication gap between medical device suppliers and healthcare provider organizations. This can be achieved by implementing a digital system that facilitates direct, real-time communications and helps manage a variety of medical device supply disruptions, with a focus on recalls.
Pressure Mounts for a Better System
With more than 2,600 recall events and hundreds of millions of units recalled in 2023 alone, there is a critical need for more efficient recall management. The integration of UDI into recall notifications can help that change.This issue is already receiving increased attention. Just this month, the U.S. Government Accountability Office (GAO) announced an inquiry into the FDA's oversight of medical device recalls. This pivotal move, initiated by Senators Richard Blumenthal and Richard Durbin (who has also proposed legislation to mandate the FDA to establish a more robust communication system for recalls) underscores a critical but often overlooked aspect of patient safety: the effective communication of medical device recalls.
As Guillermo Ramas, Founder and CEO of NotiSphere, notes, “This inquiry by the GAO isn't just a news headline; it's a catalyst for change. It's an opportunity for stakeholders in the healthcare sector to come together.”
The current recall alert communication process is insufficient for the modern healthcare industry. For years, it has failed to keep pace with technological advances and growing patient needs. It’s time for that to change. Today’s manufacturers can either wait to be handed their mandate—or they can lead the way into a safer, more-efficient future for all parties.
The Scope of the Problem (and Opportunity)
As the founder of a company that specializes in healthcare inventory control via mobile technology, I’ve witnessed firsthand just how significant the need for more-effective medical device recall management truly is. SxanPro recently partnered with NotiSphere, a company that’s looking to bridge the supply chain communication gap between medical device suppliers and healthcare organizations. By integrating NotiSphere’s capabilities with our own system for scanning and recording UDIs, we’re able to easily identify recalled items that have remained on hospitals’ shelves, despite standard recall protocols. The results of our collaboration have been eye-opening.In collaboration with NotiSphere, we identified 431 recalled products still on hospital shelves just last month. More than a quarter (28 percent) of the recalled items were class 1 recalls—in other words, recalls with a high probability of causing patient harm if not addressed.
These findings highlight the importance of technology and UDI in managing healthcare facility inventories, especially in areas typically overlooked in standard supply chain processes. Healthcare supply disruptions pose a serious threat to hospital operations, clinical performance, and, most importantly, patient safety. The UDI is a key tool that can be leveraged to improve this situation.
The lack of technology-driven visibility is a major challenge in locating recalled devices on hospital shelves, and managing product recalls in hospitals is often a manual and inefficient process. Items found in hospitals we inventoried this year are still sitting on shelves after recall checks, posing significant risks to patients.
The threat to patients posed by recalled products still on hospital shelves is real. And the pressure is on to solve this issue.
While an FDA mandate will further empower efforts to help hospitals manage recalls more efficiently, the initiative from manufacturers to include UDI in recall notifications can start making a difference now. This proactive approach, combined with the right technologies, aligns with the FDA's vision for UDI implementation, aiming to use technology to enhance patient safety.
Ashlea Souffrou, is a 17-year veteran of the medical device industry with a passion and dedication to uncovering sustainable and cost-saving solutions within healthcare. She founded SxanPro in 2019, building a technology company that digitizes inventory processes throughout the hospital supply chain. As CEO of SxanPro, Ashlea continues to drive the advancements of the company’s product line while fostering strategic partnerships with companies and healthcare systems across the industry.