In response to a formal request on December 13, 2023 from Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D.-Conn, the Government Accountability Office (GAO) is launching a probe into the FDA’s failure to properly oversee and manage medical device defects, even when they are life-threatening and cause permanent damage in patients. In their letter, Durbin and Blumenthal used the disturbing example of Philips Respironics, which recalled 15 million breathing machines in 2021. They noted that both Philips Respironics and the FDA knew about the cancer-causing defects in question for several years before the recall was initiated. According to ProPublica, Philips Respironics first received an adverse event report about this problem in 2010 and stayed silent about thousands of additional adverse event reports for over a decade.
As the Senators’ letter states, “it now appears that the FDA missed several opportunities to mitigate the harm done to the millions of patients who have used these recalled medical devices.” It would seem that little has changed since 2011 when the GAO released its last findings about the FDA’s oversight of medical device recalls, which determined that the FDA “often failed to conduct recall-related inspections,” according to Durbin’s and Blumenthal’s letter to the GAO.
Effective government oversight of recalls is unquestionably essential for patient care, but once medical devices have been recalled, hospitals must also have the capability to flag these recalled products, remove them from the shelves, and then track them to individual patients in whom they’ve been used. Tracking recalls to patients is particularly cumbersome and time-consuming, and often not done comprehensively, but hospitals must ensure they have the means to act efficiently and swiftly. Clearly, patient safety is the #1 concern – recalled medical devices or products can pose serious risks to patients, with potentially devastating consequences, including severe injury or even death – a huge responsibility and liability for hospitals.
When hospitals fail to properly manage recalled products, they place themselves at risk for legal consequences and regulatory sanctions, as well as costs associated with patient injuries, lawsuits, replacement of affected devices, and loss of revenue due to interruptions in patient care or negative publicity. Additionally, failure to manage recalls properly can cause reputational damage for a hospital and erode trust among patients in the community they serve, not to mention among other healthcare providers.
Conversely, handling recalls well can enhance a hospital’s reputation as a reliable and responsible healthcare provider. Also, timely identification and management of recalled devices minimize disruptions to hospital operations; hospitals can avoid delays in patient care, prevent confusion among staff, and maintain smooth workflow.
This is where VUEMED comes in. Our UDI-compliant, automated data capture technologies (whether barcode scanning or RFID) track medical products in real time throughout their life cycle, providing full visibility from point of entry into the hospital to point of care in a patient procedure. We enable hospitals to identify impacted inventory that are still on the shelves or those that have been used in patients WITHIN SECONDS. No more spending weeks trying to trace a recalled device back to a specific patient. And no more accidentally using a recalled item for a patient that has not yet been identified and pulled from the shelves. VUEMED’s solutions flag recalled products (through their UDI information) in specific customers’ inventories, which enables them to take immediate action to remove the identified items from use and prevent potential harm to patients.
The capture of UDI data (lot/serial number and expiration date) is an FDA-mandated standard encoding system for all medical devices, enabling track & trace from point of origin to the patient. One of the biggest advantages of UDI data capture is that it enables the immediate resolution of device recalls and rapid identification of medical devices with adverse events.
Of course, we rely on the FDA to issue the recall notification in the first place, so we welcome the pressure on the FDA right now to ensure effective and comprehensive recall oversight of manufacturers and provide diligent warning notices!
