Medical Device Supply Chain Vulnerabilities and the Public Health Impact They Have on Our Most Vulnerable Patients
FOR IMMEDIATE RELEASE
January 16, 2025
The following is attributed to Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH)
A critical focus of the U.S. Food and Drug Administration (FDA) is preventing and mitigating potential medical device shortages. From ventilators and neonatal breathing tubes to hemodialysis catheters, the scarcity of these critical devices poses a growing threat to patient care – especially for our youngest and most vulnerable populations.
For pediatric patients, medical device shortages are uniquely challenging. From premature infants in neonatal intensive care units to children with chronic illnesses requiring long-term medical interventions, the need for appropriately sized, high-quality devices is paramount. When shortages arise, there are few options that may accommodate children – compelling clinicians to adapt adult-sized equipment, which can lead to suboptimal outcomes and increased risks for patient safety.
While the vulnerabilities in the medical device supply chain are not new, we are growing increasingly concerned that the rise in shortages is having a significant adverse impact on neonatal and pediatric patients.
The roots of this critical issue are multifaceted. Shortages and other supply chain issues may result from natural disasters, limited manufacturing capacity for niche devices, manufacturing and quality problems, and insufficient investment in innovation for neonatal and pediatric populations, among others. In addition, we have already observed how ethylene oxide medical device sterilization capacity constraints can lead to shortages of the critical devices needed for these vulnerable populations.
As the global regulatory landscape evolves, the FDA risks falling behind in our ability to protect patients by assuring device availability in the United States. For example, on January 10, 2025, the EU rule on mandatory notification of medical device shortages went into effect. Now, the European Commission and member countries will have access to vital information about medical device shortages that could impact their population.
In contrast, there are no mandatory reporting requirements for potential medical device shortages in the U.S. except, as required, during or in advance of a public health emergency. The U.S. lacks comparable measures to provide critical information to our health care providers and act proactively to mitigate impacts from device shortages. This lack of transparency leaves hospitals and health care systems ill-prepared to address shortages, forcing them to rely on unpredictable or ad hoc solutions. Failing to ensure the U.S. government and health care providers in the U.S. have the same information as our European counterparts poses harm to providers, patients, caregivers, and consumers in the U.S.
We know from experience that reliance upon voluntary notifications to the FDA about device supply chain disruptions has not been effective. For example, in recent months, the FDA has had to rely mostly on hearing about medical devices shortages from health care providers and clinical professional societies. Given that this often occurs at the point-of-care, it is typically far too late to put measures into place that would otherwise avert these shortages. In many of these circumstances, neonatal and pediatric devices have been the most impacted.
The FDA recognizes that early awareness of supply chain disruptions is essential to mitigating the impacts of potential medical device shortages on patient care and protecting the public health.
Examples of Devices Impacting Children
The COVID-19 pandemic starkly highlighted the fragility of our medical device supply chains. Hospitals struggled to procure basic equipment like ventilators and personal protective equipment. For pediatric patients, who often rely on specialized devices with smaller production runs, these shortages were even more acute – often leading to increased risks and safety concerns.
Over the past several years, the FDA has seen a number of medical device shortages impacting pediatric patients – ranging from tracheostomy tubes to oxygenators to hemodialysis catheters and more. Several notable examples include:
- In 2019 and 2022, there was a shortage of the Bivona tracheostomy tube. In both instances, the shortage of these devices had larger impacts on pediatric patients because the supply of alternative tubes with similar functionality was limited. As a result of the 2022 shortage, pediatric patients and patients that required the smaller, more flexible tubes were unable to get the appropriate care in a timely fashion. In many instances, pediatric patients were even forced to stay on a ventilator for an extended period of time, which increased their risk of serious complications.
- In February 2023, there was a shortage of pediatric oxygenators, which are used in conjunction with cardiopulmonary bypass, or extracorporeal membrane oxygenation circuits, to provide respiratory and cardiac support to critically-ill pediatric and neonatal patients with severely compromised heart or lung function. Without these oxygenators, health care providers were forced at times to defer certain surgeries.
- In May 2023, pediatric gastrointestinal specialists from medical centers across North America urgently reached out to the FDA because of challenges obtaining infant duodenoscopes. These medical devices are specifically used for life-saving procedures in neonates and infants weighing less than 22 pounds. Without these devices, some infants would require more invasive surgical procedures that carry a higher morbidity and mortality rate, and for whom an adult-sized scope might potentially expose them to more serious complications, such as intestinal perforation.
- In 2023, the American Society of Pediatric Nephrology (ASPN) and other pediatric health care providers reached out to the FDA about extreme difficulties they were experiencing in obtaining pediatric hemodialysis catheters, especially those specifically designed for neonates and infants. This supply chain challenge, similar to those noted above, affected health care facilities nationwide, and was most consequential for some of our smallest and most vulnerable patients requiring hemodialysis or continuous renal replacement therapy, putting them at risk for complications such as blood clots, bleeding, and death.
FDA Actions to Prevent and Mitigate Potential Shortages
The Office of Supply Chain Resilience (OSCR), in CDRH’s Office of Strategic Partnerships & Technology Innovation (OST), is responsible for managing the FDA's activities related to anticipating and preventing disruptions to supply chains for medical devices, as well as to mitigate shortages when they do occur. As required by Section 506J of the Federal Food, Drug, and Cosmetic Act, OSCR is responsible for maintaining an up-to-date medical device shortages list. Manufacturers are required to submit 506J notifications “at least six months prior to the date” of a permanent discontinuance in manufacturing of a device, or an interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply of the device in the U.S. If that timeframe is not possible, section 506J(b)(2) requires that notification be done “as soon as practicable.”
The FDA uses the information gleaned from 506J notifications and other available sources to conduct shortage impact assessments, which are then used to inform regulatory and non-regulatory mitigations. As an example, CDRH’s analysis on supply chain disruptions has been used to inform regulatory and policy actions (e.g., expediting review of 510(k) premarket notifications, as well as exercising enforcement discretion, where appropriate), the use of the Defense Production Act (DPA), issuance of priority request letters, and transportation prioritization.
The FDA and other government agencies rely on CDRH’s analyses to inform supply chain policies and mitigations. As an example, in response to the Bivona tracheostomy tube shortage, CDRH’s impact assessments were used to support the issuance of a DPA rated order for a silicone-based raw material used in the manufacturing of the Bivona tracheostomy tube. During this shortage, CDRH also worked closely with the medical device manufacturer, raw material providers, and the Administration for Strategic Preparedness and Response (ASPR) to ensure the timely delivery of shipments. CDRH issued a public safety communication alerting health care providers, professional associations, and patients about the shortage and provided recommendations on potential alternatives and conservation strategies. These activities ultimately lessened the impact on our nation’s smallest patients.
Although CDRH routinely works to address shortages that occur with a specific device, raw material, or single manufacturer, we also work to prevent broader, more far-reaching impacts from supply chain issues that impact multiple manufacturers and multiple devices. For example, over the past two years, CDRH conducted an extensive analysis of the medical device sterilization landscape. This analysis was subsequently used to inform regulatory actions impacting sterilization capacity in the U.S. Our work helped to assure a more resilient supply chain.
Solutions and Next Steps
To safeguard patient care, especially for pediatric patients, the FDA had requested new statutory authority, to amend Section 506J of the CARES Act to remove the current temporal limitation that ties device shortage reporting requirements to public health emergencies, and full funding for the CDRH Supply Chain Program. These changes are essential for enabling proactive responses to prevent supply chain disruptions before they impact patient care, and the future of our health care system.
In recent years, Congress has provided resources to support CDRH’s efforts to respond to supply chain disruptions, and while these resources have been helpful, additional funding will be needed to sustain and enhance our abilities to help identify, prevent, and mitigate shortages.
The FDA remains committed to working within our current authorities and resources to strengthen the domestic supply chain and address vulnerabilities. The FDA is prioritizing efforts to ensure that no person’s health is jeopardized by preventable device shortages. Together, the FDA, health care providers, patients, hospitals, and Congress can work to ensure that pediatric and other patient populations receive the care they need without interruption.