Summary: The FDA warns of a severe shortage of pediatric medical devices—ranging from breathing tubes to catheters—due to supply chain vulnerabilities, manufacturing constraints, and limited pediatric innovations. Officials urge Congress to bolster FDA authority and reporting requirements so that hospitals aren’t forced to compromise child patient safety with improvised solutions.
Key Takeaways:
- Pediatric device shortages are especially dangerous because of smaller production runs and limited alternatives, forcing care providers to adapt adult equipment.
- The FDA seeks earlier, broader reporting of potential supply chain disruptions to preempt shortages, emphasizing the need for expanded regulatory authority and resources.
The U.S. Food and Drug Administration (FDA) issued a warning drawing attention to a growing crisis in the medical device supply chain that could disproportionately impacts children and newborns. According to Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), said shortages of critical devices pose a heightened risk for some of the nation’s most vulnerable patients.
Unique Challenges for Pediatric Care
While medical device scarcities can be dangerous for all patients, Tarver emphasized that shortages in pediatric care are particularly dire. Devices designed for children often have smaller production runs, leaving fewer alternatives if a primary option becomes unavailable. When hospitals can’t procure the right device, they may resort to improvising with adult-sized equipment—raising the chances of suboptimal outcomes, longer hospital stays, and increased safety risks for children.
Supply Chain Vulnerabilities on the Rise
The FDA noted multiple factors behind these shortages, including natural disasters, manufacturing capacity issues, and insufficient innovation tailored to children’s needs. Additionally, constraints on ethylene oxide sterilization, an essential method for cleaning many medical devices, have already contributed to the scarcity of items such as pediatric tracheostomy tubes and oxygenators.
The agency pointed to new European Union rules mandating notification of impending medical device shortages. Such measures, officials say, grant European regulators a proactive edge in preventing or minimizing supply disruptions. In contrast, U.S. laws only require manufacturers to report potential shortages during or in advance of a public health emergency, leaving gaps in visibility and preparedness.
RELATED: FDA Adds AAMI Sterilization Guidance to Standards Database
Real-World Impacts
Shortages have already taken a toll in pediatric wards across the country, according to the agency. A recent shortage of specialized tracheostomy tubes forced some young patients to remain on ventilators for longer than medically advisable. A shortage of pediatric oxygenators delayed surgeries, while the lack of infant duodenoscopes threatened lifesaving procedures that can’t safely be performed with full-sized adult scopes. Pediatric nephrologists have also reported difficulties obtaining the proper catheters for hemodialysis in infants, placing these patients at risk of complications like blood clots and bleeding.
FDA’s Call for Action
To address the crisis, the FDA’s Office of Supply Chain Resilience (OSCR) is working to monitor and mitigate device shortages through impact assessments and collaboration with manufacturers. However, Tarver stressed that current regulatory tools are insufficient. The FDA is urging Congress to expand its authority to require earlier and more comprehensive reporting of supply chain disruptions regardless of public health emergency status and to secure full funding for a robust device supply chain program.
Without these measures, according to Tarver, the United States risks being caught flat-footed the next time critical pediatric devices start running low. The agency remains committed to working with manufacturers, healthcare providers, and policymakers to close the information gap and ensure that children can receive the specialized care they need.