Medical device shortages present pediatric patient challenges, FDA warns

Editor's Note

Although medical device shortages threaten all patients, a recent FDA announcement highlights particular risks for pediatric populations who require size-appropriate equipment. “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,” reads the January 17 warning from Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH).

Reliance on adult-sized devices can increase complications, and options for alternative equipment can be limited, Tarver writes. Notable recent shortages have included tracheostomy tubes, pediatric oxygenators, infant duodenoscopes, and neonatal hemodialysis catheters. In addition to increased risks of complications, such shortages have resulted in delayed surgeries or the use of less suitable, more risky alternatives.

The root causes of these shortages are multifaceted, Tarver writes. Natural disasters, limited manufacturing capacity, raw material shortages, and insufficient innovation for pediatric devices exacerbate supply chain vulnerabilities. Additionally, ethylene oxide sterilization constraints have further strained the production of critical devices.

Unlike the European Union, which mandates reporting of device shortages, the US lacks comprehensive reporting requirements outside of public health emergencies, Tarver points out. The FDA currently relies on voluntary notifications, often learning of shortages too late to implement effective mitigation measures. This gap leaves hospitals and providers unprepared to address shortages proactively.

To address these issues, the FDA’s Center for Devices and Radiological Health (CDRH) uses regulatory tools, such as prioritizing premarket reviews, leveraging the Defense Production Act, and issuing conservation guidance, Tarver writes. FDA also advocates for legislative changes to enable proactive shortage reporting and sustained funding to enhance supply chain resilience.