The FDA is warning that rising medical device shortages pose an outsized risk to pediatric patients.
Shortages of key pediatric devices — including tracheostomy tubes, oxygenators, hemodialysis catheters and duodenoscopes — have forced clinicians to delay care or adapt adult equipment for infants and children, according to a Jan. 16 statement from Michelle Tarver, MD, PhD, director of the agency’s Center for Devices and Radiological Health. Many of these shortages were first identified by clinicians, not manufacturers, making them harder to mitigate in real time, Dr. Tarver said.
The FDA cited multiple incidents from 2019 to 2023 in which pediatric patients faced care delays or increased risks due to lack of appropriately sized equipment. For example, in 2023, physicians reported a shortage of infant duodenoscopes used for life-saving procedures in patients weighing less than 22 pounds. Without these devices, some infants required more invasive surgeries.
Unlike the European Union, which enacted a mandatory shortage notification rule Jan. 10, 2025, the U.S. only requires medical device manufacturers to notify the FDA of supply disruptions during a public health emergency.
To close this gap, the FDA has asked Congress for expanded statutory authority and full funding of its device supply chain program. In the interim, the agency said it will continue working within current limits to protect vulnerable patients from preventable shortages.
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