The U.S. Food and Drug Administration (FDA) is focusing renewed efforts on the need to address medical device supply chain vulnerabilities impacting children.
In a press release issued by the agency in mid-January, Michelle Travers, M.D., director of the Center for Devices and Radiological Health (CDRH), says that “the FDA risks falling behind in our ability to protect patients by assuring device availability in the United States.”
Further, Travers says that the impact of shortages of specialized medical devices with smaller production runs is more acute with pediatric patients. As examples, Travers points to the shortage of tracheostomy tubes in 2019 and 2022, and a shortage of pediatric oxygenators and pediatric hemodialysis catheters in 2023.
A factor contributing to the problem, according to Travers, is the absence of mandatory reporting requirements in the U.S. for potential medical device shortages, except in advance of or during a public health emergency. Unlike the European Union, which implemented in 2025 mandatory notification requirements of medical device shortages, the absence of reporting requirements in the U.S. “poses harm to providers, patients, caregivers, and consumers,” notes Travers
As for solutions, Travers recommends that the U.S. Congress provide the FDA with the statutory authority to remove current limitations on device shortage reporting requirements, as well as full funding for the CDRH Supply Chain Program.
The FDA press release on its efforts to address medical device supply chain vulnerabilities is available at https://www.fda.gov/medical-devices/medical-devices-news-and-events/medical-device-supply-chain-vulnerabilities-and-public-health-impact-they-have-our-most-vulnerable.
