
FDA CDRH Director Dr. Michelle Tarver [Photo courtesy of the FDA]
Specifically, the FDA’s Center for Devices and Radiological Health (CDRH) wants to address supply chain issues that disproportionately affect neonatal and pediatric patients.
CDRH Director Dr. Michelle Tarver said device shortages have a critical impact on vulnerable populations, especially when products like neonatal breathing tubes and pediatric hemodialysis catheters run low. Shortages often force clinicians to adapt adult-sized devices for children, increasing the risk of complications.
“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,” Tarver said in an FDA news release dated Jan. 16 during the final days of the Biden administration. “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.”
Related: Vision check with FDA CDRH Director Dr. Michelle Tarver
The FDA is advocating for legislative changes to expand reporting requirements under Section 506J of the CARES Act, which currently limits mandatory shortage reporting to public health emergencies. The agency also seeks additional funding to strengthen the CDRH Supply Chain Program.
Tarver also compared the U.S. system with a new European Union rule that requires notification of device shortages, which took effect Jan. 10. Without comparable measures, the FDA said U.S. hospitals and healthcare systems do not have the critical information to proactively address shortages.
For example, device shortages in recent years have included pediatric oxygenators, duodenoscopes, and tracheostomy tubes.
“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,” Tarver said.
The FDA’s Office of Supply Chain Resilience has worked to mitigate these issues, using tools such as priority reviews, the Defense Production Act, and collaboration with manufacturers. However, Tarver said that broader systemic changes are needed to prevent future disruptions.
In May 2023, under former CDRH Director Jeff Shuren, the FDA ended mandatory medical device shortage reporting.