While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal intensive care units and pediatrics.
Specifically, shortages of appropriately-sized devices may force clinicians to adapt with equipment designed for adults, leading to suboptimal care and increased risk, the agency’s device center director, Michelle Tarver, M.D., Ph.D., said in an FDA notice.
“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,” wrote Tarver, who took the helm of the Center for Devices and Radiological Health last October.
“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,” she added. “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 also pointed to recent regulatory changes that have taken effect in the European Union this month, with requirements for companies to provide early notices of supply interruptions or product discontinuations, related to certain devices and diagnostic tests.
“As the global regulatory landscape evolves, the FDA risks falling behind in our ability to protect patients by assuring device availability in the United States,” Tarver said.
“In contrast, there are no mandatory reporting requirements for potential medical device shortages in the U.S. except, as required, during or in advance of a public health emergency,” she added. “The U.S. lacks comparable measures to provide critical information to our health care providers and act proactively to mitigate impacts from device shortages.”
“This lack of transparency leaves hospitals and health care systems ill-prepared to address shortages, forcing them to rely on unpredictable or ad hoc solutions. Failing to ensure the U.S. government and health care providers in the U.S. have the same information as our European counterparts poses harm to providers, patients, caregivers, and consumers in the U.S.”
“We know from experience that reliance upon voluntary notifications to the FDA about device supply chain disruptions has not been effective,” Tarver said, adding that the agency has recently become informed of device shortages from healthcare providers and professional societies.
Named examples of device scarcity affecting children included the 2019 and 2022 shortages of ICU Medical’s Bivona tracheostomy tube—the latter stemming from difficulties in accessing silicone raw materials during the COVID-19 pandemic.
In response, the FDA supported an order for more silicone under the Defense Production Act to increase supplies, and alerted providers on conservation strategies.
February 2023 brought a shortage of pediatric oxygenators used for critical life support operations and cardiopulmonary bypass surgeries. Later that year, physicians reached out to the agency describing challenges in obtaining duodenoscopes employed in life-saving gastrointestinal procedures for neonates and infants weighing less than 22 pounds.
At the same time, the American Society of Pediatric Nephrology and other healthcare providers contacted the FDA over trouble procuring pediatric hemodialysis catheters, affecting patients requiring continuous renal replacement therapy.
While the FDA is required by law to maintain an up-to-date list of medical devices shortages —and manufacturers, in turn, are required to submit notifications at least six months ahead of a permanent end to a device’s production, as well as for meaningful supply delays, or “as soon as practicable”—Tarver said the agency has requested new statutory authority to amend the portions of the law that tie reporting requirements to public health emergencies, especially for pediatric patients, and has asked for full funding of CDRH’s Office of Supply Chain Resilience.
“In recent years, Congress has provided resources to support CDRH’s efforts to respond to supply chain disruptions, and while these resources have been helpful, additional funding will be needed to sustain and enhance our abilities to help identify, prevent, and mitigate shortages,” Tarver said. “Together, the FDA, health care providers, patients, hospitals, and Congress can work to ensure that pediatric and other patient populations receive the care they need without interruption.”