Dr. Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, said critical shortages in devices, such as neonatal breathing tubes, pediatric hemodialysis catheters and oxygenators, are putting vulnerable populations at risk, according to the agency’s news release.
While medical device shortages remain a persistent problem, the FDA is growing increasingly concerned about their effects on children, particularly those in neonatal ICUs and with chronic illnesses. The shortage of appropriately sized, high-quality devices forces clinicians to use adult-sized alternatives, which can lead to serious complications and unsafe outcomes.
Dr. Tarver pointed to multiple causes for these shortages, including limited manufacturing capacity, quality-control problems and a lack of investment in pediatric-specific devices. The FDA has been addressing these issues, but Dr. Tarver also stressed that the current system, which relies on voluntary reporting of shortages, often leaves healthcare providers unprepared to respond.
To reduce additional risks among vulnerable patients, the FDA is seeking new statutory authority and additional funding to improve its ability to predict and mitigate shortages.
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