Medical Device Shortages Pose a Serious Risk for Pediatric Patients: FDA

FDA is requesting authority from Congress to require manufacturers to report potential device shortages at all times, not just during emergencies.

Federal health officials are planning to request that Congress grant them the authority to mandate a six-month advance notice of any anticipated disruptions in medical device supply chains, regardless of whether a public health emergency exists.

During the COVID-19 pandemic, many devices for adults and pediatric patients were in low to no supply, including ventilators, neonatal breathing tubes, hemodialysis catheters and tracheostomy tubes, highlighting major supply chain production issues during public health crises.

However, since the pandemic, manufacturers have continued to experience supply chain issues with tracheostomy tubes, pediatric oxygenators, infant duodenoscopes and pediatric hemodialysis catheters, with some of those most recent shortages occurring in 2023.

As a result, the U.S. Food and Drug Administration (FDA) issued a press release on January 16, warning that potential medical device shortages during public health emergencies could threaten patient care, particularly for vulnerable groups like children and premature newborns. The agency also announced its intention to request a requirement for manufacturers to provide at least six months’ advance notice of potential shortages at all times.

Dr. Michael Tarver, the director of the Center for Devices and Radiological Health (CDRH) at the FDA, indicates that it is challenging to offer a high level of care when medical device shortages occur under normal circumstances. However, when the healthcare system is already strained, like under public health emergency scenarios, and these shortages occur, it can be deadly.

In particular, Tarver warns that many medical devices widely available on the market cannot be used, even with some alterations, on pediatric patients because they are simply too large. Premature infants in neonatal intensive care units (NICU) with chronic illnesses require long-term medical intervention, and when doctors try to make adult-sized equipment fit children, it can lead to poor quality care.

Medical device shortages and supply chain issues can occur from natural disasters, limited manufacturing capacity for niche devices, problems with manufacturing and quality, as well as an overall lack of investment in pediatric devices. Additionally, the agency said it is often notified of issues by doctors and medical societies, not the manufacturers who are at the source of the problem.

The FDA’s press release came just days after the European Union issued a mandatory notification rule on January 10, which requires member countries to be notified of instances that can lead to medical device shortages.

However, there is no mandatory reporting requirement for the U.S. except during public health emergencies. At those times, the Federal Food, Drug, and Cosmetic Act section 506J calls for notification at least six months before the date of an expected interruption in the supply chain, or if a device will be discontinued.

Tarver indicates the FDA intends to ask Congress to grant it the power to put that six-month limitation in place at all times, not just when there is a public health emergency. Furthermore, the agency is asking for increased funding for the CDRH Supply Chain Program to help prevent any supply chain disruptions, not just during emergencies.

“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. “The FDA is prioritizing efforts to ensure that no person’s health is jeopardized by preventable device shortages.”