FDA Releases Report on Supply Chain Vulnerabilities

The FDA has released a report about supply chain vulnerabilities and the public health impacts they cause.

The report specifically singles out shortages in the pediatric supply chain as “uniquely challenging,” stating that “from premature infants in neonatal intensive care units to children with chronic illnesses requiring long-term medical interventions, the need for appropriately sized, high-quality devices is paramount.” The causes of pediatric supply chain shortages include “natural disasters, limited manufacturing capacity for niche devices, manufacturing and quality problems, and insufficient investment in innovation for neonatal and pediatric populations, among others.”

Additionally, “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.” 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.”

The report lists several examples of shortages of devices that impacted children. One such example is a shortage of a tracheostomy tube that resulted in many pediatric patients being “forced to stay on a ventilator for an extended period of time, which increased their risk of serious complications.”

The FDA “uses the information gleaned from 506J notifications [by the Office of Supply Chain Resilience] and other available sources to conduct shortage impact assessments, which are then used to inform regulatory and non-regulatory mitigations.” The FDA has further requested “new statutory authority, to amend Section 506J of the CARES Act to remove the current temporal limitation that ties device shortage reporting requirements to public health emergencies, and full funding for the CDRH Supply Chain Program. These changes are essential for enabling proactive responses to prevent supply chain disruptions before they impact patient care, and the future of our health care system.”