January 21, 2025- The United States Food and Drug Administration (FDA) recently issued guidance on medical/dental device supply chain vulnerabilities and their impact on patients. Read the statement here:
A critical focus of the U.S. Food and Drug Administration (FDA) is preventing and mitigating potential medical device shortages. 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.
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.
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.
Continue Reading from the FDA.