Maintaining Peritoneal Dialysis Supply During Hurricane Helene

Background: In September 2024, the Baxter North Cove facility in North Carolina was impacted by Hurricane Helene (HH), leading to plant closure and interruption of peritoneal dialysis (PD) supplies to US patients. An urgent, integrated approach was needed to respond to supply challenges. Methods: A cross-functional team was established to manage the response to the PD solution supply disruption, which was expected to last months and which impacted approximately 50,000 US PD patients. Communication was immediately established with FDA, company manufacturing plants across the globe, professional societies (e.g., ASN) and clinical leaders of large dialysis organizations. Results: Actions are summarized in Fig 1. Supply was prioritized to prevalent patients, pediatrics and high clinical need patients. Preservation of existing inventory was supported by prescribing guidance from professional societies who published guidance online within 10 days. PD solution was imported from 5 global plants following the receipt of FDA temporary regulatory discretion using products with similar connectology as US products with a simplified portfolio. Prescription changes were implemented in conjunction with a product preservation strategy until restoration of prior production was achieved. Educational materials and training were provided to healthcare providers and PD patients to explain differences between imported and US products. Active monitoring of imported products through adverse event and device complaint reports as well as medical information requests was performed with no safety signals detected. Conclusion: HH caused disruption to PD supplies with a major impact on patients and healthcare providers. Through prioritization, preservation, communication, and simplification of PD supplies it was possible to maintain supply to US PD patients following FDA temporary regulatory discretion until production was restored. These are important lessons for PD manufacturers and PD prescribers to ensure resilience in the future.