The United States is grappling with a critical shortage of intravenous (IV) fluids, a problem that has been brewing for years and was further amplified by the recent devastation caused by Hurricane Helene. These essential fluids, including saline, dextrose solutions, and lactated Ringer’s solution, are vital for a wide range of medical treatments, from hydration and wound cleaning to dialysis.
Before the hurricane, the US was already experiencing shortages of IV fluids, as reported by the FDA. Saline solution has been in short supply since 2018, sterile water since 2021, and dextrose solution since early 2022. Hurricane Helene compounded the issue, pushing the shortage to new heights and adding peritoneal dialysis fluids to the list of scarce resources.
The closure of Baxter International’s plant in North Carolina, responsible for producing approximately 60% of the country’s IV fluids, has drastically intensified the shortage. This situation has left hospitals across the nation struggling to maintain adequate supplies, with many reporting a severe lack of IV fluids for essential treatments.
The shortage is a result of a complex interplay of factors. The high regulatory standards and delicate sterilization process involved in producing IV fluids make it a challenging endeavor. Additionally, the low profitability of manufacturing these fluids has discouraged companies from entering the market. IV fluids require significant space and resources for production and storage, while their relatively low cost provides limited financial incentive for drugmakers.
Furthermore, the production process is further complicated by the need to control endotoxins, harmful bacteria that are resistant to sterilization. This factor adds another layer of complexity and cost to the manufacturing process.
In response to this mounting crisis, the federal government has invoked the Defense Production Act, providing Baxter with priority access to materials necessary to rebuild its damaged North Carolina facility. The FDA has also granted Baxter temporary permission to import IV fluids from plants in Canada, China, Ireland, and the UK.
However, despite these efforts, Baxter anticipates meeting only 90% of its customers’ needs by the end of the year. This leaves hospitals grappling with the consequences of the shortage, including the postponement of elective surgeries due to insufficient IV fluid supplies.
The impact of the shortage extends beyond hospitals. Medical device manufacturers, such as Boston Scientific and Edwards Lifesciences, are expected to experience minimal disruption if the shortage is resolved by early next year. However, hospital operators like HCA Healthcare and Tenet Healthcare are facing significant concerns as delays in surgeries could negatively affect their revenues.
Baxter has announced that the first FDA-authorized product shipments for temporary importation are set to arrive in the US this weekend. In collaboration with the ASPR, the company estimates that by year-end, about 200 Boeing 747 cargo planes – equivalent to nearly 18,000 tons of product – will be delivered from Europe and Asia. Providers could begin receiving these shipments in the coming weeks.
This critical shortage highlights the fragility of the US medical supply chain and emphasizes the urgent need for robust solutions to ensure the availability of essential medical supplies. The situation underscores the importance of prioritizing investments in critical medical infrastructure and exploring innovative approaches to address challenges in the production and distribution of essential medications and medical devices.