Hospitals have had trouble sourcing sodium chloride injections amid recalls and supply disruptions.
B. Braun Medical recalled five lots of leaky 250 milliliter sodium chloride injections, the Food and Drug Administration announced Thursday. Hospitals use sodium chloride, also known as saline, to replenish fluids, flush wounds, compound drugs, deliver intravenous medications and stabilize patients during surgery.
Vials, syringes, bags and saline solution have been in short supply over the last two months because B. Braun Medical, Pfizer, Fresenius Kabi, Becton Dickinson, Baxter International and ICU Medical have endured manufacturing delays or product malfunctions, according to the American Society of Health-System Pharmacists.
San Diego-based Sharp HealthCare experienced significant shortages of sodium chloride IV bags, flushes and dextrose 50% syringes last month. While it is not as severe now, the integrated health system is still dealing with the shortage and is managing on week-to-week basis, according to a spokesperson. The shortage hasn’t delayed any surgeries, the spokesperson said.
University of Utah Health in Salt Lake City hasn’t been impacted by the B. Braun Medical recall, but the problem illustrates how easily the supply of sterile injectables can be disrupted, said Erin Fox, senior pharmacy director at the academic health system. “This is not good news in the face of currently constrained supplies.”
B. Braun Medical, which did not immediately respond to a request for comment, has had quality issues at its manufacturing sites in the past.
For instance, the FDA sent the company a warning letter in 2017 that cited leaking and contaminated intravenous bags. While the problems were identified in 2013, B. Braun Medical hadn’t corrected the problem as of May 2016, according to the letter. B. Braun Medical has since invested $1 billion in new and expanded facilities that produce and distribute IV solutions.
Saline solution, similar to other sterile injectables, is prone to shortages because it is expensive to produce and store. Manufacturers often stop making it and shift to higher-margin items, rendering the supply chain more vulnerable.
The wholesaler and manufacturer Cardinal Health, for instance, recalled 267 million saline flush syringes in August because of plungers that pulled air into the syringes, which could have caused potentially fatal air embolisms. The company subsequently decided to stop manufacturing these syringes, according to the American Society of Health-System Pharmacists.
No supplier has excess capacity to increase production to allow for sufficient quantities, the pharmacists’ group wrote in a recent blog post that advises hospitals to use single-use flush syringes or oral doses when possible.
“Shortages of intravenous solutions continue to plague hospitals, healthcare systems, ambulatory care infusion centers, and home infusion agencies. At times, the supply of these products is so heavily impacted that alternative strategies are needed,” the post says.
While manufacturers, hospitals and other stakeholders work to increase production capacity, the FDA should make sourcing, quality, volume and capacity information publicly available for all medical products sold in the U.S., a new report from the National Academies of Sciences, Engineering and Medicine recommends.
Health systems should incorporate quality and reliability, in addition to price, when they make contracting, purchasing and inventory decisions, the National Academies report concludes. The federal government should update the Strategic National Stockpile and free up the international supply of key medical products by banning export restrictions, the report also advises.