SURGICAL/CTRITICAL CARE
to secure saline products from plants out- side of the U.S. In late 2017, the agency announced that it had approved temporary import of products from Baxter facilities in Ireland, Australia, Mexico and Canada, and from B. Braun in Germany.
In addition to temporary imports, the FDA also continued to expedite review of drug applications, including approval of Fresenius Kabi and Laboratorios Grifols saline to help address the shortage.12 In January 2018, B. Braun Medical
announced that it has received FDA approval for 0.9% sodium chloride injec- tion, USP in its Ecoflac Plus 500 mL container, which it had been temporar- ily importing to the U.S. from its FDA inspected sterile injectable facility in Melsungen, Germany.13
More relief came in April 2018, when
Baxter initiated temporary importation of saline products produced by the com- pany’s manufacturing facility in Ireland and marketed in Europe.14
Then the market took a step back when Fresenius Kabi issued a voluntary nation- wide recall of its sodium chloride injec- tion, USP, 0.9% in November 2018, citing product labeling issues.15
The calm before the next storm Things were looking up in early 2019, after the U.S. Justice Department closed an antitrust probe examining possible com- munication among IV solutions manufac- turers during supply shortages that created higher prices.16
In May 2019, B. Braun announced Solutions
for Life, a $1 billion investment in “new and enhanced IV therapy manufacturing facili- ties including a new state-of-the-art manu- facturing facility in Daytona Beach, Fla., and modernizations to existing facilities in Irvine, Calif., and Allentown, Pa.”17
A sudden drain on sodium chloride from COVID
From the time SARS-CoV-2 hit the U.S. in early 2020, through the waves of variants that have sickened patients for nearly three years, healthcare providers have struggled with saline shortages due to a variety of factors. The supply has never fully stabilized from the production issues and recalls that have persisted since 2014, despite efforts by the FDA and manufacturers. The pandemic-driven influx of hospital- ized patients increased demand for saline
used to rehydrate patients, administer medications and flush vascular access devices (VAD).
Even COVID-19 vaccines have played a
role in saline shortages. Pfizer, a producer of the small vials of saline used to flush drugs infused through intravenous lines, shifted use of these vial to production of its Pfizer-BioTech CD- vaccine. When healthcare providers turned to large bags of saline to fill flush syringes, this snowballed into shortages of these products as well. Alongside the pandemic, recalls have con- tinued, including Cardinal Health’s August 2021 voluntary recall of select Monoject Flush Prefilled aline yringes (. sodium chlo- ride), which are intended for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.18 A subsequent recall of Aligned Medical Solutions custom convenience kits, which contained the Monoject syringes, occurred in November 2021.
Where we are now? The rollercoaster of supplies and short- ages has continued into 2022. In January of this year, B. Braun announced that it had received final FD approval for its new
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hpnonline.com • HEALTHCARE PURCHASING NEWS • November 2022 15
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