Hospitals are having trouble finding sodium chloride injections due to recalls and supply disruptions.
B. Braun Medical has recalled five batches of leaking 250 milliliter sodium chloride injections, Food and Drug Administration. announced Thursday. Hospitals use sodium chloride, also known as saline, to replace fluids, wash wounds, compound drugs, deliver drugs intravenously, and stabilize patients during surgery.
Vials, syringes, bags and saline have been in short supply for the past two months because B. Braun Medical, Pfizer, Fresenius Kabi, Becton Dickinson, Baxter International and ICU Medical experienced production delays or product failures. American Society of Health System Pharmacists.
San Diego-based Sharp HealthCare experienced significant shortages last month of sodium chloride IV bags, rinsing solutions and 50% dextrose syringes. Although it is not as serious now, the integrated health system is still coping with the shortage and dealing with it on a weekly basis, the spokesman said. The shortage has not delayed any operations, the spokesman said.
The B. Braun Medical recall did not affect the University of Utah at Salt Lake City., but the problem shows how easily the supply of sterile injectables can be disrupted, says Erin Fox, senior director of pharmacies in the academic health system. “This is bad news given currently limited supplies.”
B. Braun Medical, which did not immediately respond to a request for comment, experienced quality issues at its manufacturing sites. in in past.
For example, the FDA sent companies warning letter in 2017 it mentioned leaking and contaminated IV bags. Although the issues were identified in 2013, according to the letter, B. Braun Medical has not fixed the issue as of May 2016. Since then, B. Braun Medical has invested $1 billion in new and expanded facilities that manufacture and distribute IV solutions.
Salt solution, like other sterile injectables, is subject to shortages due to the high cost of its production and storage. Manufacturers often stop making it and switch to higher margin items, making the supply chain more vulnerable.
Wholesaler and manufacturer of Cardinal Health, for example, remembered 267 million syringes with saline flush in August due to pistons that drew air into the syringes, which could cause a potentially fatal air embolism. According to the American Society of Health System Pharmacists, the company subsequently decided to discontinue production of these syringes.
No supplier has overcapacity to ramp up production to provide enough product, the pharmacists group wrote in a recent report. Blog Post which recommends that hospitals use disposable flush syringes or oral doses whenever possible.
“The shortage of IV solutions continues to plague hospitals, healthcare systems, outpatient infusion centers and home infusion agencies. Sometimes the supply of these products is so severely reduced that alternative strategies are needed.
As manufacturers, hospitals, and other stakeholders work to increase manufacturing capacity, the FDA must make sourcing, quality, volume, and potency information publicly available for all medical products sold in the US. report Recommended by the National Academy of Sciences, Engineering and Medicine.
Health systems must consider quality and reliability, in addition to price, when they make contracting, purchasing and inventory decisions, the National Academy report says. The report also recommends that the federal government upgrade the Strategic National Reserve and free up international supplies of essential medical supplies by banning export restrictions.