Fragile Production Situation in Puerto Rico Leads to IV Bag Shortage in the United States During Severe Flu Season

By: Rachael Kratz

On September 20, 2017, Hurricane Maria made landfall in Puerto Rico as a Category four hurricane, with winds reaching 155 miles per hour. As the strongest hurricane to hit Puerto Rico in almost 90 years, Hurricane Maria left millions without power. Further, parts of Puerto Rico reported nearly 35 inches of rain, resulting in flash flooding emergencies and additional damage.

Nearly five months later, Hurricane Maria’s widespread devastation can still be felt not only in Puerto Rico but also across the continental United States. Damage and extensive power outages resulted in the temporary shutdown of Baxter International, one of the leading medical manufacturers and suppliers of intravenous (“IV”) bags, with three factories in Puerto Rico. Baxter International was the first and continues to be one of the leading manufacturers of IV bags and commercially prepared IV solutions. Before Hurricane Maria, Baxter produced 44% of the IV bags used in the United States. The shutdown of Baxter’s facilities has added to an already ongoing national shortage of medical fluid-filled IV bags. The small IV bags are used to administer antibiotics, cancer treatment, painkillers, and nutrients to patients in hospitals across the United States. Of particular concern is the shortage of sodium chloride 0.9% IV bags, or saline bags, which are the most commonly used IV bags to hydrate patients in hospitals and healthcare facilities.

The IV bag shortage is causing grave concern among hospitals and physicians alike. Over 60% of healthcare providers have referred to the current IV bag shortage as severe. Due to the severity of this year’s flu season, there is an increased need for the IV bags and solutions. The greatest flu outbreak in recent years has presently spread, and is continuing to spread, across the United States. The Center for Disease Control (“CDC”) declared the flu an epidemic, as it is so widespread across the entire continental United States. Physicians are attempting to circumvent the IV bag shortage by treating patients with oral medication and hydration, or by injecting medications directly. Healthcare providers are prepared to use such strategies for weeks if not months.

On January 16, 2018, Food and Drug Administration (“FDA”) commissioner Dr. Scott Gottlieb, M.D., issued a statement regarding the current shortage of IV bags in the United States. The FDA is optimistic that the shortage will improve in the coming weeks, as it is working with Baxter and other manufacturers to import medical supplies to the United States. The FDA recently authorized IV products from additional companies not previously approved, to be imported into the United States in the next few weeks. However, the FDA is still seeking additional prospective import sites. Further, the FDA has asked the medical supply companies to possibly extend expiration dates on the IV products in hopes of salvaging products that are near expiration. Ultimately, the FDA urged patience, as it takes time for the new product supply to reach hospitals across the United States, and admitted that “the production situation in Puerto Rico remains fragile.”


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