Who is to blame for the IV bag shortage—Hurricane Maria, resin suppliers or medical device OEMs?

Hurricane Maria has devastated Puerto Rico—eight weeks after the hurricane hit, more than half of the island’s power grid is still offline—but it is also affecting the U.S. mainland, namely by causing a shortage of plastic bags used to administer medications intravenously to hospital patients.

As NPR reported this week, the storm damaged many of the island's more than 100 drug and medical device manufacturers. “Puerto Rico produces about $40 billion worth of pharmaceuticals for the U.S. market, according to the Food and Drug Administration—more than any other state or territory,” reported Alison Fitzgerald Kodjak on NPR’s Morning Edition broadcast.

Medical device company Baxter (Deerfield, IL), one of the biggest suppliers of IV bags to U.S. hospitals, operates three facilities in Puerto Rico, all of which shut down temporarily following the hurricane. At least two of the plants are still running on generators, according to NPR.

The shortage is especially affecting small saline-solution bags, which are commonly used for IV drug delivery in hospitals. For example, the Cleveland Clinic uses the bags to administer 350 different medications, reports Bloomberg Businessweek. Hurricane Maria exacerbated the shortage, but this has been a long-standing problem, notes the article.

“Another large maker of the bags, B. Braun Medical Inc., is having problems of its own—the U.S. Food and Drug Administration is looking into reports of leaky and moldy intravenous bags. And a third, ICU Medical Inc., hasn’t been able to keep up with the increased demand. The industry has also been swept up in a U.S. Department of Justice criminal probe of possible collusion and price-fixing,” write Robert Langreth and Cynthia Koons in the Bloomberg piece.

Writing on the Spend Matters website, Tom Finn wonders if the saline bag shortage, which “has been going on for years,” isn’t engineered by resin producers to drive up prices.

“It turns out that there are very few resin producers that make the type and grade used to manufacture saline bags,” writes Finn, who describes himself as a serial entrepreneur with specific expertise in supply chain management in the healthcare sector. “Not only did these producers cut production, but they’ve increased their pricing by more than 300% in the last year. Why? The most popular answer is to cover the costs related to what the resin producers claim are potentially new and devastating liabilities.”

Blame the lawyers? Hold on, writes Finn. “The resin problem didn’t sneak up on anyone, meaning the consequences now being suffered were premeditated. Isn’t it far more likely that the resin producers are just holding out to reset their price point?” he asks.

Or should medical device OEMs share in the blame? The article in Bloomberg Businessweek notes that “basic hospital supplies with thin profit margins are low priorities for a consolidating pharma industry that has failed to modernize outmoded factories or ramp up supply.” Small saline-solution bags typically cost about $1.50.

As a short-term fix to the crisis, FDA is allowing Baxter to import bags and associated products from its plants in Europe, Australia, Canada and Mexico. Manufacturers themselves have begun rationing shipments to hospitals to prevent hoarding.

Whether the IV bag shortage is manmade or the result of a natural disaster—or, indeed, a combination of both—it is distressing that hospitals must now scramble to find alternatives to a basic, life-saving medical device.