Medical device and drug manufacturing are significant industries in Puerto Rico. The U.S. Food and Drug Administration is monitoring companies’ facilities’ recovery after destruction resulting from Hurricanes Irma and Maria, and has found manufacturing there remains fragile with potential for shortages, explains FDA Commissioner Dr. Scott Gottlieb.

 

The medical device manufacturing sector in particular is struggling, Dr. Gottleib said last week in prepared remarks. There are currently more than 50 medical device manufacturing plants in Puerto Rico. Collectively, they manufacture more than 1,000 different kinds of medical devices, ranging from simple yet essential products such as surgical instruments, to highly complex devices such as cardiac pacemakers and insulin pumps.

 

“To date, we’re monitoring about 50 types of medical devices manufactured in Puerto Rico that are critically important to patient care—because they may be life-sustaining or life-supporting and/or because there may be a single manufacturer of that device type,” said Gottleib. “The FDA is working closely with about 10 manufacturers … to prevent medical device product shortages across the U.S. We are particularly focused on blood-related medical devices.”

 

Puerto Rico’s medical device industry faces the same significant challenges as most manufacturing sectors in Puerto Rico: a lack of power, connectivity, transportation, and clean water, said Gottleib. Most, if not all, of these medical device manufacturers continue to rely on generator power, and as a result, have been unable to return to pre-hurricane production levels. Similar to agency efforts with drug manufacturers, the FDA, along with manufacturers and government partners, is working to help device facilities secure fuel and the logistical support to move critical products onto and off the island, he said.

 

“We know it will likely be months before power is fully restored and medical product manufacturing returns to pre-hurricane levels,” Gottleib continued. “As we continue to monitor at-risk products, the FDA is taking other steps to mitigate the potential for shortages. This includes considering, when necessary, importing a device from outside of the U.S., or allowing manufacturers to shift production to alternative sites.”

 

A recent New York Times article offers an example which not only shows the inherent risk when many companies and facilities are clustered in a geographic area, but also the far-reaching impact of a supply chain disruption. In this case, the product is a Mini-Bag—a small, fluid-filled bag used to dilute drugs, like antibiotics, so they can be dripped into patients’ veins. The bag’s ease of use has made it popular in small facilities as well as at nationally known hospitals. Now, however, hospital pharmacists across the country are racing to find alternatives—which are becoming scarce themselves—after Hurricane Maria halted production at the factory in Puerto Rico where Baxter International makes the product.

 

Pharmacists at half a dozen hospitals, from Utah to North Carolina, said in interviews with NYT that the fluid bag shortage has had a domino effect, leading to scarcities of a range of products as administrators race to stock up on the supplies they need to keep their hospitals running smoothly. Even products like empty bags and plastic tubing, which are also made by Baxter in Puerto Rico, have been hard to come by, some said.

 

“With drug shortages, it’s often a race to see who can find a supply of the drug on shortage and also any alternatives,” Philip Trapskin, program manager of medication use strategy and innovation at UW Health, the University of Wisconsin-Madison’s health system, says in the NYT article. “We’ve been able to get what we need to avoid disruptions in patient care, but the mix of products isn’t ideal and there are no guarantees we will continue to get the supplies we need.”

 

In the meantime, Baxter recently announced that the FDA now allows it to import fluid bags from the company’s factories in Ireland and Australia, and that production in Puerto Rico was slowly resuming. While Baxter didn’t provide a timeline for when the bags would be back in stock, the reality is that it could be weeks—or even months.

 

What are your thoughts on the supply chain disruptions of pharmaceuticals and medical devices produced in Puerto Rico? Will the FDA indeed be able to help companies bring facilities back on-line quickly?