FDA: Puerto Rico's critical medical device industry struggling after hurricanes

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The U.S. Food and Drug Administration (FDA) is working closely with federal and local organizations in Puerto Rico to remedy medical device and drug shortages on the island following the devastation of Hurricanes Irma and Maria, the agency said in a release Oct. 20.

The FDA has been monitoring more than 40 drug products and medical devices in Puerto Rico, which is a U.S. hub for such manufacturing, according to a statement by FDA Commissioner Scott Gottlieb, MD. These products include “simple but essential” tools like surgical instruments and dental products and more complex products like cardiac pacemakers and insulin pumps. The FDA said it is focusing heavily on blood-related devices.

According to the release, there are more than 50 medical device manufacturing plants on the island, which employ around 18,000 locals. The plants manufacture a collective 1,000-plus medical products.

“Puerto Rico’s device industry is facing the same basic—but significant—challenges as most manufacturing sectors in Puerto Rico: a lack of power; connectivity; transportation; and clean water,” Gottlieb wrote. “Most, if not all, of these medical device manufacturers continue to run on generator power, and as a result, have been unable to return to pre-hurricane production levels.”

The results of these shortages could stretch nationwide, impacting thousands of Americans outside of Puerto Rico as well as employees and patients on the island, he said.

Gottlieb said that, since power will likely not be fully restored in Puerto Rico for months, the FDA is considering alternative options for device manufacturing, like importing products from outside the U.S. or allowing manufacturers to move production to other sites.

“The FDA continues to stand with the people recovering from this devastating series of storms,” Gottlieb wrote. “The FDA’s chief operating officer and associate commissioner for regulatory affairs  just returned from Puerto Rico, and I hope to return to the island again soon. At the FDA we will continue to do all we can to aid in Puerto Rico’s full recovery.”