FDA chief weighs in on recovering medtech manufacturing in Puerto Rico

Scott Gottlieb
With a particular focus on blood-related medical devices, the FDA is working with about 10 devicemakers to recover their Puerto Rico operations and avoid a medical device shortage.

In the aftermath of hurricanes Irma and Maria, the FDA is monitoring dozens of medical products and working with pharma and medtech companies to get their Puerto Rico operations back on track, said FDA Commissioner Scott Gottlieb in a statement Friday.

More than 50 medtech companies maintain manufacturing plants in Puerto Rico, employing around 18,000 people and manufacturing more than 1,000 types of medical device, Gottlieb wrote.

Medtech players, including Medtronic, Abbott and Boston Scientific, scrambled to track down their employees, check in on their communities and gauge the damage done to their operations there, the Star Tribune reported in September. Now, the efforts are focusing on preventing a shortage of medical devices.


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RELATED: FDA concerned about possible drug shortages in wake of devastation in Puerto Rico

While the FDA is keeping an eye on more than 50 critically important devices, the agency is “working closely” with about 10 medical device makers, some of which are the only manufacturer of a particular device, Gottlieb said. Critically important devices are those that are life-sustaining or life-supporting and/or devices that are manufactured by a single company.

RELATED: Hurricane Maria shutters much of Puerto Rico's pharma manufacturing

Lack of electricity, transportation, connectivity and clean water is plaguing most of Puerto Rico’s industry. But while many devicemakers in the territory are running on generator power, this isn’t enough to return their productivity to normal levels, Gottlieb wrote.

Specifically, the FDA is helping devicemakers obtain fuel and logistical support to move raw materials and finished devices on and off the island. The agency is also considering options to ward off device shortages, including importing devices and allowing devicemakers to move manufacturing operations to other sites, Gottlieb said.

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