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Medical Devices / Commercial Operations

Gottlieb: Puerto Rico Device Firms Still Operating Below Capacity

Nov. 1, 2017
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Helping to restore medical manufacturing in Puerto Rico has been the “highest priority” at the FDA since hurricanes Maria and Irma struck, Commissioner Scott Gottlieb told a congressional committee on Oct. 24.

None of the facilities in Puerto Rico have reached 70 percent of their pre-storm capacity, Gottlieb said at a House Energy and Commerce subcommittee hearing on the recent hurricanes. The agency has planned more than 200 site visits to plants on the island, he said.

A focus of the FDA’s efforts is maintaining electrical power for the factories because most are running on generators. Many generators are old, however, so they cannot be counted on for sustained operation, and they all need fuel to operate, he said.

In an Oct. 20 statement, Gottlieb said the agency is monitoring about 50 types of medical devices manufactured in Puerto Rico to mitigate the potential of a countrywide shortage. Blood-related devices, such as diabetic insulin pumps, are at the top of the agency’s priority list. Puerto Rico has more than 50 medical device facilities manufacturing upwards of 1,000 devices, according to Gottlieb, and some are the only facilities that manufacture a certain type of device.

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