Gottlieb updates on Puerto Rico med device manufacturing recovery

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In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has been working with federal and local agencies, today provided an update to its efforts to help medical device manufacturers prevent potential shortages of medical devices like insulin pumps or pacemakers.

FDA commissioner Scott Gottlieb said today that there are more than 50 medical device manufacturing plants in Puerto Rico and collectively they employ 18,000 people and make more than 1,000 different types of devices.

The regulatory agency reported that it is monitoring 50 types of medical devices made on the island that are critically important to patients and that it is working with 10 manufacturers to prevent shortages, focusing specifically on blood-related medical devices.

“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 in a statement. “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.”

Device manufacturers in Puerto Rico are also facing challenges in getting the materials needed to develop and build their devices, the commissioner said. Many of the companies depend on local sub-contractors for supplies, but the sub-contractors are facing problems of their own.

The FDA is working with companies to gain access to fuel, Gottlieb wrote, and is also helping companies move critical products on and off the island.

The agency said it will probably be months before power is fully restored and the device manufacturers can return to business as usual.

“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.”

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