Medical Device Manufacturing in Puerto Rico Still Challenged: FDA Chief

More than 50 medical device manufacturing plants operated in Puerto Rico, employing about 18,000 people, prior to the hurricane. Collectively, they manufacture more than 1,000 different kinds of medical devices.

Medical device and drug manufacturing are significant industries in Puerto Rico, and the FDA is monitoring those companies' recovery after two damaging hurricanes, Irma and Maria. FDA Commissioner Dr. Scott Gottlieb issued a statement Oct. 20 saying manufacturing remains fragile there and the potential for device shortages persists. "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," he said. "We know it will likely be months before power is fully restored and medical product manufacturing returns to pre-hurricane levels. The FDA is committed to helping restore the medical product manufacturing in Puerto Rico as part of our efforts to protect the health of Americans and help the people of Puerto Rico recover their local economies and livelihoods."

The agency has been monitoring more than 40 drug products made in Puerto Rico and working with dozens of pharmaceutical and medical device companies to help them get their facilities get back online, get employees to return to work, increase their production of vital medical products, he explained.

More than 50 medical device manufacturing plants operated in Puerto Rico, employing about 18,000 people, prior to the hurricane. "Collectively, they manufacture more than 1,000 different kinds of medical devices. These include simple but essential products like surgical instruments and dental products as well as highly complex devices such as cardiac pacemakers and insulin pumps," he wrote. "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 the single manufacturer of that device type. The FDA is working closely with about 10 manufacturers – some of which are the sole manufacturer of a certain device type – to prevent medical device product shortages across the U.S. We are particularly focused 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. 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. In addition to these concerns, the medical device industry faces obstacles specific to the unique production requirements of each of these products. The device manufacturers have significant variation in the raw materials they require and the production processes they employ. These manufacturers face challenges in securing the various components critical to device development. These issues are exacerbated by the dependence on local subcontractors who provide much of the supplies needed for these unique manufacturing processes, but are facing their own challenges and shortages. This includes suppliers of components of a finished medical device or industrial gases, as well as tools that are critical to the production of devices."

FDA may decide to import a device from outside the United States or allow manufacturers to shift production to alternative sites, he wrote.

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