U.S. FDA Commissioner Scott Gottlieb has spoken out about medical device manufacturing recovery in Puerto Rico following the devastation of Hurricanes Irma and Maria. Currently, Puerto Rico is home to more than 50 medical device manufacturing plants, which produce more than 1,000 types of medical devices ranging from surgical instruments to pacemakers.
To address the potential for critical medical device shortages (among other objectives), Gottlieb said the FDA has joined federal and local relief efforts to rebuild the island. Key challenges for device manufacturers include 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,” Gottlieb said in a statement. “In addition to these concerns, the medical device industry faces obstacles specific to the unique production requirements of each of these products.”
For one thing, Gottlieb said, the raw materials these device manufacturers need vary significantly—as do the production processes they employ.
“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,” Gottlieb added. “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.”
He said the FDA is particularly focused on blood-related medical devices.
“As we continue to monitor at-risk products, the FDA is taking other steps to mitigate the potential for shortages,” Gottlieb said in a statement. “This includes considering, when necessary, importing a device from outside of the U.S., or allowing manufacturers to shift production to alternative sites.”
Gottlieb’s statement comes on the heels of a letter trade organization AdvaMed wrote to Acting Secretary of Health and Human Services Don Wright, MD to, solicit more relief efforts in Puerto Rico.
Although AdvaMed praised the “coordination efforts” between HHS, the U.S. FDA, the Federal Emergency Management Agency, and medical technology manufacturers, the trade group reinforced Puerto Rico’s need for resources, including food and fresh water. “Our industry has been in regular contact with your agency and we look forward to continuing to work together to reestablish communication and power to our members’ facilities as soon as possible,” AdvaMed wrote to Acting Secretary Wright.
