Medical Device Manufacturing in Puerto Rico after Hurricane Maria

On October 20, 2017, FDA Commissioner Scott Gottlieb, M.D., issued a statement regarding the recovery of the medical device manufacturing industry in Puerto Rico. During the weeks since Hurricanes Irma and Maria devastated the infrastructure of Puerto Rico, the FDA worked to minimize shortages of medical devices manufactured at facilities on the island.


There were more than 50 medical device manufacturing plants in Puerto Rico. Collectively, they manufactured more than 1,000 different kinds of medical devices. These included simple but essential products like surgical instruments and dental products as well as highly complex devices such as cardiac pacemakers and insulin pumps.


The FDA monitored approximately 50 types of medical devices manufactured in Puerto Rico that were critically important to patient care — because they may be life-sustaining or life-supporting and/or because there is only a single manufacturer of that device type. The FDA worked closely with approximately 10 manufacturers – some of which are the sole manufacturer of a certain device type – to prevent medical device product shortages across the U.S. The FDA particularly focused on blood-related medical devices.


Puerto Rico’s device industry faced the same 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 continued to run on generator power. Consequently, they were unable to return to pre-hurricane production levels.


In addition to these concerns, the medical device industry faced obstacles specific to the unique production requirements of each of these products. The device manufacturers had significant variation in the raw materials they required and the production processes they employed. These manufacturers faced challenges in securing the various components critical to device development. These issues were exacerbated by the dependence on local subcontractors who provided many of the supplies needed for these unique manufacturing processes, but faced their own challenges and shortages.


The FDA worked with device companies and their suppliers to restore production in Puerto Rico as quickly as possible. Similar to the FDA’s efforts with drug manufacturers, the FDA also worked — in conjunction with manufacturers and government partners — to help device facilities secure fuel and the logistical support to move critical products onto and off the island. Manufacturing on the island remained fragile and the potential for device shortages persisted.


As the FDA monitored at-risk products, it took other steps to mitigate the potential for shortages. The measures included considering, when necessary, importing a device from outside of the U.S. and allowing manufacturers to shift production to alternative sites.


See the FDA Announcement


See also Medical Law Perspectives Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory