On Oct. 20, FDA said it had “joined federal and local agencies in the effort to help the people of Puerto Rico recover and begin to rebuild the island.”
The agency reported that it is “working closely with dozens of pharmaceutical and medical device companies to help these important facilities get back online; enabling employees to return to work and manufacturers to ramp up production of medical products used by all Americans.”
Commissioner Scott Gottlieb, MD, said, “There are currently more than 50 medical device manufacturing plants in Puerto Rico, employing about 18,000 people. 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 complex devices such as cardiac pacemakers and insulin pumps.
“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 they 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.
