SILVER SPRING, Md., Oct. 20, 2017 /PRNewswire-USNewswire/ -- During the weeks since Hurricanes Irma and Maria devastated the infrastructure of Puerto Rico, the U.S. Food and Drug Administration has joined federal and local agencies in the effort to help the people of Puerto Rico recover and begin to rebuild the island. Among the challenges the FDA has addressed is the potential for shortages of critical medical products. The FDA has been monitoring more than 40 drug products and 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.

I've spoken recently about the importance of the medical product manufacturing presence in Puerto Rico, both to the economic well-being of the island, and to the health of all Americans. The FDA has provided information on the scope of drug manufacturing in Puerto Rico and our concerns around the potential for critical drug shortages resulting from impacts to these facilities.

Unfortunately, the devastation caused by the hurricanes to Puerto Rico's medical product manufacturing sector goes beyond the effects on pharmaceutical companies. The FDA has been working equally hard to minimize shortages of medical devices manufactured in facilities on the island.
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 highly 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 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.

Medical Devices Homepage