After Hurricanes in Puerto Rico, FDA Aims to Spark Medical Device Production

^{Credit: CIRA, NOAA, Wikimedia Commons}

After Hurricanes Irma and Maria battered Puerto Rico last month, any number of pressing problems have plagued the island. Among them are threats to public health and a slowdown in the manufacturing of drugs and critical medical devices.

The US Food and Drug Administration is trying to help these facilities come back online, so that they might better produce technologies that benefit not only Puerto Rico, but the rest of the country, according to a statement released today, Oct. 20, by Commissioner Scott Gottlieb, MD. The agency has been working with dozens of medical device companies to help get employees to work, secure necessary resources, and prevent equipment shortages, he said.

“We know it will likely be months before power is fully restored and medical product manufacturing returns to pre-hurricane levels,” Gottlieb said. “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.”

More than 50 medical device manufacturing plants employ roughly 18,000 people in the US territory, according to the FDA. They’re responsible for churning out 1,000 different types of devices, which range from the “simple but essential,” like surgical tools and dental products, to more complex and high-tech products.

The FDA is monitoring “about 50” of those devices that are “critically important to patient care,” Gottlieb said. Further, he added, his agency is “working closely” with 10 manufacturers, some of whom are the only ones to create a certain product, to prevent shortages. That effort most notably focuses on blood-related devices.

The medical device sector is battling a lack of power, connectivity, transportation, and clean water.

“Most, if not all, of these medical device manufacturers continue to run on generator power,” the FDA head said, “and as a result, have been unable to return to pre-hurricane production levels.”

On top of that, the raw materials required for these specialized products have been unable to reach the plants in many cases, Gottlieb claimed. A “dependence” on local subcontractors—who are trying to overcome similar challenges—has left medical device makers devoid of certain gases and tools, he said.

The FDA is trying to help these operations secure fuel, logistical support, and the ability to transport their products around and off Puerto Rico, according to the agency. But manufacturing “remains fragile,” risking device shortages, Gottlieb said.

Down the road, the government may consider importing certain devices from outside the US or allowing device makers to launch production at other locations, he said.