Here’s what you should know:
1. FDA Commissioner Scott Gottlieb, MD, released a statement saying the agency is monitoring the situation at 10 device manufacturers in Puerto Rico to avoid any sort of device product shortages. Specific devices or companies were not named.
2. The FDA is primarily monitoring blood-related medical devices.
3. The region is suffering from a lack of electrical power, connectivity, transportation and clean water.
4. Puerto Rican device manufacturers have been able to sustain production on generators, but are operating at decreased levels.
5. Manufacturers are having problems securing raw materials to fit specific device requirements.
6. Dr. 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.”
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