FDA Steps Up Efforts to Aid Med Device Production in Puerto Rico

In a statement Commissioner Scott Gottlieb said they are ‘particularly focused on blood-related medical devices.’
In a statement Commissioner Scott Gottlieb said they are ‘particularly focused on blood-related medical devices.’

The Food and Drug Administration (FDA) is working with 10 medical device manufacturers in Puerto Rico in order to prevent a shortage of medical devices that are produced on the island and distributed across the rest of the U.S.

Hurricane Maria devastated Puerto Rico's power grid and although most medical manufacturers have been able to run on generator power, they have been unable to return to pre-hurricane production levels.

The Agency hasn't specified which manufacturers they are working with, but in a statement Commissioner Scott Gottlieb said they are ‘particularly focused on blood-related medical devices.' He also stated that the Agency is actively monitoring about 50 types of medical devices and over 40 drug products.

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Device manufacturers on the island rely on local subcontractors to provide supplies, however these subcontractors have had their operations hampered by the hurricane. The FDA is working with these suppliers to secure fuel and aiding in logistical support to move critical products onto and off the island. Importing devices from outside the U.S. is also an avenue that the Agency is leaving open for at-risk products, as well as allowing manufacturers to move production to alternate sites.

Earlier this month the FDA assisted Baxter in importing sodium chloride 0.9% injection bags from the company's facilities in Ireland and Australia in order to prevent shortfalls. There are dozens of pharmaceutical and medical device companies with facilities in Puerto Rico. Some of the devices manufactured on the island include the wires used in pacemakers (Boston Scientific) and insulin pumps (Eli Lilly).

The Agency states that they will continue to monitor the situation in Puerto Rico and any at-risk products.

For more information visit FDA.gov.