Medical manufacturing facilities in Puerto Rico continue to struggle after Hurricane Maria tore through the island in September and knocked out the power grid, according to FDA Commissioner Scott Gottlieb, MD.
Shortages of medical products such as IV saline and amino acids for injection, both manufactured on the island by Baxter, were exacerbated by the hurricane, Gottlieb said in a statement, but the FDA is working with manufacturing companies on the island to rectify the situation.
The FDA has approved IV solution products from Fresenius Kabi and Laboratorios Grifols to mitigate the shortage, while the agency continues to work with Baxter to restore production operations, all of which should improve the shortage situation by the end of the year.
Baxter, one of the leading manufacturers of amino acid products for the U.S., is temporarily importing the products from its facilities in the United Kingdom and Italy, while the FDA is working with other amino acid manufacturers, including ICU Medical and B. Braun, to address the shortage, according to Gottlieb’s statement.
Approximately 90 medical products manufactured in Puerto Rico are being monitored by the FDA, including biologics, devices and drugs.
“We continue to work closely with federal and Puerto Rican authorities to address the needs of manufacturers on the island for power and other resources. ... Mitigating medical product shortages will require a sustained effort by industry, the agency and other partners as we work with manufacturers to return to production levels that adequately meet the needs of patients,” Gottlieb said in the statement.
At the Medical Technology Innovation Summit in Newport Beach, California, in October, Medtronic Chairman and CEO Omar Ishrak discussed how his company is working to keep production going at its Puerto Rico facilities.
Medtronic has approximately 5,000 permanent or temporary employees on the island, he said, and 25% of the company’s global production is done there.
“Puerto Rico is different from other [recent disasters] because the endpoint is not clearly defined,” Ishrak said. “There is no understanding of when we will have power restored on the island, and I am not even talking about small villages, I’m talking about big facilities like ours.”
“This can be going on for up to a year,” he said.
“We’ve had to get that place running with our factories, with or without government help, or anybody’s help, because without that we don’t have any devices,” he said.
As of October, approximately half of the facilities were operational through temporary or backup power, including temporary IT systems.
Medtronic has focused on providing for employees’ basic needs such as food, water, medication and generator power at their homes. It has also provided child care and laundry machines within its facilities for employees to use.
“This was necessary because it was the right thing to do,” Ishrak said. “While work is important, you have to take care of your families first.” – by Rebecca L. Forand