The FDA commissioner said regulators would keep special watch over 10 manufacturers who are the sole source of key products. If necessary, they will allow products to be imported from overseas.
Puerto Rico’s medical technology and device sector was hit even harder than the pharmaceutical sector was by Hurricane Maria, prompting FDA to come up with ways to minimize shortages of supplies made on the island, according to FDA Commissioner Scott Gottlieb, MD.
Gottlieb said Friday that damage to the electrical grid, supply chain disruptions, and shortages of subcontractors are all causing challenges to device makers, including 10 manufacturers who are being watched closely because they are the sole source of their product. FDA will allow imports of supplies or shift work to other plants if necessary, Gottlieb said.
The FDA commissioner has already visited Puerto Rico, and he said the chief operating officer and associate commissioner for regulatory affairs had just returned from a follow-up trip.
Gottlieb issued his statement about the state of the device sector more than a month after Hurricanes Irma and Maria devastated Puerto Rico’s infrastructure. The island is home to 50 medical device manufacturing plants that make 1000 different devices and employ 18,000 people. “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,” Gottlieb said in the statement.
“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 they may be the single manufacturer of that device type,” he continued. FDA is working especially closely with 10 manufacturers who are the sole source of certain devices to prevent shortages, especially blood-related medical devices.
Amid the high-profile spats between President Donald Trump and San Juan Mayor Carmen Yulin Cruz over the level of federal response to the hurricanes, Gottlieb has been working to assess the damage to the pharmaceutical and medical device sectors, which account for 30% of the island’s gross domestic product.
Puerto Rico houses manufacturing facilities for diabetes device maker Abbott Laboratories, which recently won approval for its fingerstick-free continuous glucose monitoring (CGM) system, and Medtronic, which has struggled to ramp up production of the MiniMed 670G, the “artificial pancreas” approved a year ago.
Published reports say while Medtronic partially restarted production with backup generators at 4 different plants on the island on October 2, the hurricanes will delay shipment of the 670G.
Gottlieb’s statement said the medical device makers are no different from other manufacturers: they are hampered by a lack of power, connectivity, transportation, and clean water. Because they are relying on generators, they have been unable to return to pre-hurricane production levels, he said.
But medical devices makers have unique hurdles: each device has its own components, specific raw materials, and “unique production requirements,” Gottlieb said. Disruptions in supply chains, a lack of subcontractors, and even tool shortages are all posing challenges.