Medical device, drugmakers assess operations after Hurricane Fiona

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As Hurricane Fiona reached Puerto Rico late Sunday night, flooding the archipelago and tipping its battered energy grid into a blackout, healthcare industry leaders and government agencies were bracing for impact. 

The Category 1 storm left the island in a state of emergency that persists. All of Puerto Rico’s 3.1 million residents lost power. Another 60% of residents lost access to clean water. The Port of San Juan was temporarily closed to commercial vessels on Monday and travel advisories restricting the movement of residents have been put in place while damage is assessed. It was yet another blow to a U.S. territory rife with failing infrastructure from overexposure to severe weather.

Five years ago—almost to the day—Hurricane Maria ravaged Puerto Rico, killing 3,000 people and significantly crippling its infrastructure. Healthcare providers across the U.S. grappled with delays of medical devices and drugs as manufacturers located there recovered from the wreckage.  

Hurricane Maria hit medical device company Baxter International especially hard. Its Puerto Rican facilities were largely responsible for making small-volume IV bags, while large-volume bags were manufactured on the mainland. Hospitals resorted to using the larger bags to deliver medications to patients, increasing demand for that product. Baxter’s fourth-quarter revenues were down $70 million due to manufacturing disruptions following the 2017 storm.

Today, Puerto Rico’s manufacturers of medical devices and pharmaceutical products, which represent more than half of the territory’s exports, are better positioned.

Taking lessons from Hurricane Maria, pharmaceutical and medical device manufacturers invested in backup generators, fuel, community services, food and water that are helping them navigate operational challenges. Some companies have started spreading out their manufacturing facilities across the nation to build broader resilience to regional climate disasters.

Puerto Rico has hosted medical device and pharmaceutical production for half a century. Multinational companies run 52 Food and Drug Administration-approved pharmaceutical plants in the territory. The island, roughly the size of Connecticut, also includes nearly 70 medical device manufacturers, developing pacemakers, surgical instruments, lab equipment and other essential products, according to data from Puerto Rico’s Department of Economic Development and Commerce. 

The FDA said it was “actively monitoring” the situation on the island. The American Hospital Association said it was waiting on damage assessments from the Health and Human Services Department and Federal Emergency Management Agency to understand any effects the storm might have on broader industry operations.

Shortages of drugs and medical devices could mean delayed procedures, fewer treatment options, and increased costs. But amid flooding and a power outage, many companies say their Puerto Rican sites are up and running.

Most of Baxter’s facilities in the Caribbean restarted operations Tuesday thanks to generator power and fuel supplies, but its ability to be fully up and running depends on the accessibility of local roads and bridges. For now, Baxter said it has “healthy inventory levels for the majority of products made in Puerto Rico and the Dominican Republic for U.S. customers,” according to a company statement.

Pharmaceutical company Amgen said actions taken before the storm helped ensure its flagship site in Juncos, Puerto Rico would continue its operations.

“In advance of the storm, we activated our well-rehearsed business continuity plans, which included proactively switching power for the site to generators. We have sufficient generator capacity and fuel to support ongoing operations,” said a spokesperson for Amgen, which also has smaller manufacturing sites in the U.S., Ireland, the Netherlands and Singapore.

With the island devastated, Amgen said it is checking in with the 2,400 staff members working at its largest manufacturing site and offering support. 

Abbott pre-planned for destruction by sending employees home with disaster relief kits and food. It also distributed supplies to an oncology department of a local pediatric hospital. None of Abbott’s facilities were damaged during the hurricane, a spokesperson said.

The medical device and pharmaceutical manufacturer has been investing in food banks, community health clinics and infrastructure such as generators, wireless hotspots and cold storage to prepare for emergencies long term. 

Device maker Boston Scientific also stocked up on generators, water and chainsaws for their employees. Brad Sorenson, executive vice president of global supply chain, said the company’s manufacturing plant in Dorado, Puerto Rico, switched to independent water and power systems before the hurricane arrived. The plant can run for up to two months on backup supplies, he said.

“We came off the grid onto our own power 36 hours before the hurricane made landfall,” Sorenson said. “We’re doing it on our timeline. We’re not sitting there waiting for the lights to go out.”

Prior to the storm, Boston Scientific leaders ensured product availability and adequate stockpiles and sent employees home for two days while the storm took its toll. Nearly 90% of their employees were at work on Wednesday, Sorenson said. The plant will operate on surge capacity to make up for losses.

“It will take a few weeks, but we’ll be able to make up for the two days that we proactively shut down,” Sorenson said. 

In the wake of Hurricane Fiona, the American Society of Health-System Pharmacists expressed concern about the opacity of the pharmaceutical industry. Michael Ganio, the trade group’s senior director of pharmacy practice and quality, wrote in an email that its main concern is the lack of transparency from drugmakers about plant locations and production quantities.

“Having this information in advance will help organizations prepare for potential shortages and discourage mitigation strategies like hoarding that can cause additional disruptions,” Ganio added.

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