Friday, August 23, 2019

Medtronic making progress toward resuming pre-Maria Puerto Rico operations

By on October 23, 2017

SAN JUAN – Puerto Rico’s largest medical device manufacturer, Medtronic, said it has made progress and was working with the Food and Drug administration and local government officials to resume pre-Hurricane Maria operations and conditions.

“Medtronic has been in Puerto Rico for more than four decades and we will be there into the future,” Félix Negrón, vice president of operations, told Caribbean Business in written remarks.

At the beginning of the month, Medtronic had said it was partially operating and expected to lose about $250 million this quarter.

Last week, Food and Drug Administration Commissioner Scott Gottlieb raised concerns about a possible shortage of about 50 types of life-sustaining medical devices manufactured by companies whose facilities were damaged by Hurricane Maria and have been forced to scale back operations.

FDA raises alert on shortage of life-saving medical devices because of Maria

Although working with device companies and their suppliers to restore production in Puerto Rico, the FDA noted that it is offering logistical support to move operations of critical products out of the island.

“As we continue to monitor at-risk products, the FDA is taking other steps to mitigate the potential for shortages. This includes considering, when necessary, importing a device from outside of the U.S., or allowing manufacturers to shift production to alternative sites,” he said.

It was the second alert raised by the FDA, which recently said it was monitoring more than 40 drug products manufactured on the island by pharmaceuticals that also sustained damages from the storm and had to curtail operations. The local government has acknowledged that the manufacturing sector took a hit with the historic storm.

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“Unfortunately, the devastation caused by the hurricanes to Puerto Rico’s medical product manufacturing sector goes beyond the effects on pharmaceutical companies. The FDA has been working equally hard to minimize shortages of medical devices manufactured in facilities on the island,” he said in a statement.

Negrón said that through independent efforts and with the help of local officials “we have made significant progress” in restoring operations. The firm has facilities in Humacao, Villalba, Juncos and Ponce.

“These efforts have included activating our business continuity plans in the interim to ensure we continue providing products. We continue to focus on restoring operations on the island, restoring the island and company’s infrastructure and supporting our employees’ well being,” he said.

FDA: Drug shortages possible due to Puerto Rico power outage

There are currently more than 50 medical device manufacturing plants in Puerto Rico, employing about 18,000 people. Collectively, they manufacture more than 1,000 different kinds of devices. These include simple but essential products such as surgical instruments and dental products, as well as highly complex devices such as cardiac pacemakers and insulin pumps.

“To date, 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 there may be the single manufacturer of that device type. The FDA is working closely with about 10 manufacturers—some of which are the sole manufacturer of a certain device type—to prevent medical device product shortages across the U.S. We are particularly focused on blood-related medical devices,” he stated.

 

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