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Update to medical device shortages manufactured in Puerto Rico

by
Optum Workers' Comp
| Dec 21, 2017

In October, we reported in our blog ​about the number of shortages of medical devices and drug products manufactured by facilities in Puerto Rico following the devastation and power outages from Hurricanes Irma and Maria. Recently, the U.S. Food and Drug Administration (FDA) provided an update on the situation. Though some power has been restored to the island and a handful of facilities have been able to stabilize production, many facilities continue to require the use of generators for power and have been unable to return to baseline production levels.

In particular, shortages of intravenous (IV) saline products and amino acids for injection have received much attention. The FDA worked closely with Baxter, a major supplier in Puerto Rico, to help restore their production and also worked with two other companies, Fresenius Kabi and Laboratorios Grifols, to increase the production of IV saline products. Because of this collaboration, the IV saline product shortage is expected to improve by the end of 2017. Additionally, the FDA focused their attention on increasing amino acids for injection production, also manufactured by Baxter, as these products are vitally important for patients unable to eat and require their nutrition intravenously. The FDA allowed other Baxter facilities in the United Kingdom and Italy to import supplies to the United States and continues to work with other manufacturers to increase their supplies to help address the shortage.

The FDA maintains their commitment to work with federal and local authorities to help restore manufacturing in Puerto Rico. They continue to monitor approximately ninety medical products manufactured on the island. We will continue to monitor the situation and share information as it becomes available.


Source:

  1. U.S. Food and Drug Administration. FDA Statement. Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages. November 30, 2017. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587290.htm




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