As the nationwide shortage of filled intravenous bags continues, the U.S. Food and Drug Administration said Tuesday it has taken additional steps to deal with the problem.
FDA Commissioner Scott Gottlieb said that while the agency continues to address production shortages prompted by a severe flu season, it is also asking IV bag makers to offer data on whether the expiration dates on bags already in hospitals might safely be extended. The agency is also monitoring the recent practice of filling new, but empty, IV bags with fluids to deal with the shortage.
“These empty containers are regulated by the FDA . . .,” Gottlieb said in a statement. “We understand that, with the shortage of filled bags, hospitals and other health care providers are turning to the repackaging or compounding of IV saline fluids and utilizing empty IV containers. This is resulting in diminished supplies of these containers and concerns that supplies of empty bags could tighten further,” he added.
“We’ve been in direct communication with manufacturers, distributors, hospitals and other health care providers, including the Department of Veterans Affairs, about this issue,” he noted. “However, in the meantime, we want to see what steps we can take to ensure that shortages of these empty containers do not occur, given their clinical importance and their utility as an alternative to filled bags.”
Two factors have contributed to the short supply of filled IV bags, which deliver fluids and medicines to dehydrated patients. First, the United States has been hit hard by an unusually severe flu season. Second, there have been production delays at factories that produce the bags in Puerto Rico, which is still dealing with power problems caused by Hurricane Maria in mid-September.
“The dynamics of all shortages are challenging. This situation is no different,” Gottlieb explained. “We recognize that these challenges have created hardships and, in some cases, have had an impact on patients. We’re deeply concerned by this situation. Resolving it remains one of my highest priorities. We’re actively monitoring the situation and taking actions to address this shortage.”
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