A consumer watchdog group scolded the Food and Drug Administration for taking weeks to evaluate the latest problem with Baxter’s drug pumps, which have been plagued by safety issues for years.
In January, Baxter International sent a warning to customers about issues with its Colleague infusion pumps that could cause them to stop pumping and overheat. Last week the company said the FDA classified the announcement as a Class I recall, its most severe warning. The classification applies to problems that can cause “serious adverse health consequences or death.”
Public Citizen’s Dr. Sidney Wolfe blasted the agency in a letter for not moving faster.
“Why did it take the FDA 47 days, almost 7 weeks … to decide that this problem was serious enough to merit being classified as a Class I recall?” Wolfe wrote in a letter to acting FDA Commissioner Dr. Frank Torti.
FDA’s classification has limited real-world impact. Baxter’s products are not actually being called off the market, but the serious warning is necessary because malfunctions with the devices can be fatal.
Wolfe pointed out that Baxter’s infusion pumps have been subject to problems for years. Since 2005 the FDA has issued seven Class I recalls on the Colleague pumps, which have been linked to at least 19 deaths. Wolfe called on the agency to physically remove the devices from hospitals and clinics, where they are used to deliver medicine and intravenous fluids.
“Why has the FDA not used its authority for mandatory device recalls, to remove these devices which have a long history of serious, life-threatening problems?” Wolfe asked.
The FDA did not respond to requests for comment.
A spokeswoman for Deerfield, Ill.-based Baxter noted the company stopped selling the devices in the U.S. in 2005 but said 200,000 are still in use.
“If we were to do a full market recall of this device you would create a significant health issue, because it would create a shortage of pumps which are vital to patient care,” said Baxter’s Erin Gardiner.
According to Gardiner, the company has upgraded 70 percent of the devices on the market to address previously reported problems.
But Wolfe questioned the company’s argument.
“If they haven’t sold any of these devices in four years, then someone else must be selling them,” Wolfe said Thursday. “And in all likelihood they haven’t had the same string of problems seen with these products.”
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