CHICAGO (Reuters Health) - After more than 50,000 reports of problems with pumps used to deliver drugs, including 710 deaths, the Food and Drug Administration will begin more rigorous pre-market review of the devices, one of the agency’s center directors said Friday.
“There have been problems with every kind of infusion pump on the market, across the entire industry,” FDA Center for Devices and Radiological Health director Dr. Jeffrey Shuren told the annual meeting of the Association of Health Care Journalists.
These devices are used by millions of people to deliver antibiotics for infections, chemotherapy for cancer, insulin for diabetes, and pain medication, among other drugs.
Of the 56,000 reports, there were 710 deaths. In one case, a woman died after receiving ten times the dose of a blood thinner because the zero key on her pump stuck.
Other devices have caught fire and exploded in patients’ rooms, Shuren said.
“Although some of the problems we’ve seen with infusion pumps may be the result of user error, many of them are related to deficiencies in device design and engineering, which can either create problems themselves or contribute to user error,” Shuren said. “The most common types of reported problems have been associated with software defects, user interface issues, and mechanical or electrical failures.”
Of the 87 product recalls, 14 were of the FDA’s highest-risk category, meaning there was “a reasonable probability that using the device will cause serious injury or death.” They ranked “among the top most frequently recalled devices in that period,” Shuren said.
More than 100 companies make infusion pumps, Shuren said, with Baxter and Hospira two of the major manufacturers.
The new initiative will require pump manufacturers to include more information about their design. The FDA will also offer manufacturers “the option of submitting the software code used in their infusion pumps for analysis by agency experts prior to premarket review of new or modified devices, in order to facilitate the early detection and correction of any design defects.” The agency will also launch a website for patients to learn more about the devices and to allow patients to report problems.
Today’s announcement involves all infusion pump devices. Last month, the FDA held a two-day meeting to specifically review blood glucose pumps used by diabetics, after concerns over those devices. The agency will hold another meeting to discuss the new initiative on May 24 and 25.
Shuren said despite the risks, the agency can’t just pull the devices from the market. “They’re in such ubiquitous use, you can’t pull them,” he said. “People need them to provide medications and food.”