CHICAGO — Federal health regulators yesterday revealed steps to improve the design and safety of drug pumps that have been linked to more than 700 deaths in the past five years.
“It’s clear from the history of problems we’re seeing that there is a need for more careful infusion pump design and testing,’’ said Dr. Jeffrey Shuren of the Food and Drug Administration. He disclosed the initiative at a health journalists’ conference in Chicago.
Infusion pumps are used to deliver fluids — liquid nutrients and medicines — into a patient’s body.
Over the past five years, the FDA has received reports linking 710 deaths to infusion pump problems, and that likely is an underestimate, said Shuren, the FDA’s director of the Center for Devices and Radiological Health.
In the past, many problems were attributed to human error. But FDA officials believe that software and design issues are actually at the root of many of them.