FDA Steps Up Oversight Of Drug Pumps

CHICAGO (AP) — Federal health regulators have announced 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 US Food and Drug Administration.

Infusion pumps are used to deliver fluids (liquid nutrients and medicines like insulin, morphine, chemotherapy or anesthesia) into a patient’s body. They are used in hospitals as well as by patients at home.

Over the past five years, the FDA has received reports linking 710 deaths to infusion pump problems, and that likely is an underestimate, said Dr Shuren, the FDA’s director of the Center for Devices and Radiological Health,

In the past, many problems were attributed to human error, a doctor or nurse thinking they mistyped infusion directions. But FDA officials believe software and design issues more likely.

The FDA is working on new guidelines that call on manufacturers to provide more detailed design and engineering information for new pumps. It also wants manufacturers to try out the devices in settings where they are commonly used, and to be able to inspect the manufacturing plant before approving the device.