Infusion pumps, a widely varied class of devices which typically mete out precise, time-delayed doses through IVs and related means, have been associated with 56,000 adverse events and more than 500 deaths in the past five years, Dr. Jeffrey Shuren told journalists assembled at Health Journalism 2010 this morning. Shuren is head of the FDA’s devices center. The malfunctions are often caused by hardware and software issues, and can lead to overdoses and other harmful events.
Photo by Felix42 via Flickr.NPR health blogger Scott Hensley, who was there for Shuren’s presentation, wrote that the FDA appears determined to take action to improve the pumps, which are almost ubiquitous in American hospitals.
The “widespread problems we are seeing warrant” prompt action, Dr. Jeffrey Shuren, head of the FDA’s devices center, told a meeting of the Association of Health Care Journalists in Chicago.
The agency will require design improvements, more thorough testing, and inspections of the infusion pump makers’ facilities before the devices are allowed on the market.
