FDA Takes the Initiative on Infusion Pumps

by Barbara Kram, Editor | April 26, 2010
New regs coming
The FDA is taking steps to address external infusion pump problems through its new Infusion Pump Improvement Initiative.

Over the past several years, significant safety issues related to infusion pumps have come to FDA's attention, the agency notes on its website.

For example, in the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns.

While clinician or technician error in operating the software-driven devices is an issue, FDA noted that "many of the reported events are related to deficiencies in device design and engineering, which can either create problems themselves or contribute to user error."

The most common types of reported problems have been software defects, user interface issues, and mechanical or electrical failures.

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "It is time for a more comprehensive approach than we've taken to date."

The initiative will increase regulatory oversight by requiring additional information and steps from pump manufacturers, such as including design and engineering information in premarket submissions and conducting more safety tests. FDA may also inspect manufacturing facilities before device approval. And the government says OEMs should test devices in real clinical settings or patient homes--where the devices are used, and not just in quality control labs.

FDA is working with manufacturers on matters such as software improvements.

The agency has issued draft guidance and requested public comment on its plans.

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