FDA puts infusion pumps in cross-hairs

CHICAGO (Reuters) - U.S. health regulators are placing renewed focus on preventing problems associated with infusion pumps, widely used devices that deliver fluids, such as medication and nutrients, into the body through a built-in software interface.

The new director at the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, Dr. Jeffrey Shuren, noted multiple issues in recent years with these pumps that have in some cases led to injury and death.

The FDA, he said, has concluded that many of these problems appear to be related to “deficiencies in device design and engineering” more often than user error, and has established a new initiative to improve their function.

Shuren, speaking to a group of healthcare journalists in Chicago on Friday, said the FDA would establish additional requirements for pump manufacturers, which include Baxter International Inc, Abbott Laboratories Inc, Hospira Inc and CareFusion.

Shares of Baxter fell 3.5 percent.

To date, the FDA has responded on a case-by-case basis. This represents a “major shift” in the way these devices are dealt with by getting involved before there are safety problems, he said.

He said this approach would be applied to any device category that is thought to have systemic problems. He declined to identify what other product categories the FDA was eyeing.

An industry group said it was reviewing the effort and would work with the FDA to address any issues.

“As FDA notes, infusion pumps have contributed to improving patient care and reducing medical errors,” said Janet Trunzo, an executive vice president at the Advanced Medical Technology Association.

Shuren said the FDA would require more testing before pre-market review of infusion pumps and would inspect facilities prior to review, as well as work more closely with foreign regulators.

He noted that the FDA had notified more than 100 pump makers of the tougher requirements.

The FDA will also work to increase user awareness by launching a new website as an information source and proactively facilitate device improvements by working with manufacturers more closely before they submit applications for pre-market approval.

“They can send their software to us in advance so we can work with them rather than telling them to work it out on their own,” he said.

Millions of patients rely on infusion pumps in hospitals, nursing centers and even at home.

While these devices have improved overall care, there have been too many problems, Shuren said. In the last five years, there were 87 recalls of pumps and 14 of those were Class I recalls, the FDA’s most severe.

He said the FDA had received more than 56,000 medical device reports associated with use of infusion pumps between January 2005 and December 2009. About 1 percent of insulin pump reports were reported as deaths, 32 percent were reported as serious injuries and 64 percent reported as malfunctions. Problems with these devices tend to be underreported, he said.

The FDA said it would hold a public meeting on infusion pump design on May 25 and 26.

A Baxter spokeswoman said the company was prepared to participate in the FDA’s new requirements and that it had already increased testing in the wake of the recall of its Colleague infusion pump.

Hospira said in a statement that it was evaluating the impact of the FDA effort and would provide feedback to the agency.

The company said it “regularly enhances its processes to support evolving product approval and post-market activities.”

Abbott spokeswoman Jennifer Smoter said the company had “a solid safety record” with distribution of its feeding pumps. The company sells a feeding pump called Patrol.

She said that Abbott had not seen the FDA’s new requirements but would comply with them.

CareFusion did not respond to a request for comment.

Baxter shares closed down 3.5 percent at $49.32 while CareFusion shares closed down 0.47 percent at $27.81. Abbott closed up 0.16 percent at $51.20 and Hospira closed up 0.19 percent at $57.

Reporting by Debra Sherman in Chicago and Lisa Richwine in Washington; Editing by Phil Berlowitz