By Scott Hensley
When it comes to making infusion pumps safer, the Food and Drug Administration isn't fooling around.
The agency ordered Baxter International, one of the largest makers of the devices in the world, to "recall and destroy" every single one of its Colleague brand pumps in the U.S. There may be 200,000 of the computerized pumps in use in hospitals and other health care settings. The devices automatically pump medicines and other liquids into patients.
The FDA's aggressive action comes less than two weeks after the agency unveiled a sweeping initiative to reduce errors, injuries and deaths linked to pumps with flawed designs and other problems. In the last five years, the FDA has received reports about more than 56,000 safety problems and 500 deaths associated with all sorts of the pumps.
Usually, the agency cajoles or suggests that a company recall a product with problems. But in Baxter's case, the FDA said its direct order was prompted by a "longstanding failure to correct many serious problems with the pumps."
Since 2006 the FDA has closely supervised the company's main U.S. subsidiary under a consent decree that required Baxter to stop making and selling the pumps until it fixed manufacturing and quality problems.
"The situation has languished far beyond what it should have," Baxter Chairman and CEO Bob Parkinson told shareholders attending the company's annual meeting today, the Chicago Tribune reports.
FDA said a correction plan submitted by Baxter last month wouldn't have fixed known safety problems until 2013, a timetable the agency found "unacceptable." Parkinson said the changes FDA wanted were "close to impossible" unless Baxter completely redesigned the pump, the Tribune reported.
The agency has also ordered the company to provide free replacement pumps or refunds to customers. Baxter expects the recall will cost $400 million to $600 million.