On April 30, FDA sent a letter to Baxter Healthcare Corp. ordering the company to recall and destroy all of its Colleague Volumetric infusion pumps currently in use in the United States. This action, the agency said, was based on a “long-standing failure to correct many serious problems with the pumps.” FDA believes there may be as many as 200,000 of those pumps currently in use. FDA has also ordered the company to provide refunds to customers or replace the pumps at no cost to customers to help defray the cost of replacement.

FDA says it has been working with Baxter since 1999 to correct numerous device flaws and that since that time, the pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues.

On April 8, 2010, Baxter submitted a proposed correction schedule to FDA that stated that Baxter did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. FDA says that on that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA says it found this proposal unacceptable.

Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems, the agency says. The adverse 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, according to FDA data. And problems with infusion pumps are not confined to one manufacturer or one type of device.

In response, FDA announced a new initiative to address safety problems associated with infusion pumps. As part of its initiative, FDA is moving to establish additional premarket requirements manufacturers will be expected to meet, in part through static testing in FDA’s facilities before device submissions. FDA is also holding a May public workshop on infusion pump design, and the agency is raising public awareness of the issue among healthcare workers and patients.

FDA recently created a draft guidance called, “Total Product Life Cycle: Infusion Pumps—­Premarket Notification [510(k)] Submissions.” The agency says it had received more than 56,000 reports of adverse events related to infusion pumps between January 1, 2005, and December 31, 2009. It noted that many of the pump problems appeared to be linked to faulty design, including software error messages, human factors, broken components, and battery failure.

The guidance includes tips for manufacturers submitting 510(k)s. For example, it says that companies should consider performing a use hazard analysis, which identifies any hazards particular to their infusion pumps. The agency also recommends that a clinical evaluation be conducted that evaluates device performance and human factors.

It’s important to get the problems with infusion pumps resolved, but this problem also reminds us that it’s time to be more diligent than ever in terms of safety and efficacy. The 510(k) review process is in the spotlight, and problems like this one will only fuel calls for an overhaul.

Click here to listen to an interview with Steve Wilcox about the FDA Infusion Pump Workshop.

Sherrie Conroy for the Editors