FDA Seeks to Reduce Pump Risks
This spring the Food and Drug Administration (FDA) launched an initiative to address safety problems associated with external infusion pumps. Acknowledging the important role that infusion pumps play in many people’s lives, Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, stated that pump “failures have significant implications.” “It is time,” he continued, “for a more comprehensive approach than we’ve taken to date.”
In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps (this includes use in hospitals, other clinical settings, and at home). Between 2005 and 2008, eighty-seven infusion pump recalls were conducted to address safety concerns. The most common types of problems reported have been related to software defects, including failures of built-in alarms; user interface issues, such as ambiguous on-screen instructions; and mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.
As part of its initiative, the FDA has published guidelines recommending that pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices. Consumers can comment on the draft guidance, which can be accessed from the FDA Web page noted below. Comments can be sent to Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or www.regulations.gov. Refer to Docket No. FDA-2010-D-0194. The FDA has also offered manufacturers the option of having their software codes analyzed by experts at the FDA.
The FDA has developed a Web page featuring basic information about infusion pumps and listing steps consumers and clinicians can take to prevent and report safety problems. Consumers and clinicians are encouraged to report problems. Visit this new page at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm
In May the FDA held a public workshop regarding infusion pumps. Participants discussed observed safety problems and ways to improve pump design. A summary of the meeting is available on the FDA Web page noted above. If the FDA announces additional public workshops, we encourage you to participate, and will post information on the Oley Web site (www.oley.org) as it becomes available. Watch the FDA Web page for announcements also.
You may also be interested in the FDA’s Home Use Devices Initiative. More on this at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/ucm208268.htm.
May/June 2010 LifelineLetter