Infusion pumps targeted for tighter FDA scrutiny
■ After 87 pump recalls over the last five years, the agency is seeking tougher safety rules for the entire family of medical devices.
Chicago -- The Food and Drug Administration is dramatically changing its approach to regulating medical devices, announcing in April that it will impose stricter safety standards for infusion pumps as a class rather than dealing with problems on a case-by-case basis.
The change comes after 710 deaths associated with malfunctioning infusion pumps used in homes and hospitals during the last five years. The agency has received 56,000 adverse-event reports regarding the devices during that time period and issued 87 recalls -- 14 of those in the FDA's highest-risk class I category.
"There have been problems with every kind of infusion pump on the market, across the entire industry," said Jeffrey Shuren, MD, director of the agency's Center for Devices and Radiological Health. He announced the FDA's infusion-pump initiative during a news briefing at the Assn. of Health Care Journalists' annual meeting in April in Chicago.
Because infusion pumps help deliver life-saving medications at regular intervals, device malfunctions can be fatal. There have been problems with hardware, software and user interface, Dr. Shuren said.
One such problem is "key bounce," in which the user enters a number but it is recorded twice, changing the amount of medication provided. One report to the FDA involved a nurse who intended to deliver 20 mL/hour of heparin, but due to a pump's keypad failure 200 mL/h was supplied.
The FDA issued draft guidance calling on infusion pump manufacturers to conduct additional testing of their devices before they go to market. Devicemakers would be required to document the safety steps taken to reduce risks in the pump's design, manufacture, use, servicing and maintenance. The agency said it may withhold approval until after inspecting manufacturers' facilities, and will soon push to convert the draft guidance into regulation.
The initiative "represents a major shift in FDA's approach to medical device safety," Dr. Shuren said. "Instead of responding to problems one by one and manufacturer by manufacturer, we are taking comprehensive steps to prevent problems by fostering the development of safer, more effective infusion pumps industrywide."
Dr. Shuren said the FDA will take a similar approach with other device classes "associated with systematic safety problems," though he did not specify other potential targets of tighter scrutiny. The FDA will host a workshop on infusion-pump safety May 25-26 in Silver Spring, Md.
More information about the infusion-pump initiative is available from the FDA (link).