The Food and Drug Administration will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse-event reports, the agency announced in a teleconference.
Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps. During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns.
“Infusion pumps rank among the top of most frequently recalled devices for this 5-year period, and they are one of the top categories of devices for reporting of adverse events,” Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said during the teleconference. “There have been problems with every kind of infusion pump on the market across the entire industry…. In some cases, pumps have actually exploded in a patient's room.”
The problems have ranged from manufacturing defects to software bugs to user error. Dr. Shuren described one case in which a woman who was taking the blood thinner heparin accidentally gave herself 10 times the correct dose. The culprit was “key bounce,” in which someone trying to enter 20, for example, will enter 200 by mistake. The woman died.
The FDA is taking several steps to address the devices' problems at the level of manufacture.
In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place and be prepared to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps and check patients for signs of under- or overinfusion; prevent and respond to pump problems by using available resources; and promptly report adverse events to the FDA.
The agency published draft guidance on April 23 recommending that manufacturers of infusion pumps start providing additional information on design and engineering to the agency during premarket review.
The draft guidance document, available on the FDA's Web site, is open for public comment, and the agency plans to hold a public infusion pump workshop on May 25-26.
Dr. Shuren said that the agency plans to move quickly in turning the draft guidance document into an actual set of regulations.
Among other things, the FDA recommends that each premarket submission include a structured, evidence-based discussion of all steps the manufacturer has taken to mitigate risk at each stage of the device's life cycle. That includes device design, manufacture, servicing, maintenance, and use in clinical or home settings.
FDA inspectors will visit production facilities for the first time to examine manufacturing practices.
In addition, manufacturers will need to show that they have tested their pump in the environment in which it is intended to be used and with the types of clinicians and patients who are expected to use it.
The agency offered to help manufacturers with the task of checking the software controlling these devices. Even before premarket review, manufacturers may submit software code to the FDA, whose experts will conduct “static analysis,” an automated diagnostic technique that can detect software problems early in the development process.
Dr. Shuren described the CDRH action as “a marked departure” in the way it has handled such cases in the past.
In response to a reporter's question, he noted that other medical devices have been the subject of large numbers of adverse event reports, citing implantable cardiac defibrillators as an example.
The FDA has established a Web site with detailed information on infusion pump problems and the agency's proposed solutions at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm
A white paper on the Infusion Pump Improvement Initiative can be found at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm205424.htm