FDA launches initiative to reduce pump risks

Web page addresses safety

The Food and Drug Administration (FDA) has announced a new initiative to address safety problems associated with external infusion pumps.

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance of a new draft guidance and letter to infusion pump manufacturers. FDA is also launching a new Web page devoted to infusion pump safety.

"These pumps often provide critical fluids to high-risk patients, so failures have significant implications," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "It is time for a more comprehensive approach than we've taken to date."

As part of its initiative, the FDA published draft guidance recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices. Also, the FDA issued a letter to infusion pump manufacturers, informing them that they might need to conduct additional risk assessments to support clearance of new or modified pumps.

In addition to alerting them of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis prior to premarket review. Static analysis is a diagnostic technique that can help detect software problems early in the device development process. The agency previously invited manufacturers to make use of an open-source software safety model developed through the Generic Infusion Pump project, an ongoing collaboration with outside researchers aimed at improving pump design.

The agency's new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market. (The web page can be reached at www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm.)

The FDA is also inviting providers you to listen to the replace of a stakeholder teleconference held on April 26, 2010, to discuss the ongoing safety problems associated with external infusion pumps. The teleconference involved a presentation by Anthony Watson, director of the Division of Anesthesiology, General Hospital, Infection Control & Dental Devices, Center for Devices and Radiological Health. Watson's presentation was followed by a question and answer session. FDA experts were available on the call to answer questions. The moderator for this teleconference was Theresa Toigo, RPh, MBA, director of the Office of Special Health Issues (OSHI). A replay of the teleconference will be available until July 26, 2010. You can access the replay by calling (866) 434-5255 (inside the United States) or (203) 369-1000 (International).