As part of its plan, the FDA is moving to establish additional premarket requirements for infusion pumps - the devices that deliver fluids, including nutrients and medications, into a patient's body in a controlled manner - in part through issuance of a new draft guidance and letter to infusion pump manufacturers. It also said that it is launching a May public workshop on infusion pump design, and a new Web page devoted to infusion pump safety.
Infusion pumps are used in hospitals, other clinical settings, and the home. The devices allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors. The infusion pumps also have been the source of persistent safety problems.
According to FDA data, in the past five years, there have been more than 56,000 reports of adverse events associated with the use of infusion pumps. The 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.
As part of its initiative, the FDA had published draft guidance recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the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.
The FDA had also issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps. In addition to alerting them of the intended change, the letter offers manufacturers the option of submitting the 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 had 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.
Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, said: "These pumps often provide critical fluids to high-risk patients, so failures have significant implications. It is time for a more comprehensive approach than we've taken to date. Working with industry and users, we can help develop safer, more effective infusion pumps and improve patient care."