The Washington-based U.S. Food and Drug Administration announced a new initiative to address safety problems associated with external infusion pumps.
As part of its initiative, the FDA is moving to establish additional premarket requirements for infusion pumps through issuance of a new draft guidance to infusion pump manufacturers. The FDA is also announcing a May public workshop on infusion pump design, and launching a new Web page devoted to infusion pump safety.
Failures of infusion pumps have been observed across multiple manufacturers and pump types, says the agency, adding that many of the reported problems appear to be related to deficiencies in device design and engineering.
As part of its initiative, the FDA published draft guidance today recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices. Additionally, the FDA 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.
The FDA’s public workshop will be held May 25-26, 2010.
To help reduce infusion pump risks, the FDA asks clinicians to consider the following general strategies.
- Plan ahead and be ready to respond in the event of a pump failure.
- Label infusion pump channels and tubing to prevent errors.
- Check infusion pump settings and monitor patients for signs of over- or under-infusion.
- Use available resources to prevent and respond to pump problems.
- Report adverse events promptly to the FDA.