FDA infusion pump improvement initiative

The FDA CDRH (Center for Devices and Radiologic Health) is embarking on an initiative to reduce adverse events from external infusion pumps. The FDA is planning to significantly revamp the way in which it evaluates applications for new pumps.

 In particular, it is expecting that manufacturers will address human factors risks. Hazards that in the past were solely addressed by expecting the user to follow specific procedures now may have to be addressed by design instead.

CDRH White Paper on the infusion pump initiative.

Infusion Pump Improvement Initiative home page.