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.