To combat the increase in infusion pump recalls, FDA has created the draft guidance "Total Product Life Cycle: Infusion Pumps—Premarket Notification [510(k)] Submissions." The agency says it had received more than 56,000 MDRs related to infusion pumps between January 1, 2005 and December 31, 2009.  It noted many of the pump problems appeared to be linked to faulty design—software error messages, human factors, broken components, and battery failure were among the most common complaints.

The guidance includes tips for manufacturers submitting 510(k)s. For example it says that companies should consider performing a use hazard analysis, which identifies any hazards particular to their infusion pumps. The agency also recommends that a clinical evaluation be conducted that evaluates device performance and human factors.

Infusion pump problems have been on the radar of the new FDA leadership. In March, the agency convened a panel on insulin pumps. You can read the full transcript here.