FDA plans infusion pump workshops
This article was originally published in The Gray Sheet
Executive Summary
CDRH Office of Compliance will encourage infusion pump manufacturers to attend FDA educational workshops designed to curb chronic product problems, said Office of Science & Engineering Laboratories Director Larry Kessler Sept. 13 during a risk management seminar in McLean, Va. The workshops follow FDA seizures of pumps from both Baxter (Colleague) and Cardinal Health (Alaris SE) and may include speakers from Kessler's office as well as the agency's human-factors engineers (1"The Gray Sheet" Sept. 4, 2006, p. 3). Kessler added that the agency's risk-based facility inspection plan is focused on pump manufacturers. "If you make infusion pumps, you can bet we're going to be visiting you," he said. The FDAer noted that firms that manufacture MRI products also are on the watch list...