Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for GE Healthcare’s Auxiliary Common Gas Outlet (ACGO). An incorrect setting of the ACGO switch will result in no fresh gas flow to the patient. Furthermore, if the circle breathing circuit is incorrectly attached to the ACGO, this may result in barotrauma.