CHA News Article

FDA Reports Security Issues With Some Infusion Pump Systems

The Food and Drug Administration (FDA) has issued a safety alert about security vulnerabilities with Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems. The systems are computerized infusion pumps designed for the continuous delivery of anesthetic or therapeutic drugs and can be programmed remotely through a health care facility’s Ethernet or wireless network. The security vulnerabilities reported by the FDA could allow an unauthorized user to interfere with the pump’s functioning. So far, the FDA is not aware of any patient adverse events or unauthorized device access related to these vulnerabilities. The security alert includes recommendations for health care facilities and information about reporting problems to the FDA. As new information becomes available about patient risks and any additional steps users should take to secure the devices, the FDA will issue an updated communication.