FDA Issues Recs for Reducing Risk Associated with Computerized Infusion Pumps

The Food and Drug Administration has issued a Safety Communication alerting users of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems to security vulnerabilities with these devices which are designed for continuous delivery of anesthetic or therapeutic drugs.

An independent researcher has identified certain security vulnerabilities that could interfere with the workings of the pumps that can be programmed remotely through a health care facility’s Ethernet or wireless network. Although the FDA is not aware of any adverse events or unauthorized device access related to such vulnerabilities at this time, the agency has established a set of recommendations for reducing the risk associated with the use of these particular computerized devices.