FDA Issues Warning on Hospira Pumps Over Security Concerns

The FDA issued a warning Wednesday about security vulnerabilities stemming from Hospira’s LifeCare PCA3 and PCA5 infusion pump systems.

The agency reported an independent researcher showed that software codes, if hacked into and exploited, could enable someone to remotely interfere. In a worst-case scenario, an unauthorized user could alter a device’s dosage delivery to over- or under-administer infusion treatments to a patient.

The FDA says it is investigating with Hospira and the Department of Homeland Security.

The agency does not know of any actual unauthorized access or patient adverse events, but advises medical professionals and patients to contact its MedWatch Safety Information and Adverse Event Reporting Program if such cases arise. — Jason Scott