FDA MedWatch Infusion Pump Cybersecurity Alert

FDA issued a Medwatch alert for infusion pumps May 13, 2015, regarding security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems.  A researcher has shown that exploiting the vulnerabilities could allow an unauthorized user to remotely modify the dosage delivered.  Homeland security was previously working with Hospira about this vulnerability (we reported on this previously Infusion Pump Security Vulnerability-SoftwareCPR Post).

Read the full MedWatch notice at this link http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm446809.htm

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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