Stop Using Infusion Pump Vulnerable to Hackers, FDA Says

Hospitals and other healthcare facilities should stop using the Symbiq Infusion System manufactured by Hospira because hackers could gain access to the device and give patients life-threatening overdoses or underdoses of drugs, the US Food and Drug Administration (FDA) announced today.

Hospira has ceased making this line of computerized infusion pumps for unrelated reasons and is switching customers to other pumps, the agency said. "However, due to recent cybersecurity concerns, the FDA strongly encourages healthcare facilities to begin transitioning to alternative infusion systems as soon as possible."

Neither the FDA nor Hospira is aware of any unauthorized access of these devices in a healthcare setting.

While Hospira no longer sells the Symbiq Infusion System, third parties unrelated to the manufacturer still do. The FDA "strongly discourages" healthcare facilities from buying the device from these third parties.

In May, the FDA issued a safety warning about another kind of computerized Hospira infusion pumps — LifeCare PCA3 and PCA5 — being vulnerable to hackers. However, it advised users on how to protect against unauthorized access rather than recommend they stop using the devices. At that time, the FDA said that it was working with the manufacturer and the Department of Homeland Security to investigate the problem with the LifeCare pumps.

In today's warning, the FDA said that Homeland Security is aware of the cyber vulnerability of the Hospira Symbiq Infusion System.

More information on today's announcement is available on the FDA's website.

To report problems with the Hospira Symbiq Infusion System, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Medscape Medical News © WebMD, LLC

Heartwire © WebMD, LLC

WebMD Health News © WebMD, LLC

Reuters Health Information ©

Send comments and news tips to news@medscape.net.

Cite this: Stop Using Infusion Pump Vulnerable to Hackers, FDA Says - Medscape - Jul 31, 2015.

Commenting is limited to medical professionals. To comment please Log-in.

Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

My Alerts