FDA warns on Hospira Symbiq pumps

The FDA today released a safety communication warning about cybersecurity vulnerabilities with Hospira‘s (NYSE:HSP) Symbiq infusion system.

The Symbiq infusion system can potentially be accessed remotely through a hospital’s network, which could allow for unauthorized changes to the dosage delivered by the pump, according to the federal watchdog. The issue was confirmed by Hospira and an independent researcher.

Currently, no adverse events or unauthorized accesses in a health care setting have been reported, according to the FDA and Hospira. The U.S. Dept. of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team is also aware of the issue, according to the FDA.

Hospira said it plans to phase out the Symbiq system in May, after the FDA warned on cybersecurity vulnerability issues with its remotely-programmed LifeCare PCA3 and PCA5 devices.

“As previously announced as part of Hospira’s broader global device strategy, the Symbiq infusion device is being removed from the market. After evaluating reported vulnerabilities, we are communicating with customers at the limited number of sites where Symbiq remains in use. We have worked with them to deploy an update to the pump configuration to close access ports and put additional cybersecurity protections in place. This option provides our Symbiq customers with another layer of security for the devices while they remain in the market for another few months,” Hospira said in a release about the issue.

The FDA encouraged hospitals and facilities using the system to disconnect it from the network, but warned that this would require manual entry of drug libraries for each pump. It suggested facilities also close specific network ports and monitor all network traffic to prevent any unauthorized access.

The federal watchdog encouraged users to transition away from the system, saying it “strongly encourages health care facilities to begin transitioning to alternative infusion systems as soon as possible.”

Hospira reiterated that there have yet to be any instances of cybersecurity breaches of the system. The company said that exploiting the vulnerability would require access of networks that generally lie behind layers of network security.

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