FDA Says Not to Use Popular Medical Device

No-one at Hospira was immediately available for comment. While Hospira has quit making the devices, they are still in use by hospitals, nursing homes and other health-care facilities to administer drugs intravenously, according to the agency.

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A pump used to infuse drugs at a patients bedside can be hacked through hospital networks, causing an over- or under-dose, U.S. regulators said.

“FDA strongly encourages health care facilities transition to alternative infusion systems, and discontinue use of these pumps”, it said.

On Friday, the Food and Drug Administration (FDA) said in a statement that health care companies should stop using Hospira’s Symbiq medication infusion pump, which is a computerized pump built to deliver drugs to patients in care.

However, while hospitals are transitioning to other products, the FDA said hospitals should consider disconnecting the vulnerable device from their network.

Hospira makes injectable drugs and infusion technologies.

The vulnerability shows the risky side of an increasingly connected health-care system.

The Department of Homeland Security gave a similar warning about the pump’s vulnerability a few days prior.

About a month later Rios wrote in a blog post that other Hospira pumps are also affected and said “we have yet to see a single fix for the issues affecting the PCA 3”, leading to criticism from cybersecurity expert Kevin Fu, who told FierceMedicalDevices in a June email that Hospira executives are “shameful” and “in denial about cybersecurity risks”. So far, there is no documented case of any unauthorized access in a hospital setting, according to the FDA.

In 2012, the FDA banned the import of Symbiq pumps made in Hospiras Costa Rica manufacturing facility, noting in a warning letter that the agency had found numerous uncorrected quality problems. The feds recommended software upgrades and risk-mitigation measures but did not call on use of those devices to be discontinued.

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“This could be used to hurt somebody, unequivocally, we’ve already demonstrated that”, said Rios.

Hospital infusion bag