FDA SOUNDS THE ALARM OVER INFUSION SYSTEM

US Agency Advises Healthcare Facilities to Stop Using Hospira's Symbiq Infusion System Due to Cybersecurity Flaws

Last week, the FDA released a safety communication on Hospira’s Symbiq Infusion System where it strongly urged “that health care facilities transition to alternative infusion systems, and discontinue use of these pumps.” Some commentators are taking this as indication that the FDA is set to become more vocal on the issue of medical device cybersecurity. And it is a topic that needs to be taken more seriously, just because we haven’t faced a major incident of cyber hacking so far doesn’t mean the medical devices’ industry will remain insulated forever.

The Symbiq Infusion System was already on its way off the market so this move by Federal authorities in the US may not be news for some. However as noted in this recent safety communication, the consequences of someone gaining access to the Symbiq Infusion System via a hospital network could prove deadly. It said, “This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.” The FDA could take a leading role in spreading the message that cybersecurity needs to be at the fore of everyone’s mind.