The U.S. Food and Drug Administration (FDA) recently issue a warning about
the safety of a medical device commonly used in hospitals, nursing homes,
and other healthcare facilities. According to the FDA, the Hospira Symbiq
Infusion System, a computerized pump designed to continuously deliver
medication and fluids, is susceptible to hacking.
The problem is that the infusion pump can be accessed remotely through
a hospital’s network. “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 warning states.
According to the FDA, it is currently not aware of any patient adverse
events or unauthorized access of a Symbiq Infusion System in a healthcare
setting. However, given the risks, the agency strongly advises that hospitals
stop using the pump and transition to a new system as soon as possible.
While this is the first time the FDA has issued a cybersecurity-related
safety warning for a medical device, the agency has been monitoring how
potential security vulnerabilities could impact medical device safety.
The agency recently advised medical device manufacturers to address cybersecurity
as part of the design and development of a product and submit documentation
to the agency about the risks identified and controls in place to address them.
The FDA’s warning highlights that the benefits of increasingly connected
devices can come a cost, particularly if the proper security precautions
are not in place. A few weeks ago, Chrysler Fiat recalled 1.4 million
vehicles that are equipped with in-vehicle technology that is susceptible
While insulin pumps and motor vehicles seem like unlikely targets for hackers,
a security breach could have drastic consequences. Therefore, it is imperative
that manufacturers take the risks seriously.
If you or someone you love has been seriously injured by a dangerous or
defective medical device, don’t hesitate tocontacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.