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FDA Warns Common Medical Device Is Susceptible to Hacking

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 to hacking.

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.