US warns of cyber attacks on medical devices

A man uses a robot to practice surgery in Melle on April 15, 2013. US authorities on Thursday warned makers of medical devices and hospital networks to step up efforts to guard against potential cyber attacks.

US authorities on Thursday warned makers of medical devices and hospital networks to step up efforts to guard against potential cyber attacks.

The said implanted devices, which could include pacemakers or defibrillators, could be connected to networks that are vulnerable to hackers.

An FDA warning notice was sent to medical device manufacturers, hospitals, medical device user facilities, health care technical staff and .

It said the agency has recently "become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations."

"The FDA is recommending that and take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack," the warning said.

These devices or systems could be compromised "by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks," the FDA said.

"This may sound like it is out of a science fiction movie, but the threat is conceivably a serious one," said Jon Ogg at 24/7 Wall Street.

"Can you imagine a device being retooled maliciously, like an inserted pacemaker/defibrillator? Or imagine if a system was maliciously recalibrated in even a slight manner for surgeries.

"The list of threats is endless."

The FDA said it was "not aware of any patient injuries or deaths associated with these incidents" nor does it have any specific information on targeted devices.

The FDA said it had been working with other federal agencies as well as manufacturers, which it said are "responsible for remaining vigilant about identifying risks and hazards associated with their medical devices."

Among the measures that should be taken, the FDA said, are limiting unauthorized device access, "particularly for those devices that are life-sustaining or could be directly connected to hospital networks."

add to favorites email to friend print save as pdf

Related Stories

Security experts sound medical device malware alarm

Oct 19, 2012

(Phys.org)—Speakers at a government gathering revealed more reasons for nervous patients to get out their worry beads over future hospital stays. Besides staph infections, wrong-side surgeries and inaccurate ...

Judges side with FDA in rejecting stem cell device

Mar 22, 2013

(AP)—A federal appeals court is siding with the Food and Drug Administration in a case brought by medical device maker Cytori, ruling that the agency was correct to reject fast-track approval for two company devices used ...

FDA proposes new rules for heart defibrillators

Mar 22, 2013

(AP)—The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices.

FDA pledges support for med tech initiative

Dec 03, 2012

(AP)—The Food and Drug Administration says it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.

FDA aims to accelerate medical device reviews

Feb 08, 2011

(AP) -- Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.

Recommended for you

Have a cold? Don't ask your doctor for antibiotics

Nov 26, 2014

Antibiotic resistance is a major threat to public health. Resistance makes it harder for physicians to treat infections and can increase the chance patients will die from an infection. What is more, the treatment ...

Powdered measles vaccine found safe in early clinical trials

Nov 25, 2014

A measles vaccine made of fine dry powder and delivered with a puff of air triggered no adverse side effects in early human testing and it is likely effective, according to a paper to be published November 28 in the journal ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.