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Half a million pacemakers recalled over…cybersecurity concerns?

The US Food and Drug Administration (FDA) announced on August 29th that it was recalling some 465,000 implantable pacemakers over cyber security concerns. Namely, the FDA is concerned that malicious hackers could take control of the pacemaker for nefarious purposes, including initiating improper pacing or rapidly depleting the batteries. 

Which devices are being recalled?

The recall affects Abbott's (formerly St. Jude Medical's) implantable cardiac pacemakers, including CRT-P devices, which are designed to regulate irregular or slow heart rhythms.

The following CRP-T devices are being recalled:

  • Accent
  • Anthem
  • Accent MRI
  • Accent ST
  • Assurity
  • Allure

However, it should be noted that implantable cardiac defibrillators (ICDs) and cardiac resynchronization ICDs (CRT-Ds) are not being implicated in these concerns.

What this recall means for patients

A traditional recall involves the company literally recalling the defective medical device. In this instance, that would traditionally mean that doctors would surgically remove the pacemaker and replace it with a functioning one that is considered immune from these cybersecurity threats. However, since as more and more pacemakers contain computer systems, the issue is more of a software than a hardware one.

As such, doctors are basically upgrading the “firmware” on these pacemakers, akin to updating the software on your phone, without performing an invasive surgery.

Patients are urged to visit their doctor and discuss the process.

So how does the “recall” work?

At an in-patient visit with a health care provider, individuals with pacemarkers will undergo a 3 minute firmware update, during which time the device will operate in backup mode at 67 beats per minute, while continuing to perform all life-saving functions.

While the procedure is generally considered safe, as with any update, there is the low possibility of an update error.

So far, the FDA claims that zero patients have been affected by the cybersecurity vulnerability, yet they urge patients to visit their doctor as soon as possible and schedule the update. 

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