Regulators Recall 465,000 Pacemakers After Finding Security Issues
Posted by PKSD Law Firm on August 31, 2017 in Defective Medical Devices
The U.S. Food and Drug Administration (FDA) recently decided to recall 465,000 pacemakers due to security issues.
Regulators feared that certain vulnerabilities with these devices would allow hackers to access and reprogram them, possibly putting patients’ lives at risk.
Devices in the Recall
The recall includes several devices from Abbot, formerly known as St. Jude Medical, according to the FDA safety communication:
- Accent MRI
- Accent ST
The recall excludes implantable cardiac defibrillators (ICDs) and cardiac resynchronization ICDs.
Fixing the Security Issue
Fortunately, those affected by the recall will not need to have their device removed and replaced. The security issues can be fixed with a simple upgrade to the software, which was approved by the FDA on Aug. 23.
The update takes only about three minutes, and while the update is being done, the device will go into backup mode, ensuring the essential features of the device continue operating.
Once the update is made, any device that attempts to communicate with the pacemaker must provide authorization, which will help prevent hackers from taking control of these devices. This functionality will be included in all pacemakers manufactured on or after Aug. 28.
The FDA advises patients to talk to their doctors to determine when they can receive the update and if they have any questions or concerns about it.
Scope of the Problem
The FDA is unaware of any reports of patients being harmed due to the security vulnerability in the affected devices. However, hackers have pointed out that the vulnerability creates the possibility of patients being harmed.
The FDA is reminding patients, health care providers and caregivers that medical devices connected to communications networks, such as wi-fi, may have cybersecurity vulnerabilities that hackers could exploit.
However, wireless technology and software in medical devices help to create safer, more efficient, convenient and timely delivery of health care services.
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