The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Merlin@home Transmitter, manufactured by St. Jude Medical.

The FDA is providing information and recommendations regarding St. Jude Medical's radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities.

Many medical devices—including St. Jude Medical's implantable cardiac devices—contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates.

To improve patient safety, the manufacturer has developed and validated a software patch for the Merlin@home Transmitter that addresses and reduces the risk of specific cybersecurity vulnerabilities. The FDA has reviewed St. Jude Medical's software patch to ensure that it addresses the greatest risks posed by these cybersecurity vulnerabilities, and reduces the risk of exploitation and subsequent patient harm. The FDA conducted an assessment of the benefits and risks of using the Merlin@home Transmitter, and has determined that the health benefits to patients from continued use of the device outweigh the cybersecurity risks.

The FDA urges health care providers to:

• Continue to conduct in-office follow-up, per normal routine, with patients who have an implantable cardiac device that is monitored using the Merlin@home Transmitter.
• Remind patients to keep their Merlin@home Transmitter connected as this will ensure that patients' devices receive the necessary patches and updates.

The FDA urges patients and caregivers to:

• Follow the labeling instructions provided with their Merlin@home Transmitter. Keeping their monitor connected as directed will ensure their monitor receives necessary updates and patches. Keep in mind that although all connected medical devices, including this one, carry certain risks, the FDA has determined that the benefits to patients from continued use of the device outweigh the risks.
• Seek immediate medical attention if they have symptoms of lightheadedness, dizziness, loss of consciousness, chest pain, or severe shortness of breath.

For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm535979.htm
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 10 January 2017