The Risks and Rewards of Connected Patient Monitoring

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3Q 2017 | IN-4762


Product Recalls


Typically, product recalls occur either when the company that manufactured the product uncovers a problem or an oversight agency, such as the U.S. Food & Drug Administration (FDA) or the United States Department of Agriculture (USDA), raises concerns about the product’s use or safety. Once a recall is issued, consumers are asked to stop using the product and receive a repair, refund, or replacement. However, the recall process is evolving in order to account for Internet-connected devices that have been deployed in hard-to-reach places, which include implantable medical devices, such as pacemakers.

In late August 2017, the FDA issued a recall notice for nearly half-a-million radio frequency (RF)-enabled St. Jude Medical implantable pacemakers already embedded in patients’ chests. The FDA found that there were potential cybersecurity vulnerabilities with the RF-enabled implantable pacemakers that could allow an unauthorized user to access a patient’s device using commercially a…

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