FDA Device Alert: A Catalyst for Change

Written by Feedproxy
  • Feedproxy
  • 3 years ago


The recent alert from the Food and Drug Administration advising healthcare organizations to stop using a line of infusion pumps because of cybersecurity flaws “is a very significant regulatory development,” says attorney Anna Spencer, who has represented device makers. That bold action, coupled with the FDA’s new security guidance for manufacturers, will lead the companies to be more focused on risk management, she predicts.

The FDA, in an unprecedented move, recently urged hospitals and others to discontinue use of the Symbiq line of infusion pumps from Hospira after independent researchers discovered vulnerabilities in those devices that could allow an unauthorized user to control the device and change the dosage of medication the pump delivers.

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