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The FDA recently published a notice regarding security issues with the Hospira LifeCare PCA3 and PCA5 infusion pump system. The warning advises hospitals to isolate the pumps from the Internet and untrusted networks, and conduct a clinical use case risk assessment to identify any other potential environmental vulnerability. Software security vulnerabilities in the pumps can allow access to Telnet and FTP services on the device without the need for proper authentication. This is one of the first instances of the FDA issuing a warning due to a software vulnerability regarding hospital networks and medical device cybersecurity.
In a joint statement by the FDA and Hospira, “they have become aware of security vulnerabilities in Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems” as well as the publication of “software codes, which, if exploited, could allow an unauthorized user to interfere with the pump’s functioning.” An unauthorized user with malicious intent could “access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies,” the safety advisory warned.
In June 2013, the FDA asked medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats that could compromise the devices or patient privacy. To date, the FDA says it is not aware of any patient adverse events or unauthorized device access related to the vulnerabilities uncovered with the Hospira infusion pumps.
For Further Information
More on the markets for infusion therapy devices in the U.S. can be found in this 2015 edition report published by iData entitled U.S. Market for Infusion Therapy Devices, which covers the U.S. as a whole, as well as market segments for large volume, syringe, patient-controlled analgesia, electronic ambulatory, and disposable ambulatory infusion pumps; primary, secondary and extension IV sets; and split septum, blunt cannula, and mechanical valve needleless connectors.
The iData series on the market for infusion therapy devices also covers the U.S., Australia, Japan, South Korea, and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.
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