San Clemente, Calif. January 10, 2019 – ICU Medical, Inc., a worldwide leader in the development, manufacture and sale of innovative medical devices used in infusion therapy and critical care applications, announced that its ICU Medical MedNet IV medication safety software has become the first IV safety software platform to obtain certification under the UL Cybersecurity Assurance Program(UL CAP). This certification highlights ICU Medical MedNet safety software as meeting the highest level of third-party cybersecurity standards from UL (Underwriters Laboratories) for life safety and security, UL 2900-2-1.
UL CAP is a cybersecurity management program from UL designed to minimize risks by creating standardized, testable criteria for assessing software vulnerabilities and weaknesses to help reduce exploitation, address known malware, enhance security controls and expand security awareness.
ICU Medical MedNet software facilitates networked communication between compatible computer systems and compatible infusion pumps, such as ICU Medical’s Plum 360TM and LifeCare PCATMinfusion pumps. ICU Medical MedNet joins the Plum 360, which has also earned UL CAP 2900-1 and 2900-2-1 certifications, as firsts in the industry to reach these significant milestones, providing a secure end-to-end IV drug delivery system.
In June 2018, the Plum 360 became the first medical device to obtain UL CAP certification. When used with ICU Medical MedNet, Plum 360 provides full interoperability with patient electronic health records (EHR), reducing the need for manual input and transcription of infusion data to better manage patient safety and clinician workflows. In addition, the 2018 Best in KLAS Plum 360 features closed system air management to minimize patient therapy interruptions, contamination risk and exposure to hazardous medications.
“We know that minimizing cybersecurity threats is a high priority for hospitals and IT leaders, which is why we continue to develop technologies that protect vital patient and clinical data,’’ says Dan Woolson, Corporate Vice President for Infusion Systems at ICU Medical. “We’re extremely proud of this first UL CAP certification for ICU Medical MedNet as it encapsulates and continues our mission to help make healthcare safer.”
The UL assessment uses ANSI UL 2900 medical device cybersecurity standards to assess key categories including quality management documentation, product design and use, security risk management (including safety-related controls), managing known vulnerabilities with exposures and managing software weaknesses—as well as measures to address potential zero-day vulnerabilities.
“ICU Medical is the first infusion safety software platform to have this certification for both infusion pump and enterprise server software,” says Anura Fernando, Chief Innovation Architect, Medical Systems Interoperability & Security at UL. “Certification of ICU Medical MedNet separately by UL CAP highlights ICU Medical’s strong comprehensive cybersecurity platform.”
About UL Life & Health Sciences:
UL Life & Health Sciences (LHS) helps healthcare and medical device companies navigate complex global regulatory systems in order to bring safer, more secure, usable and interoperable products and technologies to patients and healthcare providers. UL LHS is a division of Underwriters Laboratories, the company with more than 120 years of product safety expertise. Learn more about UL LHS.
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