June 20, 2018
The UL Cybersecurity Assurance Program (UL CAP) has issued its first certification to ICU Medical, a San Clemente, Calif.-based company specializing in IV therapy products and services.
ICU Medical earned UL CAP certification for its Plum 360 drug infusion system, which features closed-system air management intended to minimize patient therapy interruptions, contamination risk, and exposure to hazardous medications. In addition, Plum 360 provides interoperability with patient Electronic Health Records (EHR).
"UL is pleased to have had such a dedicated and proactive partner as ICU Medical for going through the UL CAP certification process to help jump-start this initiative under the US Cybersecurity National Action Plan," says Anura Fernando, Principal Engineer, Medical Systems Interoperability & Security at UL. "This sets the bar for establishing demonstrable, evidence-based cybersecurity hygiene across the healthcare industry."
The completed certification of the ICU Medical Plum 360 infusion pump makes it the first UL CAP certified medical device to enter the US market. The UL assessment covers key categories including: Quality Management Documentation, Product Design and Product 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.
UL CAP utilizes the ANSI UL 2900 series of cybersecurity standards to minimize security risks and help reduce exploitation, address known malware, enhance security controls, and expand security awareness and preparedness. UL has longstanding expertise in safety science, standards development, testing and certification, and has worked with industry, US and international government agencies, academia, regulators, and other stakeholders per the ANSI consensus process to develop UL 2900. This helps manufacturers demonstrate, via objective evidence, that they’ve established a baseline of cybersecurity hygiene.
About ICU Medical
ICU Medical, Inc. (Nasdaq: ICUI) is one of the world's leading pure-play infusion therapy companies with global operations and a wide-ranging product portfolio that includes IV solutions, IV smart pumps, dedicated and non-dedicated IV sets and needle-free connectors, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. In addition, the company manufactures automated pharmacy IV compounding systems with workflow technology, closed systems transfer devices for hazardous IV drugs, and cardiac monitoring systems to optimize patient fluid levels. Learn more about ICU Medical.