SAN CLEMENTE, Calif.,
June 19, 2018 /PRNewswire/
-- ICU Medical, Inc., a worldwide leader in the development,
manufacture and sale of innovative medical devices used in infusion
therapy and critical care applications, has become the first
medical device manufacturer to obtain certification under the UL
Cybersecurity Assurance Program (UL CAP), a new 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 earned UL CAP certification for its Plum 360 drug
infusion system that 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, Plum 360 features
closed-system air management to minimize patient therapy
interruptions, contamination risk, and exposure to hazardous
medications.
"ICU Medical continues to dedicate significant energy and
resources to developing technologies that help protect vital
patient and clinical data. We are grateful for the opportunity to
partner with UL in in this important initiative to help make
healthcare safer." says Dan Woolson,
Corporate Vice President for Infusion Systems at ICU Medical,
Inc.
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.
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 to help manufacturers address cybersecurity
hygiene.
"UL is very pleased to have had such a dedicated and proactive
partner as ICU Medical to help us 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 UL CAP certification for Plum 360 comes on the heels of the
device winning 2018 Best in KLAS designation as the top performing
IV smart pump by KLAS Research, a leading global healthcare
research firm.
Contact: Tom McCall
949-366-4368
tmccall@icumed.com
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.
About UL Healthcare: UL LLC Healthcare 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 Healthcare.
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SOURCE ICU Medical, Inc.