BD Announces completion of enterprise level cybersecurity assessment from UL

BD FACSLyric Flow Cytometer is First BD Product to Earn UL Cybersecurity Assurance Program Certification

Dec 11, 2018

FRANKLIN LAKES, N.J., December 11, 2018 – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the completion of an enterprise level cybersecurity assessment from UL. This independent assessment evaluates corporate cybersecurity programs and policies to ensure that all medical devices developed by a company are built with robust cybersecurity standards, in line with the UL Cybersecurity Assurance Program (UL CAP), and are only released to the market after appropriate protocols and testing are completed.

“Product security is of utmost importance to BD, our customers, and ultimately the patients they serve,” said Rob Suarez, director of Product Security for BD. “We strive to achieve a transparent and proactive approach to cybersecurity giving our customers confidence that all the products we sell are designed with the most sophisticated cybersecurity technologies available.”

“We are very pleased to see BD leading the way to show that it is not only important to have corporate product security policies in place, but that it is equally important to show that these security policies have been effectively implemented and demonstrated through product testing,” adds Anura Fernando, Chief Innovation Architect, Medical Systems Interoperability & Security at UL.

The UL CAP incorporates the UL 2900 set of standards, including UL 2900-1, a software cybersecurity standard for network-connected medical devices that has received official recognition from the US Food and Drug Administration.

In addition to UL assessment of cybersecurity as it relates to BD security processes, BD also announced the BD FACSLyric™ flow cytometer, as the first BD product to receive certification under the UL Cybersecurity Assurance Program (UL CAP). As an addition to the corporate level cybersecurity assessment, product certification provides an additional level of scrutiny and attests to the application of corporate cybersecurity standards to this specific product.

The corporate level assessment was a comprehensive analysis of relevant BD processes and quality procedures for areas 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 and measures to address other potential vulnerabilities. 

Product level certification for the BD FACSLyric™ flow cytometer with BD FACSuite™ Clinical software v 1.3.0 involved evaluating the product against requirements confirming that the product adhered to the corporate level processes validated by UL under the enterprise level assessment, as well as additional product testing.

Both the UL enterprise level cybersecurity assessment and UL CAP certification for the BD FACSLyric™ flow cytometer with BD FACSuite™ Clinical software v 1.3.0 are components of a broader BD cybersecurity strategy for products, announced last year, to partner with government and industry to enhance cybersecurity efforts. In the coming months and years, BD plans to continue to seek additional product level certifications from UL CAP. 

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 Healthcare is a division of Underwriters Laboratories, the company with more than 120 years of product safety expertise. Learn more about UL Healthcare.

About the BD FACSLyric™ Flow Cytometer

The BD FACSLyric™ flow cytometer, available in in vitro diagnostic (normal) and research use only (RUO) configurations. When used with BD Multitest™ assays, BD FACSLyric™ flow cytometer is intended for immunological assessment of individuals and patients having or suspected of having immune deficiency. The benchtop-sized instruments pair with BD software, reagents and services and are available in the U.S., Europe, and other geographies. The UL CAP version of the BD FACSLyric™ flow cytometer will be available in 2019.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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