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BD issues statement on COVD-19

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BD issued the following statement on how the company is working with companies and agencies during the COVID-19 outbreak:

FRANKLIN LAKES, N.J. — BD is closely monitoring the COVID-19 (coronavirus) situation across the world and guidance from the U.S. Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and health officials in a variety of affected countries to ensure the health and safety of BD employees while ensuring continuity of BD’s critical medical devices at this unprecented time.

Status of BD operations:

BD manufactures and sources product from multiple locations around the world:

The new coronavirus tests will be run on the BD MAX™ Molecular Diagnostic Platform, which is already in use in nearly every state across the U.S. at hundreds of laboratories, with each unit capable of analyzing hundreds of samples per day. The system is fully automated, reducing the opportunity for human error and increasing the speed to result. Samples are capable of being analyzed start to finish in two to three hours.

• Within the U.S., all of BD’s manufacturing and distribution centers are operating normally. Similar to the healthcare providers we serve, BD’s manufacturing and distribution center teams are considered essential workers and are exempt from the “shelter in place” directives multiple states have issued.

• In Europe, all of BD’s manufacturing and distribution centers are fully operational. In Italy, Spain, Ireland and France, where local governments have imposed stricter “lockdown” measures to slow the spread of coronavirus, BD’s operations continue to operate with measures in place to ensure business continuity. In Belgium, our major European Distribution Centers continue to replenish stock via BD’s Global Supply Chain network.

• In Greater Asia, the vast majority of BD’s manufacturing and distribution centers are operating normally. We have implemented business continuity measures in response to the “lockdown” directive in Malaysia, which has temporarily restricted the number of employees able to report to work in Malaysia and Singapore. As a result, these plants are currently operating at a reduced capacity through March 31 while we work with local government agencies to seek an exemption and assess additional business continuity options to maximize our manufacturing output. In India, our facility in Haryana is continuing to operate normally and there is no interruption to the production. The lockdowns in India and Malaysia are currently expected to be in place until March 31, and we are making every effort to maintain production and ensure the continued flow of BD products to our customers.

• In addition, BD continues to assess its key suppliers that provide raw materials and components to BD manufacturing plants around the world. BD continues to have sufficient raw material and component inventory to meet manufacturing demand.

Product Availability

• BD has ramped up production and continues to meet current demand for the vast majority of our products. However, we are seeing high demand in select product categories because of a prolonged flu season and the coronavirus pandemic. We are closely monitoring this dynamic situation and will keep customers informed on any meaningful changes to product availability as the situation evolves.

• Based on very high demand, the following products are on manual inventory allocation to supply our customers as much as possible:

• BD Alcohol Swabs sold to retail pharmacies and used in other ‘small-medical’ settings.

• BD Universal Viral Transport (UVT) System (including swabs, vials and prepackaged kits). These products are used to collect and transport clinical specimens for viral testing, including for the diagnosis of the flu or the coronavirus. Alternative product options may be available.

• Swab-based specimen collection portfolio, inclusive of additional swabs approved for use by the U.S. Food and Drug Administration (FDA).

• BD MAX System and BD MAX Open-System Reagents that support COVID-19 testing, such as the Total Nucleic Acid (TNA) reagent suite.

• Point of care testing portfolio, including BD Veritor™Plus System Analyzer, BD Veritor Flu A+B CLIA Waived Kit and BD Veritor Flu A+B Moderately Complex Kit.

• Relevant vascular access and injection-related products used in treatment of COVID-19. We are currently in a healthy inventory position for the majority of these formulary critical products being used for the treatment of COVID-19

• BD and Alaris infusion sets. To help ensure continuity of supply, we have placed all BD and Alaris infusion sets on manual inventory allocation until further notice. As a part of our supply continuity plan, we are also reducing the number of available product SKU’s of our Alaris System pump sets, enabling us to maximize manufacturing production while ensuring we meet our customers’ clinical needs. Additional information on the infusion set allocation process and SKU prioritization is available at bd.com/allocation.

• BD Alaris System. We understand that while distribution is suspended for the BD Alaris™ System, you may have an immediate medical need that requires a limited shipment. As a result, we have established a process by which existing customers with Alaris™ System devices may request limited shipment of the BD Alaris™ System software compatible devices upon certification of medical necessity. Further due to increased COVID-19 demand, BD will limit approved medical necessity orders to an equitable allocation to ensure we effectively serve our existing customers as well as serve areas of the country with high census due to treatment of COVID-19 patients.

• Manual inventory allocation is an internal process that allows BD to retain greater visibility and control of available product to effectively serve our customers by ensuring an equitable allocation of available inventory. This includes reviewing orders for disproportionate quantities based on historic demand. An up-to-date list of products on manual inventory allocation can be found at bd.com/allocation.

• While this may result in longer than normal call times for customer service, customers do not need to take any special action related to this process and it will not otherwise delay the ordering or shipping process. Customers may receive a backorder notification when an order is placed, and orders may be filled as partial shipments as inventory becomes available. We believe these practices will help minimize supply disruptions.

Business Continuity Planning

• BD has business continuity plans for these types of situations. If a product or raw material is deemed at risk, BD will adopt numerous contingency plans including seeking alternative suppliers, expediting shipments, redeploying raw materials and/or finished goods from other parts of the BD network and placing at-risk products on order review to prevent hoarding behavior. BD also institutes preventative pandemic precautions at facilities to protect employees, including increasing cleaning protocols, implementing temperature screenings for on-site employees, encouraging work-from-home for all employees who are able, suspending travel and group meetings, limiting on-site visitors, and regularly educating employees about good hygiene and health practices, including social distancing, self-quarantining and handwashing.

Supporting Global Response

• As one of the largest global medical technology companies in the world, BD is deploying our capabilities, expertise and scale to address critical health needs related to coronavirus – from our diagnostic offerings to identify COVID-19, to real-time informatics and electronic surveillance technology, to essential medical devices to support patient care. Specifically, BD:

• Announced new products to help aid in the detection and identification of COVID-19, including a molecular test for the detection of COVID-19 for clinical laboratories in countries recognizing the CE mark.

• Partnered with BioGX to announce that the companies have submitted Emergency Use Authorization (EUA) requests to the FDA for new diagnostic tests that would increase the potential capacity to screen for COVID-19 by thousands of tests per day.

• Participated in a recent White House meeting with CEOs of private sector partners who have been involved in the effort to expand access to COVID-19 testing and test development.

• Is urgently undertaking additional clinical studies to validate multiple swabs and saline as a transport medium. Our intent is that these swabs may be used for nasal collection and to include a self-collection process. We currently expect results and subsequent submission under the EUA process to the FDA in the coming weeks.

• In addition, BD is deploying $1.1 million in cash and product donations to seven non-profit organizations – Direct Relief, the International Medical Corps, Americares, the World Health Organization-United Nations Foundation COVID-19 Solidarity Response Fund, Project HOPE, the CDC Foundation and the Wuhan Red Cross – to advance their work to contain COVID-19, support healthcare workers and treat patients in countries throughout the world.

• BD will continue to monitor the situation and provide regular updates at bd.com/COVID-19.

 


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