We recognize the urgent need to restore production of BD BACTEC™ blood culture vials and addressing immediate customer demand is our top priority.
This website contains the latest information about the supply of BD BACTEC™ blood culture vials for the U.S. market.
BD has worked diligently with our supplier to increase production output, addressing technical issues and improving production line efficiency to increase plastic vial output. We implemented a range of efficiency measures, including streamlining quality testing and approval turnaround times, expediting delivery of vials from the supplier to our production facility, and extending the shelf life of certain products by 30 days in the interim.
To add supplemental capacity, we have temporarily re-introduced production of BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vials. It is imperative we get as many customers as possible to convert temporarily to glass vials.
These efforts are having a positive effect, and we are experiencing greater output from our supplier and more product entering the market. We are working closely with our distributors to align with our customers’ needs and minimize the time gap between receiving product from BD and distribution to customers.
We now expect to get production levels back to meeting 100% of historic demand levels by end of September for the U.S. market. And by the end of 2024, we expect to produce 125% of historical weekly demand to enable distributors and customers in the U.S. to begin rebuilding inventory and safety stock.
It is important to understand that reaching that level of supply requires as many U.S. customers as possible to use Lytic glass vials when they can.
Complete the form below to receive notices of updates. As always, feel free to reach out to your BD sales representative with questions or contact our dedicated BD BACTEC™ hotline at 1.888.834.4332.
NEW/UPDATED as of October 8, 2024
Although BD does not have manufacturing facilities in Florida, we do have suppliers in the region and utilize the Jacksonville, FL port for both inbound materials and outbound finished goods. We are working closely with our suppliers and logistics providers to assess any potential impact from Hurricane Milton and are diligently implementing contingency and business continuity plans as the storm progresses. Contingency planning includes potentially diverting shipments to an alternate port on the East Coast as well as shipping via air freight. We will provide updates if we become aware of any disruptions that could affect product availability or customer service.
We now expect to get production levels back to meeting 100% of historic demand levels by end of September for the U.S. market. And by the end of 2024, we expect to produce 125% of historical weekly demand to enable distributors and customers in the U.S. to begin rebuilding inventory and safety stock.
Because of the complexities associated with our manufacturing and shipping process, we cannot provide universal guidance on allocation that would be accurate for all labs. Please contact our dedicated BD BACTEC™ hotline at 1.888.834.4332 or your BD Account Executive using the “Contact Us” form at the bottom of this tab for the latest and most accurate information about your open orders.
These plastic vials are only used in the production of BD BACTEC™ blood culture vials and do not impact production of other BD products. Please see list of impacted products below.
Other regions are also experiencing supply challenges.
BD uses strict testing standards in line with product and design requirements to assign shelf-life for each of its products. As a global manufacturer, careful consideration is required to account for broad coverage of targeted organisms, the environments where our products may be used, and variations in logistic pathways.
The current process for establishing shelf-life for regulated devices includes obtaining a successful time point beyond the claimed expiry time-period and recently this data has been used as supporting evidence to grant an interim extension to 10 months for specific lots.
While we are aware of published data that suggests that some blood culture media may, under certain conditions and for certain pathogens, meet requirements beyond the stated shelf-life, products in the market are expected to meet all design input requirements. BD has looked at expanding shelf-life for BACTEC™ media as it has many positive benefits for both BD and our customers, however our internal data does not support broad extensions beyond what we have determined for each specific lot at this time.
Production schedules for blood culture media are regularly updated to ensure optimal product mixes based on regional demands.
The BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vials was previously cleared by FDA under the same name prior to the BD BACTEC™ Lytic/10 Anaerobic/F Culture being made in plastic vials. Although the BD BACTEC™ Lytic Anaerobic glass vial product is a different SKU (#442265), there are no changes in the intended use or media formulation of the product when compared to plastic.
As a manufacturer, we cannot recommend or say if you need a verification to utilize the glass vials versus the plastic vials. The requirement and choice of a verification strategy for the BD BACTEC™ Blood Culture media is ultimately the decision of the laboratory.
No.
Per CMS, “when the laboratory introduces an unmodified, FDA-cleared or approved test system, it must conduct a verification of performance specification study.” Your regulatory entity would be best positioned to help answer any questions you have on verification and or validation requirements.
One set can be collected in one plastic vial and one glass vial. The BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vial has the same intended use as the plastic vial.
We define a “set” as having an anaerobic and an aerobic vial, not by them being glass or plastic.
As a manufacturer, we cannot make recommendations on what is the minimum number of organisms needed. We created our suggested verification protocol keeping in mind regulatory requirements from CAP and CLIA. Your regulatory entity would be best positioned to help answer any questions you have on verification protocols.
Please use the “Contact Us” form at the bottom of this tab and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.
Customers who live in the United States and select countries in Europe1 where lytic anaerobic media in glass is available, must place separate orders for these products under SKU #442265.
No. Lytic anaerobic media in both glass (SKU #442265) and plastic (SKU #442021) will continue to be offered. We are reintroducing lytic anaerobic media in glass to improve overall media availability, allowing for more manufacturing of plastic vials for other SKUs. When we are able to return to full plastic supply and healthy customer inventories we plan to discontinue the manufacturing of glass.
The CLIA categorization for the BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials (SKU #442265) in glass is moderate complexity and is the same complexity as the BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials (SKU #442021) in plastic.
Based on our current manufacturing capabilities, we can most quickly launch the BD BACTEC™ Lytic Anaerobic media in glass (SKU #442265). Other media types require more specialized manufacturing processes which would take longer to deploy and given the urgent nature of the current supply situation we are looking to expedite product availability. By re-launching BD BACTEC™ Lytic Anaerobic media in glass (SKU #442265), we expect to improve overall quantities of all products including our BD BACTEC™ Plus Aerobic media (SKU #442023) and BD BACTEC™ Peds Plus media (SKU #442020).
There are distinct differences in media formulation and organism recovery between the media that should be considered before switching media types.
From a manufacturing standpoint, we believe the supply for the BD BACTEC™ Lytic anaerobic vial in glass is enough to supply the U.S. region so there is no need to move media types.
There has been no disruption to pediatric vial production. We are managing Pediatric vial production similar to all other media types. BD BACTEC™ Pediatric media will not be available in glass.
We can manufacture the BD BACTEC™ Lytic/10 Anaerobic/F Culture media in glass without disruption to our automated lines for plastic. Lytic in glass in a semi-automated production process. One of the reasons we can do this is because there are no resins in the BD BACTEC™ Lytic/10 Anaerobic/F Culture media, which makes it a much easier media for us to manufacture on a semi-automated basis, without impacting our automated production lines. We do not plan to move to glass for any other media.
For customers migrating to BD BACTEC™ Lytic Anaerobic media in glass, one case (100 holders of BD BACTEC™ Holders (SKU# 445771)) has been provided at no charge. To order additional BD BACTEC™ Holders, please contact your BD sales representative.
The shelf-life for glass and plastic vials is the same.
Users will have to consider the implications of glass vials when using pneumatic tube systems, however, BD offers a bottle holder (SKU #445771) to help protect glass vials during transport.
BD BACTEC™ Myco F Lytic in glass (SKU #442288) will be discontinued in markets where Myco F Lytic media in plastic (SKU #442794) is available. Discontinuing Myco F Lytic in glass will enable us to streamline our operations and focus manufacturing on improving overall media production. Laboratories with access to Myco F Lytic media in plastic should plan appropriately for this transition by ensuring that any verification requirements have been completed.
Please use the “Contact Us” form at the bottom of this tab and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.
The BD BACTEC™ Bottle Holder is an accessory to aid in transport of glass vials, primary through pneumatic tube systems.
No. The BD BACTEC™ Bottle Holder is considered an accessory and not required for use with glass blood culture vials.
As an accessory product, the BD BACTEC™ Bottle Holder does not have associated instructions for use.
To reduce the risk of biohazardous exposure, laboratories may choose to place the bottle holder containing the blood culture vial into a biohazard bag with a zip enclosure. The BD BACTEC™ Bottle Holder should be immobilized inside the pneumatic tube carrier using padded inserts or liners to cushion the sample during transfer.
Yes, the BD BACTEC™ Bottle Holder is reusable. It is designed for multiple transport cycles; however, the holder should be regularly inspected for signs of damage or loss of integrity, particularly around the screw top, to ensure its longevity.
The BD BACTEC™ Bottle Holder is made from a high-impact resistant polypropylene copolymer.
Customers can be advised to follow the CDC’s Guideline for Disinfection and Sterilization in Healthcare facilities for low-level items with a smooth, hard surface (Table 1A). This includes options like using 70% isopropyl alcohol (contact time of <1 minute) or quaternary ammonium chloride/alcohol-based solution (such as a Super Sani-Cloth® Germicidal Disposable Wipe, which has a 2-minute contact time). Frequency of disinfecting may be at the discretion of a facility’s own infection control department.
If a glass vial breaks while in the BD BACTEC™ Bottle Holder, the holder may provide an extra layer of protection, but we cannot guarantee it will contain all spills in every circumstance. To help contain leaks, it is recommended that the bottle holder containing the specimen is placed in a biohazard bag with a zip closure.
Please use the “Contact Us” form on BDBACTEC-UPDATE.com and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.
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