BD Diagnostics, a segment of BD (Franklin Lanes, New Jersey) reported the launch of BD Bactec FX Blood Culture System for the detection of bloodstream infections.
This new system, which is an updated version from the 1991 FDA-approved Bactec 9000 system, is said by the company to improve clinical decision-making and laboratory workflow.
"What it does is streamlines the workflow in the lab, and allows for remote observation of a blood culture," Diane Flayhart, U.S. marketing manager for BD, told Medical Device Daily.
Since the system is only a slight modification of the older version, the company didn't need FDA approval for the device.
The system enables remote observation of blood culture data from outside the microbiology department through integration with the BD EpiCenter Microbiology Data Management System. This innovative capability allows clinician access to laboratory results during any shift and provides a visible and audible alarm on the remote BD EpiCenter client or on an existing computer monitor in a more highly occupied area of the lab.
"Lab personnel no longer need to interrupt evening or midnight workflow to repeatedly check the microbiology department for positive blood cultures," Flayhart said regarding the device.
Irregularities in the blood are spotted through fluorescent marks.
By providing data access at the same remote computer that provides the alarm, the system facilitates immediate decision-making. With the information provided, clinicians can initiate appropriate next steps to diagnose the infection, such as performing a Gram stain, subculture, or direct identification of methicillin-susceptible or methicillin-resistant Staphylococcus aureus with the BD GeneOhm Staph SR assay. These steps could lead to earlier appropriate clinical decisions for effective antimicrobial interventions.
Multi-source data integration provides for comprehensive reporting capabilities across all Bactec FX and Bactec 9000 blood culture instruments, eliminating the need for manual report consolidation on more than five instruments. Data from up to numerous Bactec FX instruments can be consolidated into one reporting system with the BD EpiCenter system.
"That's the key behind the device, to be able test these blood cultures for a positive, and to get those results back to a physician as quick as possible," Flayhart said. "Once a positive is found in the blood, then it takes only a matter of minutes to get that information to the physician, so he can make an adequate choice regarding treatment."
That information usually is available by fax, e-mail, mobile phone text messaging or beeper to any off-site healthcare professional.
"The new BD Bactec FX System responds to customer requests for an efficient blood culture workflow process by reducing hands-on time and enhancing blood culture observation in and out of the microbiology lab," said David Panneton, VP worldwide marketing, BD Diagnostics. "It is the result of 40 years of blood culturing expertise and customer interaction, with more than 10,000 blood culture instruments installed worldwide."
BD has been rolling along with strong profits and on an upward acquisition path as of late.
Late last year it reported record quarterly revenues of $1.651 billion for 4Q07, an increase of about 13% over the year-ago quarter (Medical Device Daily, Nov. 2, 2007). The company said the quarter's growth rate reflected the favorable impact on all segments from foreign currency translation, which overall is estimated to account for three percentage points of the increase in quarterly revenues.
BD completed its $230 million acquisition of GeneOhm Sciences in February 2006 (MDD, Feb. 15, 2006). GeneOhm develops molecular diagnostic testing for the rapid detection of bacterial organisms, including those known to cause healthcare-associated infections.
The company also finalized its $350 million acquisition of TriPath Imaging (Burlington, North Carolina) last month after announcing the planned acquisition last December. TriPath makes products intended to improve the clinical management of cancer.
Since the beginning of this year the company has been rolling out a steady stream of products for the U.S. and European markets.
Last month the company reported the CE-marking of the BD GeneOhm VanR assay for the rapid detection of vanA and vanB genes, which are associated with vancomycin-resistant Enterococci (VRE). The BD GeneOhm VanR assay is a qualitative, in vitro polymerase chain reaction (PCR) test for the detection of vancomycin-resistant genes directly from perianal and rectal swabs (MDD, May 3, 2008).
In January the company received FDA clearance for its GeneOhm StaphSR assay, an advanced test derived from a previous assay developed by its GeneOhm (San Diego) subsidiary (MDD Jan.2, 2008) BD says that this test is the first available to rapidly and simultaneously identify two deadly healthcare-associated infections (HAIs) — Staphylococcus aureus (SA) and MRSA, from patients with positive blood cultures and that it can produce results in two hours.