FRANKLIN LAKES, N.J.,
April 30, 2019 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced it has received U.S.
Food and Drug Administration (FDA) approval for BD ChloraPrep™ skin
preparation with sterile solution, the only fully sterile
chlorhexidine gluconate (CHG) antiseptic skin preparation
commercially available in the U.S.
This new BD ChloraPrep™ product uses a proprietary and patented
process to sterilize the antiseptic solution inside the sealed
ampoules located in the BD applicator. With the new sterilization
process in place, the BD ChloraPrep™ solutions portfolio that
undergo this proprietary added level of sterility will now be
labeled as a "sterile solution" on all packaging.
"At BD, we are constantly exploring new opportunities to protect
patients and advance health," said Michael
Garrison, worldwide president of Surgery at BD. "The FDA
approval of BD ChloraPrep antiseptic skin preparation with sterile
solution ensures that the solution inside of the applicator
receives the same level of sterilization as the applicator itself
to help further reduce the risk of intrinsic contamination."
Following FDA hearings in 2012 focused on sterility of skin
antiseptic products and subsequent label changes in 2013, BD
determined to proactively address the sterilization challenge in
the U.S. Over the last six years, BD has invested in the
development of an innovative sterilization process that not only
can handle the volume of product demanded, but also improves
overall efficiency versus traditional sterilization
methods.1
"The idea of contaminated antiseptic solutions seems
counter-intuitive because the function of an antiseptic is to kill
bacteria," said Donald E. Fry, M.D.,
a nationally recognized expert in infection prevention. "Outbreaks
of highly resistant bacteria and spore contamination have been
reported with contaminated antiseptic products in the past. Now
with a fully sterilized skin preparation product, BD is assisting
health care providers with a tool to enhance patient safety by the
reduction of risk from intrinsic contamination in antiseptic
solutions."
Novel Sterilization Process
BD's proprietary sterilization process was designed to achieve a
minimum sterility assurance level (SAL) of 10-6, the
same level required for injectable products.1 The SAL
indicates there is less than 1 in 1 million chance that a sterile
BD ChloraPrep™ applicator containing sterile solution will contain
a single, viable microorganism following terminal sterilization of
the ampoules through BD's new sterilization process.1
While a product labeled as non-sterile does not suggest that it is
contaminated with bacteria, it indicates that the contents have not
been sterilized individually. Traditionally, BD ChloraPrep™
applicators have been sterilized at the end of the manufacturing
process and the solution inside of the applicators was not treated
with a separate sterilization process. This new process adds
another layer of assurance to an already-proven product and builds
on the heritage and reliability of BD ChloraPrep™ skin
preparation.
The new BD ChloraPrep™ sterile solution will include a mark to
indicate that it is sterile. Though not required by the FDA, BD
developed this mark to distinguish sterile solution from
non-sterile antiseptic skin preparations. In 2013, the FDA asked
manufacturers to voluntarily change labeling on products (sterile
vs. non-sterile) to further educate customers on the issue.
As a leader in antiseptic skin preparation and patient
pre-operative skin preparation, BD is continually working to
improve technology and patient safety. BD ChloraPrep™ skin
preparation continues to be the leading standard of care for
preoperative antiseptic skin preparations. Since its introduction
over 18 years ago, more than four billion applicators have been
used. BD ChloraPrep™ skin preparation, and its efficacy, is
supported by more than 50 clinical publications.
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. For more information on
BD, please visit bd.com.
[1] Degala, et al. United States Patent 9,078,934.
July 14, 2015.
Contacts:
|
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Sandra
Moskowitz
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Monique N.
Dolecki
|
BD Public
Relations
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BD Investor
Relations
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201.847.5976
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201.847.5378
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sandra.moskowitz@bd.com
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monique_dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)