FRANKLIN LAKES, N.J.,
July 7, 2020 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced the availability of BD
PurPrep™ patient preoperative skin preparation with sterile
solution, the first and only fully sterile povidone-iodine plus
isopropyl alcohol single-use antiseptic skin preparation (PVP-I;
0.83% available iodine and 72.5% isopropyl alcohol) commercially
available in the United
States.
BD PurPrep™ joins BD ChloraPrep™ patient preoperative skin
preparation as the only fully sterile skin preparations available
on the market that use a single-use applicator specifically
designed to prevent cross-contamination and promote aseptic
non-touch technique. The BD PurPrep™ patient preoperative skin
preparation is an effective skin preparation alternative when the
use of a chlorhexidine gluconate (CHG/IPA) is contraindicated or
the patient is sensitive to CHG.
"Though progress has been made, health care-associated
infections remain a problem," said Donald
E. Fry, M.D., a nationally recognized expert in infection
prevention. "Sterile single-use products have been shown to reduce
the risk of outbreaks linked to microbial contamination of
antiseptic products. By developing fully sterile PurPrep and
ChloraPrep, BD is providing health care professionals with a more
complete set of tools to reduce the risk of intrinsic contamination
in antiseptic solutions."
The new BD PurPrep™ formulation includes a fluid-resistant,
film-forming polymer developed to facilitate drape adhesion and
help create a durable antimicrobial barrier1,2 that
helps iodine bind to the skin for residual antimicrobial activity.
In an irrigation study, mimicking real-world clinical practice, BD
PurPrep™ patient preoperative skin preparation with sterile
solution remained on the skin immediately following a saline
challenge.2
"BD PurPrep strengthens our commitment to health care
professionals and patients by providing an alternative fully
sterile option to help reduce the risk of intrinsic contamination,"
said Michael Cusack, BD, Vice
President/General Manager of Infection Prevention. "By adding a
non-CHG, fully sterile skin preparation option, BD is expanding the
number of tools available to help reduce the risk of infection in
patients with CHG sensitivities and during procedures when CHG/IPA
is not indicated."
BD PurPrep™ will replace Prevail™ and Prevail FX™, and is
available now through BD and other distribution partners.
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 one in 1 million chance that a sterile
BD PurPrep™ or 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.
Like BD ChloraPrep™, the new BD PurPrep™ sterile solution will
include a mark to indicate that the solution is sterile. Though not
required by the U.S. Food and Drug Administration (FDA), BD
developed this mark to distinguish sterile solutions 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.
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
healthcare by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for healthcare 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 healthcare. For more information on BD, please visit
bd.com.
Contacts:
|
|
Troy
Kirkpatrick
|
Monique
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.617.2361
|
201.847.5378
|
troy.kirkpatrick@bd.com
|
monique_dolecki@bd.com
|
|
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1Jeng, D.
A new, water-resistant, film-forming, 30-second, one-step
application iodophor preoperative skin preparation. Am J Infect
Control. 2001, 29(6):370-376
|
2Mashiatulla, M. (2020). Iodine-based
Pre-Operative Skin Preparation Product Performance on Porcine
Abdominal Skin. Internal BD report: unpublished.
|
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SOURCE BD (Becton, Dickinson and Company)