3M Tegaderm CHG I.V. Securement Dressing Receives FDA 510(k) Clearance for Expanded Indication to Reduce Catheter-Related Blo...
June 06 2017 - 10:00AM
Business Wire
Catheter-related bloodstream infections (CRBSI) are
life-threatening for patients and costly for the medical
professionals and facilities caring for them. 3M is pleased to
announce that the U.S. Food and Drug Administration (FDA) has
recognized the efficacy of 3M™ Tegaderm™ CHG Chlorhexidine
Gluconate I.V. Securement Dressing in reducing CRBSI, expanding the
product’s 510(k) indication to include CRBSI reduction.
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3M™ Tegaderm™ CHG Chlorhexidine Gluconate
I.V. Securement Dressing (Photo: 3M)
The expanded indication is supported by a randomized, multi-arm,
controlled clinical trial of 1,879 subjects that found Tegaderm CHG
I.V. Securement Dressing reduced CRBSI by 60 percent in patients
with central and arterial lines (p=0.020).1
“While we are making great strides in reducing CRBSI nationwide,
these preventable infections are still responsible for significant
morbidity, mortality and excess costs,” stated Pat Parks, MD, PhD,
medical director for 3M Critical and Chronic Care Solutions
Division. “Successful CRBSI prevention practices rely on dedicated
clinicians using proven technology, such as Tegaderm CHG I.V.
Securement Dressing, in alignment with current best practice
standards.”
Tegaderm CHG I.V. Securement Dressing is the only transparent
dressing indicated and proven to reduce CRBSI and vascular catheter
colonization that aligns with evidence-based guidelines and
practice standards. The dressing provides four essential elements
to cover and protect patients’ catheter sites and secure devices to
skin.
- Infection Reduction: Clinically
proven to reduce CRBSI by 60 percent in patients with central and
arterial lines. The dressing features an integrated gel pad
containing 2 percent w/w CHG, a well-known antiseptic agent with
broad spectrum antimicrobial and antifungal activity that maintains
antimicrobial activity for 10 days.
- Site Visibility: Transparent
film and gel pad allow for continual site observation, enabling
early identification of complications at the insertion site.
- Consistent Application:
Integrated CHG gel pad and dressing design ensure standardized,
correct application.
- Catheter Securement: Designed to
minimize catheter movement and dislodgement.
“Providing effective, proven technology such as Tegaderm CHG
I.V. Securement Dressing is just one of the ways that 3M partners
with clinicians to help them achieve their infection prevention
goals,” said Parks. “We also provide clinical expertise and tools
to support training and compliance, and engaging educational
resources to help facilities implement the latest evidence-based
guidelines and standards.”
For more information about coordinating a Tegaderm CHG Dressing
product trial, please visit 3M.com/TegadermCHG.
3M and Tegaderm are trademarks of 3M Company.
About 3MAt 3M, we apply science in collaborative ways to
improve lives daily. With $30 billion in sales, our 90,000
employees connect with customers all around the world. Learn more
about 3M’s creative solutions to the world’s problems at www.3M.com
or on Twitter @3M or @3MNewsroom.
1 Timsit JF et al. Randomized controlled trial of chlorhexidine
dressing and highly adhesive dressing for preventing
catheter-related infections in critically ill adults. Am J Crit
Care Med. 2012;186(12): 1272-1278
http://www.atsjournals.org/doi/pdf/10.1164/rccm.201206-1038OC.
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Inprela CommunicationsJackie Vos,
612-677-2022Jackie@inprela.comor3MNan Farnsworth,
651-733-5747nfarnsworth@mmm.com
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