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Agion’s trusted antimicrobial solutions for medical devices

According to the U.S. Centers for Disease Control and Prevention (CDC), more than two million people become ill with antibiotic-resistant infections each year. Healthcare-associated infections (HAIs), many of which are caused by antibiotic-resistant bacteria, impact 1 in 25 patients and claim the lives of 75,000 people in the U.S. each year. Annually, they also cost the healthcare industry between $36 to $45 billion.

Agion-antimicrobial-solutions-medical-devices

On top of these startling statistics, the Affordable Care Act (ACA) has provisions that financially penalize facilities with high infection rates, and increasingly informed, connected healthcare consumers are using tools like Medicare’s “Hospital Compare’ to make decisions about where to go for quality care.

All of these factors are forcing healthcare providers to put more pressure on medical-device manufacturers and other suppliers to share in the responsibility to improve patient care while simultaneously reducing costs. These shifts in healthcare will essentially change the suppliers’ role in the industry — especially when it comes to infection prevention. Agion Antimicrobial Solutions

Agion Antimicrobial Solutions

Agion Antimicrobial technology inhibits the growth and colonization of microorganisms on the surfaces of medical devices and equipment by adding an important layer of protection to these critical products. Unlike common disinfectants and antibacterial products, Agion Antimicrobial protection can be designed to meet your unique product requirements for antimicrobial performance and lifetime. With several medical grade formulations and a controlled release mechanism of action, a customized solution can be developed to meet your needs.

Agion-antimicrobial-solutions-works

Agion’ Antimicrobial Performs Against Clinically Relevant Organisms

Microbe  Type Name Associated HAIs Log Reduction Performance
 

 

 

 

Gram +

Staphylococcus aureus Bloodstream infections. Surgical site infection Pneumonia 6
Methicillin-resistant

Staphylococcus aureus (MRSA)

Bloodstream infections, Surgical site infection. Pneumonia
Vancomycin-resistant Enterococci (VRE) Bloodstream infections, Surgical site infection, Urinary tract infections
 

 

 

 

 

 

 

Gram

Pseudomonas Bloodstream infections. Surgical site infection, Pneumonia
 

Klebsiella pneumonia

Pneumonia, Bloodstream infections, Surgical site infection
 

E. Coli

Urinary tract elections, Pneumonia,

Bloodstream  infections,

Surgical site infections

Acinetobacter Pneumonia. Bloodstream infections, Surgical site infection
Carbapenem-resistant

Enterobacteriaceae

Bloodstream infections. Urinary tract infections, Pneumonia
 

Fungi

Bloodstream infections, Surgical site infection
 

 

 

 

 

 

 

 

 

 

 

 

 

Virus

 

H1N1

 

 

 

 

 

 

 

 

 

 

Influenza

 

 

 

 

 

 

 

 

 

 

 

 

99.99% inactivation

 

H 3N2

 

H2N2

 

Avian Influenza A (HSN 1 )

 

Avian Influenza A (H9N2)

 

Swine Influenza (H1N1 )

 

Equine Influenza (H 3N8)

 

Influenza B

Trusted Antimicrobial Partner

Agion Antimicrobial is a trusted solution for various applications within the healthcare industry. With an experienced staff and proven product, Agion has become a leading supplier of antimicrobials in the healthcare industry. Beyond its experience and reliability, its technology is backed by:

  • A recommendation by the Society for Healthcare Epidemiology of America for use of Agion-treated catheters for the prevention central-line associated bloodstream infections
  • Clinical data supporting the use of Agion antimicrobial in medical devices
  • FDA Master Files on our medical grade formulations
  • An Active Substance Master File with an EU Competent Authority

MedMAP      – Medical Device Market Acceleration Program

Accelerating time/o market for devices incorporating antimicrobial technology

Agion’s expertise and capabilities

At Sciessent, products are only as good as the experts behind them. With in-house microbiology and analytical laboratories, it provides the support and testing needed to quickly and efficiently design the optimal antimicrobial performance for the product.

Lab Testing Capabilities

Analytical Testing Antimicrobial Testing
GFAA Analysis for Metal Ions ASTM-E2149-01 JIS L 1902 : 2008
Ash Test ASTM E2180-01 JIS Z 2801 : 2000
Moisture Content Analysis AATC C100 ISO 20743 : 2013
Scanning Electron Microscopy ISO 22196 : 2007

**Custom testing can be performed based on customer requirements.

Examples of applications Where Agion® Antimicrobial Can Add Value:

  • Implantable Devices
  • Bio Connectors & Adaptors
  • Medical Monitoring Devices
  • Medical Tubing
  • Drug Delivery Devices
  • Reusable Medical Devices
  • Wound Care Devices

Predicate Devices Using Agion Antimicrobial

  • Central Venous Catheters (Vygon — K061250)
  • Pain Management Catheters (Stryker – K072702)
  • Luer-activated Needless Connectors (Medegen/CareFusion — K083765)
  • Balloon-style Gastronomy Tube (Novartis — K001916)
  • Respirator Face Mask (Nexera — K090414)
  • Stethoscope Diaphragm (DRG — K002047)
  • Introduction/Drainage Catheter (Health Shield — K991117)

Compatible with the Full Range of Medical Polymers

Agion Antimicrobial is easily compounded into plastics to provide embedded, durable antimicrobial surfaces to molded or extruded parts. Using the same processing techniques as adding a color pigment, Agion can be incorporated into essentially all polymers.

Incorporating Agion Antimicrobial throughout the polymer is particularly valuable for intricate or complex surfaces, such as with catheters where it is desirable for both the exterior and the lumen to have antimicrobial properties.

In addition to ease of processing, Agion has the benefit of controlled delivery of silver ions. Other silver antimicrobials simply dissolve to release their silver, while Agion delivers silver ions through a controlled ion exchange process, resulting in longer use life and greater durability.

  • TPU
  • Silicone
  • PEEK
  • UHMWPE
  • ABS
  • PP
  • PC
  • PMMA
  • PTFE
  • PET

The Agion Antimicrobial is presently registered by the United States Environmental Protection Agency as a preservative and bacteriostatic agent for use in treated articles under 40 CFR 152.25a. The Agion Antimicrobial is also used in medical desires under the Food and Drug Administration in the US, those medical device claims are based on safety and efficacy testing and are limited to those approved by FDA.

In the EU, the Agion Antimicrobial is used in medical devices under the Medical Device Directive; those medical device claims are based on safely and efficacy testing and are limited to those approved by the designated Competent Authorities and/or Notified Bodies

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