Hospitals around the world provide critical care to sick patients every single day. Unfortunately, the environments in these hospitals are often perfectly suited for bacteria growth. There are various medical devices that can act as carriers for HAIs (Healthcare-associated infections). In hospital environments, there are so many contact points, from catheters to feeding tubes, that antimicrobial protection is no longer a luxury - it is a necessity.
As Healthcare-associated infections (HAIs) increase in number in hospitals, protecting patients and staff is as important as ever. This means protecting the medical devices that are used on the patients. Preventable HAIs claim the lives of 75,000 people and cost the healthcare industry billions annually. Additionally, the Affordable Care Act has provisions that penalize hospitals for high infection rates.
Agion Antimicrobial incorporates the power of copper and silver in a zeolite carrier, which can then be integrated into a broad spectrum of medical devices. Not only does Agion help products resist the growth and spread of microbes, but it is also fully supported by the Sciessent team, who can help you in the FDA process and bring your product to market.
Why Incorporate Antimicrobials Into Your Medical Devices?
Sciessent – A Trusted Partner
We have over ten years of experience in antimicrobial medical device product development
We reference, create and use multiple U.S. FDA cleared and approved predicate devices with the Agion Antimicrobial
We maintain active substance master files in the European Union
We have years of experience with regulatory strategy and antimicrobial submissions
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 information presented herein is not intended to support or endorse public health claims for treated articles. The Agion Antimicrobial is also used in medical devices 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 safety and efficacy testing and are limited to those approved by the designated Competent Authorities and/or Notified Bodies.