Typically, reusable medical devices, including endoscopes, surgical instruments, leads and cables, have been subject to traditional disinfection techniques. But with recent events, including infection outbreaks linked to endoscopes and the discovery of HPV on “disinfected” ultrasound wands, the healthcare industry can no longer rely on disinfection alone to ensure the safety of reusable medical devices.
While the FDA’s recent guidelines for “reprocessing” reusable medical devices is a step in the right direction for infection prevention, reprocessing procedures require multiple critical steps, are labor intensive and fraught with inherent variability.
With the rising concern around reusable medical devices acting as gateways to infection – and the inherent challenges with the complex reprocessing methods themselves – what can medical-device manufacturers do to help reduce the risk of infection?
Having leveraged antimicrobials in devices such as catheters and wound-care products for years, manufacturers are now looking to antimicrobials for their reusable medical devices as well. Embedded antimicrobials have proven to have high-kill rates against some of the most dangerous strains of resistant bacteria and act as second-line of defense against the growth of microbes.
Incorporating Sciessent’s Agion® Antimicrobial into the design of reusable medical devices adds a built-in feature to the product that doesn’t require changes in clinical practice or reprocessing methods. This built-in protection provides long-lasting efficacy against even the most dangerous, resistant microbes.
For more information about Sciessent and how we can improve your implantable devices, please feel free to contact us.
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.