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additives feature | Antimicrobials and biocides


PolyOne sees opportunities for antimicrobi- als in health- care applica- tions such as flooring and window treatments


polymers for healthcare or consumer applications; the solution can use different active ingredients depending on the polymer and end use. “Healthcare customers are demanding germ protection for all common touch surfaces, ranging from phones to light switches and everything in between,” says Seal Shield CEO, Brad Whitchurch.


Medical devices A highly regulated segment of healthcare that can benefit from antimicrobials is medical devices. In catheters and needleless connectors, for example, silver-based antimicrobials are used to help prevent device-related infections. In May 2015, Sciessent released results of a study


that compared medical-grade polymers treated with its silver-based Agion antimicrobial technology to untreat- ed materials. The study found that polymers treated with Agion killed more than 99% of antibiotic-resistant pathogens. The study also compared treated and untreated central-venous catheters (including paediat- ric, adult polyurethane and adult silicone types) and found that “MRSA was reduced by 99.56 to 99.999% and CRE was eliminated by 99.9999% or more, with no viable bacteria detected after inoculation for most catheter types,” reports Moloney. These same paediat- ric central venous catheters were also studied in a clinical trial and found to have a 90% lower rate of infection than the untreated catheters (Bertini, 2013). Moloney adds: “The stakes have never been higher


PolyOne reports strong interest in its WithStand antimicrobials in food-related applications


for health systems to prevent HAIs – not only for patient safety, but to avoid provisions that penalize hospitals with high infection rates. In order to significantly reduce HAIs and combat the increased threat of antibiotic- resistant bacteria, healthcare organizations have to adopt broader, more vigilant infection-control strate- gies. The Sciessent test results add yet another layer of proof that incorporating antimicrobial-treated medical


devices and surfaces into these broader infection-pre- vention plans can help to minimize and ultimately eliminate these risks.” Sciessent announced a partnership in March 2015 with Compounding Solutions, based in Maine, USA, which specializes in compounds for the medical device market. Under the partnership, Compounding Solutions will supply ready-to-use compounds as well as concentrates incorporating Sciessent’s additives. Manufacturers that want to use antimicrobials in


medical applications must obtain the appropriate regulatory clearances. In the US, antimicrobials intended to control microorganisms on or in people or animals (e.g., on medical devices with this intent) fall under the jurisdiction of the Food and Drug Administra- tion (FDA), while any other antimicrobial use falls under the Environmental Protection Agency’s (EPA’s) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Claims made for devices under FDA must be cleared by the 510(k) premarket notification process. In Europe antimicrobial medical devices must be


cleared by a Notified Body and frequently require a consultation with an EU Competent Authority, notes Moloney. In March 2015, Sciessent launched the Medical Device Market Acceleration Program (Med- MAP), which is designed to help manufacturers efficiently move antimicrobial-treated products from concept and development to regulatory approval and commercialization in the US, Europe, Asia, and Latin America. For example, Sciessent worked with a company to obtain Class I CE Mark approval for an antimicrobial-treated, disposable, hygienic barrier that attaches to a blood-pressure cuff to prevent hospital- acquired infections. Sciessent recently put an Active Substance Master File on file with a Competent Authority in Europe as a resource for medical-device manufacturers looking for Class III CE Mark approval. Healthcare applications that are not medical devices or disposables, such as flooring, window treatments and


38 COMPOUNDING WORLD | July 2015 www.compoundingworld.com


PHOTO: ISTOCKPHOTO.COM/POLYONE


PHOTO: ISTOCKPHOTO.COM/POLYONE


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