Q: How are supply partners to medical device OEMs aiding in ensuring patient safety with home healthcare devices?
As a leading supplier of acrylic-based thermoplastic products sold to the disposable medical device market, Evonik Cyro is continually working with its end-users on the identification of current and future product needs. Citing the demand for products that have antimicrobial capabilities designed to lessen the chance for a patient to obtain a secondary infection and the harmful effect they can have on the health of the patient, Evonik Cyro has been on the forefront in the development of products that possess antimicrobial capabilities. Key to the development of products that can be used for the production of antimicrobial medical devices was the identification of the organisms that are frequently associated with secondary infections (i.e., Staphylococcus aureus, Pseudomonas aeruginosa, Staphylococcus epidermidisand Klebsiella pneumonia). Working with its customer base regarding the identification of an acceptable test method, Evonik Cyro utilized the JIS Z 2801 test method in order to conduct detailed testing. With Evonik Cyro's customers stating that materials supplied must meet FDA regulations for Class I or Class II medical devices covered by 510(k) submission, Evonik Cyro has introduced its line of antimicrobial products, which now includes CYROLITE Protect, CYREX Protect, and soon to be introduced CYROLITE Protect 2. All three of Evonik Cyro's Protect products provide antimicrobial capabilities against the targeted organisms commonly found in healthcare facilities per the JIS Z 2801 test method for time durations of 24 and 96 hours. In addition to having antimicrobial capabilities, Evonik Cyro's line of Protect products offer the medical device design engineers materials that exhibit the characteristics of toughness, transparency, bondablility to PVC tubing, and resistance to gamma and e-beam, while also being easy to process and offering good chemical and lipid resistance.