Applications of polymeric resins in medical devices for life saving treatments
Polymeric chromatographic resin beads are extensively used in life-saving and life-supporting medical devices. Applications include liver and kidney dialysis, for detoxification relating to hepatitis, alcohol/drug misuse, cirrhosis, fatty liver or cancers or for treating kidney chronic diseases. Other application where polymeric resins find application as medical devices is enteral nutrition for patients suffering from Cystic fibrosis, or for treatment of patients before organ transplantation, to ensure higher rates of survival, or as a treatment for several autoimmune disorders by therapeutic removal of antibodies and molecules from plasma, used. Significant potential for hazards is inherent when using a device for medical purposes and thus medical devices must be proven safe and effective before regulating bodies permit the device to be marketed in their country. This paper will explore applications of chromatographic separation resins in medical devices, differentiations of classifications of medical devices, and typical regulatory compliance requirements for polymeric beads when incorporated into medical devices or diagnostics.