ALESSANDRA BASSO
Senior Business Development Manager, Purolite, An Ecolab Company, United Kingdom

Abstract

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.

Any device intended to be used for medical purposes is defined as a medical device. They enable healthcare providers to diagnose and treat patients to overcome sickness or disease, ultimately improving their quality of life.

Significant potential for hazards is inherent when using a device for medical purposes and thus medical devices must be proved safe and effective before regulating bodies permit the device to be marketed in their country.

Historically, in the United States, it wasn’t until the Federal Food, Drug and Cosmetic Act (FD&C Act) was passed in 1938 that medical devices were regulated. Later, in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. In Europe, medical device regulation as we know it today came into effect in 1993 with what is collectively known as the Medical Device Directive (MDD). On May 26, 2017 the Medical Device Regulation (MDR) replaced the MDD.

DIFFERENTIATION OF MEDICAL DEVICES
Medical devices vary in both their intended use and indications for use. E ...