Physical And Chemical Characterization: The First Stage In Assessing The Biocompatibility Of Medical Device Materials

From programmable pacemakers and laser surgical devices to inactive medical devices such as intraocular lenses, resorbable bone screws or intravascular catheters, today’s state-of-the-art medical devices are a vital tool in the diagnosis and treatment of diseases and illnesses. Despite their numerous benefits, however, all medical devices present some degree of risk to a patient, even when used appropriately. For this reason, a risk assessment of any medical device must include an evaluation of the inherent safety of a device and its components.

A particular safety concern associated with the use of medical devices is the risk presented by simple contact with the human body. Even when used as designed, medical devices and their constituent materials may have the potential to produce unintended local or systemic effects. Depending on the duration of contact, some materials may also be harmful or toxic to the body, or may have adverse developmental or reproductive effects. Further, processes such as manufacturing, packaging, shipping and routine sterilization may adversely affect a material’s composition, rendering an otherwise safe device potentially harmful.

Biocompatibility testing represents a series of staged assessments to determine the potential harmful effects that can result from human contact with a medical device or component, and is an essential aspect of the overall product safety assessment required for global regulatory approval. The physical and chemical characterization of materials is the first stage of biocompatibility testing, and involves the analysis of substances that can potentially leach from a medical device during normal, anticipated use. When conducted in advance of other biocompatibility testing, material characterization testing may reduce overall testing time and speed regulatory approval.