BIO Compatibility: The Key To Maximizing Medical Device Safety
Medical device manufacturers have a lot to keep track of when it comes to ensuring their devices are as safe as possible. Medical device developers typically test their products in a controlled environment, such as a laboratory or an operating room. However, that does not mean medical devices will function the same way outside those settings. Biological variability is one of the biggest challenges for medical device safety. This is because the human body differs from one person to another in so many ways, which can have an impact on what people tolerate and how they react to different treatments. Biological Compatibility Index (BCI) Biochemical compatibility testing (BCI) is used to assess how well a given medical device will work when implanted in a particular patient. The BCI numbers are intended to reflect the degree of risk to the patient posed by the procedure, as well as the degree of risk to the medical device posed by the patient's biological makeup. An accr