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 accreted biocompatibility lab can test different aspects such as Cytotoxicity, Irritation, Sensitization, Hemocompatibility, Toxicity, and Implantation. This way, the lab can ensure whether it is safe for the patient or not. Along with pharmaceutical companies, many medical device makers take help from an accreted lab for biocomp testing.

 

What Are the Benefits of Improving Medical Device Biosafety?

 The biocompatibility concept was introduced by Harvard Medical School back in 2015 to address this challenge and help improve the quality of life for patients undergoing surgery. This topic has been gaining significant attention in recent years, as both surgical and medical device risks are amplified by biological variability. The BIO-Comfort concept aims to address these challenges by developing and testing technologies to minimize variations in the body's response to implanted medical devices. 

 For this reason, it is important that the biocompatibility for medical devices test should be done from an accreted laboratory. You need to ensure that the labs are ISO 17025, GLP, and AAALAC accredited.


  • Make sure the biocompatibility test lab is able to do these tests quickly
  • Make sure the biocompatibility test lab deliver consistent and reliable rest result
  • Make sure the biocompatibility test lab does these tests at an affordable price

 Limitations of biocompatibility Testing

 There are some limitations to biocompatibility testing. First, this method can only detect so-called “in vivo” reactions. This means that the device will not be completely safe if it is implanted in a lab animal, for example, but a reaction may occur in a person who acquires the device in a different way.

 Though the BIO-Comfort concept is still in its infancy, its potential to revolutionize medical device development and testing is undisputed. Medical device manufacturers will soon be able to test their products on humans, who are much more complex organisms than lab rats or computer models, giving them an unprecedented look into how their devices will function in the real world. Quick and reliable biocompatibility test results help medical companies develop new medical products for mankind.

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