Medical devices or materials are expected to deliver their intended functionalities without causing any potential adverse reactions to a patient, ranging from acute to chronic effects to their body including mutagenic effects. That is why evaluation and Biocompatibility for medical devices is very important for assessing the interaction between the device and cells, tissue and body fluids of patients. Biocompatibility testing is designed mainly for protecting the patient from biological risks.

The biocompatibility testing procedure follows three steps

· Planning

In this stage, information about the materials that are used in manufacturing the device is collected, BEP (biological evaluation plan) is also developed for determining the kind of testing which is needed.

· Testing

This step begins with in vitro screening through cytotoxicity testing. Some other tests such as chemical characterization or extractable leachable testing are also performed prior to in vivo testing.
· Evaluating the data

In vitro Cytotoxicity

This biocompatibility test is conducted on cultured mammalian cells for evaluating the materials or toxicity as well as chemicals.

Chemical characterization

Chemical analysis and characterization of the components of a device is performed before any biological testing. In this process, leachable materials are extracted from the device at a high temperature and then analyzed using different instrumentations. Toxicological risk assessment is performed on those extracts for potentially toxic or harmful chemicals.

In vivo

Once in vitro testing is done, in vivo testing is conducted and the type of tests depends on the intended use of the device. In vivo biocompatibility testing includes sensitization testing, skin irritation testing, systemic toxicity testing and implantation testing. The duration for this testing can vary from couple of weeks to few months, based on the particular data required.Chronic or sub-chronic systemic toxicity testing may take longer time.

Biocompatibility testing for dental materials can be characterized by parameters including

· Mutagenicity

· Carcinogenicity

· Genotoxicity

· Cytotoxicity

· Histocompatibility

· Microbial effects

Though, adverse effects are not usual to dental materials, it is not impossible and can happen locally and systematically.A dentist should take the responsibility for accessing the risk of dental materials. Dental amalgam is a common problem that dental staff faces oftentimes. They can also be exposed to resin and latex based dental materials.

Note

As medical devices are associated with the well being of patients, it is the most important thing that they are tested properly and efficiently. Biocompatible medical devices are safe to use and they do not cause any adverse reaction to the patient.

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