In Europe, Medical Device Regulation (MDR) & in the USA, Food and Drug Administration (FDA) and Central Drugs Standard Control Organization (CDSCO) in India postulated stringent rules that bio-compatibility is a must for healthcare devices, especially for class-III devices.
Why bio-compatibility is necessary and what are those class-III medical devices?
Hydroxyapatite is one such material.
Fluoride doped Hydroxyapatite exhibits many similarities to asbestos which is known to cause cancer in the stomach and other tissues.
Recently in Australia a famous manufacturer of infant formula was forced to withdraw product from the market due to discovery of nanocrystals of Fluoride doped Hydroxyapatite in its product.
The European Commission adopted a position on Hydroxyapatite in 2016 stating: “The available information indicates that nano-hydroxyapatite in needle-shaped form is of concern in relation to potential toxicity. Therefore, needle-shaped nano-hydroxyapatite should not be used in cosmetic products. It is of note that Material 2 of the submission also includes nanofibres of needle-like structure.”
I think Biocompatible is very important because isn’t produce any toxic response,So that the substance does not affect the body and the body does not affect it
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