Biomateriales Flashcards
pioneers biomaterials
gold, copper, wood, PMMA
first generation biomaterials
inertness
inertness
encapsulation of a system by a biomaterial that will not cause any reaction in the body
second generation biomaterials
reabsorbable or bioactive
biocompatibility definition
ability of a material to perform with an appropriate host response in an specific application
reabsorbable definition
degraded by body and the residuals are metabolised and secreted
bioactive definiton
has a growth factor which increases healing process, and an antibacterial covering which releases microorganisms and substances to reduce infections
third generation biomaterials
regeneration
regeneration definition
stimulate specific cellular responses at molecular level: tissue engineering, regenerative medicine and nanomedicine
biocompatibility definition
“ability of a biomaterial to perform its function as a medical therapy, without eliciting undesirable local or systemic effects in recipients or beneficiary, generating the most appropriate beneficial cellular or tissue response in that specific situation and optimising clinically relevant performance of therapy”
steps to asses biocompability
- determine potential toxicity from the contact of the device with the body
- determine if the device directly or by the release of material constituents produces dangerous effects
- evaluation of new device
dangerous effects that can cause a device tested for biocompability
- adverse local or systemic effects (pain, swelling, necrosis)
- be carcinogenic
- adverse reproductive and developmental effects
how’s the evaluation of a new device process
requires data from systematic testing to ensure benefits provided by final product will exceed any potential risks posed by device biomaterials.
biocompability testing panel
- acute, subchronic and chronic toxicity
- irritation to skin, eyes, and mucosal surfaces
- cytotoxicity
- sensitisation
- hemocompability
- genotoxicity
- carcinogenicity, and effects on reproduction, including developmental effects
- short-term implantation effects
process to design an implant (from basic science to clinics)
- research on biomaterials (lab, scientific knowledge)
- engineering to develop a medical device
- preclinical (animals or in vitro) and clinical testing (patients, formed by 3 phases)
- regulatory approval
- commercialisation and clinical applications.
regulatory organisations
FDA, CDRH, EMA
what does the FDA
Food and Drug Asministration regulates the food, drugs, medical devices, animal feeds and drugs, cosmetics, ration emitting products