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
what does the CDRH
Center for Devices and Radiologic Health are regulating firms for the manufacture, repackage, relabel and/or import of medical devices in US. It regulates the radiation emitting electronic products, medical and non-medical
what does the EMA
European Medicines Agency regulates the human and veterinary medicines
classification of medical devices
class I, class II, class III
what’s a class I medical device
those of minimal invasiveness, does not contact user internally, for example: crutches, bedpans, adhesive bandages
what’s a class II medical device
posses a higher degree of invasiveness and risk than class I, but have a relatively short duration, for example: healing aids, blood pumps, catheter, contact lenses, and electrodes
what’s a class III medical device
are considered more invasive and can pose immense risk to the user-implantable, for example: cardiac pacemakers, intrauterina device, intraocular lenses, heart valve, orthopaedic implant
types of biomaterials
metals and alloys, ceramics, polymers, and composites
