Biocompatability

Question 1

Define biomaterial.

Answer 1

any substance or combination of substances synthetic/natural in origin which can be used for any period of time as a whole/part of a system which treats, augments or replaces tissue, lorgan or function

Question 2

What is biocompatibility?

Answer 2

Capacity of a biomaterial to perform, with an appropriate host response in a specific context over the product life

Question 3

What is tissue engineering?

Answer 3

Application of cells, drugs, biomaterial scaffolds to repair/regenerate tissue & thereby restore health

Question 4

What will a biocompatible material reach?

Answer 4

Healthy equilibrium with biological environment over time

Question 5

What 4 cases are biomaterials being used for?

Answer 5

Drug delivery
drug-device combinations (drug eluting stents)
tissue engineering
nanotech products

Question 6

What are 4 adverse reactions to implant devices?

Answer 6

Direct damage
functionality may be impaired due to abberant cellular response/accumulation
Thrombus formation
non-thrombo device - local or systemic effects

Question 7

What are 3 responses to implanted devices?

Answer 7

Wound healing response
inflammatory reactions
remodeling around implant

Question 8

What are 3 interactions in in vivo systems?

Answer 8

Interaction with regulatory, parenchymal * stromal cells
paracrine & endocrine factors
interaction with blood

Question 9

What 5 things dictate the foreign body response?

Answer 9

Extent of injury & surgical technique
implantation site
implant shape/size
material chemical & physical properties
systemic health of recipient

Question 10

What is the ideal implantation reaction?

Answer 10

High neutrophil response which dissipates after 12 hrs
increasing macrophages & foreign body giant cells
some fibrosis

Question 11

Why is biofilm so important?

Answer 11

outer contacting layer - can influence how immune system responds

Question 12

What are 2 coatings?

Answer 12

Collagen IV
Collagen VII

Question 13

What are 4 non-biological factors?

Answer 13

Hydrophobicity
Charge
Functional groups
Roughness

Question 14

Why is hydrophobicity important?

Answer 14

Protects against bio-fouling

Question 15

What does toxicology risk assessment identify?

Answer 15

Context-specific threshold safety limits for human health effects of chemicals using epidemiological & experimental toxicology data

Question 16

What does toxicology risk assessment estimate?

Answer 16

Association between exposure to a chemical or physical agent & incidence of adverse outcome

Question 17

What is ISO 10993?

Answer 17

Primary guidance for biological evaluation of medical devices

Question 18

What does ISO 10993 allow for?

Answer 18

Manufactures to appropriately mitigate biological risks to an acceptable benefit/risk level & determines level of biological testing required
Detailed test protocols

Question 19

What are 3Rs of animal testing?

Answer 19

Reduce
Refine
Replace

Question 20

What are 3 sections to the biological risk assessment?

Answer 20

1. Identification of intended use/purpose
2. hazard identification
3. Risk estimation