Overview

Question 1

Biomaterial

Answer 1

material of natural or synthetic origin that comes in contact with tissue, blood, or biological fluids and is intended for use in prosthetic, diagnostic, therapeutic, or storage applications without adversely affecting the living organism and its components.

nonviable material used in a medical device, intended to interact with biological systems.

Question 2

Hardbound Materials

Answer 2

provide support
used for:
- metal based and cement mix, can be used for orthopedics
- stent for the treatment of cardiovascular disease
- bone impacts
- dentistry

Question 3

Softbound Materials

Answer 3

flexible, adapt to the environment applied to
used for:
- suture
- wound dressing
- contacts

Question 4

catheters vs stent

Answer 4

catheter uses a balloon. stent is metal

Question 5

In-drug delivery

Answer 5

want the drug to be concentrated at the disease site, usually taken systemically, distributed all over the body vs concentrated at the disease site, interact with biomaterial and be released to the body
- hydrogel

Question 6

biocompatibility

Answer 6

biomaterial, device, or construct can be brought into direct contact with the body without
- toxic reaction
- tumorigenic potential
- harmful tissue reaction that could compromise function

Question 7

Does the FDA approve materials?

Answer 7

No, the properties and safety of these materials must be carefully assessed with respect to the specific application in question and its degree of patient contact.

Question 8

Biocompatibility Testing

Answer 8

performed to determine the potential toxicity

Question 9

biocompatibility complexity

Answer 9

have to consider the site of implantation, mechanical properties, surgical procedure, implant movement, biodegradation, design and construction, sterilization, material-cell interaction
- protein absorption on material surface
- intentionally degradable materials
- tissue reconstitution

Question 10

Applications of biomaterials

Answer 10

• storage of fluids, tissues, and other biological products
• diagnosis
• monitoring
• therapy

Question 11

manufacturing of a medical device

Answer 11

• selecting material
• physical and chemical nature of the material
• sufficiently biocompatible or nontoxic for intended use
• safety assessment