Ebme 306 exam 1 2024 - Study guides, Class notes & Summaries

Biomedical Device - ANSWERAny instrument, appliance, machine, material or other related article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. Class 1 Medical Devices - ANSWERLow risk, not intended to support or sustain life or cause unreasonable illness or injury Do not need to be reviewed by the FDA Ex: tongue depressors, elastic bandages Class 2 Medical Devices - ANSWERDevic...

Medical Device - ANSWERAny equipment, instrument, implant, material, or apparatus used in the diagnosis, treatment, or monitoring of human beings. Class 1 Medical Device - ANSWERLow risk; not intended to support or sustain life; do NOT need to be reviewed by FDA before marketing Class 2 Medical Devices - ANSWERDevices that present more risk; regulated by the FDA , special controls needed to perform function, doesn't sustain life Class 3 Medical Device - ANSWERDevices that are intended ...

Class 1 - ANSWERLow risk devices that don't require FDA approval before marketing Ex: Clamps or Bandaids Class 2 - ANSWERMore risk than Class 1 but not life sustaining Ex: surgical needles Class 3 - ANSWERLife sustaining Ex: heart valve Combination Product - ANSWERusually drug+device Ex: condom with spermicide Hemotoxylin and Eosin Stain - ANSWERused for general morphology, stains pink and blue Collagen Stain - ANSWERMasson's Trichrome (blue) to see live cells Bacteria Stain ...

Medical Devices - ANSWERanything used for humans for diagnostics, prevention, monitoring, treatment, disinfectant, birth control, or life support Etiology - ANSWERcause of disease Pathology - ANSWERstudy to find cause, origin and nature of disease Biocompatibility - ANSWERability of a material to perform with an appropriate host response in a specific application Pathogenesis - ANSWERsequence of events that lead to structural or functional abnormalities How immunostaining works - ...

What are the 3 main classes of biomaterials? - ANSWERMetals, ceramics, and polymers Name 4 natural biomaterials - ANSWER1. Proteins: collagen, fibrin, elastin 2. Polysaccharides: alginate, chitosan, glycosaminoglycans, cellulose 3. De-cellularized scaffolds 4. Lipids Advantages of natural biomaterials - ANSWERbiofunctionality, biodegradable, less inflammation Disadvantages of natural biomaterials - ANSWERMechanical properties, stability, processing, immunogenicity (provoke immune res...