Download Biol1120: Biomaterials February 2013 Exam 1 Each answer is worth

Biol1120: Biomaterials
February 2013
Exam 1
Each answer is worth TWO (2) points. Please choose the BEST answer for each multiplechoice question. There is only one answer for each multiple-choice question.
Introduction:
1. The FDA regulates all of the following except
a. The import of medical devices into the US
b. The use of medical devices by hospitals and physicians
c. Manufacturing of medical devices
d. Relabeling of medical devices by US-based companies
2. Medical devices developed and manufactured in the US
a. Have been regulated by the FDA since the implementation of the Pure Food and Drug
act of 1904
b. Have been regulated by the FDA since the 1976 amendment to the PF&DA
c. Can be manufactured elsewhere without FDA oversight
d. Are regulated by the medical companies from which they are developed and
manufactured without FDA involvement
3. Medical devices such as urinary catheters and IV lines are considered
a. Class I devices
b. Class II devices
c. Class III devices
4. Novel devices that have no substantially equivalent predecessors on the market
a. Are approved through pre-market approval protocols (PMA)
b. Are approved through 510k protocols
c. Can be approved through either PMA or 510k protocols
d. Are not subject to post-market evaluations by the FDA
5. The following statements are all true regarding medical device PMA submissions except
a. Documented safety and efficacy data are required
b. PMA submissions primarily involve class III devices
c. Devices approved through the PMA pathway require post-market assessment
following product launch
d. Substantially equivalent predecessors must already exist in order for the submission
to be approved
6. Human device exemptions can be applied to
a. Class II devices that target very small patient markets and are associated with
substantial risk
b. Primarily Class I and II devices that are fairly low risk and target patient markets in
the US of less than 10,000 patients
c. Class III devices that have a high risk to benefit ratio but are considered the only
treatment options
d. Class III devices that target markets of less than 4000 patients in the US/year
Inflammation and Infection
7. The most frequent sources of hospital-acquired infections are
a. Urinary catheters
b. Tracheal tubes
c. Central venous catheters
d. Drainage tubes
8. The four stages of normal wound healing are
a. Hemostasis
IGNORE THIS QUESTION
b. Inflammation
c. Proliferation
d. Remodeling
9. The critical component of the proliferative stage of wound healing is
a. Macrophage activation
b. Scar tissue formation
c. Neutrophil migration
d. Granulation tissue formation
10. Insufficient healing of a diabetic wound usually results in
a. Ulcer formation
b. Foreign body giant cell responses
c. Hyperfibrotic responses
d. Tissue encapsulation
11. The risk of implants becoming hematogenously infected
a. Increases with time after surgery due to enhanced bacterial colonization
b. Decreases with time after surgery due to host tissue integration with the implant
c. Increases with implantation of the primary device as opposed to secondary revision
surgery
d. Decreases following secondary revision surgeries due to development of immune
tolerance by the patient
12. Bacteria that have colonized implant surfaces communicate with each other by a process
known as __quorom sensing________________.
13. Implants that have been colonized with bacteria that produce biofilms are difficult to treat
with oral and systemic antibiotics
a. Due to bacterial enzymatic activities that degrade the antibiotics
b. Due to the ability of the bacteria to live in anaerobic environments resulting in
avoidance of antibiotic exposure
c. Due to accumulation of tissue fluid around the biofilms
d. Due to secreted bacterial proteins that block antibiotic functions
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14. The silicone layer of artificial skin substitutes provide protection for the host against
___infection______________ and ___dehydration_______________.
Reconstructive Surgery
15. Bone cells that function as phagocytic cells and are highly active in osteoporosis patients are
called
a. Osteoprogenitor cells
b. Osteoblasts
c. Osteoclasts
d. Fibroblasts
16. The predominant stress responsible for the mechanical load on the mandible is called
a. Tensile stress
b. Fatigue stress
c. Shear stress
d. Compressional stress
17. The mode of failure most often associated with ceramic dental implants is
a. Brittle failure
b. Ductile failure
c. Tensile failure
d. Fatigue failure
18. The lowest stress that gives permanent deformation in a material is called
a. Compressive stress
b. Tensile stress
c. Impact stress
d. Yield stress
19. According to the stress-strain curve that represents Young’s modulus (elastic modulus)
a. Bone has a lower elastic modulus than stainless steel alloy
will accept either A or C
b. Bone has a higher elastic modulus than titanium
c. Bone has a lower elastic modulus than tendon
d. Bone has a higher elastic modulus than Cobalt chromium alloy
20. Plastic failure of a material can refer to
a. The failure of a ceramic dental implant
b. The failure of a stainless steel cranial plate
c. The failure of a polymeric mandibular ligament
d. The failure of a titanium orbital implant
21. The optimal pore size of a material for cellular integration is
a. 25-50 microns
b. 50-100 microns
c. 100-150 microns
d. Above 150 microns
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22. The smooth surface of a poly methyl methacrylate implant is most likely to induce
a. Chronic inflammation due to resorption
b. Fibrosis and collagen encapsulation
c. Foreign body giant cell proliferation
d. Ulceration
23. Titanium alloy is considered to be
a. Osteoinductive
b. Osteostimulatory
c. Osteoconductive
d. Osteoinhibitory
24. The gold standard for repair of defects above the critical size is
a. Polymeric composites
b. Pre-bent metallic alloys
c. Allogeneic tissue
d. Autologous tissue
25. Rejection of allogeneic implants can be minimized by
a. Co-implantation with autologous tissue
b. Co-implantation with stem cells
c. Decellularization
d. Demineralization
Meniscal repair
26. The portion of the meniscus that experiences the most successful rates of natural healing
following damage is/are
a. The portions of both the medial and lateral menisci that are associated with the perimeniscal capillary plexus
b. The medial portion of the meniscus only
c. The lateral portion of the meniscus that contains chondrocytes and collagen
d. The lateral portion of the meniscus that contains fibrochondrocytes only
27. The most common long-term complication associated with complete menisectomy is
a. Infection
b. Loss of sensory perception in the knee
c. Excessive scarring and fibrosis
d. Development of arthritis
28. Suture and mechanical fixation of damaged meniscus
a. Are only applicable when treating degenerative tears
b. Are not applicable when treating degenerative tears
c. Are not applicable when treating tears due to traumatic injury
d. Are only applicable when treating tears in the white zone
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29. Meniscal allograft tissue
a. May be transplanted as fresh, freeze-dried and cryo-preserved tissue
b. Can only be transplanted as a fresh tissue
c. Carry a high risk of disease transmission
d. Induce rejection responses in most patients
30. The MAT (meniscal allograft transplant)-Bone Bridge procedure
a. Provides biomechanical stability but does not have much of an impact on stress
distribution in the joint
b. Has not been shown to provide more stability than traditional implantation procedures
c. Provides biomechanical stability and improves stress distribution
d. Is a risky procedure due to high rates of associated immunorejection
31. Immunosuppressive therapy is required for MAT-Bone Bridge transplantation. (T/F)
32. Collagen meniscal implantation is appropriate for lesions in the
a. Red/Red or Red/White zones
b. Red/Red only
c. Red/White only
d. White/White only
Device Related Infections
33. Infection is defined as?
a. Contamination of a manufacturing process with parts that are out of specification.
b. Invasion by and multiplication of pathogenic microorganisms in a bodily part or
tissue, which may produce subsequent tissue injury and progress to overt disease.
c. The process by which the body integrates a device over time.
d. None of the above
34. Pus is defined as?
a. A hard substance used in device manufacturing.
b. A crystallized substance that is produced following device sterilization.
c. A viscous, yellowish-white fluid formed in infected tissue, consisting of white blood
cells, cellular debris, and necrotic tissue.
d. A clear fluid that is produced by the body when no bacterial infection is present.
35. What are clinical symptoms associated with a surgical site infection?
a. Hot Incision
b. Swelling/Hardening of the Incision
c. Redness
d. All of the above
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36. In the microvascular unit, where do white cells typically extravasate out of vascular system
into the surrounding tissues to fight bacterial infection?
a. Arterioles
b. Capillaries
c. Post-Capillary Venules
d. Aorta
37. What is an imaging technique used to directly visualize leukocyte-endothelial cell
interactions within a blood vessel?
a. Intravital Video Microscopy
b. Scanning Electron Microscopy
c. X-Ray
d. Transmission Electron Microscopy
38. This person proved the “germ theory” of disease, and developed the process of
pasteurization?
a. Hippocrates
b. Joseph Lister
c. Louis Pasteur
d. Claudius Galen
39. What did Joseph Lister apply to his hands and surgical drapes to reduce bacterial infection in
the operating room?
a. Carbolic Spray
b. Acetic Acid
c. Sodium Chloride
d. Bleach
40. In a modern day operating room, what are techniques used to prevent bacterial infection?
a. Pre-operative Hand and Patient Surgical Scrub
b. Instrument Sterilization
c. Gown, Gloves, Cap and Mask
d. All of the above
41. What is a strain of gram-positive bacteria that has developed antimicrobial resistance and has
been demonstrated to cause hospital acquired device infections?
a. E.Coli
b. MRSA
c. Staphylococcus Aureus
d. None of the above
42. What is/are optimal characteristic(s) of an antimicrobial device coating?
a. Efficacy Against Most Potential Pathogens
b. Toxic to Humans
c. Efficacy During the Time Period at Highest Risk of Infection
d. Both A and C
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Breast Reconstruction
43. Which is NOT an anatomical structure in the female Breast?
a. Lobule
b. Cartilage
c. Areola
d. Duct
44. A Type (or Types) of Breast Cancer is/are?
a. in situ
b. Terminal
c. Metastatic
d. Both A and C
45. The most common type of breast cancer is?
a. Lobular carcinoma
b. Ductal carcinoma
c. Sarcoma
d. Angiosarcoma
46. Which clinical scenario is most representative of Stage IV Breast Cancer?
a. Tumor is no more than 2 cm in diameter, with no lymph node involvement
b. Tumor is 5 cm in diameter, with metastasis to remote organs
c. Tumor is 5 cm in diameter, with no lymph node involvement
d. Tumor is less than 5 cm, with lymph node involvement above the collar bone
47. Which clinical symptoms may be associated with Breast Cancer?
a. A lump or thickening of breast tissue
b. Bloody discharge from the nipple
c. Inversion of the nipple
d. All of the above
48. Which procedure would NOT be utilized to initially diagnose an Atypical Hyperplasia?
a. Mastectomy
b. Mammogram
c. Pathological Biopsy Assessment
d. Physical Examination
49. Which surgical procedure does NOT utilize autologous tissue transfer?
a. Latissimus Dorsi Flap Breast Reconstruction
b. DIEM Flap Breast Reconstruction
c. TRAM Flap Breast Reconstruction
d. None of the above
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50. What is a common complication associated with Latissimus Dorsi Flap Breast
Reconstruction?
a. Difficulty lifting arm(s) above head
b. Abdominal Hernia formation
c. Poor tissue integration into graft
d. Silicone implant foreign body reaction
51. Acellular Dermal Matrix Breast Reconstruction requires use of which of the following
materials over time?
a. Silicone Tissue Expander
b. Port Locator Magnet
c. Silicone Implant
d. All of the above
52. Fat grafting utilizes which of the the following techniques to harvest and prepare adipose
tissue for implantation?
a. Surgical Flap Excision
b. Liposuction
c. Centrifugation
d. Both B and C
Hernia Repair
53. A Hernia is a defined as:
a. Escape of blood from a ruptured blood vessel.
b. Postprandial abdominal distention.
c. A protrusion of an organ or other bodily structure through the wall that normally
contains it.
d. None of the above.
54. What type of hernia can result in the herniation of abdominal contents into the thoracic
cavity?
a. Umbilical Hernia
b. Inguinal Hernia
c. Hiatal Hernia
d. Femoral Hernia
55. What type of synthetic hernia repair material allows for the most rapid tissue integration?
a. ePTFE
b. Macroporous Polypropylene
c. Oxidized Regenerative Cellulose
d. Hyaluronic Acid/Carboxy-Methyl-Cellulose/Polyethylene Glycol
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56. The emergence of what minimally invasive technique led to the rapid proliferation of
numerous devices for ventral hernia repair?
a. Laparoscopy
b. Tissue-to-tissue Repair
c. Laparotomy
d. Endoscopy
57. What step is NOT performed during Open Ventral Hernia Repair?
a. Insert Mesh
b. Measure Hernia Defect
c. Insert Trocars
d. Fixate Mesh
58. What device can be used in a partially-contaminated hernia repair setting?
a. Macroporous Polypropylene
b. Biologically-derived Implant
c. ePTFE
d. Macroporous Polyester
59. During laparoscopic ventral hernia repair, what facilitates short-term stabilization of the
hernia repair mesh, with long-term resorption and less foreign body for the patient?
a. Laparoscopic Fixation Device with Titanium Fasteners
b. Interrupted Trans-fascial Polypropylene Sutures
c. Suture Passer
d. Laparoscopic Fixation Device with Polylactic Acid Fasteners
60. What model would be the most appropriate to histologically characterize long-term hernia
repair mesh resorption?
a. in vivo - Large Animal - Pig Model
b. in vivo - Small Animal - Rat Model
c. Bench Model
d. ex vivo – Porcine Abdominal Wall (PAW) Model
61. What model would be the most appropriate to characterize short-term hernia repair device
intra-abdominal performance in a clinically-relevant fashion?
a. in vivo - Small Animal - Rat Model
b. in vivo - Large Animal – Pig Model
c. ex vivo – Porcine Abdominal Wall (PAW) Model
d. Bench Model
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