1
Q
- Q: What is the preparation and packaging zone in SPD?
A
A: The clean area where decontaminated instruments are inspected, assembled, wrapped, and labeled before sterilization.
2
Q
- Q: What is the air pressure requirement for the preparation and packaging area?
A
A: Positive air pressure relative to adjacent areas to prevent contaminated air from entering the clean zone.
3
Q
- Q: What is the temperature and humidity requirement for the preparation and packaging area?
A
A: Temperature ≤75°F (≤24°C); relative humidity 30–60%.
4
Q
- Q: What is the purpose of instrument inspection before packaging?
A
A: To verify instruments are clean, functional, undamaged, and complete before packaging for sterilization.
5
Q
- Q: What tools are used for instrument inspection?
A
A: Magnifying glass (lighted), bright light source, and manual testing of instrument function (e.g., ratchet, jaw alignment, sharpness).
6
Q
- Q: What is the “tip-to-tip” alignment check?
A
A: A test for scissors and forceps to verify that the jaws or tips meet evenly when closed; misalignment indicates damage or wear.
7
Q
- Q: What is the “ratchet test” for hemostats?
A
A: The hemostat is opened fully and closed to the first ratchet; it should hold without springing open under light pressure.
8
Q
- Q: How should scissors be tested for sharpness?
A
A: Cut through a single layer of cotton gauze; the blade should cut cleanly to the tips without catching or tearing.
9
Q
- Q: What should be done with an instrument that fails inspection?
A
A: Remove it from service, tag it as defective, and send it for repair or replacement; document the removal.
10
Q
- Q: What is a pin-hole test for gloves?
A
A: A test for integrity of surgical gloves to detect pinholes; relevant in preparation area where gloves are used.
11
Q
- Q: What is the maximum weight for a sterilization tray?
A
A: Per AAMI ST79, the maximum is 25 lbs (11.4 kg) for wrapped trays; check sterilizer and IFU specifications.
12
Q
- Q: What is the maximum weight for a rigid container set?
A
A: Per AAMI and container IFU — typically 25 lbs (11.4 kg); always verify with the container and sterilizer manufacturer IFU.
13
Q
- Q: What is the purpose of absorbent material (towels) in the bottom of instrument trays?
A
A: To absorb moisture and facilitate drying during the sterilization cycle, preventing wet packs.
14
Q
- Q: What type of absorbent material should be placed at the bottom of sterilization trays?
A
A: Lint-free, non-woven sterilization-compatible towels; should not be folded excessively (≤3 layers).
15
Q
- Q: What is the recommended maximum number of towel layers in a sterilization tray?
A
A: No more than 3 layers to allow steam penetration.
16
Q
- Q: How should instruments be arranged in a tray for sterilization?
A
A: Hinged instruments open, heavier instruments on the bottom, tips protected, delicate instruments separated, and all surfaces accessible to the sterilant.
17
Q
- Q: Why should hinged instruments be in the open position during sterilization?
A
A: To allow steam or sterilant to reach all surfaces of the hinge, box-lock, and jaw; closed position creates a shielded area where sterilization may fail.
18
Q
- Q: What is a tip protector?
A
A: A small device (usually plastic or foam) placed over sharp or delicate instrument tips to prevent damage during storage and sterilization.
19
Q
- Q: What are instrument stringers?
A
A: Plastic or stainless steel rods used to organize instruments in a tray by threading through ring handles; ensures they remain open during sterilization.
20
Q
- Q: What are instrument holders (racks)?
A
A: Devices that hold instruments in the correct position within a sterilization tray to ensure steam contact to all surfaces.
21
Q
- Q: What is a peel pouch?
A
A: A sterilization packaging consisting of a transparent film side and a paper (or non-woven) side; items are inserted and the pouch is sealed for single items or small instruments.
22
Q
- Q: What is the minimum seal width for a peel pouch?
A
A: Per IFU and AAMI ST79 — typically ≥6 mm (¼ inch) for an adequate seal.
23
Q
- Q: How should a peel pouch be sealed?
A
A: Heat-sealed using a validated sealing machine; do not staple, tape, or hand-seal unless validated for that method.
24
Q
- Q: What is the correct orientation of an instrument in a peel pouch?
A
A: The handle end should be toward the peel (open) end of the pouch so the user can grasp the handle without touching the sterile tip.
25
25. Q: What is the minimum clearance between an instrument and the seal in a peel pouch?
A: At least 1 inch (2.5 cm) between the instrument and the seal to prevent seal failure during sterilization expansion.
26
26. Q: What is a double-peel pouch?
A: A peel pouch placed inside another peel pouch; used when extra protection is needed or for items delivered to the sterile field; the inner pouch is opened by the scrub tech.
27
27. Q: What is the correct way to open a peel pouch at the point of use?
A: Peel back (do not tear) the two sides apart; present the inner sterile contents to the scrub tech without contaminating them.
28
28. Q: What is woven wrap (muslin)?
A: A reusable textile wrap made of cotton; requires sequential double-wrapping (two layers); being replaced by non-woven materials in many facilities.
29
29. Q: What is non-woven wrap?
A: A single-use sterilization wrap made of polypropylene; provides a consistent barrier; does not require multiple layers when used per IFU.
30
30. Q: What is the sequential (serial) wrapping technique?
A: Wrapping a tray in two complete layers of wrap, one at a time; provides a two-layer barrier that can be opened aseptically at the sterile field.
31
31. Q: What is the simultaneous wrapping technique?
A: Wrapping a tray using two sheets of wrap at the same time; less effective than sequential wrapping for maintaining a sterile barrier.
32
32. Q: What is the envelope (diagonal) wrap technique?
A: A method where the tray is placed diagonally on the wrap sheet and opposite corners are folded in; creates a tortuous path that maintains sterility during opening.
33
33. Q: What is a square wrap (parcel wrap) technique?
A: A method where the tray is placed with edges parallel to the wrap; used for rigid containers or as an alternative; less commonly used in SPD.
34
34. Q: What is the correct fold sequence for envelope wrapping?
A: Fold up the front flap (cuff back), fold in both side flaps (cuff back), then fold up the back flap and tuck or secure; each fold should create a cuff to allow aseptic opening.
35
35. Q: What is a "cuff" in sterile wrap technique?
A: A fold-back of the edge of the wrap at each opening, allowing the person opening it to grasp the outside without contaminating the sterile inside.
36
36. Q: What secures a wrapped instrument set?
A: Chemical indicator (process) tape; should not use regular tape; tape provides a tamper-evident seal and changes color upon sterilization.
37
37. Q: What is a chemical indicator (CI) tape?
A: Adhesive tape containing a chemical indicator that changes color when exposed to the sterilization process; used to secure wrapped packages and provide visual evidence of process exposure.
38
38. Q: What is the purpose of placing a chemical indicator inside a package?
A: To verify that sterilant reached the inside of the package, not just the outer surface; a CI inside confirms internal process parameter exposure.
39
39. Q: What is the difference between an internal and external chemical indicator?
A: External CI (e.g., process tape) shows the package was exposed to the sterilization process; internal CI shows that conditions inside the package were reached.
40
40. Q: What is a Class 1 chemical indicator used for?
A: Process indicators (e.g., autoclave tape) that distinguish processed from unprocessed items; do not indicate sterilization was achieved.
41
41. Q: What is a Class 5 integrating indicator?
A: Responds to all critical parameters of the sterilization cycle; provides the highest level of assurance among CIs; used inside packs.
42
42. Q: What is the role of a Class 6 emulating indicator?
A: Responds to all specified critical parameters of a specific sterilization cycle; cycle-specific (labeled for the cycle it is designed to monitor).
43
43. Q: What labels must be on a sterilized package?
A: Contents, sterilizer number/lot, load number, date of sterilization, expiration date (if applicable), and operator identification.
44
44. Q: What information must appear on the outside label of a sterilized tray?
A: Tray name/contents, sterilizer number, load number, cycle date, expiration date (if time-related sterility is used), and tech initials.
45
45. Q: What is a load number?
A: A unique number assigned to each sterilization load; used for tracking and recall purposes.
46
46. Q: What is event-related sterility in the context of packaging?
A: A sterile item is considered sterile as long as the packaging remains intact and the item has not been exposed to events that could compromise sterility (e.g., moisture, puncture, tamper).
47
47. Q: What events compromise the sterility of a package?
A: Moisture (wet-strike-through), visible damage to packaging (tears, holes), package being opened or tampered with, dropped on the floor, and excessive compression.
48
48. Q: What should be done if a sterile package is found on the floor?
A: Consider it non-sterile; do not use; reprocess the item following the full sterilization process.
49
49. Q: What is the significance of package integrity in sterile storage?
A: The packaging barrier is the only thing maintaining sterility of the contents after sterilization; any compromise renders the item non-sterile.
50
50. Q: What is a rigid sterilization container system?
A: A reusable metal or plastic container with a lid and filter system that replaces wrap for instrument sets; provides durable, reusable packaging.
51
51. Q: What are the advantages of rigid containers over wrapped trays?
A: Reusable (cost savings), more durable, easier to open aseptically, better protection in storage and transport, less risk of wet packs when used correctly.
52
52. Q: What must be inspected on a rigid container before use?
A: Latches, gaskets, filters, valves, and frame integrity; filters must be replaced per IFU; gaskets must be undamaged and properly seated.
53
53. Q: What is the function of the filter in a rigid container?
A: Allows steam to enter and exit during sterilization while blocking microbial penetration after sterilization; acts as a sterility maintenance barrier.
54
54. Q: How often should rigid container filters be replaced?
A: Per IFU — typically after each sterilization cycle (disposable filters) or on a time schedule (reusable filter systems).
55
55. Q: What is a gasket in a rigid container?
A: A rubber or silicone seal around the container lid that prevents air and microorganisms from entering after sterilization.
56
56. Q: What is the purpose of a locking latch on a rigid container?
A: Secures the lid to maintain the sterile barrier; tamper-evident indicator shows whether the container has been opened.
57
57. Q: What is a tamper-evident seal?
A: A device (security seal, lock tab, or indicator) that shows whether a sterile package has been opened; provides assurance of integrity.
58
58. Q: What is the role of the SPD technician in loaner set inspection?
A: Verify the count, inspect for damage, ensure IFU is available, decontaminate, and package/sterilize per IFU before clinical use.
59
59. Q: What is a basin set and how is it packaged?
A: A set of basins (bowls) used for instrument soaking or fluid collection during surgery; nested and packaged with absorbent material for sterilization.
60
60. Q: How should basin sets be prepared for sterilization?
A: Basins should be nested, separated by absorbent material, placed on edge or inverted if possible to allow drainage of condensate; per IFU.
61
61. Q: What is the correct position for a basin during steam sterilization?
A: On its side or inverted (upside down) to allow condensation to drain and steam to contact all surfaces.
62
62. Q: What is a peel-apart package (peel pouch) advantage?
A: Allows aseptic presentation of single items to the sterile field; transparent side allows visual verification of contents.
63
63. Q: What is the shelf life of sterilized items?
A: Per event-related sterility — sterile until the packaging is compromised; time-specific expiration may be applied per facility policy.
64
64. Q: What is the FIFO principle?
A: First In, First Out — items sterilized first are used first; ensures rotation of stock and reduces risk of long-term storage issues.
65
65. Q: What is the purpose of dating sterilized packages?
A: To allow FIFO rotation, facilitate recalls, and provide traceability; not primarily to indicate expiration under event-related sterility.
66
66. Q: What is a recall and when is it initiated in SPD?
A: Retrieval of potentially non-sterile items from circulation; initiated when a sterilization failure is confirmed, a positive BI result is received, or a packaging compromise is identified.
67
67. Q: What information is used to perform a sterilization recall?
A: Load number, sterilizer number, date of sterilization, and distribution records; items are tracked using the lot/load number on the label.
68
68. Q: What is a "gravity displacement" steam sterilization cycle and how does packaging affect it?
A: A steam cycle that relies on gravity to displace air; requires packages to be placed correctly (paper facing up or per IFU) to allow air evacuation and steam penetration.
69
69. Q: What is a dynamic air removal (pre-vacuum) cycle and how does it differ for packaging?
A: Uses vacuum pulses to remove air before steam is introduced; more effective at steam penetration of complex items and tightly wrapped packages.
70
70. Q: What is a flash (immediate-use) sterilization cycle?
A: A rapid steam sterilization cycle performed for unwrapped or specifically contained items needed immediately; should not be used routinely; has limitations on patient safety documentation.
71
71. Q: What is immediate-use steam sterilization (IUSS)?
A: The updated term for flash sterilization; sterilization of items for immediate patient use without delay; requires documentation and specific protocols; should not be used for implants.
72
72. Q: What documentation is required for IUSS?
A: Patient identification, item processed, reason for IUSS, cycle parameters (time, temperature, exposure), CI result, and operator identification; all per AAMI/AORN.
73
73. Q: What are the limitations of IUSS?
A: Items cannot be stored in wrapped form; no storage is possible; should not be used for implants except in documented emergency; increases risk if documentation is inadequate.
74
74. Q: Why should IUSS not be used for implants?
A: Implants must have a negative biological indicator result before release for use; BI incubation takes hours to days; IUSS does not allow time for BI confirmation.
75
75. Q: What is the correct cycle for implant sterilization?
A: A full terminal sterilization cycle with biological indicator monitoring; the implant should not be released until the BI result is confirmed negative.
76
76. Q: What is a sterilization load record?
A: Documentation of every sterilization cycle including sterilizer number, cycle type, load contents, load number, date/time, operator, CI results, and BI results.
77
77. Q: What is a sterilizer printout?
A: A paper or electronic record generated by the sterilizer showing cycle parameters (temperature, pressure, time) for each cycle; part of the load record.
78
78. Q: Who should sign the sterilizer printout?
A: The SPD technician who performed the cycle; confirms that cycle parameters were met and the load was released.
79
79. Q: What is a set assembly sheet?
A: A document listing every instrument that should be in a specific tray; used during assembly to verify completeness and count.
80
80. Q: What is the purpose of a tray inventory card?
A: Lists the contents of a specific instrument tray; used for assembly, inspection, and instrument count verification.
81
81. Q: What is the purpose of color-coding in SPD?
A: To facilitate tray identification, department routing, and instrument organization; reduces assembly errors.
82
82. Q: What is a sterilization wrap that is approved by the FDA?
A: Wrapping materials must be FDA-cleared as a 510(k) device for use as a sterile barrier system; must meet ANSI/AAMI standards.
83
83. Q: What is a sterile barrier system (SBS)?
A: The minimum packaging that prevents ingress of microorganisms and allows aseptic presentation of the sterile contents; defined by ISO 11607.
84
84. Q: What is ISO 11607?
A: International standard specifying requirements for materials, sterile barrier systems, and packaging systems for terminally sterilized medical devices.
85
85. Q: What is the meaning of "aseptic presentation"?
A: Opening a sterile package without contaminating the sterile contents; the technician/nurse peels back the outer packaging and presents the sterile inner item without touching it.
86
86. Q: What is the role of instrument count in assembly?
A: Verifies that all instruments assigned to a tray are present before packaging; prevents lost instruments in patients and incomplete surgical sets.
87
87. Q: What does "instrument set" mean?
A: A collection of instruments assembled, packaged, and sterilized together for a specific surgical procedure.
88
88. Q: What is a custom procedure tray?
A: A pre-assembled collection of supplies for a specific procedure, which may include sterile instruments and disposables.
89
89. Q: What is the importance of assembling trays per the instrument count sheet?
A: Ensures complete and correct instrument sets reach the OR; prevents delays and potential patient harm from missing instruments.
90
90. Q: What is weight distribution in tray loading?
A: Heavier instruments should be placed at the bottom of the tray; lighter and delicate instruments on top; prevents damage and promotes steam penetration.
91
91. Q: What are microsurgical instruments and how should they be packaged?
A: Extremely delicate instruments used in eye, ear, and neurosurgery; must be handled carefully, separated by foam or silicone mats, and packaged in rigid containers or padded trays.
92
92. Q: What is silicone matting used for in instrument sets?
A: To cushion and separate delicate instruments in a tray; prevents contact damage and maintains position during sterilization and transport.
93
93. Q: What is a needle counter?
A: A foam pad or magnetic device used to count and secure needles during surgery; returned to SPD for safe disposal.
94
94. Q: What is the purpose of inspecting packaging material before use?
A: To verify the material is intact, within expiration date, appropriate for the sterilization method, and free from damage or moisture exposure.
95
95. Q: What is the maximum recommended size for a wrapped package?
A: Per AAMI ST79 — maximum 12" × 12" × 20" for a wrapped package; rigid containers per IFU; size affects steam penetration.
96
96. Q: What is the purpose of the chemical indicator inside a peel pouch?
A: Verifies that sterilant conditions were reached inside the pouch; must change color per the indicator IFU for the pack to be considered processed.
97
97. Q: What is the appropriate shelf life for sterile supplies stored in a closed cabinet?
A: Per event-related sterility — indefinite as long as packaging is intact; time-specific dates may be applied per facility policy.
98
98. Q: What are the environmental conditions required for sterile storage?
A: Temperature ≤75°F; relative humidity 35–60%; at least 4 air exchanges per hour; positive air pressure.
99
99. Q: What is the minimum distance from the floor that sterile items should be stored?
A: At least 8–10 inches (20–25 cm) above the floor to prevent moisture and contamination from floor cleaning.
100
100. Q: What is the minimum distance from the ceiling that sterile items should be stored?
A: At least 18 inches (46 cm) from fire sprinkler heads per fire codes; typically at least 5 cm from the ceiling.
101
101. Q: What is the minimum distance from outside walls that sterile items should be stored?
A: At least 2 inches (5 cm) from outside walls to prevent temperature variation and condensation.
102
102. Q: What is the purpose of maintaining sterile storage environmental controls?
A: To prevent package degradation, maintain packaging integrity, and ensure sterile items remain sterile until point of use.
103
103. Q: What is a sterilization load configuration?
A: The arrangement of packages within the sterilizer chamber; must allow steam/sterilant to contact all surfaces of all packages.
104
104. Q: Why should packages not be stacked on top of each other in a sterilizer?
A: Stacking can prevent steam penetration, cause wet packs from trapped condensate, and lead to pack compression that damages packaging.
105
105. Q: What is the correct placement of peel pouches in a steam sterilizer?
A: On edge, paper side facing paper side or per manufacturer IFU; allows steam to penetrate both sides and prevents condensate accumulation.
106
106. Q: What is the correct placement of basins in a steam sterilizer?
A: On their side or inverted to allow condensate to drain and steam to enter.
107
107. Q: What does "load configuration" mean in sterilization?
A: The specific arrangement of items within the sterilizer to ensure steam reaches all surfaces and maximum load efficacy.
108
108. Q: What is a gravity displacement steam sterilizer?
A: A steam sterilizer that relies on gravity to displace air from the chamber; steam enters from top and forces air out through a bottom drain.
109
109. Q: What items are appropriate for gravity displacement sterilization?
A: Unwrapped solid items, simple wrapped items, liquids in specific cycles; NOT items with complex lumens (use pre-vacuum for those).
110
110. Q: What items are appropriate for pre-vacuum sterilization?
A: Porous loads, complex instruments with lumens, large instrument sets; the vacuum pulses ensure air removal and steam penetration.
111
111. Q: What is the sterilization temperature and time for a gravity displacement steam cycle (132°C)?
A: 132°C (270°F) for a minimum of 4 minutes (wrapped) or 3 minutes (unwrapped); per AAMI ST79.
112
112. Q: What is the sterilization temperature and time for a pre-vacuum steam cycle (132°C)?
A: 132°C (270°F) for a minimum of 4 minutes; per AAMI ST79.
113
113. Q: What is the sterilization temperature and time for a 121°C gravity displacement cycle?
A: 121°C (250°F) for a minimum of 15–30 minutes depending on the load configuration; per AAMI ST79.
114
114. Q: What is the role of drying time in steam sterilization?
A: Removes moisture from packs after the steam phase; inadequate drying leads to wet packs that are considered non-sterile.
115
115. Q: What is the appropriate response to discovering a wet pack after sterilization?
A: Consider it non-sterile; do not release for use; investigate the cause; document and report; reprocess the items.
116
116. Q: What is the purpose of sterilization tray dividers?
A: To separate instruments within a tray, prevent contact between delicate items, and organize instruments for efficient counting and use.
117
117. Q: What is the significance of "lumen" in packaging and sterilization?
A: Hollow channels in instruments (e.g., cannulas, laparoscopic instruments) require specific attention during packaging to ensure the sterilant reaches the interior.
118
118. Q: What is a lumened instrument and why is it challenging to sterilize?
A: An instrument with a hollow channel; sterilant must reach the full length of the lumen; requires proper orientation and pre-treatment (e.g., flushing) per IFU.
119
119. Q: What is a port extender and what is its purpose?
A: A device used to connect cleaning or sterilization equipment to instrument channels; ensures sterilant is delivered to the full length of a lumen.
120
120. Q: What is the significance of instrument disassembly before sterilization?
A: Multi-part instruments must be disassembled to allow sterilant contact to all surfaces, joints, and internal components.
121
121. Q: What is the purpose of a medical-grade pouching machine?
A: To create sealed peel pouches for individual instruments; must create a consistent, reliable seal; requires validation and regular maintenance.
122
122. Q: What is seal integrity testing?
A: Testing the seal of a peel pouch or other packaging to confirm it meets the required strength and consistency standards; performed during machine validation and QC monitoring.
123
123. Q: What is a visual seal check?
A: Inspecting a sealed pouch for channels, unsealed areas, or wrinkles in the seal that could allow microbial ingress; performed on every sealed package.
124
124. Q: What is a channel in a package seal?
A: A gap or tunnel in the heat seal that provides a path for microorganisms to enter the package; a sign of seal failure; pouch must be discarded and repackaged.
125
125. Q: What is the correct storage position for peel pouches?
A: Stored on their edge or flat, not compressed; transparent side protected; no heavy items placed on top.
126
126. Q: What is peelable packaging material?
A: A sterile barrier material that can be peeled apart by the user to aseptically present contents to the sterile field; the paper or non-woven side is porous and the film side is transparent.
127
127. Q: What is the purpose of the transparent (film) side of a peel pouch?
A: Allows visual identification of the contents and verification of the chemical indicator without opening the package.
128
128. Q: What is the significance of wrinkles in the seal area of a peel pouch?
A: Wrinkles can indicate seal failure or channels; such packages should be rejected and contents repackaged.
129
129. Q: What is the recommended maximum number of items in a single peel pouch?
A: Per IFU; only items that fit without overstretching or compromising the seal; generally one instrument or a small set; do not overfill.
130
130. Q: What is the standard protocol for assembling a cesarean section (C-section) instrument set?
A: Assemble per tray card/count sheet including all required instruments; verify count; package in appropriate wrap or container; include internal CI; label and sterilize.
131
131. Q: What is the purpose of a sterilization load sheet?
A: Documents the contents of each sterilizer load for traceability; used for recall purposes.
132
132. Q: What is the role of the SPD technician in maintaining the surgical schedule awareness?
A: Ensures that instrument sets are sterilized, ready, and available in time for scheduled procedures; coordinates with OR for special requests and add-on cases.
133
133. Q: What does "set priority" mean in SPD?
A: The designation of instrument sets that must be sterilized first based on surgical schedule urgency; ensures critical cases have instruments ready on time.
134
134. Q: What is the function of a case cart pick list?
A: A list of all instruments, supplies, and equipment needed for a specific surgical case; used by SPD to build the case cart.
135
135. Q: What is case cart management?
A: The process of preparing, assembling, transporting, and returning case carts for surgical procedures; a key SPD function.
136
136. Q: What information should be on a case cart label?
A: Patient name/ID, procedure, surgeon, OR room number, and scheduled time; ensures the right instruments reach the right patient.
137
137. Q: What is the risk of mislabeling a sterilized tray?
A: Wrong instruments could be opened for the wrong patient or procedure, resulting in delays, patient harm, or use of incorrect instruments.
138
138. Q: What is the difference between wrapping and rigid container systems in terms of sterile barrier maintenance?
A: Wrapping can be compromised by tears, moisture, or compression; rigid containers provide superior mechanical protection but require filter/gasket maintenance.
139
139. Q: What is the significance of the package weight limit in sterilization?
A: Excessive weight compresses packages, impairs steam penetration, and leads to wet packs; 25 lbs (11.4 kg) is the AAMI maximum for wrapped packs.
140
140. Q: What is instrument tray perforations and why are they important?
A: Holes in the tray bottom allow steam to penetrate from below and condensate to drain; trays without holes or with blocked perforations impair sterilization.
141
141. Q: What is a silicone mat and when is it used in a tray?
A: A cushioned mat placed in the bottom of instrument trays to prevent instrument movement, reduce noise, and protect delicate instruments during sterilization.
142
142. Q: What are the risks of stacking trays in a sterilizer?
A: Steam cannot penetrate between trays; condensate accumulates causing wet packs; load parameter monitoring may not reflect conditions in the center of the stack.
143
143. Q: What is a carriage (rack) for a sterilizer?
A: The internal support structure that holds sterilization trays; must be used per the sterilizer IFU to ensure proper steam circulation.
144
144. Q: What is "cooling time" after steam sterilization?
A: The period after the sterilization cycle during which packs are allowed to cool to room temperature; handling hot packs can cause condensation and wet packs.
145
145. Q: How long should packs cool before handling?
A: Per AAMI ST79 — typically 30 minutes minimum on a cooling rack before being moved to storage; do not place on cold surfaces.
146
146. Q: What surface should sterilized packs be placed on during cooling?
A: A wire rack or perforated surface that allows air circulation and prevents condensation from forming on the bottom of packs.
147
147. Q: What is the risk of placing hot sterilized packs on a solid, cold surface?
A: The temperature differential causes condensation to form on the bottom of the pack, potentially causing wet-strike-through and compromising sterility.
148
148. Q: What is the minimum cool-down period for sterilized items before they are placed in storage?
A: At least 30 minutes at room temperature on a wire rack; per AAMI ST79.
149
149. Q: What is the role of the chemical indicator (tape) on the outside of a sterilized pack?
A: Provides visual evidence that the pack was exposed to the sterilization process (Class 1 indicator); does not confirm sterility was achieved.
150
150. Q: What is the difference between a process indicator and a sterilization indicator?
A: A process indicator (Class 1) shows the item was exposed to the sterilization process; a sterilization indicator (Class 5 or 6) confirms all critical parameters were met.
151
151. Q: What is the purpose of the internal CI in every sterile package?
A: Confirms that sterilant conditions were met inside the package, not just on the exterior; checked at point of use before opening.
152
152. Q: What should the OR nurse or scrub technician check before opening a sterile package?
A: Package integrity, CI change (external and internal), label information, and absence of events (moisture, damage) that could compromise sterility.
153
153. Q: What is the appropriate action if the CI in a sterile package has not changed color?
A: Do not use the item; return it to SPD; investigate whether the package was sterilized; reprocess.
154
154. Q: What is the purpose of the sterilization label?
A: Provides traceability (sterilizer number, load, date), operator identification, and verification that the item has been sterilized.
155
155. Q: What is non-woven polypropylene wrap and what are its advantages?
A: A synthetic sterilization wrap material; single-use; consistent barrier quality; strong; compatible with steam, EtO, and hydrogen peroxide plasma sterilization.
156
156. Q: What is the correct disposal of single-use sterilization wrap?
A: Disposed of after each use per facility waste policy; not to be reused as it cannot maintain consistent barrier quality on second wrapping.
157
157. Q: What is reusable woven wrap (muslin) and what are its disadvantages?
A: Cotton textile wrap requiring laundering and inspection between uses; risk of weave degradation, thread count reduction with washing, and inconsistent barrier quality.
158
158. Q: What is the minimum thread count required for muslin sterilization wrap?
A: 140 thread count per inch (per AAMI); must be inspected for holes, thin areas, and staining before each use.
159
159. Q: What is the inspection procedure for muslin wrap?
A: Hold wrap up to a light source to check for holes, thin areas, or damage; discard if any defects are found; check for staining and laundering residue.
160
160. Q: What is the impact of detergent residue on sterilization wrap?
A: Detergent residue in laundered woven wrap can reduce barrier effectiveness and may cause chemical reactions with sterilization agents.
161
161. Q: What is the purpose of a sterilization wrap compatibility check?
A: Ensures the chosen wrap material is compatible with the intended sterilization method (steam, EtO, hydrogen peroxide plasma); incompatible materials can fail or release toxins.
162
162. Q: What wrapping materials are NOT compatible with hydrogen peroxide plasma sterilization?
A: Paper (cellulose-based materials) absorbs hydrogen peroxide, quenching the plasma and causing cycle aborts; use only non-woven polypropylene or approved materials.
163
163. Q: What wrapping materials are NOT compatible with EtO sterilization?
A: Foil and impermeable materials that do not allow EtO gas penetration; EtO-compatible materials must be porous (paper, non-woven wrap, specific films).
164
164. Q: What is an implant definition for sterilization purposes?
A: A device placed into a surgically formed or natural body cavity intended to remain for 30 days or more (per FDA); examples include orthopedic screws, mesh, vascular grafts.
165
165. Q: What is the special requirement for implant sterilization?
A: A biological indicator must be run with every implant load; the implant should not be released until the BI result is confirmed negative; implants should not be processed with IUSS.
166
166. Q: What is a loaner implant and what documentation is required?
A: An implant provided by a vendor for a specific patient case; requires a complete instrument list, IFU, and must be fully decontaminated and sterilized before use.
167
167. Q: What is the minimum advance delivery time required for loaner implants?
A: Per AAMI/AORN — at least 24 hours before the scheduled procedure; allows adequate time for decontamination, sterilization, and BI confirmation.
168
168. Q: What is the significance of the DIN (device identification number) in packaging?
A: Allows tracking of specific devices through the reprocessing cycle and to the patient; essential for recalls and post-market surveillance.
169
169. Q: What is a Bowie-Dick pack and what does it test?
A: A specific test pack (standardized) used in dynamic air-removal (pre-vacuum) sterilizers to test air removal; detects air pockets and non-condensable gases.
170
170. When should the Bowie-Dick test be performed?
A: Daily, first thing in the morning, in an empty sterilizer, before processing any loads; must pass before the sterilizer is used for patient items.
171
171. What is a Bowie-Dick test failure?
A: Any non-uniform color change on the test sheet indicates air removal failure; the sterilizer must be taken out of service, investigated, and cleared before use.
172
172. What is a dynamic air removal test pack?
A: A standardized package used to perform the Bowie-Dick test; contains a multi-sheet test indicator.
173
173. What is the significance of air in a steam sterilizer?
A: Air pockets prevent steam from contacting instrument surfaces, causing sterilization failure; air must be completely removed for steam sterilization to be effective.
174
174. What is a non-condensable gas and why is it problematic in steam sterilization?
A: A gas (e.g., air) that does not condense like steam; creates air pockets in the sterilizer chamber that block steam penetration; leads to sterilization failure.
175
175. What is the appropriate size of a peel pouch for a small instrument?
A: The pouch should be approximately one inch larger than the instrument on all sides; never use an oversized pouch that allows the instrument to shift and potentially compromise the seal.
176
176. What is the purpose of fenestrated trays (perforated trays)?
A: Perforations allow steam and condensate to pass through, improving steam penetration and preventing wet packs.
177
177. What is the risk of using a solid (non-perforated) tray in steam sterilization?
A: Condensate collects in the tray bottom, causing wet packs; steam may not reach all surfaces; increases sterilization failure risk.
178
178. What is a sterilization container reprocessing protocol?
A: After each use, rigid containers must be inspected, washed, rinsed, dried, and prepared for reuse per IFU; filters replaced per schedule.
179
179. What is the validation of a cleaning process?
A: Documented evidence that a cleaning process consistently removes contamination to an acceptable level; required for washer-disinfectors per ISO 15883.
180
180. What is a challenge device?
A: A test device with defined soil used to challenge and validate cleaning processes or sterilization cycles (e.g., instrument with a lumen containing defined test soil).
181
181. What is a process challenge device (PCD)?
A: A device that is placed in a sterilization load to simulate the most challenging conditions; used with BI or CI to verify sterilization efficacy within a load.
182
182. What is the recommended location for the PCD (with BI) in a sterilizer load?
A: In the area of the sterilizer that is most difficult to sterilize (typically the coolest, most challenging point); front-bottom-center in gravity sterilizers.
183
183. What is a routine release criterion for a steam sterilization load?
A: Satisfactory sterilizer printout (all parameters met), external CI color change, internal CI color change; for implant loads, also a negative BI.
184
184. What is a quarantine of a sterilization load?
A: Holding items from a sterilization load while awaiting BI results; required for implant loads per AAMI/AORN; items not released until BI is negative.
185
185. What is the incubation time for a steam BI?
A: Typically 24–48 hours in an incubator at 55–60°C; rapid BI systems provide results in 1–3 hours.
186
186. What is a rapid biological indicator?
A: A BI that provides a result in 1–3 hours rather than 24–48 hours; used in facilities that cannot hold implant loads for traditional BI incubation.
187
187. What is the implication of using a rapid BI for implant loads?
A: Allows faster release of implant loads while still meeting the requirement of a negative BI before use; reduces surgical case delays.
188
188. What should be done if an implant must be used before BI results are available?
A: Per AAMI/AORN, use should be documented as an emergency; the implant can be released with documentation of the reason and accepted risk; maintain tracking for follow-up.
189
189. What is the difference between "terminal sterilization" and "sterilization"?
A: Terminal sterilization is the process of sterilizing a product in its final packaging; in SPD, all packaged instrument sets are terminally sterilized.
190
190. What are the AAMI standards for sterile package storage conditions?
A: Temperature ≤75°F (≤24°C), relative humidity 35–60%, protected from dust, moisture, vermin, and temperature extremes.
191
191. What is the significance of inspecting sterilized packages before opening?
A: Detects compromised integrity (moisture, damage, CI failure) before the item is used; prevents use of non-sterile items on patients.
192
192. What is the "open method" of instrument presentation to the sterile field?
A: The circulator or SPD technician opens the outer packaging and presents the sterile contents to the scrub technician using aseptic technique.
193
193. What is the role of the circulating nurse in sterile item verification?
A: Inspects package integrity, CI status, label, and expiration (if applicable) before opening; confirms correct item for the case.
194
194. What is a "pull-down" shelf in sterile storage and what is its purpose?
A: An adjustable shelf used to maximize vertical storage space while maintaining accessibility for sterile items.
195
195. What is "just-in-time" sterilization?
A: Sterilizing items close to the time of need to minimize storage time; can reduce waste but requires careful scheduling and should not replace proper sterile storage.
196
196. What is a "sterile field" contamination event?
A: Any occurrence where the sterile field or sterile items within it are known or suspected to be contaminated; requires immediate remediation and documentation.
197
197. What is the difference between a "pass-through" window and a regular door in SPD?
A: A pass-through window allows items to move between contaminated and clean areas without personnel crossing zones; maintains separation of contaminated and clean zones.
198
198. What is a pass-through sterilizer?
A: A sterilizer with two doors (loading and unloading) on opposite sides; contaminated side loads, sterile side unloads; prevents cross-contamination between zones.
199
199. What is the importance of proper assembly sequence in preparing instrument sets?
A: Incorrect assembly (wrong instruments, missing items, improper arrangement) can delay surgery, cause patient harm, or result in sterilization failure.
200
200. What is the ultimate goal of the preparation and packaging domain in SPD?
A: To ensure that all instruments reach the patient in a sterile, functional, complete, and correctly identified state through rigorous inspection, assembly, packaging, and documentation.
CBSPD EXAM
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