Chapter One

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24 Terms

1
  1. Packaged devices must be _____ before being sterilized

  1. Devices need to be ________ unless the MIFU states differently

  2. Ratchets and valves need to be in what position?

  1. Lumens need to be inspected for what?

Dried

Disassembled

Open position

make sure they are not obstructed

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2

Can you use moisture with lumens?

No, unless the manufacturer recommends it…

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3

Syringes need to have what removed from the barrel?

The plunger

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4

Do you need to remove obturators or stylets?

Yes

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5

Before sterilization: all packs containing reusable textiles need to be cooled to _____ and ______ in __ to __ degress C and __

to ___ % humidity

Room temperature and humidity

18 to 23 Degrees and 30 to 60% humidity

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6

The combined weight of the wrapped instruments and their container shall not be more than ____ Kg

10 Kg

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7

Should lumens be open on both sides?

Yes they should, unless MIFU states otherwise

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8

What types of products shall not be used with vaporized hydrogen peroxide and hydrogen peroxide gas plasma?

Can devices adversely affected by vacuum be sterilized with hydrogen peroxide and hydrogen peroxide ozone systems?

Cellulose-based products

No

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9

Before any packaging system is used in a healthcare setting for the first time the following must be qualified which includes

Installation qualification

Operational qualification

performance qualification

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10

Facilities that reprocess reusable surgical textiles must have documented policies and procedures for

1

2

3

Evaluation and purchase of reprocessing equipment

Access to reprocessing areas

Requirements pertaining to subcontractors

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11

If laundry is being done by an external contractor, the health care setting has to audit it ____ a year against the CSA standard ______

once a year

CSA Z314-18

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12

If any devices hits the floor, where must you send it?

Back through the whole process, starting at decontamination

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13

A “HAI” can increase a patient’s hospital stay by up to ___ days or more

10 days or more

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14

Why should you not wrap items too tightly?

Sterilization wrapping needs to be large enough to ________ of the wrap during the sterilization process.

The wrapper should be large enough to cover the medical device, but it should not be so large that you have to wrap it ____

Too tightly wrapped can create holes or tears

Accommodate movement

several times around

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15

Assembly surfaces need to be __ ___ of _____size, ____lit and ____

Flat, smooth, of adequate size well lit and clean

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16

Wrapper configuration shall provide a _____ path to stop microbial migration

tortuous

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17

The sterilization wrapping method shall ensure that the opened wrapper will drape_____ from the sterile field

The wrapped package needs to be designed so all the edges are secured and do not interfere with ________ into the sterile field

Methods and materials used when wrapping a pack or medical device for sterilization shall not _____ sterilization or maintenance of sterility

Away from the sterile field

aseptic presentation

Inhibit

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18

Why is lint bad?

Lint can be carried by air and deposited anywhere; the lint fibers could have microorganisms on them. Lint could fall into a wound and cause infection.

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19

What is meant by a “clean” item?

Ready to be assembled, in the assembly area

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20

What direction should the basins follow?

The same direction

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21

Who is responsible for the facilities,
personnel, equipment, organization and
processes?

Administration of the healthcare facility

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22

True or False Questions

  1. Packaging materials must facilitate aseptic presentation of contents

  2. Sharps do not need to be shielded because the wrapping acts as a barrier

  3. The number of reprocessing cycles that can be tolerated needs to be stated in the product labelling and/or the end of the useful life shall be detectable

  4. Hospitals will have a limited number of patches that can be used to repair textiles

  5. “Memory free” means that the devices outline will show through the package

  1. True

  1. False

  2. True

  3. True

  4. False: memory free means that the material will not spring back along the fold lines

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23

True or False Questions

  1. Metals and textiles can be mixed

  2. You should not place a packaged item into another package

  3. If you use chemical indicator tape, it must be placed on the inside

  1. False

  2. True: unless the MIFU states otherwise

  3. False: the tape can only be used on the outside

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24

Define: Ingress

Define: Egress

Ingress: act of entering

Egress: act of exiting

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