# Presentation: 023027

## Module 6

- STERILIZATION

**Notes:**
Instructor Notes 
This module describes the sterilization process, procedures, and equipment.

Learning activities:

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
How can you prove that something is sterile?

## Identify types of sterilizers and their components.
Identify and sequence the steps in sterilizer cycles.
Identify EtO monitoring and personal protection requirements. 

**Identify and sequence the steps in sterilizer cycles.**
**Identify EtO monitoring and personal protection requirements.**

**Notes:**
Instructor Notes 
Review the instructional objectives
You can translate them into common language (“Today we are going to talk about sterilizers and how they work.”)
Explain that these objectives reflect what students will be learning in this module and that there will be a self assessment at the end, based on these objectives.
Mention the online course  (**insert URL) and that the objectives are the same.

## Factors Affecting Sterilization

**Number of organisms**
**Their resistance to the sterilizing agent**
**Debris on the item providing protection for organisms**
**Proper loading techniques**
**Functional efficiency of the sterilizing equipment**
**Achieving required sterilization parameters**
**Human performance **
**Post sterilization handling techniques**

**Notes:**
Instructor Notes 
Introduce the concept of sterilization as a probability rather than an absolute. Since the only way to see if an item is sterile is to test it, and testing it renders it contaminated, the best we can do is subject objects to conditions that will kill all microbial life and then protect the item from becoming recontaminated.
These factors all influence the likelihood that an object is sterile.

Learning activities:
Discuss each factor and how/why it impacts sterility.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
How do you know sterilization works?
Once we get the sterilizer up and running, why do we have to constantly recheck it?
What is the biggest variable (the one with the most impact)?

## Types of Sterilizers

**Steam**
**Ethylene Oxide (EtO)**
**Plasma**
**Dry heat**
**Chemical**
**Flash **

**Notes:**
Instructor Notes 
Steam and EtO are the prevalent means, some medical centers, depending on the type of service they provide, will have access to some of the other types.

Learning activities:
Discuss the types used locally.
This is meant to be a quick overview; subsequent slides will go into further detail.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
How do you decide which method to use. 
Is one used more than the others? 
What is flash sterilization used for?

## Steam Sterilization 

- Very effective
- Easy to produce
- Relatively inexpensive
- Moist heat; saturated steam under pressure

**Notes:**
Instructor Notes 
Heat alone would kill microorganisms but adding the water vapor lets it work at lower temperatures in less time. This makes medical devices last longer.

Learning Activities:

Points for Discussion
Why is steam relatively inexpensive?

## Surface contact

Time and Temperature

Temperature and Pressure

- Time and Temperature
- Temperature and Pressure

- TEMPERATURE 	 KILL TIME
- HEAT UP + KILL TIME + SAFETY FACTOR = EXPOSURE

- PRESSURE 		TEMPERATURE
- Processing temperature from 250 degrees F to 275 degrees F

-   BARRIERS, AIR BUBBLES, PLACEMENT

- Factors Affecting Steam Sterilization

**Notes:**
Instructor Notes 
Time = 30 - 45 minutes @ 250 degrees  or 3 - 5 minutes @ 270 degrees F

Learning activities:
Discuss each factor. Give examples.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
What things can be barriers to the sterilant?
What happens when air gets trapped in the sterilizer?
Why does how the cart is loaded and where items are placed affect the efficiency of the sterilization?
What role does pressure play?  
Why not just sterilize for longer times?
What is the safety factor?

## Steam Quality

- The amount of moisture in the steam
- Saturated =  97% dry    3% moisture
- ^ temperature = Super heated steam
- v temperature = Wet steam
- Impure steam – additives
- Solid
- Liquid
- Vapor

**Notes:**
Instructor Notes 
Learning activities:
Discuss the consequences of changing the temperature without the equivalent change in pressure.
Ask students to postulate what might make steam impure.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Can steam be impure but still be sterile?
What are some warning signs of impure steam?
What should you do if you notice evidence of impure steam?

## Steam Sterilizer Equipment

- Many styles/models
- 2 basic types
- gravity displacement
- prevacuum.
- Basic components

**Notes:**
Instructor Notes 
The focus here is not on a specific sterilizer, but on the basic operating principles of all steam sterilizers.
Learning activities:
Talk about each component. Ask students what each does.
Point out the
a.    Door
b.     Jacket
c.     Chamber
d.     Steam inlet
e.     Chamber drain
f.      Pressure gauge
g.     Temperature gauge
h.     Operator controls
i.      Mechanical Monitoring controls
j.      Vacuum pump (with prevacuum units)
Points for Discussion
What types are used locally?

## Prevacuum Sterilizers

- Conditioning
- Pulse/pull sequence
- Exposure
- Come down
- Cool down

- Insert FLASH animation if possible.

**Notes:**
Instructor Notes 
Find out which type is in use locally.
This screen should play the animation from the online course, but the ST0211.swf file has to be in the same directory and you must have the flash player installed, otherwise, you can view the animation inside the SPD Web-based course (go to  “server name” /sterilization/lesson_2/ST0211.asp)
Learning activities:
Use the online animation to help students understand the sterilizer phases. 

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why are there a number (3) of push/pulls?
What does the conditioning phase do?
How does the vacuum help ensure sterilant contact with device surfaces?
Where does the air come form that gets pulled in after the exposure stage?

## Gravity Displacement Sterilizers

- Initiation
- Exposure
- Exhaust
- Drying

**Notes:**
Instructor Notes 
This screen should play the animation from the online course, but the ST0212.swf file has to be in the same subdirectory as the .ppt file and you must have the flash player installed, otherwise, you can view the animation inside the SPD Web-based course (go to  “server name” /sterilization/lesson_2/ST0212.asp)

Learning activities:
Use the online animation to help students understand the sterilizer phases. Point out the difference between Prevacuum and Gravity displacement.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why doesn’t this type need the initial steam pulses?
When does the sterilizer drain close? How does it know?
What replaces the steam in the exhaust phase?

## Testing Sterilizer Function

- Bowie Dick Test
- Tests vacuum effectiveness
- Performed daily
- Done in empty sterilizer
- Placed on bottom near drain

**Notes:**
Instructor Notes 
This test is only preformed on prevacuum sterilizers.
Learning activities:
Pass around an exposed package for students to examine. (If possible show an inconclusive or failed one.)
Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why is the test pack placed near the drain?
What do you do if the Bowie Dick fails?

## Table Top Steam Sterilizers

- Small gravity displacement units
- Found in clinics/dental offices

**Notes:**
Instructor Notes 
Generally SPD technicians will have little experience with these, but should recognize one when they see it.

Learning activities:
Determine if there are any located in the local center.

Points for Discussion
Use the following question to guide classroom discussion during the presentation of the module.
What are they used for?
What is an autoclave?

## EtO Sterilization

- Used for heat and moisture sensitive devices
- Functions through alkalization**—**chemical disruption of cell
- Requires caution**—**Toxic and flammable
- Expensive and time consuming
- Can produce polyglycol if mixed with water

**Notes:**
Instructor Notes 
Stress the appropriate use of EtO and the necessity for careful handling.

Learning activities:
Talk through EtO characteristics.
Poll the students to see who has worked with it and what it is used for.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why not just sterilize everything with EtO?
What is polyglycol? Why is it a problem in SPD?

## EtO Sterilization

- Use a mixture of EtO and carrier gas
- 4 Phases
- Vacuum
- Conditioning
- Exposure
- Purge

## Loading and Unloading

- Arrange items loosely with sufficient clearance
- Aeration required following sterilization

**Notes:**
Instructor Notes 
Aeration is critical to safe patient care. Know the capabilities of the sterilizer you are using.

Learning activities:
If possible, tour the local EtO area. Examine the sterilizer. Determine what type of aeration is performed (and where). Locate the tanks and the hazard alarms.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
What does aeration do?
How is loading the EtO sterilizer different form loading the steam sterilizer?
Why can’t items touch the sides of the sterilizer during processing?
What is the minimum acceptable aeration time?

## Monitoring

- OSHA requirement
- Limits
-  PEL
-  STEL
-  Action Level
- Medical exams

## EtO Sterilization

-  **2 consecutive measurements**
** ****At least 7 days apart**
** ****Additional whenever there is a change**

**Notes:**
Instructor Notes 
These limits and the associated numbers are sometimes difficult for people to grasp. Discuss why the action level is half of the PEL and why the limits for short term excursions would be more lenient than the 8 hour average.

Learning activities:
Review each requirement and the rationale behind it.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
What activities represent increased risk?
What should you do if you think you have been exposed to EtO?
Why are two measurements required? 
Why must they be redone when there is a change? What sort of changes qualify?

## Environmental Monitoring

- EtO emergency alarm
- Ventilation alarm

## Precautions

- PPE
- Avoid sparks, heat
-   or flames
- Immediate response if exposed
- Know location of fire extinguishers and showers

**Notes:**
Instructor Notes 
It is critical that personnel know how to respond in the event of an EtO emergency.

Learning activities:
Discuss PPE. Pass around examples. Describe non-examples and ask “How about this? Why can’t I just wear that?”
Tour area and point out extinguishers and showers (may assign this as homework if class time is tight).
Demonstrate the proper approach to donning EtO gear, including the respirator. (Wearing and using the respirator should be covered thoroughly in a separate class.)

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
What should you do if, while you are changing the tank, EtO starts spewing out all over?
Why are the showers important in dealing with EtO?
Describe the PPE required to load the EtO sterilizer?
To unload?
To change the tanks?

## Storage

- 100% EtO Cartridges
-  no more than 3 day supply
-  12 or less 50 gram cartridges
- EtO Gas Mixture Cylinders
-  temperature regulated, designated storage area,  away from traffic flow
-  upright, secured in place

**Notes:**
Instructor Notes 
Storing these items correctly is just as important as using them correctly. Empty containers are treated the same as full ones.

Learning activities:
Discuss/locate storage facilities. Do they conform to requirements?

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why is there a limit on how much you can have on hand?
Who regulates/mandates the requirements?

## Annual Training

**Mandatory**
**Should include:**
**•         ****EtO sterilizer and aerator operation and maintenance**
**•         ****work practice/precautions for safe use of EtO**
**•         ****safe handling and storage of EtO tanks**
**•         ****physical and health hazards**
**•         ****accidental spill/leak plan**
**•         ****emergency first aid procedures**
**•         ****personal protective equipment**
**•         ****professional EtO monitoring methods**

**Notes:**
Instructor Notes 
Find out when this training is provided and what is included.

Learning activities:
Ask class how many have been EtO trained.
Review what they are expected to know about EtO.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why is there a limit on how much you can have on hand?
Who regulates/mandates the requirements?

## Other Types of Sterilizer

- Plasma
- Dry Heat
- Chemical
- Flash

**Notes:**
Instructor Notes 
Different medical facilities will have different equipment. Find out what is in use at this location.

Learning activities:
Review types and uses.
Stress that Flash sterilization is only used in emergency situations in VA facilities.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
When would it be appropriate to use one of these instead of steam or gas?
Why is flash sterilization limited to emergency use?

## Verifying Sterility

**Biological**
**Chemical **
**Mechanical**

**Notes:**
Instructor Notes 

Learning activities:
Review types if monitoring.
Establish frequency for each.

Points for Discussion
Use the following questions to guide classroom discussion during the presentation of the module.
Why do we need to do all three types?
How reliable is sterilization?
What should you do if a test fails?

## Special Situations

- Implants
- Sterilizer load requires biological indicator
- 48 hour quarantine
- Manufacturer’s directions
- Loaner equipment
- Advance notice
- Count sheet

## How can you prove that something is sterile?

**  ****Examine the label**
**  ****Check the chemical indicator**
**  ****You can’t**
**  ****Look it up on the sterilizer log**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## What is the purpose of the Bowie Dick test?

- Ensure sterilization occurs
- Check the efficiency of the sterilizer
- Ensure that effective vacuum is achieved
- Check for air displacement

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## What factors can affect the steam sterilization process?

** ****time**
** ****temperature**
** ****surface contact**
** ****pressure**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Order the steps in the steam sterilization process.

**  ****conditioning**
** ****exposure**
** ****come down**
** ****drying**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Following EtO sterilization, why is aeration important?

**Residual EtO can cause burns to the patient, physician, or staff**
**It speeds up the sterilization process**
**It removes excess moisture, reducing the risk of polyglycol forming**
**It removes all excess EtO from the items**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Order the steps in the EtO sterilization process.

** ****Remove residual air**
** ****Inject steam and bring to required temperature and humidity**
** ****Inject  EtO gas under pressure**
** ****Exhaust gas and purge chamber**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Match the term to its limit.

**STEL –**
**Action Level –**
**PEL –**

**5 parts EtO per million parts of air in a 15 minute period**

**.5 ppm TWA**

**One part EtO per million parts of air over an eight hour period**** **

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## What types of monitoring are used in the medical center sterilization process?

**  ****Chemical**
**  ****Biological**
**  ****Remote**
**  ****Mechanical**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## The cycle phases for a prevacuum sterilizer include

conditioning, 
three ____________  ____________
and four _________   ___________,
followed by exposure and then the  _______________ of filtered air.

**conditioning, **
**three ____________  ____________**
**and four _________   ___________,**
**followed by exposure and then the  _______________ of filtered air.**

- steam      pulses

- vacuum     pulls

- exhaust

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Standard aeration times, 
as outlined in 
MP-2 Subchapter E, 
subpart 108-76.303(c), are: 

50o Centigrade (122 degrees F) for _____ hours.

**as outlined in **
**MP-2 Subchapter E, **
**subpart 108-76.303(c), are: **
**50****o**** Centigrade (122 degrees F) for _____ hours.**

**12**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Liquids must

** ****be**** ****tightly sealed before sterilization**
** ****not be mixed in sterilizer  loads with other items**
** ****not be sterilized in VA facilities**
** ****carefully monitored to prevent flashback**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Steam sterilization is the best method for:

-  anything that is needed in a hurry
-  all reusable items
-  items that can withstand heat and moisture
-  plastic and rubber items

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Which form of sterilization is known to be harmful to the ozone layer?

**Steam**
**EtO**
**Plasma**
**Flash**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Standard steam sterilization time is:

** ****250 degrees F for 30-45 minutes**
** ****270 degrees F for 3-5 minutes**
** ****130 degrees F for 1 hour and 45 minutes**
** ****100 degrees for 4 hours**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## When loading sterilizers;

**  ****Always put the larger items on top**
**  ****Place items so that they overlap**
**  ****Avoid allowing items to touch the sterilizer walls**
**  ****Leave  at least one shelf empty to prevent condensation**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Chemical indicators are used for:

-   ensuring that items are sterile
-   indicating that an item has been     	 exposed to the sterilization process
-   preventing bleed through or 		   	 wicking
-   overriding biological indicators.

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Biologic controls must be run 
In every load
Once a week or more, as needed
At least once per day when the  sterilizer is in use
Whenever a problem is detected or suspected

**In every load**
**Once a week or more, as needed**
**At least once per day when the  sterilizer is in use**
**Whenever a problem is detected or suspected**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

##  
Only when the aeration cycle is complete
Before the aeration cycle finishes with a signed release from the Chief of SPD
When something is needed in the O.R.
6-8 hours after processing

**Only when the aeration cycle is complete**
**Before the aeration cycle finishes with a signed release from the Chief of SPD**
**When something is needed in the O.R.**
**6-8 hours after processing**

**When can items be removed from the aerator?**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## Biologic controls must be run 
In every load
Once a week or more, as needed
At least once per day when the  sterilizer is in use
Whenever a problem is detected or suspected

**In every load**
**Once a week or more, as needed**
**At least once per day when the  sterilizer is in use**
**Whenever a problem is detected or suspected**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## What is the Action Level for EtO exposure?

**.5 ppm in 8 hour TWA**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion

## What is STEL and what are the limits?

- Short Term Excursion Limit
**5 ppm in 15 minute period**

**Notes:**
Instructor Notes 

Learning activities:

Points for Discussion