Download - Chapter 14 point of use processing
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Point of Use Processing
Chapter 14
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Objectives: As a result of successfully completing this chapter, students
will be able to: Define the term, “flash sterilization,” and review industry
standards for the process Explain the need for and basic procedures to undertake
flash sterilization Describe quality control monitoring procedures for flash
sterilizers Review concerns about point-of-use processing of heat-
sensitive medical devices Discuss the use of oxidative agents for low-temperature
point of use processing
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Point of Use Processing
Occurs immediately before an item is used and/or close to a patient care area. For example, a sub-sterile sterile room in the operating room
Items processed in Point of Use Processing are unwrapped
Point of Use Processing is accomplished using Flash Sterilization or Oxidizing Chemicals
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Flash Sterilization The process by
which unwrapped instruments are sterilized for immediate use when an emergency situation arises
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Standards, Guidelines and Recommendations
Several agencies and organizations have issued
statements regarding Flash Sterilization. The following slides
review those statements.
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Association for the Advancement of Medical Instrumentation
www.aami.org
ANSI/AAMI ST79:2006 states: “Flash sterilization should only be considered when:
Work practices ensure proper cleaning, decontamination, inspection and placement of instruments in trays or containment devices recommended for flash sterilization”
“The area’s physical layout provides for direct delivery of sterilized items to the point of use
Procedures are developed, followed, and audited to ensure aseptic handling and personnel safety during transport to point of use.
The item is used immediately after sterilization”
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ANSI/AAMI Standards:
Are not laws
Are nationally recognized standards for best practice
Are recognized in a court of law as professional standards
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Association of Peri-Operative Registered Nurses (www.aorn.org)
Publishes “Recommended Practices and Guidelines” which are based on AAMI guidelines and best peri-operative practices
AORN states: “Flash sterilization should only be used in selected
clinical situations and in a controlled manner” “The use of Flash Sterilization should be minimized Flash sterilization should only be done when there is
insufficient time to process by the preferred wrapped or container method
Flash Sterilization should not be used as a substitute for an inadequate instrument inventory”
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AORN Recommended Practices and Guidelines - continued
“Flash sterilization should only be performed if: The device manufacturer’s instructions are available and
followed All devices and all lumens are thoroughly cleaned Placement of the instruments in the container or tray
allows for steam penetration” “Flash sterilization should only be performed if:
There is a procedure for aseptic transfer to the sterile field
Documentation and monitoring results are maintained to allow tracking of processed items to individual patients”
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The Joint Commission
The Joint Commission has the following expectations of flash sterilization:
It is used only for unanticipated situations
It is not a routine practice for turnover instruments
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The Joint Commission’s Expectations
There is a plan to ensure that the daily case schedule does not require the same instrumentation multiple times, and that there is sufficient time for appropriate instrument reprocessingThe instrument inventory is increased, if necessary, to avoid the need for flash sterilization.
A plan is identified for improving or decreasing the use of flash sterilization
Attention is paid to the frequency of flash sterilization.
Documentation is detailed and adequate to track instruments to the patient for which they are used
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Large and Multiple Trays
Large and multiple trays should not be flash sterilized because:
They require longer heat up time
They increase total cycle time
They increase instrument cooling time
They may need increased exposure time
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Implant According to the
FDA, an implant is an item that is placed into a surgically- or naturally-formed body cavity with the intention of remaining there for 30 days or more
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Flash Sterilization of Implants
AORN AORN standards do not recognize
flash sterilization for implants
AAMI AAMI also specifies that implantable
medical devices should not be flash sterilized. If they are, specific documentation must be completed
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Flash Sterilization Cycles
Gravity – traditionally called flash cycles
Pre-Vacuum – developed to adjust to more complex instruments
Express* – limited application for single instruments in a single wrap
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*Note:
Express cycles are not available on all sterilizers. Users should not attempt a single wrap Express process unless their sterilizer is
designed to perform that function
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Flash Sterilization Cycles
1. Condition – steam enters the chamber and air is removed. The pressure increases and the temperature rises to the sterilizing temperature
2. Exposure – Predetermined time at set exposure temperature. Usually 3, 4 or 10 minutes
3. Exhaust – filtered air enters the chamber, steam is removed and the pressure inside the chamber returns to atmospheric pressure
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Complex Medical Devices
…may require longer exposure times
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Decontamination in the OR
All instruments must be decontaminated before flash sterilization
The decontamination area in the OR should follow the same requirements as Central service
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Item Preparation in the OR
Appropriate PPE must be worn Items must be:
Precleaned Manually or mechanically cleaned using the
appropriate cleaning chemicals Inspected Placed in the sterilizer opened,
disassembled, and in positioned in a manner that will facilitate the sterilization process
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Transport of Sterile Items after Flash Sterilization
Because the items are unwrapped, they are very
vulnerable to contamination
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Quality Controls for Flash Sterilization
Chemical Monitoring
Biological Monitoring
Residual Air Removal (Bowie-Dick) Tests
Cycle Monitoring
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Recordkeeping for Flash Sterilization
Flash Documentation should contain:
Patient’s Name Contents of the Flash Cycle Type of Sterilization Cycle Used Cycle Parameters Reason for Flash Sterilization Signature of Staff Person Responsible for
Release of the Load
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Point of Use Processing
For Heat Sensitive Devices
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Heat Sensitive Items
Cannot be Flash Sterilized
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Spaulding’s Classification System
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Critical Devices
Instruments or objects that will be introduced directly into the Patient’s bloodstream
Examples include: Surgical Instruments, Implants
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Semi-Critical Devices
Objects which come in contact with non-intact skin or mucous membranes
Examples include: Flexible Fiberoptic Endoscopes
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Non-Critical Devices
Objects which come in contact with the patient’s intact skin
Examples include: Patient Care Equipment, Crutches, Blood Pressure Cuffs, etc.
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Criteria for Selecting Disinfection/Sterilization
Methods:
Safety
Efficacy
Efficiency
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Terminology
Oxidation: The process by which a molecule, atom, or ion loses an electron. The act or process of oxidizing, chemical breakdown of nutrients for energy
Molecule: The smallest quantity of matter than can exist in a free state and retain all its properties
Atom: The fundamental unit of a chemical element Ion: An electronically-charged particle that is formed by the
loss or gain of one or more electrons Electron: A negatively-charged particle that moves around
the central core of an atom Oxidizing Agent: A material that removes electrons from
another substance Oxidative Chemistries: A class of compounds that uses
oxidation to interrupt cell function
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Liquid Chemical Sterile Processing System
Introduced in the 1980s
Uses a Peracetic Acid-based sterilant
Operates at 1220 – 1330F (500 – 560C)
Has an exposure time of 12 minutes
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Process Monitoring
Operator Observation
Parametric Monitoring
Chemical Monitoring
Biological Monitoring
Diagnostic Cycle
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Process Limitations
Devices must be totally immersible
Devices must be able to withstand temperatures of 1220 – 1330F
No shelf life – Items must be used immediately
Devices must fit into special containers
The sterilant must make contact with all parts of the device
Not all devices have been validated by the system’s manufacturer
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Automatic Endoscope Reprocessors
Several manufacturers have recently released automatic endoscope reprocessors that use a high-level disinfectant with a mechanical process
They are economical and easy to use. And they incorporate patient and staff safety features