2. 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
3. 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
4. Flash Sterilization
The process by which
unwrapped
instruments are
sterilized for
immediate use when
an emergency
situation arises
6. 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”
7. ANSI/AAMI Standards:
Are not laws
Are nationally recognized standards for
best practice
Are recognized in a court of law as
professional standards
8. 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”
9. 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”
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. *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
17. 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
19. 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
20. 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
21. Transport of Sterile Items
after Flash Sterilization
Because the items are
unwrapped, they are very
vulnerable to contamination
22. Quality Controls for Flash
Sterilization
Chemical Monitoring
Biological Monitoring
Residual Air Removal (Bowie-Dick) Tests
Cycle Monitoring
23. 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
24. Point of Use Processing
For Heat
Sensitive
Devices
27. Critical Devices
Instruments or
objects that will be
introduced directly
into the Patient’s
bloodstream
Examples include:
Surgical
Instruments,
Implants
29. Non-Critical Devices
Objects which
come in contact
with the patient’s
intact skin
Examples include:
Patient Care
Equipment, Crutches,
Blood Pressure
Cuffs, etc.
31. 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
32. Liquid Chemical Sterile
Processing System
Introduced in the 1980s
Uses a Peracetic Acid-based
sterilant
Operates at 1220
– 1330
F (500
– 560
C)
Has an exposure time of 12 minutes
33. Process Monitoring
Operator Observation
Parametric Monitoring
Chemical Monitoring
Biological Monitoring
Diagnostic Cycle
34. Process Limitations
Devices must be totally immersible
Devices must be able to withstand temperatures of 1220
– 1330
F
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
35. 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