Chapter 14 point of use processing

1. Point of Use Processing
Chapter 14

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

5. Standards, Guidelines
and Recommendations
Several agencies and organizations
have issued statements regarding
Flash Sterilization. The following
slides review those statements.

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

18. Complex Medical Devices
…may require longer exposure times

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

25. Heat Sensitive Items
Cannot be Flash
Sterilized

26. Spaulding’s Classification
System

27. Critical Devices
Instruments or
objects that will be
introduced directly
into the Patient’s
bloodstream
Examples include:
Surgical
Instruments,
Implants

28. Semi-Critical
Devices
Objects which come
in contact with non-
intact skin or
mucous membranes
Examples include:
Flexible Fiberoptic
Endoscopes

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.

30. Criteria for Selecting
Disinfection/Sterilization Methods:
Safety
Efficacy
Efficiency

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 122
0
– 133
0
F (50
0
– 56
0
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 122
0

– 133
0
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