Point of Use Processing

Chapter 14

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

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

Flash Sterilization The process by

which unwrapped instruments are sterilized for immediate use when an emergency situation arises

Standards, Guidelines and Recommendations

Several agencies and organizations have issued

statements regarding Flash Sterilization. The following slides

review those statements.

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”

ANSI/AAMI Standards:

Are not laws

Are nationally recognized standards for best practice

Are recognized in a court of law as professional standards

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”

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”

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

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

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

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

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

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

*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

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

Complex Medical Devices

…may require longer exposure times

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

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

Transport of Sterile Items after Flash Sterilization

Because the items are unwrapped, they are very

vulnerable to contamination

Quality Controls for Flash Sterilization

Chemical Monitoring

Biological Monitoring

Residual Air Removal (Bowie-Dick) Tests

Cycle Monitoring

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

Point of Use Processing

For Heat Sensitive Devices

Heat Sensitive Items

Cannot be Flash Sterilized

Spaulding’s Classification System

Critical Devices

Instruments or objects that will be introduced directly into the Patient’s bloodstream

Examples include: Surgical Instruments, Implants

Semi-Critical Devices

Objects which come in contact with non-intact skin or mucous membranes

Examples include: Flexible Fiberoptic Endoscopes

Non-Critical Devices

Objects which come in contact with the patient’s intact skin

Examples include: Patient Care Equipment, Crutches, Blood Pressure Cuffs, etc.

Criteria for Selecting Disinfection/Sterilization

Methods:

Safety

Efficacy

Efficiency

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

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

Process Monitoring

Operator Observation

Parametric Monitoring

Chemical Monitoring

Biological Monitoring

Diagnostic Cycle

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

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