Chapter 14 point of use processing


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Chapter 14 point of use processing

  1. 1. Point of Use Processing Chapter 14
  2. 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. 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. 4. Flash Sterilization  The process by which unwrapped instruments are sterilized for immediate use when an emergency situation arises
  5. 5. Standards, Guidelines and Recommendations Several agencies and organizations have issued statements regarding Flash Sterilization. The following slides review those statements.
  6. 6. Association for the Advancement of Medical Instrumentation  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. 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. 8. Association of Peri-Operative Registered Nurses (  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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 18. Complex Medical Devices …may require longer exposure times
  19. 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. 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. 21. Transport of Sterile Items after Flash Sterilization Because the items are unwrapped, they are very vulnerable to contamination
  22. 22. Quality Controls for Flash Sterilization  Chemical Monitoring  Biological Monitoring  Residual Air Removal (Bowie-Dick) Tests  Cycle Monitoring
  23. 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. 24. Point of Use Processing  For Heat Sensitive Devices
  25. 25. Heat Sensitive Items Cannot be Flash Sterilized
  26. 26. Spaulding’s Classification System
  27. 27. Critical Devices  Instruments or objects that will be introduced directly into the Patient’s bloodstream  Examples include: Surgical Instruments, Implants
  28. 28. Semi-Critical Devices  Objects which come in contact with non- intact skin or mucous membranes  Examples include: Flexible Fiberoptic Endoscopes
  29. 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. 30. Criteria for Selecting Disinfection/Sterilization Methods:  Safety  Efficacy  Efficiency
  31. 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. 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. 33. Process Monitoring  Operator Observation  Parametric Monitoring  Chemical Monitoring  Biological Monitoring  Diagnostic Cycle
  34. 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. 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