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Process Quality Monitor

  • Designed as a quality assurance tool, the Process Quality Monitor assists the SPD technician by giving him/her valuable information that will prevent wet packs from making their way to the operating room.
  • Help monitor condensation that could lead to wet packs by equipping your facility with a comprehensive measurable variable (humidity).
    (Aorn 2017, XII.C.3)
  • Incoming Steam Quality is also monitored
  • Preventing one contaminated surgery, due to wet packs, will more than pay for this unit.
  • Empower the department to have real time information on the efficacy of the sterilization equipment.
    (IAHCSMM 8th Edition, Chapter 14: Cause of We Pack/Root Cause Analysis)
  • Allow the department to diagnose and correct steam issues sooner.
  • Can detect wet conditions
  • Monitors steam quality
  • Defective chamber traps
  • Door gasket seal leaking
  • Faulty chamber drain valve
  • Wet steam / not saturated

Normally after a load is removed, the operator checks for signs of a wet pack situation. The Process Quality Monitor is a compliment to these end of cycle procedures as well as monitoring incoming steam temperature (saturated steam). The Process Quality Monitor is simple to operate.

  1. Before starting a load (sterilizer hot), open door allowing hot gasses emanating from the chamber to establish starting humidity level.
  2. Observe steam quality (Green = Good)
  3. Press set button. Note: step one and two should only be repeated once a day.
  4. After cycle has completed, crack door. Note: do not fully open door.
  5. Wait 5 minutes
    1. after 2 minutes, humidity should return to set humidity point;
    2. After 5 minutes, humidity should not increase. if humidity level does not return to set point or if humidity begins to rise after reaching set point, load may be compromised.

*Humidity may increase while sterilizer door is closed and in cycle. This is normal.

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Provisional Patent #60/607,410
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AAMI recommends you perform a series of dry tests. Document the results and retain on file to verify that drying effectiveness is being monitored.

Any pack which is still wet after sterilization and drying is considered wet. There are three possible scenarios; visible moisture on outside of packs; moisture inside pack (e.g. moist towel) or visible water inside the set/tray. When multiple wet packs are found in the same load, the load is referred to as a wet load.

This system will enable hospitals to better implement their existing wet pack prevention protocols.

AORN 2017 Sterilization and Disenfection XII.c.3

  • During periodic product quality assurance testing of packaging systems, sterilization efficacy and drying effectiveness should be evaluated for each sterilizer and cycle used.
  • Health care organizations are responsible for obtaining and maintaining manufacturers' documentations of methodology and performance testing for packaging systems.
  • Health care personnel are responsible for ensuring that packaging systems are suitable for proposed sterilization used and compatible with existing sterilizers.

IAHCSMM 8th Edition
Causes of Wet Packs

Monitoring post cycle gases and monitoring incoming steam temperature (saturation) are very useful in detection of the following:

  • Improper placement of concave items, such as medicine cups, in a position that does not allow for drainage
  • Gasket not completely intact
  • Clogged chamber drain strainer
  • Broken valves
  • Faulty drain valves
  • Steam quality that does not meet the requirements of the sterilizer-water content greater than 3% not saturated

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