How to Conduct a Sterilization Failure Investigation

How to Conduct a Sterilization Failure Investigation
Susan Klacik Clinical Educator

Objectives Discuss how to identify a sterilization failure
Discuss different types of sterilization failures Describe how to perform sterilizer qualification testing Types of common sterilization failures

Types of Sterilization Failures
Sterilizer Utility Operator COMPLEX PROCESS Human FACTORS PREPARATION PACKAGING LOADING CYCLE SELECTION

Methods to Detect Sterilization Failures
Physical parameters External chemical indicator (CI) Biological indicator process challenge device (BI PCD) CI PCD Internal CI Wet Packs Use of quality monitors all along the way to show conditions are correct Sterilization DETECTION TOOLS Culture only way to demonstrate “STERILIZATION” indicator Process Challenge Device (BI PCD) (BI challenge test pack or CI challenge test pack) Sample trays If physical monitoring during the cycle indicates any malfunction or suspicious operation, the following steps should be taken: a) The department head or designee should be notified. b) If overloading is suspected, the sterilizer should be reloaded and the cycle rerun. c) After examination, if the malfunction cannot be corrected immediately, the cycle should be terminated in accordance with the sterilizer manufacturer’s written IFU. d) The load should be considered nonsterile, and the sterilizer should be removed from service. e) The load should be removed from the sterilizer and quarantined so that it is not inadvertently released for use. f) The hospital engineer or maintenance contract service should then be notified, the root cause should be identified, and the sterilization process failure should be corrected. g) The same investigative procedure should be followed at the completion of the cycle if the physical monitors, external CIs, or the monitor in a PCD (BI challenge test pack or CI challenge test pack) indicates a questionable cycle. See also

Failure Identification
The department head or designee should be notified Load &/or item quarantined Investigation

Physical Monitoring Failure
If physical monitors shows the sterilization parameters were not met The load is not released & considered unsterile Sterilizer is placed out of service until investigation shows the sterilizer is fully functional TIME TEMPERATURE

Steps to take for physical monitoring failures
The hospital engineering department or outside repair technician should then be notified, the root cause should be identified, and the sterilization process failure should be corrected. If physical monitoring during the cycle indicates any malfunction or suspicious operation, the following steps should be taken: a) The department head or designee should be notified. b) If overloading is suspected, the sterilizer should be reloaded and the cycle rerun. c) After examination, if the malfunction cannot be corrected immediately, the cycle should be terminated in accordance with the sterilizer manufacturer’s written IFU. d) The load should be considered nonsterile, and the sterilizer should be removed from service. e) The load should be removed from the sterilizer and quarantined so that it is not inadvertently released for use. f) The hospital engineer or maintenance contract service should then be notified, the root cause should be identified, and the sterilization process failure should be corrected. g) The same investigative procedure should be followed at the completion of the cycle if the physical monitors, external CIs, or the monitor in a PCD (BI challenge test pack or CI challenge test pack) indicates a questionable cycle. See also

Steps to take for physical monitoring failures
The load should be considered nonsterile, and the sterilizer should be removed from service. The load should be quarantined and not released for use. If physical monitoring during the cycle indicates any malfunction or suspicious operation, the following steps should be taken: a) The department head or designee should be notified. b) If overloading is suspected, the sterilizer should be reloaded and the cycle rerun. c) After examination, if the malfunction cannot be corrected immediately, the cycle should be terminated in accordance with the sterilizer manufacturer’s written IFU. d) The load should be considered nonsterile, and the sterilizer should be removed from service. e) The load should be removed from the sterilizer and quarantined so that it is not inadvertently released for use. f) The hospital engineer or maintenance contract service should then be notified, the root cause should be identified, and the sterilization process failure should be corrected. g) The same investigative procedure should be followed at the completion of the cycle if the physical monitors, external CIs, or the monitor in a PCD (BI challenge test pack or CI challenge test pack) indicates a questionable cycle. See also Steam Load

Bowie-Dick Test Daily test to detect air leaks
Evaluates the ability to reduce air residuals Provides evidence of air leaks Shows ineffective air removal Failed Bowie-Dick Test detect air leaks and to evaluate the ability of dynamic-air-removal sterilizers to reduce air residuals in the chamber space sufficiently to prevent air compaction by reentrainment into a load (the “small-load effect”) as steam is introduced after evacuation. It was later found that the same test could provide evidence of air leaks, ineffective air removal with other air-removal techniques that do not utilize a deep vacuum, and the presence of noncondensable gases (i.e., air or gases from boiler additives)

POTENTIAL CAUSES FOR STERILIZATION PROCESS FAILURES
Operator Error

Single Failure A single failure, confined to one load or one item that is immediately identified should be corrected and the load or item should be reprocessed Improper positioning Wrong CI Incorrect preparation  Actions to take when BIs, CIs, or physical monitors indicate a sterilization process failure General procedure Wrong cycle Run BI and Bowie dick together

Single Failure If a wet pack is observed, consideration should be given to opening other packs in the questionable load to check for moisture and/or to recalling all items from the load

Operator Error Biological Monitor
Inappropriate use of BI or BI PCD Use of wrong BI or BI PCD for the load Incorrect placement of the BI PCD Not incubating the BI correctly Misinterpretation of BI result Documentation of BI result incorrectly

BI PCD not placed over drain BI PCD not placed over drain

PCD placed on container PCD placed under package

Correct placement of BI PCD

Operator Error Chemical Indicator
Using the wrong type of CI PCD Not placing a CI PCD in the correct location Not interpreting the results of the CI correctly

Operator Error Chemical Indicator
Incorrect documentation CI results Not using the CI correctly Using the wrong CI

Operator Error Defective CI CI is expired CI faded
CI has partial color change due to incorrect storage EXTREME HEAT & HUMIDITY

Operator Error Incorrect storage of the quality monitors Temperature
Humidity Exposure to light

Operator Error Instruments or containment devices not dry before packaging

Operator Error Use of absorbent material may be needed

Operator Error Packaging Errors
Using the wrong package for the sterilization cycle parameters Not preparing the package correctly Use of wrong filters Container not validated for cycle

Operator Error Packaging
Improper double packaging of paper–plastic pouches Proper double packaging of paper–plastic pouches  

Operator Error Wrapped too tight or too loose

Operator Error Solid bottom trays placed incorrectly

Operator Error Not loading the sterilizer correctly
Incorrect placement of basins Correct placement of basins Not placing basins on their sides so that water can drain Place basins on their sides so that water can drain Not loading the sterilizer correctly Stacking of instrument trays Stacking of sterilization containers Improper placement of instrument trays (e.g., not laying instrument trays flat or parallel to the shelf) • Incorrect placement of paper–plastic pouches (e.g., placing pouches flat instead of on edge; not allowing sufficient space between pouches; not placing pouches with plastic sides facing one direction) • Incorrect placement of basins (e.g., not placing basins on their sides so that water can drain) • Incorrect placement of textile packs (e.g., not placing them on edge) • Placement of packages too close together, impeding air removal and sterilant penetration in the load

Operator Error Packaging
Placing a paper–plastic pouch inside a wrapped set Dense textile packs  

Operator Error Peel pouches not properly placed on edge

Stacking of instrument trays

Stacking of instrument sets Stacking of instrument trays

Stacking of sterilization containers Stacking of instrument trays

Stacking of plastic peel pouches Stacking of instrument trays

Correct loading Steam Load

Clinical Practice Sterilization Process
Cooling vents located directly over cooling loads Temperature of area designated for cooling sterilized loads too cool Manufacturer's prescribed cool down procedure not followed

Sterilizer or Utility Malfunctions
POTENTIAL CAUSES FOR STEAM STERILIZATION PROCESS FAILURES Sterilizer or Utility Malfunctions

Sterilizer Performance
Clogged strainer Non-intact gasket

Sterilizer or Utility Malfunctions Steam Delivery System (Piping)
Steam dryness not between 97% and 100% (i.e., too much water in the steam)

Potential causes for steam sterilization process failures
Wet steam Steam trap malfunction or no trap in steam line Drain check valve malfunction Superheated steam Improper come-up of chamber Dehydrated textiles Steam pressure too low for the temperature Steam control valve malfunction

Potential causes for steam sterilization process failures------Wet steam
Poor or no insulation of steam lines Boiler producing too much water in steam

Sterilizer or Utility Malfunctions Boiler System
Boiler feed water that contains too many noncondensable gases (such as air)

Sterilizer or Utility Malfunctions Boiler System
Malfunction of trap in steam line or no trap in steam line

Clogged filters, Excessive demands for steam Pressure gauges and controllers out of calibration Clogged steam lines Clogged chamber drain line, strainer, or chamber drain screen Malfunction of valves

Insufficient time at temperature Control timer out of calibration Wrong cycle parameters for the load being processed Load oversized

Utility Malfunctions Change of season

Sterilizer or Utility Malfunctions Environmental Issues
Geographic areas where high humidity is the norm (actual testing should be performed to determine the potential for absorbent items to become contaminated).

How to resolve

Recall Process If the cause of the failure is not immediately identified, the load should be quarantined, All loads back to the last negative BI should be recalled. The sterilizer in question should be taken out of service until the cause of the failure is identified and corrected Actions to take when BIs, CIs, or physical monitors indicate a sterilization process failure General procedure If the cause of the failure is not immediately identified, the load should be quarantined, and all loads back to the last negative BI should be recalled. Items in these loads should be retrieved, if possible, and reprocessed (see ). The sterilizer in question should be taken out of service until the cause of the failure is identified and corrected

Recall Process If items are in quarantine remove and reprocess
To obtain items, immediately contact all affected areas that they may be located in Provide instructions on what needs to occur, provide specific information Specific items What to do with affected items Document who contacted in each area A written report should follow listing the affected items Recall procedure

Recall Process Use the load record card to identify the items
The lot control should pinpoints the exact items This information may also be available thru an instrument tracking system Some still using handwritten lists

Recall Report Persons &/or departments to who were contacted
Record all items affected Name Quantity What instructions were given to those contacted Document what was retrieved and what was not Recall procedure

Investigative Documentation
Date and time of the incident Load control number that includes the sterilizer identification Complete description of the incident, Results of physical monitoring and of internal CIs and BI results Any additional relevant information

Failure Identified in BI PCD
A multidisciplinary team should attempt to determine the root cause of the sterilization process failure and implement corrective action. Look at all possible causes

Qualification TEsting

Qualification Testing Sterilizer qualification testing with a BI PCD after
installation relocation malfunctions major repairs 13.8 Qualification testing General considerations Qualification testing with a BI PCD should be performed on all sterilizers after sterilizer installation, relocation, malfunctions, major repairs, sterilization process failures, or changes to the utilities (e.g., steam or water supply). If a steam sterilizer is designed to be used for multiple types of cycles, then each sterilization cycle type used should be tested. If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132°C to 135°C [270°F to 275°F]) for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time should be tested.

Major Repair Weld repairs of the pressure vessel
Chamber door replacement Control rebuilds or upgrades New vacuum pump Major piping assembly As described in , a major repair is a repair outside the scope of normal maintenance, such as weld repairs of the pressure vessel; replacement of the chamber door, vacuum pump, or a major piping assembly; or rebuilds or upgrades of controls. Normal preventive maintenance, such as the rebuilding of solenoid valves or the replacement of gaskets, is not considered a major repair. Major repairs of or changes to the utilities (e.g., the installation of new boilers) should be treated as major repairs to the sterilizer, and sterilizer testing should be performed as defined in this section to provide the necessary qualification for use.

Major Utility Changes Major changes to the utilities connected to the sterilizer water-main breaks annual boiler maintenance additional equipment loads Significant changes to the utilities connected to the sterilizer (e.g., changes necessitated by water-main breaks, annual boiler maintenance, or additional equipment loads) could affect sterilizer performance Qualification The performance of the sterilizer depends on the utilities connected to it. The sterilizer manufacturer specifies certain utility line sizes, maximum and minimum pressures, and dynamic flow requirements for the required utilities. Water quality also might be specified, especially for stand-alone steam generators (which are typically shut down on weekends). Sterilizers are designed to function with a nominal electrical supply and can be operated within a specified range of that nominal value. Significant changes to the utilities connected to the sterilizer (e.g., changes necessitated by water-main breaks, annual boiler maintenance, or additional equipment loads) could affect sterilizer performance.

Qualification Testing
Sterilizer qualification testing with a BI PCD for utility changes: Steam supply Water supply New boiler 13.8 Qualification testing General considerations Qualification testing with a BI PCD should be performed on all sterilizers after sterilizer installation, relocation, malfunctions, major repairs, sterilization process failures, or changes to the utilities (e.g., steam or water supply). If a steam sterilizer is designed to be used for multiple types of cycles, then each sterilization cycle type used should be tested. If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132°C to 135°C [270°F to 275°F]) for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time should be tested.

Qualification Testing PCD Placement
In otherwise empty chamber Area most challenging to sterilization Consult sterilizer IFU for cold point Typically near the drain in the front bottom Placement of the PCD The PCD should be placed flat (layers of towels horizontal if the 16 towel PCD is being used) on a rack or shelf in an otherwise empty chamber, in the area least favorable to sterilization (i.e., the area representing the greatest challenge to the BI) (see Figure 13). The sterilizer manufacturer should identify the exact location of this area, the “cold point,” in the IFU and instruct users to place the PCD at this location. This area varies with sterilizer design, but is normally in the front, bottom section of the sterilizer, near the drain.

Qualification Testing Dynamic air removal
3 consecutive cycles should be run, one right after the other, with a BI PCD with negative results Physical parameters showing acceptable results Acceptable chemical indicators 3 consecutive Bowie-Dick tests with acceptable results For dynamic-air-removal sterilizers, three consecutive cycles should be run, one right after the other, with a PCD (see , , and ), yielding negative results from all test BIs and appropriate readings from all physical monitors and CIs. In addition, three consecutive Bowie-Dick tests should be run, one right after the other with each test result demonstrating sufficient air removal (see ); as in routine Bowie-Dick testing, an empty chamber should be used for the tests. Rationale: Testing in this order presents the greatest challenge.

Qualification Testing Gravity
3 consecutive cycles should be run, one right after the other, with a BI PCD obtaining negative test results Physical parameters showing acceptable results Acceptable chemical indicators For gravity-displacement sterilizers, three consecutive cycles should be run, one right after the other, with a PCD (see , , and ), yielding negative results from all test BIs and appropriate readings from all physical monitors and CIs.

Qualification Testing Table-top sterilizer
BI PCD reflective of routinely processed items Chamber fully loaded The PCD should be placed on its edge if it is a small pack PCD placed on edge flat if it is a large pack or tray Placed in area most resistant to sterilization, typically in the center towards front of the chamber Qualification testing of table-top sterilizers (sterilizers having a chamber volume less than or equal to 2 cubic feet) Composition of the PCD The PCD should be representative of the items routinely processed in the sterilizer and contain a BI and CI (see ). Rationale: There currently are no standardized PCDs for table-top sterilizers. Therefore, a representative package or tray that is routinely processed in the sterilizer is used as the PCD. Placement of the PCD The PCD should be placed in a fully loaded chamber. The PCD should be placed on its edge if it is a small pack or flat if it is a tray or large pack. It should be positioned in the area of the sterilizer chamber and load that is least favorable to sterilization. This area, the “cold point,” varies with sterilizer design but is normally in the center of the load toward the front of the chamber.

Qualification Test Pack IUSS Sterilizer
Dynamic air-removal Gravity Cycle Standard BI test pack or a commercially prepared PCD A BI and 1 or more CIs placed in a tray configuration that has been selected to be tested A BI test pack as described in or a commercially available disposable BI PCD should be used to test the dynamic-air-removal cycle for IUSS 1 BI and 1 or more CIs should be placed in an appropriate sized tray for the sterilizer being tested for example that has been validated by the sterilizer manufacturer: open surgical tray rigid sterilization container system protective organizing case single-wrapped surgical tray

Qualification Test Pack IUSS sterilizer Gravity
1 BI and 1 or more CIs should be placed in an appropriate sized tray for the sterilizer being tested for example that has been validated by the sterilizer manufacturer: open surgical tray rigid sterilization container system protective organizing case single-wrapped surgical tray For qualification testing of gravity-displacement cycles for IUSS, one BI and one or more CIs should be placed in the tray configuration that has been selected to be tested. The PCD (BI challenge test tray) should be of appropriate size for the sterilizer being tested. The BI and CI(s) should be located in the most difficult-to-sterilize portion of the PCD. NOTE—The open surgical tray, rigid sterilization container system, protective organizing case, or single-wrapped surgical tray should be a product that has been validated by the manufacturer for use in sterilization. Rationale: Only one BI need be used for the test in order to achieve a microbial challenge. There are no data to support the need for more than one BI. It is recommended that one or more CIs be placed in the PCD, because CIs give immediate information regarding sterilization process efficacy.

Qualification Testing PCD Placement IUSS sterilizer
In otherwise empty chamber Area most challenging to sterilization Consult Sterilizer IFU for cold point Typically near the drain in the front bottom Placement of the PCD The PCD should be placed on the bottom shelf of an otherwise empty chamber, in the area least favorable to sterilization (i.e., in the area representing the greatest challenge to the BI). The sterilizer manufacturer should identify the exact location of this area, the “cold point,” in the instruction manual and instruct users to place the PCD at this location. This area varies with sterilizer design, but is normally in the front, bottom section of the sterilizer, near the drain. Rationale: The BI test is conducted in an otherwise empty chamber, rather than in one containing patient care items, because for IUSS this configuration is a more rigorous biological challenge to sterilizer performance than is a filled chamber. Performing the test in an empty chamber minimizes come-up time (because there is little metal mass to absorb the heat) and, therefore, minimizes the lethality of the process and creates a greater challenge to the BI. The area near the drain is usually the coolest portion of the sterilizer and therefore presents the greatest challenge.

Wrap Up Sterilization is a complex process that requires all best practices, IFUs and parameters to be in place for sterilization to be successful Investigation of sterilization failures includes examining sterilizer and utility operations and operator performance After a major repair is performed on a sterilizer or major utility change, qualification testing needs to be performed before being placed back into service.

References ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities sterilization standards

How to Conduct a Sterilization Failure Investigation

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