Steam Sterilization Monitoring in the New CSA Standard (Z )

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1 Speaker Disclaimer Steam Sterilization Monitoring in the New CSA Standard (Z ) Rick Bauer, Ph.D. Senior Technical Services Advisor 3M Canada Employed in technical services for 3M Canada Education, technical support, and standards Not a sales function Chair of the CSA steam sterilization committee All requirements referenced are from the 2014 and 2009 CSA Z314.3 steam sterilization standards 2014 standard published on September 24, 2014 MDR Leading the Way Winnipeg, MB 3M 2014 All Rights Reserved. 2 3M 2014 All Rights Reserved. Outline Introduction Monitoring Steam Sterilization Routine Monitoring Non-Routine Monitoring IUSS, aka Flash sterilization Summary Steam Sterilization Used in hospitals, clinics, and dental offices to spas, vet hospitals, and tattoo parlours Estimated that 85% of reusable devices are steam sterilized Why is steam sterilization so common? Effective Inexpensive Available Safe 3 3M 2014 All Rights Reserved. 4 3M 2014 All Rights Reserved. 1

Sterilization Monitoring What is sterilization monitoring? Verifying that sterilization is effective Why do sterilization monitoring?

General What does Z314.3-14 mean? All CSA reprocessing standards are Z314.

care tattoo parlours Written by professionals from healthcare facilities, consultants, industry experts 6 3M 2014 All Rights Reserved.

2 Sterilization Monitoring What is sterilization monitoring? Verifying that sterilization is effective Why do sterilization monitoring? Assure high probability that microorganisms were killed Detect failures as soon as possible Prevent the use of devices involved in failures Improve patient outcomes 5 3M 2014 All Rights Reserved. General What does Z mean? All CSA reprocessing standards are Z314.3 is just a numerical identifier -14 is 2 digits for the year Revised or reaffirmed every 5 years Standard is intended for all Canadian health care facilities Hospitals, clinics, dental offices, foot care tattoo parlours Written by professionals from healthcare facilities, consultants, industry experts 6 3M 2014 All Rights Reserved. Language Shall = a requirement Used for critical aspects Should = a recommendation Used for good practices, or if not always practical e.g. Steam treatment chemicals should be monitored May = an option Neither required or recommended, nor forbidden e.g. Packs may be leaned against each other e.g. Cycles may be verified by signature or electronically 7 3M 2014 All Rights Reserved. Validation vs. Verification Validation: Formal procedure to establish that a process consistently produces product that meets specifications Performed by manufacturers and labs Verification: Procedure to confirm that a process met specifications Performed by health care facilities 8 3M 2014 All Rights Reserved. 2

New Format for Steam Standard Common principles moved Now found in CSA Z314.0-13 Medical Device Reprocessing General requirements Sections removed from Z314.

3 New Format for Steam Standard Common principles moved Now found in CSA Z Medical Device Reprocessing General requirements Sections removed from Z314.3 include: Policies, procedures, and documentation Personnel (training, PPE, IPC) Work area design and maintenance Evaluation and purchase of devices, equipment, supplies Storage Common definitions 9 3M 2014 All Rights Reserved. Annexes Annex F: List of relevant CSA reprocessing standards Annex G: Guidance for moisture assessment 10 3M 2014 All Rights Reserved. Monitors of Physical Parameters The New Steam Sterilization Standard: Routine Monitoring of Sterilization e.g. timer, pressure gauges, thermometer Formerly called physical monitors Only quantitative measure of process Clauses Verify conditions after every cycle Time, temperature, and pressure Sign only after confirmed (electronically or on printout) MDR Leading the Way Winnipeg, MB 3M 2014 All Rights Reserved. 12 3M 2014 All Rights Reserved. 3

indicator tape, locks, arrows Internal Chemical Indicators (CIs) Verify steam penetration of packages to reach devices Detect incorrect packaging Detect sterilizer and loading errors Every package

4 External Chemical Indicators (CIs) Differentiate processed from unprocessed packages E.g. indicator tape, locks, arrows Internal Chemical Indicators (CIs) Verify steam penetration of packages to reach devices Detect incorrect packaging Detect sterilizer and loading errors Every package must have an external chemical indicator An external indicator is not required if the internal one is visible Many facilities use an external indicator anyway Verify after every cycle Every package must have an internal chemical indicator Multi-layer containers must have at least one CI on each level If using 2 packaging layers, must be inside the inner layer Must be placed in most challenging location Often hard to identify 13 3M 2014 All Rights Reserved. 14 3M 2014 All Rights Reserved. Internal CIs Placement Follow device manufacturer instructions CSA recommendations: Package Type Location Instrument trays (single level) Geometriccentre Instrument sets (multi-level) Peel pouches Double pouched devices Basins, nested devices Textiles Centre of top level, opposite corners of lower levels Geometric centre Inner pouch, geometric centre Whereair pockets form Centre, within layers of pack Internal Chemical Indicators (CIs) If releasing load based only on physical parameters and CI results, then internal CI must be Class 5 or 6 i.e. if Biological Indicator (BI) is not used with load Class 5 and 6 CIs monitor all critical variables for sterilization Other CI classes may not measure all critical variables Greater risk of missing a process failure Class 4 CIs can be used if load is monitored with a BI 15 3M 2014 All Rights Reserved. 16 3M 2014 All Rights Reserved. 4

Biological Indicators (BIs) Confirm that the sterilization process killed microorganisms Must use BI PCD daily in full load, and in every implant load Typically done at beginning of day Must test

5 Air Removal Tests Confirms efficient air removal and steam penetration E.g. Bowie-Dick test Air inhibits sterilization Required every day for each pre-vacuum steam sterilizer North American test is defined in ISO M 2014 All Rights Reserved. Biological Indicators (BIs) Confirm that the sterilization process killed microorganisms Must use BI PCD daily in full load, and in every implant load Typically done at beginning of day Must test each type of cycle: C dynamic air removal (e.g. pre-vacuum) cycles; C gravity displacement cycles; 121 C gravity displacement cycles; C Immediate Use Steam Sterilization (IUSS) cycles Wrapped and unwrapped 18 3M 2014 All Rights Reserved. Load Release Routine Loads Can release based on: A BI PCD and physical parameters; or A CI PCD and physical parameters; or Physical parameters No new requirement US AAMI ST79:2010 standard has similar language Load Release Implant Loads Required to quarantine implant load until BI result is known Implants pose greater risk to patients In an emergency, early release may be needed e.g. an urgent unplanned need for a trauma-related set PCDs hint at indicator results for rest of the load 19 3M 2014 All Rights Reserved. 20 3M 2014 All Rights Reserved. 5

6 Load Release Implant Loads For risk assessment of early release, must use Results from a Class 5 chemical indicator in the BI PCD Records of physical parameters (e.g. printout) Results from all other indicators A report on the early release must also be completed, including patient and surgeon names and the procedure details Plus results from all indicators Failed Tests Incorrect Physical Parameters Based on data from monitors of physical parameters Load must not be released Failed Chemical Indicator Tests Device/set must be repackaged and resterilized Also if one CI of many in a package fails the test Investigate other CIs to determine if there is a load problem If possible 21 3M 2014 All Rights Reserved. 22 3M 2014 All Rights Reserved. Failed Tests Failed Biological Indicator or Air Removal Test If cause is immediately found (e.g. human error) Fix issue, repackage and resterilize load, repeat test If cause is not immediately found Do immediate recall to last passed BI test Remove sterilizer from service, investigate issue, fix, Previously, could do a second test before recall Many facilities do a recall on the first failed test anyway Recall Scenario #1: 2009 vs Load Time Monitoring Event Load Status Comments 1 8:00 BI Fail 2 9:00 None Incubate BI Unknown 3 10:00 None Unknown 4 11:00 None Unknown 5 12:00 BI (Retest) BI Test Failed Fail CSA 2014: Recall 6 1:00 Incubate BI 7 2:00 8 3:00 9 4:00 BI Test Failed CSA 2009: Recall 2009: Recall action is potentially delayed to 4:00 pm 23 3M 2014 All Rights Reserved. 24 3M 2014 All Rights Reserved. 6

6 1:00 Incubate BI 7 2:00 8 3:00 9 4:00 BI Test Pass CSA 2009: No Recall 2009: Status of loads 2-4 is unknown, but no recall required Failed Tests Common causes are: Human error Process/procedure not

7 Recall Scenario #2: 2009 vs Load Time Monitoring Event Load Status Comments 1 8:00 BI Fail 2 9:00 None Incubate BI Unknown 3 10:00 None Unknown 4 11:00 None Unknown 5 12:00 BI (Retest) BI Test Failed Pass CSA 2014: Recall 6 1:00 Incubate BI 7 2:00 8 3:00 9 4:00 BI Test Pass CSA 2009: No Recall 2009: Status of loads 2-4 is unknown, but no recall required Failed Tests Common causes are: Human error Process/procedure not followed Process/procedure are incorrect Poor steam quality Equipment failure Test used/interpreted incorrectly Unless cause is apparent, assume test is correct Have sterilizer serviced if needed 25 3M 2014 All Rights Reserved. 26 3M 2014 All Rights Reserved. Log of Issues Test failures must be recorded in a separate log Cause of a single test failure can be challenging to identify Log will help identify trends and resolve issues Could include indicator details, date/time, cycle details, technician, load contents, pack contents, Extended Cycles Defined as a cycle that is longer than a standard steam cycle Prevacuum cycle 132 C 10, 20 minutes Gravity cycle 121 C 40, 60 minutes Reasons: Manufactured in country with a different standard cycle Complexity (e.g. weight, lumens) Product Type Cycle Type (gravor Minimum Cycle 3M Product code Lot # Date Time of Day Cycle Temp Cycle Time Sterilizer # (BI/ CI / B-D) vac) Pressure Inc. well #(if Location of Load # Technician Load Contents Pack Contents and Type of Packaging Total tests in month applic.) Indicator 27 3M 2014 All Rights Reserved. Monitoring requirements and frequency are the same Monitors of physical parameters Chemical indicators Biological indicators 28 3M 2014 All Rights Reserved. 7

Extended Cycles Typical: Extended: 4 mins 4+ mins Guidance: Request alternative processing conditions Ensure materials are compatible with necessary

challenging in load (e.g. similar set) BI and/or CI in package in most challenging position Label to identify PCD 29 3M 2014 All Rights Reserved.

Documentation Retain: Printout or electronic cycle record (verified) Load control label Sterilization process records: Formerly separate process records and

8 Extended Cycles Typical: Extended: 4 mins 4+ mins Guidance: Request alternative processing conditions Ensure materials are compatible with necessary conditions Use indicators validated for extended cycles Use PCDs designed for extended cycles Commercial PCDs In-house PCDs made from: Package equal to most challenging in load (e.g. similar set) BI and/or CI in package in most challenging position Label to identify PCD 29 3M 2014 All Rights Reserved. In-House PCD Example Test Pack Sterilization 30 3M 2014 All Rights Reserved. Documentation Retain: Printout or electronic cycle record (verified) Load control label Sterilization process records: Formerly separate process records and sterility records Indicator results Physical parameters Contents of load The New Steam Sterilization Standard: Non-Routine Monitoring of Sterilization Clauses M 2014 All Rights Reserved. MDR Leading the Way Winnipeg, MB 3M 2014 All Rights Reserved. 8

9 Installation Qualification (IQ) Verification that sterilizer is installed correctly Clearly defines installer and facility responsibilities Installer Inform facility of what is needed (e.g. utilities, space) Complete installation Provide documentation of IQ Facility Provide what is needed (e.g. utilities, space) Review and retain documentation Operational Qualification (OQ) Verification that sterilizer consistently works 3 Bowie-Dick tests and 3 BI PCDs 3 tests will determine if process is functioning consistently Required after: Installation Major sterilizer repairs Interruptions to steam pressure, supply, or delivery (including boiler maintenance and shutdowns) Unexplained sterility test failures And at least annually 33 3M 2014 All Rights Reserved. 34 3M 2014 All Rights Reserved. Operational Qualification (OQ) Leak rate test must meet manufacturer specs Typically around 1 mm Hg or less Table-top sterilizers may have a different test Performance Qualification (PQ) Verification that specific conditions at the facility can effectively sterilize packages and loads aka Product Testing OQ testing with BI PCDs: Dynamic air removal (e.g. prevacuum) Gravity air removal Test both types if used See earlier for response to failed tests Empty chamber Full chamber Required after changes in: Packaging (e.g. type, model, wrapping technique) Set/load configuration Sterilization cycle variables And for packages that inhibit air removal/steam penetration PQ for extended cycles is also important! 35 3M 2014 All Rights Reserved. 36 3M 2014 All Rights Reserved. 9

10 Performance Qualification of Loads Performance Qualification of Loads Process: 1) Identify common load types for each set of conditions 2) Place PCDs throughout load (minimum 6 recommended) 3) Test each load type 3 times If a load fails PQ: Cannot use load types that fail PQ Verify conditions and materials Separate load into smaller loads and retest Example: Conditions 132 C, 4 minutes 132 C, 4 minutes 132 C, 4 minutes 132 C, 10 minutes Load Type Textiles Maximum metal mass Mixed load: Sets, wrapped devices, pouches Extended cycle sets 37 3M 2014 All Rights Reserved. 38 3M 2014 All Rights Reserved. Performance Qualification of Products Process: 1) Group devices/sets by composition and process conditions 2) Assign all devices to groups 3) Identify most challenging groups for all process conditions 4) Identify most challenging devices/sets from 3 5) Test each device/set from 4 three times with BIs and CIs If a device/set fails PQ: Cannot use devices/sets that fail PQ Verify conditions and materials Separate sets Performance Qualification of Products Example: Conditions Group Example 132 C, 4 mins Textiles Gowns 132 C, 4 mins Basin Sets Basins 132 C, 4 mins Device Sets in Container Laparoscopy instruments 132 C, 4 mins Peel Pouches Dental hand piece 132 C, 4 mins Power Equipment Orthopaedic drill 39 3M 2014 All Rights Reserved. 40 3M 2014 All Rights Reserved. 10

11 PQ Placement of Internal BIs/CIs Follow device manufacturer instructions CSA recommendations: Package Type Location Minimum Instrument trays (single level) Geometric centre and each corner 5 Instrument sets (multi-level) Geometric centre and each corner 5 per level Peel pouches Geometric centre 1 Double pouched devices Geometriccentre of innerpouch, and between pouches Basins, nested devices Between each basin # of basins Textiles Within each textile # of textiles 2 Utilities (clause 4) Testing parameters for sterilizer inputs (e.g. steam, water) Verifies that conditions are suitable Reference data for troubleshooting Aspect Steam Additional clauses for design of piping for water and steam See also Annex D Frequency Annually; after significant changes Steam Condensate Annually; after significant changes Boiler Feedwater Regularly; after significant changes 41 3M 2014 All Rights Reserved. 42 3M 2014 All Rights Reserved. Summary CSA standards are written by a group of experts from a variety of fields involved in device reprocessing Changes and new clauses are intended to: Improve patient safety Streamline existing processes Clarify requirements Introduce a higher level of care in Canada References The Canadian Standards Association. CSA Z Effective sterilization in health care facilities by the steam process. Published in The Canadian Standards Association. CSA Z Effective sterilization in health care facilities by the steam process. Published in M 2014 All Rights Reserved. 44 3M 2014 All Rights Reserved. 11

12 Thank you for your attention! Questions? All statements, technical information and recommendations herein are based on data we believe to be reliable, but the accuracy or completeness thereof is not guaranteed. There is no representation, warranty, guarantee or other obligation of 3M or its employees arising out of this presentation. 3M shall not be liable for any loss and/or damage, whether direct, indirect, incidental, special or consequential arising out of this presentation. 3M is a trademark of 3M. Used under license in Canada. 2014, 3M. All rights reserved. 45 3M 2014 All Rights Reserved. 12

Medical Device Reprocessing Quality Assurance. 3M All Rights Reserved.

Medical Device Reprocessing Quality Assurance Additional Content Qualification Testing Flash Sterilization Extended Cycles Recalls Wet Packs Finish 2 Qualification Testing and Required Monitoring Installation