12/18/2016

Investigation of Sterilization Process

Sterilization Process Failures: Failures Video - AAMI
Investigation and Prevention • 35-minute instructional video provides information on
sterilization process failures

• Filmed at the New England Baptist Outpatient Care

Center in Dedham, MA.
– Special thanks Mark Duro, and Karen Nauss, help in the
development and filming of this video.

• Script written by Rose Seavey

Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT
http://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=2725
1 2

TJC National Patient Safety Goals – Goal 7: Professional Organization Guidelines

Reduce Risk of Healthcare-associated Infections
NPSG.07.05.01
– “Implements policies and practices aimed at reducing the risk of
surgical site infections. These policies and practices meet
regulatory requirements and are aligned with evidence-based
guidelines (for example, the Centers for Disease Control and
Prevention [CDC] and/or professional organization guidelines).”
• AORN Guidelines for Perioperative Practices, 2015
• AAMI ST79 Comprehensive guide to steam sterilization and sterility
assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010
&A2:2011 & A3:2012 &A4:2013
• AAMI ST58:2013 Chemical sterilization and high-level disinfection in
health care facilities

• AAMI ST41:2008 (R2012) Ethylene Oxide Sterilization

In Health Care Facilities: Safety And Effectiveness

• CDC Guideline for Decontamination and Sterilization in Healthcare

Facilities, 2008

3 SHC © 4

ANSI/AAMI ST79 Comprehensive guide to steam ANSI/AAMI ST79

sterilization and sterility assurance in health care facilities Continuously Updated
2006 and A1:2008 2008-2009 amendments:
& A2:2009 2010 & A1:2010 ST79:2010/A2:2011 – TASS,
– Peel pouches,
– Steam quality,
– Devices with lumens,
– Chemical indicators,
– Product families,
– Evaluation of containers,
– Risk analysis,
– Verification of cleaning and
sterilization process failures.
2010 -2nd edition changes:
– Steam quality requirements,
– Paper-plastic pouches,
– Mechanical cleaning equipment,
– Product quality assurance testing
– Risk analysis,
– Additional info on type 6 CIs,
– New section on New Product
Evaluation.
2011 amendments
– Manufacturer’s written instructions
for use = IFU, and
– Hand washing = hand hygiene

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ANSI/AAMI ST79 Recommended Practice ANSI/AAMI ST79 Recommended Practice

If You Have This AAMI What To Purchase What To Download Free
Document
ANSI/AAMI ST79: 2006 Purchase ANSI/AAMI If You Have This AAMI What To Purchase What To Download Free
Document
ST79:2010 & A1:2010 &
A2:2011 & A3:2011 ANSI/AAMI ST79:2010 Download A3:2012 PDF
& A1:2010 & A2:2011 and replace pages
(Consolidated Text)
ANSI/AAMI ST79:2006 Purchase ANSI/AAMI
and A1:2008 & A2:2009 ST79:2010 & A1:2010 & ANSI/AAMI ST79:2010 Most-up-do-date
A2:2011 & A3:2012 & A1:2010 & A2:2011 &
A3:2012
ANSI/AAMI ST79:2010 Download A2:2011 PDF
& A1:2010 (Consolidated and replace pages
Text) Then download A3:2012
PDF and replace pages

7 8

Essential Elements of Sterility Assurance

We use Multiple Sterilization Monitors
ANSI/AAMI ST79 (section 10)
Physical • Quality assurance means monitoring all sterilization processes:
monitors
• Every package and every sterilization load (10.6)
• Periodic product quality assurance testing (10.9)
Chemical
Indicators • Sterilizer qualification testing:
(CI)
Installation,

Relocation, and
Biological
Indicators
Sterilizer malfunction (10.6.4 and 10.8)
(BI)
• Two helpful resources in ST 79
• Table 6 - Sterilization processes monitoring recommendations (also 10.7)
• Table 7 - Types and applications for use of sterilization monitoring devices

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012&A4:2013

9 10

Physical Monitors (10.5.1) Chemical Indicators (10.5.2)

• Designed to respond with a chemical or physical change to
• Physical (mechanical) monitors
one or more of the physical conditions within the sterilizing
– Displays,
chamber.
– Gauges, and
– Digital printouts
• Type 1 through 6 - not a hierarchical rating
• Verify and record parameters
– Time,
– Type 1 – External process indicators
– Temperature, and – Type 2 – Specific tests (Bowie-Dick)
– Pressure – Type 3 – Single-variable indicators
• Records – Type 4 – Multi-variable indicators (two or more critical variables)
– Readable – Type 5 – Integrating indicators (all critical variables)
– Signed – Type 6 – Emulating indicators (all critical variables –are cycle specific)

11 12

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Routine Load Release

Using Chemical Indicators (10.5.2.2)
• Physical monitors
• External CI on the outside of each
• External process indicator (Type 1) on outside of every
package package - unless internal CI is available
– Examined after sterilization and before use
• Internal CIs inside each package
– Must be visible
• PCD with at least a Type 5 or 6
• Internal CI within each package, tray, or – checked before releasing any load
rigid sterilization container system • Implants
– Placed in area considered least accessible – BI and a Type 5 CI (AORN and AAMI)
to sterilant penetration

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4: 2013 ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Table 6
AORN Guidelines for Sterilization 2017 13 SHC © 14

Load Release Nonresponsive or Inconclusive CI

Signature of person • A single nonresponsive or inconclusive CI should not be

releasing the load considered definitive evidence that the entire load is nonsterile.
after checking all
parameters, including • Professional judgment should be used in determining whether to
the PCD recall the entire load.

• Check all performance indicators:

– Physical monitors,
– CI, and
– BI responses

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012

SHC © 15 16

Biological Indicators (10.5.3) Sterilization Process Failures Actions to Take

(10.6.4)
• Only process monitoring device that provides a direct measure
of lethality of the process • Notify department head & investigative procedures –
• Physical monitors – malfunction or suspicious
• BIs should be used within PCDs (10.5.4): • External CIs or PCD monitor (BI or CI challenge
 Routine sterilizer monitoring test pack) – questionable
 Implant loads
• Quarantine until BI results available • If malfunction cannot be identified or corrected immediately
 Qualification testing (10.8) • Consider load nonsterile
• Installation, • Quarantine items
• Relocation, • Remove sterilizer from service
• Malfunction and major repairs, and • Notify hospital engineer or maintenance contract service
• After sterilization process failures • Identify root cause
17 18
ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 • Correct failure

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George Mills MBA, FASHE, CEM, CHFM, CHSP

Faulty Sterilizer (10.6.4)
Joint Commission Director of Engineering
• Identify and correct the problem
• Extending the cycle or increasing the cycle temperature not appropriate • Beginning Jan. 1, 2017, HTM departments must have
documentation on-hand for specific devices at the time of a survey.
• Ask for copy of the report to determine testing required • Starting January, if they ask for it and you don’t have it. They will
• Minor or major repair? write you a finding.
• Weld repairs,
• Replacement of the chamber door, vacuum pump,
or major piping assembly, or
• Rebuilds or upgrades of controls
• Re-qualify sterilizer

AAMI's Joint Commission Discussion Group Digest for Tuesday June 28, 2016
19 SHC © 20

Qualification testing (10.8) Actions to take when BI, CI or Physical Monitors

Indicate Sterilization Failure (10.7.5)
• Three (3) consecutive BI PCDs
• One right after the other • Failed PCD (BI or CI) or failed physical monitor
– Sterilizers larger than 2 cubic ft. and IUSS cycles, otherwise empty – Demonstrated failure for the entire load
chamber – Report immediately to supervisor and Infection Prevention and Control (IPC)
– Table-top, fully loaded sterilizer
• Three (3) Bowie-Dick tests for prevacuum cycle • Followed up by a written report which includes:
– Date and time of the questionable cycle,
• Acceptance criteria (10.8.2.4) – Description of the sterilizer and load, (reference lot control number),
• Demonstrate correct and complete sterilization cycles – Results of physical monitoring, and of internal CIs (if applicable,)
– Appropriate CI results, – Other useful information that could help determine if valid failure, or
– 3 negative BI test results, questionable because of operator error
– 3 satisfactory Bowie-Dick tests (prevacuum cycle), and
– Cycle printout records ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012

21 22

Cause of Failure Product Recalls (10.11)

• If immediately identified (operator error) and confined to one load or a
single item • P&P for recall of issued items or stored loads
– Correct the cause and reprocess – Developed in cooperation with Infection Prevention and Control
(IPC) and Risk Management
• Cause NOT readily known
1. Figure 12 - Quarantine entire load,
• Department head (or delegate) makes the decision to recall
2. Remove sterilizer from service, and • Evidence of sterilization failure
3. Recall all items back to the last negative BI (Product recalls 10.11) – IPC notified ASAP
4. Investigate cause of failure – Follow-up surveillance of patients

Decision Tree for conducting investigations process failures

Table 8 – Checklist for identifying reasons for process failures

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012

23 24

4

Product Recalls - 3 Parts
1. Written recall procedure 3.
– Outline circumstances and
responsible persons
2. Sterilization recall order
should:
– Include all items processed
back to last negative BI,
– Be communicated to all areas,
– Identify lot number,
– Identify departments involved,
– Record all items obtained
Investigating a Sterilization Process Failure
AAMI ST79 Figure 12

Decision Tree is a visual aid for conducting investigations of
steam sterilization process failures

BI, CI and physical monitors

Clarify steps and provides additional guidance

Appropriate for any type of process failure (steam or low temp)
AAMI ST79
Steam Sterilization Posters
Set of Parts One & Two posters ©
2014 by the Association for the
Advancement of Medical
Instrumentation
http://www.aami.org/publications/p
osters/posters.html
12/18/2016
(10.11) Failed or Positive BI
Recall written report should:
– Identify the circumstances,
• Microbiology lab - presumptive identification
– Specify corrective action(s) Test – specific microorganisms or other growth
taken to prevent a recurrence, According to BI manufacturer’s IFU
– State percentage of products Micro lab test instructions (10.7.5.2)
located, and
– Provide verification that the
• Do not delay recall
recalled items were • Determine root cause
reprocessed or destroyed
Review practice
Arrange for corrective action
• Training education (review)
• Return demonstration
25 26
Decision Tree for Conducting Investigations of Steam Sterilization Process
Failures Figure 12
27 28
Variables Affecting the Outcome of Steam
Sterilization Process
Equipment Utilities
malfunction 5%
10%
Human error
85%
Personal Communication, Charles
Hancock, President, Charles O. Hancock
Associates, Inc.
30
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Solving the Big Mystery: Table 8

Why Sterilization Failures Happen Checklist for identifying
reasons for steam
AAMI ST79 Table 8 sterilization process

Checklist for identifying reasons for process failure failures

Clarify steps and provide additional guidance
1- Operator errors
2- Sterilizer or Utility Malfunctions

31 32

AAMI Steam
Sterilization Posters Operator Errors
Set of Parts One & Two posters © Four categories of possible human errors
2014 by the Association for the
Advancement of Medical
Instrumentation 1. Incorrect use and interpretation of monitoring tools
2. Selection of incorrect cycle for load contents
http://www.aami.org/publications/post
ers/posters.html
3. Use of inappropriate packaging materials or packaging
technique
4. Incorrect loading of sterilizer

34

Incorrect Use and Interpretation of Incorrect Use and Interpretation of

Monitoring Tools Monitoring Tools

• Use of defective CI
• Examples include:
• Expired
• Incorrect placement of the PCD
• Faded, partial color change
• Incorrect incubation of BI • Incorrect storage, or
• Incorrect use of internal indicators • Previously exposed
• Incorrect storage of CIs or BIs
• Use of broken media ampoule or missing spore strip

35 36

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Human Error
Inappropriate Packaging Materials or Technique Inappropriate Packaging Materials or
Technique
•Incorrect Packaging for cycle parameters
•Incorrect preparation of containment device •Folded paper–plastic pouch
•(e.g. incorrect filters, valves or bottom tray)
• Tray that does not allow air removal • Paper–plastic pouch inside set
• Wrapper too large
• Textile packs that are too dense
•Incorrect placement of basins in set
•Failure to use absorbent material between nested basins
•Inadequate preconditioning of packaging materials

37 38

Human Errors Human Errors

Sterilization Errors Sterilization Errors
• Incorrect loading • Selection of incorrect cycle for load contents
• Stacking
– Container and/or medical device manufacturer’s IFU
• Containment devices
not followed
• Perforated trays

• Incorrect placement
• Trays not flat
• Pouches flat on shelf
• Basins not tilted
• Textile packs not on edge
• Packages too close
39 40

AAMI Steam AAMI Steam

Sterilization Posters Sterilization Posters
Set of Parts One & Two posters © 2014
Set of Parts One & Two posters ©
by the Association for the
2014 by the Association for the
Advancement of Medical
Advancement of Medical
Instrumentation
Instrumentation

http://www.aami.org/publications/poster
http://www.aami.org/publications/post
s/posters.html
ers/posters.html

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Sterilizer or Utility Malfunctions

Steam Quality
Four categories of possible • Significantly contributes to process failures
malfunctions
• Assessment of the entire steam delivery system
1. Poor steam quality or quantity
• ST 79 Annex M - How to achieve and maintain
2. Incomplete air removal
adequate steam quality
3. Inadequate cycle temperature
• Adequate and continuous supply of
4. Insufficient time at temperature saturated steam
• Critical variables
– Dryness of the steam (97 -100%)
– Level of noncondensable gases (such as air)
that does not impair steam penetration

43 44

Poor Steam Quality or Quantity Poor Steam Quality or Quantity

• Wet steam (overly saturated with moisture) • Superheated steam
– Steam lines – Improper chamber heatup
• Improper insulation – Desiccated packaging materials (dry
• Malfunction or no trap packaging) (8.3)
– Malfunction of drain check valve • Freshly laundered – rehydrates the fabric

– Steam contact with cold load – Excessive reduction of steam

– Too much water in produced steam pressure too close to sterilizer
at boiler – Control valve or pressure reducer is
faulty

45 46

Steam Quality Problems

Poor Steam Quality or Quantity
Difficult to Diagnose
• Variations in pressure
– Clogged filter, • Steam quality problems may be difficult to
– Poorly engineered piping, or
replicate in a given situation.
– Excessive demands

• Pressure gauges • Steam quality varies with total system load

out-of-calibration throughout the work day and is not constant
• Clogged
– Steam lines
– Steam strainer
– Drain line or screen

• Malfunction of valves
47 48

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Incomplete Air Removal Incomplete Air Removal

Inadequate vacuum or other air removal systems
• Low steam pressure
• Clogs:
• Chamber drain line,
• Strainer,
• Water:
– Temperature too high
• Drain screen, or
• Vent lines – Pressure inadequate
• Leaks: – Supply strainer clogged
• Faulty door gaskets, or
• Other areas of the chamber
• Air trapped by the load
• Control valves:
• Plugged, faulty, or • Incorrect cycle parameters
• Incorrectly adjusted 49 50

Inadequate Cycle Temperature Inadequate Cycle Temperature

• Steam pressure variations
• Temperature gauge, out-of-calibration
– Clogged filters,
– Poorly engineered piping, or
• Heat lag - long heatup time for large loads
– Excessive steam demands
• Clogs
• Presence of noncondensable gases
– Drain line,
– Strainer, or
• Inadequate pressure for steam supply
– Drain screen

• Clogged steam supply strainer

51 52

Personal Experience:
Insufficient Time at Temperature
Process Failures
• Control timer out-of-calibration
• Intermittent positive BIs
• Inappropriate cycle parameters
• Six days of investigation
– Not following Manufacturer’s IFU
• Clogged drain screen
• Come-up time less than 1.5 minutes in a 270°-275°F
• Now remove and check drain screen every shift
gravity-displacement cycle
• Oversized load

53 54

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Decreasing Risks
Objective 3 Sterilization Process Failure
Identify ways to help prevent • Not all are preventable
Sterilization process failures • Best Practices
– Use evidence based published practices (AAMI ST 79, AORN)
– Quality controls and process improvements
• Competent personnel (section 4)
• Packaging, preparation and sterilization (section 8)
• Quality control (section 10)
• Quality process improvement (section 11)
– Risk analysis (11.2.2)
• New product evaluation (section 12)

55 56

Personnel Considerations (Section 4) Sterile Processing Certification

• Guidelines for qualifications (4.2)
• Minimum criteria for training, education, personnel health, • Training and continuing education (4.3)
hygiene and attire – At a minimum - all staff should be certified within 2 years
• Supervisor (level of responsibility)
• Supervisory personnel (4.2.1)
• Technicians
• Prepared for responsibility by education, training and
experience
– Certification develops
• Sterile processing personnel (4.2.2) • Basic level of understanding and knowledge,
• Qualified individuals • Consistencies and standardization,

Initial orientation

On-the-job-training
• Professional element to the department, and

Competency-based knowledge • Boosts self-esteem, confidence and authority
 Demonstrated and documented competencies in all aspects

57 58

Sterile Processing/Central Service Certification

Sterile Processing/Central Service Certification

IAHCSMM CBSPD IAHCSMM

CBSPD
• The Certification Board for
Sterile Processing and
Distribution, Inc.
– Independent and international
certifying body
– Accredited by the National
Commission for Certifying Agencies
(NCCA)
– Educational books, seminars and
tools
www.sterileprocessing.org
• International Association of
Healthcare Central Service
Materiel Management
– International certifying body
– Associated with Purdue University
– Professional membership
organization
– Educational books, on-line classes
and tools
www.iahcsmm.org
• Exam offered 4 times year
• Exams scheduled anytime
• 2.5 hour test • 3 hour test
• Lasergrade/PSI official test site • Parametric site-based testing
• Certification expires in 5 years facilities
• Types of certification offered • Certification expires annually
• Types of certification offered
• CSPDT (Technicians)
• CRCST (Technicians)
• Managers
• CHL (Healthcare Leadership)
• Surgical Instrument Techs
• CIS (Instrument Specialist)
• Flexible GI Scope Techs
• CCVS (Vendor Certification)
• Certified Ambulatory Surgery
Sterile Processing Technician

10

Sterile Processing/Central Service Certification
CBSPD
• Prior to taking the exam • Prior to taking the exam
• 12 months full time employment
in SPD, or one of the following:
• Sterile Processing certification
course,
• Related course and 6 months
experience, or
• Sales or service in healthcare
Packaging, Preparation and Sterilization
(Section 8)
• Selection of packaging material (8.2)
– Wraps, peel packs and rigid container systems
– Obtain and keep on hand
• MFG test data,
• Instructions for use (IFU), and
• Care and handling instructions
• Package configuration and preparation (8.3)
– Materials held at room temp and relative humidify
(30-60%) for minimum of 2 hours
© 2013 Association for the Advancement
of Medical Instrumentation www.aami.org
Paper-Plastic Pouches
• Paper-plastic pouches (8.3.4)
– Only used for small, lightweight,
low-profile items
– Double peel pack not recommended
(unless validated from manufacturer)
– Two sequentially sized pouches
– Do not fold
– Not appropriate for use within
wrapped sets or containment devices
12/18/2016
Sterile Processing/Central Service Certification
CBSPD IAHCSMM
IAHCSMM
• 5 year renewal process • Annual renewal
– 100 points of continuing – 12 points of continuing
• 400 hours hands-on experience education in 5 year period education per year
plus one of the following: – 10 points awarded per year for • Additional 6 points required for
• On-line course, CIS or CHL
working full time in SPD
• Distance learning course,
• Approved instructor course,
www.iahcsmm.org
• Self study, or www.sterileprocessing.org
• Challenge the exam
AAMI Steam
Sterilization Posters
Set of Parts One & Two posters
© 2014 by the Association
for the Advancement of
Medical Instrumentation
http://www.aami.org/publication
s/posters/posters.html
63 64
Packaging, Preparation & Sterilization
(Section 8)
• Preparation and assembly of instrumentals
– Multiple parts – disassembled
– Excessive moisture removed
– Nonlinting absorbent material
– Maximum weight limit – 25 pounds
• Loading the sterilizer
– Pouches on edge and loosely loaded
– Textiles loosely loaded and on edge
– Tilt items capable of holding water
– Heavy metal items below wrapped items
65 66
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Installation, Care and Maintenance of Sterilizers Sterilization Process Monitoring Tools

(Section 9) (Section 10.5)
• Maintaining equipment helps prevent malfunctions • Monitoring tools (physical, CI and BI)
– Proper installation Physical
– Process challenge devices (PCDs) monitors
– Routine care • Provides additional challenge
• Inspect and clean daily according to Manufacturer’s IFU
• PCD may contain
• Preventative maintenance (by a qualified individual) Chemical
• BI,
• Periodic calibrations preformed and documented Indicators
• BI and a Class 5 integrating CI,
• type 5 integrating CI, or
• Record-keeping
• type 6 emulating indicator Biological
– Maintenance record for each sterilizer
• Table 6 and 7 provides Indicators
– Sufficient information to establish a history of service repairs
– Monitoring recommendations, and
– Applications for use
67 68

Quality Control (Section 10) Routine BI Monitoring Frequency

• To ensure quality, manufacturers’ IFU must • Steam: weekly, preferable daily and every load
be followed: containing an implant
• Sterilizer, • EtO: every load
• Packaging material, and
• Hydrogen peroxide: daily, preferable every load
• Device
• Ozone: every load
• Routine sterilizer efficacy monitoring (10.7) • Some facilities are moving to BI in every load:
and qualification testing (10.8) based on: – Standardization, and
– Size of sterilizer (Table-top or larger than 2 cubic feet), – Patient safety
– Type of process (Terminal or IUSS)

69 70

Quality Process Improvement (Section 11)

Risk Reduction & Process Improvement
• CQI programs –improves performance measures and The Heart and Soul of Accreditation Surveys
process monitors
– Sterilization CQI encompasses the entire process (decontam
through distribution) for verifying compliance with procedures
• Planned,
• Systematic, and
• Ongoing process

71 72

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74

The Joint Commission (TJC) Common High-Risk Areas

• IUSS
Standard IC.01.03.01 • P&Ps not standardized
• “The hospital identifies risks for acquiring and transmitting • Loaner instrumentation
infections.” • Torn wrappers
• No IFUs
Element of Performance # 4
• “The hospital reviews and identifies its risks at least annually • Sets weighing more than 25 pounds
and whenever significant changes occur with input from, at • Sterilization process failures
a minimum, infection control personnel, medical staff,
nursing, and leadership.” • Inefficient staff orientation
• No standardization
• Lack of competency documentation
The Joint Commission: 2017 Hospital Accreditation Standards (HAS)

73

Common Approaches for IP Risk Reduction Risk Analysis Articles

• Successful interventions include: Worth the risk assessment!
• Team driven, staff empowered Sue Klacik
• Commitment from administration Published in Healthcare Purchasing News. Dec. 2016
• Involvement of practice leaders as champions http://www.hpnonline.com/worth-the-risk-assessment/
• Uniform P&P that include evidence-based practices
• Supplies facilitating safe and evidence-based practice
• Education and competency verification
Risky business: Risk analysis in CSSD.
• Monitoring of practice and outcomes via surveillance Sue Klacik
• Communication, including outcome feedback to staff Published in Healthcare Purchasing News. Aug. 2010
• Evaluation of interventions and continuous improvement http://www.hpnonline.com/ce/pdfs/1008cetest.pdf
• Hardwiring of intervention into “culture” to maintain the gain
• Celebration of success!
Are You Taking Risks When Cleaning Reusable Medical Devices?
Soule B.M., Arias, K.M.: The APIC/JCAHO Infection Control Workbook, 2nd Ed. OakbrookTerrace, IL: Joint Martha Young
Commission Ressources, 2010, p. 71 Jan. 2013 In-service article archived at http://www.3m.com/sterileu

Preventive Risk Analysis Quality Process Improvement

• Ensures the corrective action does not simply fix the issue at hand

• Focuses on identifying and addressing underlying reasons that

Risk analysis (11.2.2) =
caused the issue Risk assessment +
Risk management +
• Efforts also focused on preventing future occurrences of the high risk
Risk communication
issue

Objective is to identify the risks to reduce the likelihood of a

sterilization process failure

ANSI/AAMI ST79:2010 & A1:2010 Section 11.2.2

http://www.jcrinc.com/using-the-risk-assessment-to-set-goals-and-develop-the-infection-prevention-and-
control-plan/ 78

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New Product Evaluation (Section 12)

Sterilization Process Errors - Summary
• Systematic process of product evaluation
– Product evaluation committee - Multidisciplinary • Competent staff
• Infection Prevention and Control,
• Operating Room,
• Effective process monitoring devices
• Sterile Processing, – Physical monitors
• Risk Management, and – Chemical indicators
• Staff Development/Education – Biological indicators

– Considerations include: • Be proactive - prevention

• Contribution to patient safety, – Stay current – evidence-based guidelines
• Cost/value analysis (ROI) – Follow manufacturer’s IFU
• Ability to reprocess
– Maintain equipment
• Necessary education to implement
– Perform annual risk analysis (don’t wait for a process failure)
• Ease of use
– Standardization – monitoring and new products etc.
• Standardization – (helps to prevent errors)

79 80

References
 ST79 - Comprehensive guide to steam sterilization and sterility assurance in
It only takes one health care facilities, ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012
&A4:2013
negligent mistake to make  Investigation of Sterilization Process Failures Video – AAMI
a big change in a patient's
 Guidelines for Sterilization. In: Guidelines for Perioperative Practices.
life! Denver, CO: AORN, Inc; 2017

 Guidelines for Packaging Systems – Selection and Use. In: Guidelines for
Perioperative Practices. Denver, CO: AORN, Inc; 2013

 CDC Guideline for Decontamination and Sterilization in Healthcare Facilities

2008
Safety isn’t expensive – It’s priceless.
 http://www.aami.org/meetings/summits/reprocessing/Materials/2011_Reproce
ssing_Summit_publication.pdf
81 82

Thank You for Sponsoring this Presentation

http://readysetsurgical.com

SEAVEY HEALTHCARE CONSULTING®

STERILE PROCESSING SURGICAL SERVICES .
Established in 2003

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