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3M Health Care AcademySM
Critical Issues in Sterilization for theInfection Preventionist
April 27, 2018
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Disclosure Statement
Steven J. Zeplin, MSN, RN, CSPDT
3M Clinical Specialist
3M Sterilization Tech Line: (800) 441-1922 (option 2)
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Learning Objectives
1. Describe the Joint Commission survey process
2. Examine recent sterilization outbreak breaches
3. Describe current practices for IUSS and Sterilization Monitoring
4. Discuss Infection Prevention rounds in the OR and Sterile Processing
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Learning Objective 1
Describe the Joint Commission Survey Process
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The Joint Commission Mission: improve health care for the public
How often do they survey?
Ref: The Joint Commission. 2015 Hospital Accreditation Standards (HAS)
Between 18-36 months- unannounced
Tracing the care, treatment, and services rendered to patients Example: VRE patient scheduled for gall-bladder surgery Looking for inconsistencies
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The Joint Commission National Patient Safety Goals (NPSG)
NPSG.07.05.01
“Implement evidence-based practices for preventing
surgical site infections.”
• Element of Performance 3
• “Implement 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 Center for
Disease Control and Prevention [CDC] and/or professional organization
guidelines).”
Ref: The Joint Commission. 2015 Hospital Accreditation Standards (HAS)
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The Joint Commission High-Level Disinfection (HLD) and Sterilization BoosterPak
“Goal of this BoosterPak:
To ensure work practices are carried out
following regulatory standards and
evidence-based guidelines for HLD and
sterilization in order to minimize the
potential risk of infection transmission to
patients.”
http://www.jointcommission.org/standards_booster_paks/
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IC.02.02.01 Medical Equipment, Devices, and Supplies
The hospital reduces the risk of infections associated with
medical equipment, devices, and supplies – implements
infection prevention and control activities
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IC.02.02.01 Medical Equipment, Devices, and Supplies“The hospital implements infection prevention and control activities when
doing the following”:
EP 1: Low-level disinfection
EP 2: Intermediate and high-level disinfection and sterilization of medical
equipment, devices and supplies, such as scopes; contamination issues
EP 3: Disposing of medical equipment, devices and supplies
EP 4: Storing medical equipment, devices and supplies
Ref: The Joint Commission. 2015 Hospital Accreditation Standards (HAS)
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The Joint Commission- Noncompliance with Standard IC.02.02.01 by Setting
TJC: High-Level Disinfection (HLD) and Sterilization BoosterPakhttp://www.jointcommission.org/standards_booster_paks/
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Cleaning, Disinfection, and Sterilization: Key FindingsObservations related to: Standards / EPs to consider:
Failure to follow guidelines IC.01.05.01 EP 1
Lack of standardized processes for cleaning the same same types of equipment
IC.02.02.01 EPs 1 & 2
Lack of oversight of cleaning, disinfection, and sterilization (CDS) processes
LD.04.01.07 EP 2
Inconsistent or lack of staff orientation or on-going training on CDS processes
HR.01.04.01 EPs 1-4; HR.01.05.03 EPs 1 & 4
Incomplete or missing quality check or sterilization sterilization logs (equipment, not process)
EC.02.04.03 EP 4
Lack of a process to document or follow-up on equipment failures
EC.02.04.01 EPs 1-6
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Joint Commission: Hand Hygiene
Launched in 2004: previous standard did not set the bar particularly high
2018: New Hand Hygiene Standard falls under IC.02.01.01, element of performance (EP)
2, states, “The [organization] uses standard precautions, including the use of personal
protective equipment, to reduce the risk of infection.”
Surveyor witnesses a clinician not washing their hands, even one time, the hospital will
be cited as a deficiency resulting in a Requirement for Improvement (RFI)
https://www.jointcommission.org
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Learning Objective 2
Examine recent sterilization outbreak breaches
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Sterilization Breaches in the Media Denver (2018). Infection Control breach with joint and spine surgical
patients over a 18 month period. Surgical cases were suspended after the
Colorado Dept of Public Health discovered lapses in instrument cleaning
practices after surgeries.
Ft. Leonard Wood Army Hospital (2018). 135 patients were treated with
laparoscopy equipment not properly sterilized.
Between 2012 and spring 2015, closed-channel duodenoscopes were
linked to at least 25 different incidents of antibiotic-resistant infections
that sickened at least 250 patients worldwide.
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Sterilization Breaches in the Media
Seattle Children’s (2015): surgical equipment may have been unsterile.
12K patients notified and offered HIV, Hep B & C testing.
Philadelphia (2013): DOH investigates a dentist for potential breaches in
infection control and sterilization.
Houston (2009): joint infections related to unclean arthroscopic shavers.
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Houston Hospital SSI Outbreak 2009- (7) reported joint infections over a two-week period
OR suites were closed until the hospital and CDC completed their investigation
Investigators (using a borescope) found retained pieces of human tissue and bone
arthroscopic shaver handpiece and inflow/outflow cannula’s
One isolate from the gross decontamination sink had a PFGE pattern indistinguishable
from the case patient isolates
Tosh P. K. et al. (2011). Outbreak of pseudomonas aeruginosa surgical site infections after arthroscopic procedures: Texas 2009. Infect Control Hosp Epidem, Vol. 32, No. 12, 1179-1186.
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Houston Hospital SSI Outbreak P. aeruginosa grew from 62 of 388 environmental sample
One isolate from the gross decontamination sink had a PFGE pattern indistinguishable
from the case patient isolates
All surgical instrument cultures showed no growth
SSIs were likely related to instrument contamination with p. aeruginosa during
reprocessing. Retained tissue could have allowed the bacteria to survive sterilization
reprocessing
Tosh P. K. et al. (2011). Outbreak of pseudomonas aeruginosa surgical site infections after arthroscopic procedures: Texas 2009. Infect Control Hosp Epidem, Vol. 32, No. 12, 1179-1186.
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ECRI- Independent, Non-profit Research Institute
• Founded in the 1960’s by Joel Nobel after a 4 year old boy died in his arms
from a defibrillator not working
• Mission: The discipline of science and integrity of independence
• Review all relevant evidence
• “The country’s most respected lab for testing medical devices” (New York
Times quote)
https://www.ecri.org
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ECRI (2017) Reprocessing Contaminated Instruments
ECRI Institute PSO identified 234 events in its database pertaining to dirty
surgical instruments.
The top five factors for the contamination were:
Inadequate cleaning before sterilization (34%)
Immediate-use steam sterilization (also known as flash sterilization) issues (12%)
Holes in wrappers (11%)
Instruments not sterilized in time for case (10%)
Vendor instrument issue (9%)
https://www.ecri.org/components/PSOCore/Pages/e-lert041117.aspx
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ECRI continued…
Of the events in which inadequate cleaning before sterilization was
identified as a factor, the instruments were identified as the
following
• Complex instrument (39%)
• Cannulated or lumened instrument (35%)
• Simple noncomplex instrument (9%)
• Other or unidentified (16%)
https://www.ecri.org/components/PSOCore/Pages/e-lert041117.aspx
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Disease Transmission Cycle
Chain of Infection
Infectious Agent
Mode of Transmission
Susceptible HostReservoir
Portal of ExitPortal of Entry
Sterilization/Disinfection
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Spaulding's Law: Disinfection Based on Use
https://www.jointcommission.org/standards_booster_paks/
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Pre-cleaning at the Point of Use
Using a product recommended for pre-cleaning following manufacturer’s
instructions-for-use (IFUs)
Applied at point-of-use in the procedure room or O.R. to remove blood,
body-fluids, and bioburden from items that are to be re-processed based
on manufacturer’s instructions-for-use and evidence-based guidelines
https://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQId=1479
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Pre-cleaning at the Point of Use
Use of a foam, gel, spray solution, or moist towel indicated per
manufacturer to keep instruments and devices moist during transport
prevents blood/body fluids/ bioburden from hardening on the equipment
This is particularly true if instruments have to wait to be cleaned because
other areas are also transporting instruments to the decontamination area
Pre-cleaning is the initial step to the sterilization process
https://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQId=1479
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Learning Objective 3
Describe current practices for IUSS and Sterilization Monitoring
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ANSI/AAMI ST79Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• Promote Sterility Assurance
• Quality of Care
• Policy and Procedure Development
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Sterilization Process Monitoring
Goal of Sterilization Process:
To kill microorganisms
You can’t see sterility!
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Sterilization Process Monitoring
Monitoring Tools
• Physical monitors
• Chemical indicators
• Biological indicators
• Process challenge devices (PCDs) test packs or challenge packs
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Routine Load Release Implants
Physical monitors
External process indicator (Type 1) on every package
Internal CI (Type 3, 4, 5, 6) inside every package
A PCD containing a BI and a Type 5 integrating indicator
“Implants should be quarantined until the results of theBI testing are available (CDC, 2008).”
ANSI/AAMI ST79:2017, Section 13.6.3
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Routine Load Release Implants
ANSI/AAMI ST79:2017, Sections 13.6.3, table 2
“Biological monitoring provides the only direct measure of the lethality of a sterilization cycle.”
“Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule.”
Type 5 integrating indicator is used to release an implant in emergency situations
“Emergency situations should bedefined…”
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Early Release Implant Loads
• If documented medical exceptions dictate release of implant before BI result
• Use implant log and an exception form
• Critical that this documentation be fully traceable to the patient
ANSI/AAMI ST79:2017, Section 13.6.3 and Annex K
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When To Do a Recall
If cause of failure immediately
identified and confined to one
load or item
• e.g., using incorrect
sterilization cycle
• No recall, correct problem and
reprocess load
If cause of failure not identified
• Quarantine load, recall all items processed since last negative BI
• Determine cause of failure
Sterilization process failure (BI, CI, or Physical Monitor)
Quarantine load, remove sterilizer from service, investigate cause of failure
ANSI/AAMI ST79:2017, Section 13.7.5 and Figure 10
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BI Monitoring Frequency
Some facilities have moved to a higher
standard of patient care by monitoring
every sterilization load with a biological
indicator
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BI Monitoring Frequency
Why monitor every load?
• Universal standard of patient care
• Cost and impact of a recall
• To be certain all implants, including those in loaners, are appropriately monitored
• Reduce risk and cost of healthcare-associated infections (HAIs)
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Cleaning Verification: ANSI/AAMI ST79
Monitoring of mechanical cleaning equipment
Frequency of testing
• Upon installation
• Daily during routine use
• After major repairs
-Review and initial mechanical washer cycle printouts
-Document results
Ref: ANSI/AAMI ST79:2017, Sections 13.2 and Annex DTOSI is a registered trademark of Pereg GmbH
TOSI®
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IUSS- immediate use steam sterilization
Formerly known as:
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IUSS- Revised Definition
IUSS of unwrapped items is no longer an option
Use a rigid container system
Should not be used for purposes of convenience or as a
substitute for insufficient instrumentation
AAMI ST79:2017, Section 10.2.3
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IUSS Sterilization
“Sterilization method that involves the shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field.
Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants..”
ANSI/AAMI ST79:2017, Section 2.50
Photo courtesy of Rose Seavey, The Children's Hospital - Denver
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Implants and IUSS
“Implantables should not be sterilized for
immediate use”(CDC, 2008)
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Routine Efficacy Testing – IUSS Cycles
A BI test pack as described in 13.7.2.2 or a commercially
available disposable BI PCD should be used to test the:
dynamic air removal for IUSS
or
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.
Ref: ANSI/AAMI ST79:2017, Section 13.8.4.1
New Recommendation
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Routine Efficacy Testing - IUSS Cycles
• Each type of tray configuration used should
be tested
• BI PCD placed on bottom shelf over the drain
• Otherwise empty chamber
• Frequency: weekly, preferably daily
• When: After Bowie-Dick test if dynamic air-
removal sterilizer
Ref: ANSI/AAM ST79:2017, Table 2
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Association of periOperative Registered Nurses
• Guideline for Cleaning and Care of
Surgical Instruments
• Guideline for Sterilization
• Guideline for Selection and Use of
Packaging Systems for Sterilization
Ref: AORN Guidelines for Perioperative Practice (2018)
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AORN Guideline for IUSS Sterilization • “Immediate use steam sterilization (IUSS) should be kept to a
minimum and should be used only in selected clinical situations and in a controlled manner.” (Recommendation VII)
• “Biological and chemical indicators should be used to monitor sterilizer efficacy and to assess whether conditions of sterilization have been achieved.” (Recommendation VII.c.2.)
• A class 5 chemical integrating indicator or a class 6 indicator should be used within each sterilization container or tray used for IUSS. Class 6 indicators are cycle-specific and should be used only in the specific cycles for which they are labeled." (Recommendation VII.c.3)
Ref: AORN Guideline for Sterilization 2018, Recommendation VII
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IUSS
• Recommends the use of rigid sterilization
containers designed and intended for IUSS
cycles
• Reduce risk of contamination during
transport to point of use
• Ease of presentation to sterile field
AORN Guideline for Sterilization
Ref: AORN Guideline for Sterilization, Recommendation VII.e.
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Implant Loads
“Immediate use steam sterilization
should not be used for implantable
devices except in cases of defined
emergency when no other option is
available.”
Photo courtesy of Rose Seavey, The Children's Hospital -
Denver
Ref: AORN Guideline for Sterilization, Recommendation VII.f.
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Implant Loads – IUSS Cycles“When IUSS of an implant is unavoidable, cycle selection should be
determined by the manufacturer’s written instructions for use, and a
biological indicator and a class 5 chemical integrating indicator should
be run with the load…”
Ref: AORN Guideline for Sterilization, Recommendation VII.f.1.
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IUSS- DocumentationLog or data base to trace sterilized items used on patients
should include information on each load:
• Items processed
• Patient on whom items were used
• Type of cycle (e.g., gravity-displacement or dynamic air-removal)
• Cycle parameters used (e.g., temperature, duration of cycle)
• Monitoring results
• Day and time cycle was run
• Operator information
•Reason for IUSS
Ref: AORN Guideline for Sterilization, RP VII.g.1.
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Healthcare Facility Responsibility
Obtain and adhere to manufacturer’s written instructions
• Cleaning
• Cycle type
• Exposure time
• Temperature
• Drying time (if recommended)
Reconcile differences between cycle parameters recommended by the
sterilizer and device manufacturer
Ref: AORN Guideline for Sterilization, VI.b. and VII.a.2.
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Learning Objective 4
Discuss Infection Prevention rounds in the OR and Sterile Processing
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Role of Infection PreventionistCDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
“Conduct infection control rounds periodically (e.g., annually) in high-risk reprocessing areas (e.g., the Gastroenterology Clinic, Central Processing); ensure reprocessing instructions are current and accurate and are correctly implemented. Document all deviations from policy. All stakeholders should identify what corrective actions will be implemented”. Category 1B
CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, p. 92, Quality Control, 19c.
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CDC & FDA Health Update Recommendations
Have an expert/consultant assess reprocessing procedures to assure:
• Reprocessing is performed correctly
• Adequate time is allowed/taken
• All steps from the IFU are followed
Recommendations
• Training
• Audit & Feedback
• Infection Control Policies & Procedures
http://emergency.cdc.gov/han/han00383.asp
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HVAC Operating Parameters Identify which version of ANSI/ASHRAE/ASHE 170 will be used based on
when the HVAC system was initially installed or last upgraded.
Facility engineering personnel or designated responsible personnel should
establish policies and procedures for monitoring and maintaining HVAC
parameters within the sterile processing areas.
Procedures should include maintaining records of monitoring results that
are retrievable either from a central system or a local log.
AAMI ST 79:2017, Section 3.3.5.5
NEW
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Monitoring AirflowMake sure users know appropriate airflow for their area and what to do if it’s
wrong
Helpful to use visual and/or audible alarms
Post Directions
Room should be NEGATIVE Pressure at all timesIf Red Ball is not visible:1. Ensure all doors are closed2. If still not visible: Stop work and notify
supervisor
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Environmental ControlsTemperature
• AAMI: 18°C to 24°C [65°F to 75°F]
Humidity
• AAMI: 30% to 60%
Airflow
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Hinged InstrumentsClarification
Accreditation surveyors often misinterpret the word “open” in the sentence:
“All jointed instruments should be in the open or unlocked position with
ratchets not engaged”
Now reads: “Ratcheted instruments should be unlatched”
AAMI ST79:2017, Section 8.2
NEW
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IC.01.03.01 Risk Assessment
Identify all locations where all or part of High-level Disinfection (HLD) and
Sterilization processes are conducted
Know where all scopes, probes, and devices requiring HLD and
Sterilization are located
Review, maintain, and conduct competency verification training of front-
line staff and those that have oversight for HLD and Sterilization
processes
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Endoscope Hang Time
SGNA: 7 Days storage interval for reprocessed scopes
• Based on a recent systematic review (Schmelzer, Daniels, & Hough, 2015)
AORN: No recommendation (was 5 days)
AAMI ST91: No recommendation
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Monitoring Liquid Chemical Sterilants (LCS) & High Level Disinfectants (HLD)
Solution test strips and chemical monitoring devices
• Designed to determine whether the concentration of the active ingredient in the
LSC/HLD solution is above or below the product’s Minimum Effective Concentration
(MEC)
• Frequency: Test the solution before each use
• If concentration of the active ingredient is inadequate…..
discard the solution
• Monitoring Automated Processes
• Solution test strips and chemical monitoring devices should be used at the same frequency as
for manual processes
• Use only automated processing equipment that has physical-monitor recording devices
AAMI ST58:2013 Section 9.3.3 and 9.4
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Questions for the OR
Is staff wearing PPE when cleaning/ decontaminating surgical instruments?
Are medical device manufacturer’s written reprocessing instructions being followed?
Are implants only sterilized by IUSS in documented emergency situations?
Are items which are IUSSed transported aseptically to the sterile field?
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Questions for Decontamination Is staff wearing PPE?
Environment
• Controlled temp & humidity?
• Negative pressure in decontam?
• Adequate air exchanges?
Are cleaning agents used according to label instructions?
Are items cleaned according to manufacturer’s IFUs?
Is the efficacy of mechanical cleaning equipment tested?
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Questions for the SPD/CSSD
Competency: Is staff certified?
Do we have and follow a Policy for use of Loaner Instrumentation?
Is our policy and procedure for routine sterilizer efficacy testing current?Is it based on AAMI and/or AORN recommended practices?
Is a positive control biological indicator from the same lot incubated each day a test biological indicator is incubated?
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Questions for the SPD/CSSD
How are we collecting and staying current with manufacturers’ written Instructions for Use?
Do we have a policy and procedure for recall of items from a failed sterilization process?
Can I help you conduct a sterilization risk analysis?
Would you like to be a member of the Infection Prevention and Control Committee?
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Key Learnings• Facility reprocessing and sterilization practices should be based on
guidance provided by the CDC, AAMI, and AORN
• Survey agencies expect reusable device reprocessing (cleaning and HLD/sterilization) to be done by competent staff according to the device manufacturer’s written reprocessing instructions
• Investigate where medical device reprocessing is being done in your facility and pay them a visit!
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Association for the Advancement of Medical Instrumentation (AAMI)• ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• ANSI/AAMI ST58:2013, Chemical sterilization and high-level disinfection in health care facilities
Association of periOperative Registered Nurses (AORN) 2018
Centers for Disease Control and Prevention• Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
• Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care
http://www.cdc.gov/hai/pdfs/guidelines/Ambulatory-Care+Checklist_508_11_2015.pdf
• CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning,
Disinfecting, and Sterilizing Reusable Medical Devices
http://emergency.cdc.gov/han/han00383.asp
The Joint Commission. 2015 Hospital Accreditation Standards (HAS)
References