Safe and Effective Use of Ethylene Oxide Sterilizationmultimedia.3m.com/mws/media/1100372O/safe-and-effective-use-of-e… · Safe and Effective Use of Ethylene Oxide Sterilization

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Date, 2015

Safe and Effective Use ofEthylene Oxide Sterilization

2 18 August 2015. All Rights Reserved.© 3M

Welcome!Topic: The Safe and Effective Use of Ethylene Oxide Sterilization

Facilitators: Christophe de Campeau, 3M Sandra Velte, 3M

Speaker: Larry Talapa, 3M

For more information: www.3M.com/3MSterileU© 3M 2015. All rights reserved.


House Keeping

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arrow to expand your control panel (upper right-hand corner of your screen).

• Type a question in the question box and click send.

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House Keeping - Continuing Education Contact HoursEach 1 hour web meeting qualifies for:

1 Contact Hour approved by the CSPD Certification Board

1 Contact Hour approved by the IAHCSMM1 contact hour for nursing. 3M Health Care Provider is approved by the California

Board of Registered Nurses CEP 5770.

Post webinar email

•Link to Course Evaluation

•CE Certificate Included

•Forward eMail to Others in Attendance


Disclosure

Larry TalapaTechnical Services

3M Infection Prevention Division3M Center, 270-04-N-01 | St. Paul, MN, 55144

Potential Conflict of Interest: Employee of 3M

Follow Questions – 3M Infection Prevention Division

Sterilization Tech Line 1-800-441-1922 option 2


Learning Objectives

Review improvements recently implemented for the control of CRE transmissions with the use of ethylene oxide sterilization

Identify engineering controls, procedures and practices for the safe use of the ethylene oxide

Explain OSHA and EPA regulations associated with the use of ethylene oxide in healthcare facilities

Describe EO sterilization process monitoring recommendations provided in ANSI/AAMI ST41:2008/(R)2012

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CRE Outbreaks: In the news but not new…..there is a well documented history of outbreaks


What is the issue?

In the past year or more there has been a significant increase in reports of outbreaks related to the use of Duodenoscopes for ERCP.


CRE Outbreaks – A Wake Up Call

Tampa

Chicago

Pittsburgh

Seattle

Wisconsin (Milwaukee)

Los Angeles (1)

Los Angeles (2)

Unreported –CDC has info on at least 5 others (ID week, 2014)

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FDA sought expert scientific and clinical opinion

19 member advisory panel

2 days of presentations (May 14th & 15th ) with advisory panel questions

Key Invited SpeakersWilliam A Rutala PhD, M.P.H University of North Carolina, School of Medicine, Chapel Hill NCAndrew Ross M.D. Virginia Mason Medical Center Seattle WAZachary A. Rubin M.D. UCLA Clinical Epidemiology & Infection Presentation Los Angeles CA

Reference presentations and Webcasthttp://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/ucm445590.htm

CRE Outbreak - FDA Gastroenterology and Urology Devices Advisory Panel

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Date Issued: August 4, 2015“Combined with strict adherence to the duodenoscope manufacturer’s reprocessing instructions, the following supplemental measures may further help reduce the risk of infection transmission associated with the use of duodenoscopes.”

“When possible and practical, duodenoscopes should be sterilized due to the greater margin of safety provided by sterilization.”

Supplemental Measures for Facilities and Staff that Reprocess Duodenoscopes to Consider:

Microbiological Culturing

Ethylene Oxide Sterilization

Use of a Liquid Chemical Sterilant Processing System

Repeat High-Level Disinfection


Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication August 4th 2015

Ethylene oxide (EtO) sterilization following cleaning and high-level disinfection…

“It is critical that devices are meticulously cleaned and disinfected prior to EtO sterilization. Gas sterilization with ethylene oxide may fail in the presence of viable microorganisms after inadequate cleaning and disinfection.”

All methods of sterilization and high level disinfection would be challenged by microorganisms embedded in clinical soil that is lodged inside an endoscope channel. Meticulous cleaning is always important.

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Ethylene oxide (EtO) sterilization following cleaning and high-level disinfection…“Implementing EtO gas sterilization is costly and the process may not be readily available in or accessible to all health care facilities.”

Over 600 U.S. health care facilities have ethylene oxide sterilization capability, total number of ethylene oxide sterilizers in the U.S. is greater than 1000 sterilizers.

The two newest EO sterilizers on the U.S. market received FDA 510(k) clearance this year in January 2015.




“EtO may affect the material and mechanical properties of the duodenoscope.”

No published references to support this statement. 3M has customers that have successfully used ethylene oxide sterilization for their endoscopes for many years.

It is possible that this presumption is based on confusing ethylene oxide with hydrogen peroxide which has known (published) material compatibility limitations.




“EtO may be toxic to reprocessing personnel, and to patients if residual EtO remains on the device after sterilization.”

EO has been safely used in health care for over 50 years. If in doubt, monitor your employees and procedures directly to demonstrate safety !

EO is safe when used per medical device manufacturer's (MDM) instructions for use (IFU) and sterilizer manufacturer’s operators manual cleared by the FDA.

Medical device manufacturer's (MDM) validates the device is safe for patient use; FDA reviews MDM’s device safety testing before clearance to market in U.S.

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“Health care facilities should assess their supply and clinical demand for duodenoscopes when considering EtO sterilization.”

May require additional scopes (purchase new or rent).

Surgery / procedure schedules can be optimized to accommodate reprocessing times.

Currently EO sterilization turnaround of endoscopes is a minimum of 17 hours

Purchase new additional EO Sterilizers

EO sterilize offsite (longer turn around times)




“Users should follow duodenoscope manufacturer reprocessing instructions pertaining to EtO concentration, sterilization temperature, exposure time, and relative humidity.”

These are the four critical parameters for EO sterilization.


Package* Scope

Sterilize*in Locked Chamber

Under Vacuum

Aerate* Safely in Chamber

Store DRY Sterile in Package

Overview - Ethylene Oxide Sterilization (EO) Endoscopes

Estimated 5 hours Estimated 12* hours *Follow device manufacturers IFU !

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EO Sterilization is Safe for Workers!

When properly installed and operated according to manufacturer’s instructions and recommended practices !

Best Practices include:

• Engineering controls - Facility

– Installation, facility layout, air flow

– Ventilation: non-circulating 10 air exchanges / hour (minimum)

• Engineering controls - Equipment and process designed for operator safety

• Education and work practices

– In-chamber aeration

– Following device and sterilizer manufacturer’s IFUs and recommended practices.

Engineering Controls - Facility


Signs demarcating regulated areas and entrances

EO sterilizers located in containment area

Route traffic around or away

Restricted personnel access in accordance with OSHA

ANSI/AAMI/ST41:2008/(R)2012

Engineering Controls Facility Layout and Workflow

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Engineering Controls Facility Layout and Work Flow





Air flow away from sterilizer operator’s breathing zone.

Minimum of 10 room air exchanges/hour (ACH).

Ventilation rates should be monitored and documented at least annually

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EO Area Monitor Photo courtesy of chemDAQ

OSHA 29 CFR 1910.1047

EO Area MonitorsDo not replace personal (breathing zone) monitoring

Not required by OSHA

OSHA Occupational Exposure Standard for EO Emergency Plan

• Facilities using EO must have a written emergency plan

• Means to alert employees of emergencies promptly

– Option – Area Monitors in fixed locations with continuous sampling

– Alerts employees to leak or spill using visible and audible alarm

Packaging, Preparation, and Loading

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Association for the Advancement of Medical Instrumentation. EO sterilization in health care facilities: Safety and effectiveness. ANSI/AAMI ST41:2008(R) 2012, Arlington, VA. www.aami.org

Association of periOperative Registered Nurses (AORN) Recommended Practices section on EO processing.




Clean, dry, and package devices to be sterilized

Always follow device manufacturer’s instructions for use (IFU); including device cleaning, drying, packaging, sterilization and aeration

Do not sterilize devices with energy sources which could create a spark in the sterilization chamber during the sterilization cycle


Terminal Sterilization Packaging

Rigid containers

Plastic trays, metal baskets with disposable sterilization wraps or (woven) muslin

Pouches (paper / plastic or spun-bonded olefin / plastic)

Must be cleared for use in EO by U.S. FDA for use in the U.S.


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Load items with common aeration time

Use metal baskets

Load items loosely

Items should not touch chamber walls

Limit stacking

Pouches on edge, if possible; transparent side facing opaque side

Reference packaging manufacturer’s instruction for use (IFU)

Use good loading practices

“Full Load definition – means the maximum number of items that does not impede proper air removal, humidification of the load, or sterilant penetration and evacuation in the sterilization unit.”

40CFR 63.10448


EPA National Emission Standards for Hospital EO Sterilizers

EPA recognizes the necessary use of EO

40 CFR 63, subpart WWWWW - December, 2007

Adopt a management practice:

• Hospitals without an air pollution control device must sterilize full loads except under medically necessary circumstances

― Record date and time of each cycle

― Note any cycles that were not a full load

― Hospitals are NOT required to purchase an air pollution control device

• The use of an air pollution control device (e.g., 3M™ EO Abator) is an acceptable alternative

Ref. http://www.epa.gov/ttn/atw/area/eoapg.html

3M™ EO Abator



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Operation and the Process



Engineering controls - Equipment

100% EO Process

Designed for Safety

• EO delivered in single dose cartridges

• Relatively smaller chamber sizes

• Entire process maintained in a vacuum

• Interlocked sterilizer doors; cannot open until process complete

• Aeration of load begins automatically



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EO delivered in single dose cartridges

Operation and the process - 3M™ Steri-Gas™ EO Cartridge: Handling Full Cartridges

Dropped cartridges – Use immediately or dispose of as described in Instructions for Use (IFU)

Personal Protective Equipment (PPE)

Unloading


Unloading - Ethylene Oxide Penetration

Superior characteristic of EO is ability to penetrate

• No other chemical sterilant available today penetrates as efficiently as EO

• EO absorbs and adsorbs onto many materials

• Property that necessitates extended periods of aeration

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Unloading - Ethylene Oxide Aeration

During aeration, heated air is flushed through chamber to remove EO residuals from sterilized items

• Imagine molecules blowing off the surface of a material

Consult the medical device manufacturer for recommended aeration times

• Material composition of device

• Structural composition of device

• Intended application of the device


Aeration Time Guidelines*

Temperature Aeration Time

50°C 12 hours

60°C 8 hours

* Based on polyvinylchloride (PVC) tubing

Ref: ANSI/AAMI ST41:2008/(R)2012 Section 8.8.4

Unloading - Ethylene Oxide Aeration

“Some materials will require less time; others will require much more time.”


In hospitals, required risk mitigation, effective Feb 28, 2010:

• Use of a single chamber process, i.e., sterilization and aeration occur in the same chamber

http://www.epa.gov/oppfead1/cb/csb_page/updates/2008/ethylene-oxide.htm

EPA Reregistration Eligibility Decision (RED) for Ethylene Oxide

RED: “…determined that the benefits of continued use outweigh the associated occupational risks, provided that risk mitigation measures specified by the Agency are adopted and reflected on product labeling.”

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Considerations for Unloading the Sterilizer

EPA RED hospitals, required risk mitigation, effective Feb 28, 2010

• Use of a single chamber process, i.e., sterilization and aeration occur in the same chamber

Always follow the Sterilizer Manufacturers Operator’s Manual

Inspect display screen and cycle reports for error codes and listen for audible notifications (if enabled); always take action for error codes as indicated in Operators Manual

Always review the elapsed aeration time on the sterilizer display prior to opening the sterilizer door

Always inspect cycle reports (printout or electronic) to ensure the total aeration time matches the device manufacturer’s instructions for use (IFU)

Performance Monitoring and Routine Load Release

45 18 August 2015. All Rights Reserved.© 3MANSI/AAMI ST41:2008, Section 10


Routine Load Release / Sterilizer Efficacy Monitoring

1. Physical monitoring of cycle (sterilizer cycle report)

2. External and internal monitoring of packages with chemical indicators

3. Monitoring of every load with a PCD (routine test pack) containing a BI and a CI or equivalent, commercially available BI PCD

Quarantine implants until BI results are known

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Physical monitoring of cycleDo not use sterilizers that don’t have a recording device

Operator should examine the printout / chart to verify cycle parameters were met and then initial



Chemical Indicators for EOExternal chemical indicator distinguish between processed and unprocessed items

Internal chemical indicator equipment malfunctions & assist certain procedural errors

Use chemical indicators as described in the sterilizer manufacturer’s Operator’s Manual and according to device manufacturer’s IFU.


Bacillus atrophaeus

Performance Monitoring and Routine Load ReleaseBiological Indicators for EO

Select BIs that contain spores of Bacillus atrophaeus

• Rationale: BIs are the onlysterilization process monitoringdevice that provide a direct measureof the lethality of the process

BIs should comply with ANSI/AAMI/ISO 11138-1,2:2006

Use biological indicators as described in the sterilizer manufacturer’s Operator’s Manual and according to device manufacturer’s IFU

AAMI ST41:2008/(R)2012 – Biological Indicators (10.5.3)

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BI Process Challenge Device (PCD)

PCD may be:

• User-assembled test pack

• Commercially available, FDA-cleared preassembled test pack

ST41 describes two types of PCDs

• Routine BI test pack

• Challenge BI test pack

“A PCD is a device used to assess the effective performance of a sterilization process by providing a challenge to the process that is equal or greater than the challenge posed by the most difficult item routinely processed.”

AAMI ST41:2008/(R)2012 Process Challenge Device (PCD) (10.5.4)


Reprinted from ANSI/AAMI ST41:2008 with permission of the Association for the Advancement of Medical Instrumentation, Inc. (C) 2008(R)2012 AAMI www.aami.org. All rights reserved.

Challenge BI Test PackRoutine BI Test Packs


AAMI ST41:2008/(R)2012 Process Challenge Device (PCD) (10.5.4)

Sterilizer qualification testing after installation, relocation, or after a major redesign.



BI PCD

• AAMI routine test pack or commercially available, FDA cleared BI PCD

• Full load in center

• Frequency: in each load

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Acceptance criteria

• Appropriate readings from physical monitors

• Appropriate readings from CIs

• Negative result from BI in PCD

• Positive BI control result

― Run a control BI, with matching lot #, each day

• Document all results in sterilization cycle record


1 Routine load release Testing of each non-implant and implant load

2Routine sterilizationefficacy monitoring

Each sterilization cycle should have a routine BI test pack or a commercially available BI PCD

3Sterilizer testing after sterilization process failures

Testing of the sterilizer after any monitoring device suggests that the process was inadequate. Testing consists of monitoring one cycle with routine BI test pack or commercial equivalent.

4Sterilizer qualification testing after malfunctions, major repairs

Malfunctions identified after sterilization process failures must be corrected. Major repair: repair outside the scope of normal maintenance. Qualification consists of three consecutive cycles with routine BI test packor commercial equivalent.

5Sterilizer qualification testing after installation, relocation

Testing of the sterilizer after installation or relocation using one or more challenge BI test pack(s). Three consecutive cycles using simulated loads.

6Sterilizer qualification testing after major redesign

Three consecutive half-cycles w/ challenge BI test pack(s) in simulated load.

Three consecutive full cycles w/ challenge BI test pack(s) in an otherwise empty chamber.

7 Periodic product testingTesting of routinely processed items to ensure the effectiveness of the sterilization process.

Seven Levels of Quality Control

ANSI/AAMI ST41:2008/(R)2012 Section 10

OSHA Keeping Us Safe at Work !

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55 18 August 2015. All Rights Reserved.© 3M*http://www.osha.gov/about.html

Occupational Safety & Health Administration

Regulatory Agency – mandates compliance

• Examples:

― PPE required for working in decontamination for protection against blood borne pathogens

― Fit testing requirements for employees who wear respirators to protect against M. Tuberculosis, SARS, Smallpox

― Oxygen use; lines and tanks

― OSHA Occupational Exposure Standard for Ethylene Oxide (29 CFR 1910.1047)

Mission: “To ensure safe and healthful working conditions for working men and women….” *


OSHA Occupational Exposure Standardfor Ethylene Oxide (29 CFR 1910.1047)

Toxicity of EO is well understood

Acute

• Skin contact, eye contact and inhalation hazard

Chronic

• Carcinogenic

• Mutagenic

• Reproductive hazard

57 18 August 2015. All Rights Reserved.© 3MOSHA 29 CFR 1910.1047

OSHA Occupational Exposure Standard for EO Exposure Limits

Permissible exposure limit (OSHA PEL)

• 1 part per million (ppm) over an 8-hour time weighted average (TWA)

Action level (AL)

• 0.5 parts per million (ppm) over an 8-hour time weighted average (TWA)

Excursion limit (EL)

• 5 parts per million (ppm) over a 15-minute sampling period

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3M™ Ethylene Oxide Monitor 3550

OSHA Occupational Exposure Standard for EO Exposure Limits

Employer required to monitor employee exposure WHAT?• Monitor for 8-hour TWA• 15-minute sampling periodHOW?• Breathing zone air samplesWHO?• Representative employee on each shift

for each job classificationIf EO exposure 0.5 ppm AL, 8-hr TWA• Monitoring of those employees can be discontinued

OSHA 29 CFR 1910.1047


Occupational Limits of Ethylene Oxide

EO is colorless gas at ambient conditions!

Do not rely on sense of smell for the detection!

High odor threshold – sense of smell exceeds 500-750 parts per million (PPM)!

Storage 100 % Ethylene Oxide

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Environmental Protection Agency (EPA)

EO is regulated by the EPA as a chemical pesticide

• Chemical pesticide manufacturers must register product label claims with the EPA

• e.g., EPA registration number appears on all 3M™ Steri-Gas™ 100% EO Cartridges (7182-1)

• EPA Regulates via approved labeling – violation of Federal Law not to use the product per labeling instructions


“Rumors of my death have been greatly exaggerated.”

– Mark Twain

“Rumors of my death have been greatly exaggerated.”

– Mark Twain

EPA recognizes the necessary use of EO –EO is not being banned!


Keep a maximum one (1) box of twelve (12) 3M™ Steri-Gas™ EO Gas Cartridges in the sterilizer area (outside a vented flammable liquid cabinet)

Area (sterilizer room) must be ventilated to the outside and have at least 10 air changes per hour

Keep cartridges at least 2 meters (6 feet) away from the operator’s desk or workstation

Sterilizer Room – 3M Storage Recommendations

3M™ Steri-Gas™ EO Cartridge: Storage

Greater than one (1) box of twelve (12) 3M™ Steri-Gas™ EO Gas Cartridges must be stored in a flammable storage cabinet vented to the outside

In addition, local requirements for ethylene oxide storage must be followed

Keep all ignition sources away (lighters, matches, sparks, etc.)

Store at 15-30C (59-86F) in upright position

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Additional cartridges (>12) should be stored in an approved flammable liquid cabinet

Cabinet must be vented to the outside atmosphere

Cabinet must have a non-recirculating, continuously operating, dedicated exhaust system

Flammable cabinets – 3M Storage Recommendations

3M™ Steri-Gas™ EO Cartridge: Storage

Education and Work Practices



ANSI/AAMI ST41:2008 (R)2012 Ethylene oxide sterilization in health care facilities: Safety and effectiveness

Association of periOperative Registered Nurses (AORN) Recommended Practices section on EO processing

International Association of Healthcare Central Service Materials Management (IAHCSMM)

Certification Board for Sterile Processing and Distribution (CBSPD)

FDA-Recognized Consensus Standard

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Always follow device manufacturer‘s instructions for use (IFU) and the sterilizer manufacturers Operators Manual

Always follow EPA and OSHA requirements

Follow the industries recommended practices

Participate in yearly in-services and continuing education on ethylene oxide


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Ethylene oxide is a highly efficacious low-temperature sterilant with a long history of safe use and materials compatibility.

Always consult the Medical Device Manufacturer (MDM) for reprocessing instructions.

Facility must comply with OSHA and EPA regulations associated with the use of EO.

Monitor each EO sterilization cycle with a BI PCD.

Ethylene Oxide Sterilization Key Learnings

Next Live Webinar:

How can Human Factors Engineering concepts be applied to medical device reprocessing?

Date: September 17st, 2015

THANK YOU!

© 3M 2015. All rights reserved.

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References


References

• Association for the Advancement of Medical Instrumentation. Ethylene oxide sterilization in health care facilities: Safety and effectiveness. ANSI/AAMI ST41:2008/(R)2012

• Association for the Advancement of Medical Instrumentation. Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities ANSI/AAMI ST24:1999/(R)2013

• Association of periOperative Registered Nurses (AORN). Recommended Practices for Sterilization in periOperative Practice Setting, 2015

• Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008


References

• Federal Register / Vol. 72, No. 248 / Friday, December 28, 2007 / Rules and Regulations. Environmental Protection Agency. 40 CFR Part 63: National Emission Standards for Hospital Ethylene Oxide Sterilizers.http://www.epa.gov/fedrgstr/EPA-AIR/2007/December/Day-28/a25233.pdf

• Occupational Safety and Health Administration. Occupational Exposure Standard for Ethylene Oxide (29 CFR 1910.1047)

• US Environmental Protection Agency Office of Pesticide Programs, Reregistration Eligibility Decision for Ethylene Oxide, March 31, 2008http://www.epa.gov/oppfead1/cb/csb_page/updates/2008/ethylene-oxide.htm andhttp://www.epa.gov/pesticides/reregistration/REDs/ethylene-oxide-red.pdf

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