3M Medical Template v2 7.13.07 Welcome! · 2012-02-14 · 3M Medical Template v2 7.13.07 1 Welcome! Thank you for attending today’s meeting, it will begin shortly. How do I get

3M Medical Template v2 7.13.07

1

Welcome!Thank you for attending today’s

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Infection Prevention Division

Attest™ Sterile U Network

© 3M 2011. All Rights Reserved.

A Day at the Races:IAHCSMM Conference Highlights

Welcome!Facilitators:

� Sandra Velte, 3M SterilizationTechnical Service

� Diane Koch, 3M Sterilization Assurance

Housekeeping� Questions

� Mute feature (*7 = unmute; *6 = mute)

� “Chat” feature

� Technical difficulties

� CE Credits

� Post session follow-up

For more information: www.3M.com/AttestSterileUOnline


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IAHCSMM Annual Conference

April 30 – May 4, 2011

Louisville, KY

Title: A Day at the Races: IAHCSMM Highlights

Guest Speakers:

Sue Klacik

� CSS Manager, St. Elizabeth’s Healthcare

� In Immediate Pursuit of Sterile Instrumentation: “Immediate Use

Sterilization” replaces “Flash Sterilization”

Cheron Rojo

� SPD Educator, Children's Hospital Central California

� Orientation and Annual Competencies: Where Do I Start?

Rose Seavey

� President/CEO Seavey Healthcare Consulting, Inc.

� Former Director of SPD, Children’s Hospital of Denver

� Decontamination Highlights and Standards Review

� Disclosure Statement: All of today’s guest speakers are consultants

and/or speakers for 3M

In Immediate Pursuit of Sterile Instrumentation: “Immediate Use Sterilization” replaces

“Flash Sterilization”

Objectives:

� Discuss why the process of “Flash Sterilization” had

to be changed

� Describe the correct process of “Immediate use

steam sterilization”

� Discuss the training requirements of “Immediate use

steam sterilization”


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Members on the Position Statement for Immediate Use Steam Sterilization

� International Association of Healthcare Central Service Materiel Management (IAHCSMM)

� Perioperative Registered Nurses (AORN)

� The Joint Commission

� Association for the Advancement of Medical Instrumentation (AAMI)

� Centers for Medicare and Medicaid Services (CMS)

� Accreditation Association for Ambulatory Health Care (AAAHC)

� American Society of Cataract and Refractive Surgery (ASCRS)

� Association for Professionals in Infection Control and Epidemiology (APIC)

� Centers for Disease Control and Prevention (CDC)

� American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF)

� ASC Quality Collaboration

� American Dental Association (ADA)

� U.S. Food and Drug Administration (FDA)

Why Change??????????

� Consistency promotes patient safety. Flash

sterilization is performed at various locations

� Hospitals

� Ambulatory care

� Complex medical instrumentation

� Standards and Recommendations must be

consistently followed.

“Flash” Sterilization Issues

� The original intent of “flash sterilization” has been

abused

� Large heavy or multiple sets

� Routine use

� Loaners

� Implants


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What is “Flash Sterilization?

�A process?

What is “Flash Sterilization?

� A cycle?

Flash Sterilization

� Unwrapped sterilization that used shorter sterilization

cycles.

� Sterilization cycle 3 or 10 minutes

� Dry Time 1 minute or less


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Terminal Sterilization 270°F

Gravity displacement

Instruments

Sterilization 15

Dry Time 15-30

Textiles

Sterilization 25

Dry Time 15

Dynamic air removal

Instruments

Sterilization 4

Dry Time 20-30

Textiles

Sterilization 4

Dry Time 5 to 20

Flash SterilizationCleaning

Flash SterilizationSterilization


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Flash SterilizationTransportation

System Improvements Needed

� Flash/Immediate use sterilization is safe and effective when

performed correctly:

Follow manufacturers instructions

Use proper documentation

Use appropriate quality monitors


Proper cleaning & adequate rinsing

Verification of sterilization process

Transported aseptically

No storage of flash/immediate use sterilized items


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� Be realistic in expectations for sterilization

� Emphasize for emergent use only!!!

Not as a substitute for insufficient inventory

Not to be used for convenience

Immediate Use Sterilization

• Sterilization cycles with little or no dry time are efficacious when used in

compliance with validated instructions provided by the device

manufacturers, sterilization equipment manufacturers, and (if applicable)

container manufacturers and when done in accordance with professional

guidelines.


� Personnel involved in evaluating organizations that

sterilize medical devices should be adequately

educated and should be capable of exercising critical

thinking and judgment. The regulatory or accrediting

agency should ensure adequate training, education,

and competency of staff and should ensure that

adequate resources are provided.


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Follow Standards and Recommended Practices

AAMI

AORN

CDC-HIPAC


� Sterilization process monitoring is essential to

ensure that sterilization practices are efficacious.

� Examples of process monitoring tools are physical

indicators, biological indicators, and chemical

indicators.

Immediate Use SterilizationPreparation

� Instrumentation is thoroughly inspected and

assembled for full exposure to sterilization.


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Immediate Use SterilizationSterilization

The device manufacturer's written instructions for reprocessing any reusable device must be followed.

� Use the correct cycle

� Extended cycles

Gravity Cycle “Flash Sterilization”

� Cycle 270°F

Cycle Time

Condition 1:47

Sterilize 5:00

Exhaust 2:37

Total Time 9:24

Dynamic Air Removal

� Cycle 270°F

Cycle Time

Condition 8:52

Sterilize 5:00

Exhaust 2:59

Total Time 16:11


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Immediate Use SterilizationTransportation

• Aseptic transfer from the sterilizer to the

point of use is critical to protect

instrumentation from contamination.


• Only items sterilized and packaged in

materials cleared by the FDA for

maintenance of sterility can be stored.

Utilizing both cycles

� When using both the gravity and dynamic air removal

cycles, a biological monitor must be processed each

day they are run.

� Assure that the correct biological monitor is used

with each cycle and that they are incubated properly.


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Not Recommended

� Instrumentation or loads that have not been validated

with specific cycle employed.

Not Recommended

� Implants, except in a documented emergency

situation when no other option is available.

Flashy SynopsisImmediate-use steam sterilization entails following standards

and recommended practices for the critical reprocessing steps

of:

Cleaning/decontamination

Assembly

Packaging for transport

Sterilization

A safe process does not include short-cuts or work-

arounds


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Questions

Orientation and Annual Competencies; Where Do I Start?

Cheron Rojo, AA, CRST, CIS

Objectives:

� Review common competencies used in the Sterile Processing Arena

� Demonstrate ability to describe and use basic competency descriptors

� Build a competency that can effectively evaluate an employee’s performance

� Review common categories/sections for competencies

� Demonstrate ability to decide on areas/tasks for your annual competency


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Orientation Competencies


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Annual Competencies

2011 Bi-Annual Competencies for Sterile Processing

SPD Tech I & II

1. PPE 2. Cleaning steam sterilizers 3. Loaner process 4. Bowie-dick testing 5. Recall process 6. Fire Evacuation/Safety

Supply Technician:

1. Proper set-up of a case cart 2. Sterile Storage: do’s and don’ts, exp. dates, card boxes, etc, traffic

control. 3. Soil Pick-up: PPE and correct process 4. Fire Evacuation/Safety


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Questions?

Decontamination Highlights and Standards: Review from ST79 2010

Objectives:

� Review best practices in care and handling of

contaminated devices

� Discuss the importance of proper transportation of

contaminated instruments.

47© 3M 2010. All Rights Reserved.

Decontamination Highlights and Standards Review

ST79 2010 – Related Sections

� Department Design Considerations (3.1 – 3.4)

� Personnel Considerations (4.1 – 4.6)

� Receiving (5.1 – 5.3)

� Handling, Collection, and Transport of

Contaminated Items

(6.1 – 6.5.6)

� Cleaning and other Decontamination Processes

(7.1 – 7.7.5)


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Related Annexes

� Annex A – Examples of work place design

� Annex B - Infection transmission

� Annex C - CJD

� Annex D - User verification of cleaning processes

� Annex E - Selection and use of chemical disinfectants

� Annex F - Thermal disinfection

� Annex G - Devices returned to the manufacturer

� Annex H - OSHA blood borne pathogen standard

� Annex N - TASS

Department Design Considerations (Sections 3.1 – 3.4)

� Guidelines for the design, maintenance and workflow

� Design Criteria

� General area considerations

� Decontamination area

� Workflow patterns

� Traffic control

� Physical facilities

� Space requirements

� Mechanical, electrical and steam requirements

� General area requirements (floors, ceilings, doors, ventilation)

Examples of Workplace Design(Annex A)

� Sample illustrations

• Typical small hospital

• Medium-sized hospital

• Regional processing center

• Ambulatory surgery facility

• Dental facility


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Design Considerations (Highlights)

• Space proportioned to expected volume

• Floors and walls• Level, and able to withstand frequent cleaning

• Ceilings • Flush surface, with recessed and enclosed pipes

• Doors and windows kept closed(Including pass through windows)

• Handwashing stations conveniently located:• Clean, and decontamination areas

• Eye wash stations • Within 10 seconds travel time

• Ability to flush for 15 minutes

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Design Considerations (Highlights)

• Traffic patterns ◦ Dirty to clean

◦ Restricted to authorized personnel

• Temp and humidity levels monitored and recorded daily,

◦ Temperature• 68-73° F clean areas• 60-65° F decontamination areas

◦ Humidity• 30-60% in work areas

• Not over 70% in sterile storage areas

• Housekeepingo Separate cleaning equipment for decontam

o All areas cleaned daily (should be the same as in OR)

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Personnel Considerations (Sections 4.1 – 4.6)

• Qualifications• Supervisor

• SP personnel

• Training and continuing education• SP personnel

• Service personnel

• Other personnel

• Health and personnel hygiene

• Attire• General

• Decontam (PPE)

• Service personnel

• Standard transmission-based precautions (employee safety)


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Personnel Considerations (Highlights)

• Supervisors –– Certified at the level of their responsibilities

– Participate in CE programs and courses

– Demonstrate and improve knowledge• Current Standards, state and federal regulations

• Participate in facility committees (IPC, RM, Safety, Product Eval.etc.)

• Sterile processing personnel– Qualified in all aspects

– Demonstrated and documented competence

– All staff should be certified within 2 years

• Training and CE– Comprehensive Orientation

– Training manual (guidance documents, checklist etc.)

– Must be documented (TJC)

Personnel Considerations (Highlights - Attire)

• Scrubs should be provided by and donned at the HC facility,

• All head and facial hair should be completely covered• No skull caps

• Jewelry and wristwatches • Not worn in the decontamination, prep, or sterilization areas

• Fingernails• Short, clean, natural

• No artificial nails

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Personnel Considerations (Highlights - PPE)

• Attire for Decontamination

• Heavy-duty utility gloves (not procedure or surgeons gloves)

• Liquid-resistant covering with sleeves:• Jumpsuit, apron with sleeves, or gown

• Any risk of splash or splatter -

• Fluid-resistant face mask

• Eye protection

• Safety glasses wrap around the eye, or

• Face shield

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Receiving (Sections 5.1 – 5.3 Highlights)

� Disposition of sterile items (issued but not used)

• Issued to a controlled environment, (eg. OR) may be returned to sterile storage if the

integrity of the package has not been compromised

• Opened, or have damaged packaging, should be reprocessed through

decontamination.

� No external shipping containers in the preparation or sterile storage area

Transport (Sections 6.1 – 6.5.6 Highlights)

� Point of Use

• Gross soil should be removed

• Waste and reusable items separated

� Carts, reusable covers, bins and other containers

should be decontaminated after each use.

� Dedicated soil lifts should be periodically decontaminated

� Items kept moist in the transport container

• Towel moistened with water, foam, spray, or gel product

• Avoid transporting in liquid

Transport Between Buildings and Off-site (Highlights)

� Vehicles should provide for complete separation of contaminated items

from clean and sterile items.

� Transportation vehicles should be completely enclosed and

decontaminated between trips

� Procedures for packaging and transporting contaminated items off-site

for processing must comply with applicable DOT and state regulations.


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Presoaking and Disassembly (Sections 7.3-7.4 Highlights)

� Presoaking with a specialized product

(e.g., an enzymatic solution) is recommended

� Thoroughly rinse after presoaking

� Instruments composed of more than one part should be

disassembled

� Care should be taken to ensure that

all small parts are contained.

� Sterilization container systems should

have filters, labels and locks removed.

Manual Cleaning(Highlights)

• Brushes and other cleaning implements should be specifically designed

for use on medical devices

– Single-use

– If reusable, be decontaminated at least daily

• The device manufacturer should provide information regarding brush

size for cleaning devices with lumens

• Brush and flush under water

• If item cannot be immersed - clean in a manner

that will not produce aerosols

Mechanical Cleaning(7.5.3.3 Highlights)

• Types– Utensil and cart

washers,

– Washer-sanitizers,

– Pasteurization

equipment,

– Washer-disinfectors,

– Washer decontaminators,

and

– Washer-sterilizers

• Ultrasonic cleaners:– De-gassed prior to use

– Clean items of gross soil before placing in ultrasonic

– Use recommended ultrasonic detergent (low foaming)

– Lid must be kept closed (aerosolization)

– The water must be changed frequently


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Mechanical Cleaning (Sections 7.5.3.3 Highlights)

� Regular PM should be performed according to MFG instructions

upon installation, weekly (preferable daily) during routine use, and

after major repairs.

• Outside the scope of routine preventive maintenance, and

significantly affects the performance of the equipment

• Examples of major repairs

Replacement of the water pump(s), detergent delivery system,

heating system, water delivery system, water treatment

system, computer control or an upgrade to software.

Rinsing(Sections 7.5.4 Highlights)

� After cleaning (manual and mechanical) items should be

thoroughly rinsed

� Copious amounts of tap water can be used

� Final rinse should be preformed with free flowing

treated water

� No “bird bath”

Cleaning and Decontamination (Section 7)

� After cleaning items should be subjected to a

microbicidal process (7.6)

� Chemical disinfection

� Chemical sterilization for decontamination

� Thermal (hot water) disinfection

� Thermal sterilization for decontamination

� Terminal sterilization

� Chemical sterilization

� Thermal terminal sterilization


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Flow chart for microbicidal processes (7.6.1)

Thermal Disinfection (hot water) (Highlights 7.6.2.3)

� Thermal disinfection is accomplished

with automated equipment such as:

� Washer-sanitizers,

� Pasteurization equipment,

� Washer-decontaminators, and

� Washer-disinfectors

� The level of disinfection achieved depends

on the water temperature and contact

time.

Servicing and Repair of Devices in the HC Industry (Highlights 7.7)

• Device manufacturers should:– Provide training for their service personnel, and

– Instructions to users to help prevent exposure

• HC institutions should provide PPE and establish P&P to ensure

service personnel are not exposed to infectious agents

• Service personnel include:

– Manufacturers’ representatives,

– In-house clinical engineers and biomedical technicians, or

– Third-party service providers


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Infection Transmission (Annex B)

� Purpose of decontamination process is prevent the transmission of

disease

� Understanding the chain of infection:

� Helps to develop and implement policies and procedures

� Reduce the risk of infection transmission

Processing of CJD-contaminated Patient Care Equipment (Annex C)

� Provides general guidance for reprocessing instruments

and medical devices exposed to patients known or

suspected to have Creutzfeldt-Jakob disease (CJD)

� Not readily inactivated by conventional disinfection and

sterilization procedures

Devices Contaminated with High-risk Tissue (Highlights C.2)

� High-risk tissues

� Brain,

� Spinal cord, and

� Eye tissue

� High-risk patients

� Known to have, or

� Suspected to have CJD

• Devices that can easily and effectively

have tissue removed (e.g., surgical

instruments)

• Cleaned and steam sterilized

• Prevacuum sterilizer at 134 °C for greater than or equal to 18 minutes, or

• Gravity-displacement sterilizer at 121 °C to 132 °C for 1 hour

• Impossible or difficult to clean should be

discarded


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User Verification of Cleaning Processes (Highlights Annex D)

� Cleaning verification by users should include:

� Visual inspection and assessment:

• External surfaces, inner housing, and channels

� Testing the cleaning efficacy of equipment, and

� Monitoring key cleaning parameters (e.g., temp.)

� Manufacturers should provide users with cleaning verification

tests that enable them to quickly test medical devices directly

after cleaning

� Table D.1 and D.2 currently available test methods

TASS (Highlights Annex N)

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Specified concentration of the recommended cleaning agent

Final rinsing sterile, distilled, or deionized water

Single-use brushes should be used and disposed

Sterilize per instrument manufacturer recommendations

Avoid Immediate User Steam Sterilization (Flash)

Questions?


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2012 IAHCSMM Conference

April 29 – May 2

Albuquerque, New Mexico

Next 3M Sterile U Webinar – July 21, 2011

What’s Happening in Your Washer/Disinfector?

76© 3M 2010. All Rights Reserved.

Documents

3M Medical Template v2 7.13.07 Welcome! · 2012-02-14 · 3M Medical Template v2 7.13.07 1 Welcome! Thank you for attending today’s meeting, it will begin shortly. How do I get