STEAM Sterilization Issues (Extended Cycles & Flashing)

STEAM Sterilization Issues

(Extended Cycles & Flashing)

Presented by SPSmedical

• Largest sterilizer testing Lab in North America with over 50 sterilizers

• Develop and market sterility assurance products that offer advanced technologies

• Provide full day sterilization Seminars and on-site Facility audits for compliance with best practices

• Corporate member: CSA and AAMI, serving on numerous sterilization working groups

Association for the Advancement of Medical InstrumentationAssociation for the Advancement of Medical Instrumentation

ANSI/AAMI ST79 consolidates five (5) other standards into

one comprehensive guide, which was published in October,

These other standards are:

ST46 Steam sterilization and sterility assurance

ST42 Steam sterilization using table-top sterilizers

ST37 Flash sterilization

ST35 Decontamination of medical devices

ST33 Selection and use of packaging systems

Association of periOperative Registered NursesAssociation of periOperative Registered Nurses

Standards, Recommended Practices, and Guidelines are also developed by the AORN Recommended Practices Committee and approved by the AORN Board of Directors.

The 2008 edition is now availableand comes in text and CD-ROM.

JCAHO inspects facilities for compliance with best practices.

Objectives

At the end of this program, participants will be able to…

• discuss the different types of steam sterilizers,

• list issues related to processing heavy trays and/or instruments that require extended cycles,

• identify examples of extended cycles required by leading orthopedic instrument manufacturers,

• review the recommended parameters for when Flash sterilization is considered acceptable, and

• explain minimum cycle times for flashing loads with porous versus nonporous items.

How important is it to comply with best practices?According to CDC statistics, more than 5,000 patients each day come down with a nosocomial (hospital acquired) infection and over 360 per day* die. These statistics are expected to get worse, as many of these preventable infections can no longer be treated with traditional antibiotics.

While the delivery of non-sterile instruments certainly is not a leading cause of surgical site infections, this has been documented by the CDC as one of the problems.

* Statistics based on 250 business days per year

How important is your work?

“A major responsibility of the perioperative registered nurse is to minimize patient risk for surgical wound infection…One of the measures for preventing surgical wound infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to a sterilization process”.

-2008 AORN Recommended Practices and Guidelines

Sterilization is a patient safety issue and requires a “systems approach”

Surgery• Prepares soiled items for decontaminationSterile Processing & Distribution (SPD)• Clean & disinfect soiled items in decontamination area• Inspect and assemble items in prep & pack area• Process items in sterilization area• Maintain sterility of items in sterile storage area• Distribute items sterile, complete and on time.Infection Control• Audit Surgery/SPD for compliance with best practices

Steam Sterilization

Saturated steam under pressure

is one of the oldest methods

used to sterilize items.

AAMI, AORN and the CDC

recommend steam sterilization

as the PROCESS of CHOICE,

because it’s fast, efficient and

relatively inexpensive. Chamberland autoclave built in 1880

Steam Sterilizers

All Class II medical

devices are subject to FDA

clearance per a 510(k)

approval.

Sterilization Parameters:• Time• Temperature• Saturated Steam

Steam Sterilization

There are two (2) different types of steam sterilizers:

1. Gravity displacement

2. Dynamic air removala) Pre-vacuum

b) Steam-flush-pressure-pulse

Note: Flash sterilization is typically a “shortened cycle” that can usually be run on any type of steam sterilizer.

Steam Sterilization

Steam sterilizers usually have the following standard

cycle parameters:

• gravity displacement (250°F/121°C for 30 min. exposure, or 270°F/132°C for 15 min. exposure, plus drying)

• dynamic air removal (270°F/132°C for 4 min. exposure, or 275°F/135°C for 3 min. exposure, plus drying)

Tray Weight

AAMI standards (for users) recommend…The weight of an instrument set should be based on:

• proper body mechanics• the design and density of the individual instruments

comprising the set,• the recommendations of the medical device and

sterilizer manufacturers• the distribution of mass (the density) in the set and

sterilizer load.

Covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument cases, cassettes, and organizing trays.

Among other things, ST77 limits total tray weight to 25 pounds. This will assist users in two important ways:

1)Ergonomics = safer to lift and transport,

2)Sterilization = use standard exposure & dry times.

AAMI ST 77 passed November, 2005 (for Mfg’s)

Sterilization Parameters

The FDA requires manufacturer’s to validate sterilization parameters for all Containment devices (rigid containers, instrument cases, organizing trays and cassettes).

AAMI standards state that medical devices purchased by healthcare facilities should include written, validated processing instructions from the manufacturer.

Extended Cycles?

Did you know some heavy and/or complex instrument sets (i.e. orthopedic trays) have been validated with extended cycles in their instructions for use?

SYNTHES: Sterilization Parameters

Power Drive PN 530.100

Wrapped Temperature Minimum Exposure Time

Pre-vacuum 132-135°C/270-275°F 24 minutes

Gravity Displacement – Not recommended

Unwrapped (Flash) is same as wrapped parameters.

DePuy aa Johnson & Johnson Company Johnson & Johnson Company

Instruments – 0902-00-721 Rev. D, Page 2.

Large Bone (Total Hips, Knees, Shoulders, Ankles, Elbows, Wrist)

Sterilization Instructions

Cycle Type Minimum Temperature Minimum Exposure Time / Dry TimePre-vacuum 132 - 134º C 8 min. / 20 min. dry time for metalwith 4 pulses or metal/poly trays and 45

minutes for all poly trays.

134 - 137º C 5 min./ 20 min. dry time for metal or metal/poly trays and 45 minutes for all poly trays.Note: DePuy Moreland Revision Instruments

are recommended at 132°C for 18 mins pre-vacuum.

Zimmer

Recommendations for Care, Cleaning, Maintenance and Sterilization for Zimmer Manual Orthopaedic Surgical Instruments

Cycle Type Temperature Sterilization Time

Pre-vacuum 270°F/132°C 4 min.

8 min. for wrapped Universal Instrument Cases without

defined load configurations. 18 min. for Acetabular reamer system.

Gravity displacement sterilization cycles are not recommended because cycle times are too long to be practical.

Issues with Extended Cycles

Extended cycles can have a detrimental effect on

efficiency and sterility assurance for healthcare facilities.

For example…

1) Extended cycles tie up the sterilizer and can backlog sterilizer loads needing to be processed. Does your facility have enough resources for these delays?


2) Devices validated for standard cycles may be damaged in extended cycles. Have you contacted each device mfg. if extended cycles are used?

3) Barrier characteristics of sterile packaging (disposable wrap and rigid container filters) may be adversely affected. What testing has been done by mfg’s to validate their packaging’s barrier effectiveness in extended cycles?


4) ANSI/AAMI/ISO 12161 states:

“Users should not over process the culture medium, as extended sterilization may induce changes that can affect its growth-promoting properties. The ability of the culturing medium to promote the growth of low numbers of microorganisms should be demonstrated.”

What testing has your BI mfg done to validate their media’s growth promotion ability in extended cycles?

AAMI Recommendations

“Because of the increased complexity of instrumentation,

consideration may be given to the installation of a separate

steam sterilizer designated for use on medical devices

requiring nonroutine cycles”

How many of you are aware that your facility is running extended cycles?

FLASH Sterilization

Surgery may need to decontaminate and flash sterilize an instrument or instrument set for quick turnaround.

AORN recommended practices cautions facilities that flashing should only be used when there is insufficient time to process by the preferred wrap or container method.

FLASH Sterilization

Flash sterilization should

not be used as a substitute

for sufficient instrument

inventory.

FLASH Sterilization (Examples of typical cycle parameters)

Gravity-displacement sterilizer270°F/132°C, 3-4 min. exposure for nonporous items270°F/132°C, 10 min. exposure for porous items

Pre-vacuum sterilizer270°F/132°C, 3 - 4 min. exposure for porous or nonporous

items

FLASH Sterilization

Flash sterilization should be

used only in selected clinical

situations and in a controlled

manner.

Flash sterilization should only be

considered if all of the following

conditions are met:

Sterilization & Infection Control

Flash Sterilization Conditions

1) The device manufacturer’s written instructions are available and followed.

Many device manufacturers only provide terminal

sterilization parameters and not flash. It is important

that users verify the items can be flashed and how.



2) Items are disassembled and thoroughly cleaned with detergent and water to remove soil, body fats and other substances.

This requires an appropriate cleaning area with an

approved detergent, cleaning brushes and personal

protective equipment (PPE) worn properly by staff.



3. Lumens are flushed with the cleaning solution and rinsed thoroughly.

Lumens are particularly difficult to clean and

sterilize. It is important to consult with the device

manufacturer for cleaning information.



4. Items are placed in an instrument tray or container in a manner that allows proper steam contact.

Specialized flash containers are available and can be

used according to their label claim. Flash containers

should be cleaned between uses.



5. Measures are taken to prevent contamination during transfer to the sterile field.

Personnel may use sterile towels as “potholders” or

sterile gloves when removing trays from the sterilizer.

The flashed items may then be removed from the tray

by the scrub person and taken to the sterile field.



6. Documentation of cycle information and monitoring results is maintained to provide for tracking to the individual patient.

Physical parameters, chemical indicators and

biological indicators should be monitored/used to test

the efficacy of the sterilizer. Records should be kept

for each sterilization cycle.

Caution: Increased Risk

Pressure on personnel could eliminate one or

more steps in the cleaning and sterilization

process. ALL Steps in the sterilization process

must be performed properly!

FLASH Sterilization

• Decontamination process is essential for

removing bioborden.

• Cleaning- remove debris from all parts of instrument, disassemble (if possible).

• Instruments should be dry before sterilization

FLASH Sterilization

• Packaging & wrapping should not be used in flash cycles (unless specifically approved)

• Special handling of items during transport • Sterile gloves• Avoidance of contact with unsterile surfaces

Note: Specialized flash sterilization containers are commercially available and may reduce the risk of contamination during transport.

FLASH Sterilization

Each sterilization cycle should be monitored to verify that

parameters required for sterilization have been met.

1) Physical indicators:• Time

• Temperature

• Pressure

Quality Control

Is the sterilizer chart or printout reviewed and initialed after each cycle, before opening the door?

Physical indicators should be recorded and maintained for each sterilizer cycle.

FLASH Sterilization

2) Chemical Indicators:It is recommended that one or more CI’s be used because

CI’s give immediate information regarding sterilization

process efficacy.

Chemical Indicators

Pre-vacuum type Steam

sterilizers should be tested

daily with a Bowie-Dick

type test.

This is usually done in the

morning, before the first

processed load.

Chemical Indicators

The Bowie-Dick test is placed

over the drain in empty chamber

and run at 273°F for 3.5 minutes.

The indicator inside the test pack

should show a uniform color

change to pass.

9/05/06 2 CAH

Pass Test Sheet

FLASH Sterilization

3) Biological Indicators:Should be used daily and with every load that contains

an implant.

Each sterilization MODE needs to be tested with a

biological indicator (gravity and pre-vac). A control

should be run each day from the same lot as the test BI.

FLASH Sterilization

Both the BI and CI are placed

loose in an empty tray or rigid

container (in the area most

difficult to sterilize) This if often

the area nearest the drain.

Why an Empty Chamber?

This configuration is a more rigorous biological

challenge to sterilizer performance than is a

filled chamber. • Minimizes heat-up time (because there is little

metal to absorb the heat) which minimizes the lethality of the process making it harder to kill the BI

FLASH Sterilization

An unprocessed control BI (from the same lot) should be incubated each day the sterilizer is tested to confirm spore viability and proper function of the incubator.

FLASH Sterilization

A lot number should be assigned to each flash sterilization

load and a load record should be generated for each

sterilization cycle:• assigned lot number, including sterilizer identification and cycle

number

• general contents of the load

• duration and temperature of the exposure phase of cycle

• signature or other identification of the operator

• date and time of the cycle

Implantable Devices

Flash sterilization should NOT be used for implantable

devices. Implants are foreign bodies, and they increase

the risk of surgical site infection.

Careful planning, appropriate packaging, and inventory

management in cooperation with suppliers can minimize

the need to flash implantable medical devices.

Smith & Nephew

Important Sterilization Note:Smith & Nephew, the Association of Operating Room

Nurses (AORN), and the Center for Disease Control

(CDC) in Atlanta (USA), do not recommend the use of

flash steam sterilization on implants. Due to the increased

risk of contamination, Smith & Nephew encourages the

return of all opened porous coated implants for recleaning

and sterilization.

Implantable Devices

If flash sterilization is unavoidable, full traceability of the item to the patient should be maintained. Both a BI and Class 5 integrator are recommended with implants.

Wrap up Questions

• Are sterilizers being monitored by physical, chemical and biological indicators?

• Are you requesting written sterilization parameters from your medical device manufacturers?

• Are you running extended cycles? • If flash sterilization is being used, is it being done only in

selected clinical situations and in a controlled manner? • If implants are being flashed, are you using a BI and a Class 5

integrator every time?• Are the items traceable to the patient?

Conclusion

Infection Control, Surgery and Sterile Processing should work together to comply with sterilization best practices.

1) Flash only in selected clinical situations, 2) Avoid flashing implantable devices, and 3) Follow medical device mfg’s validated instructions

for sterilization parameters (time & temperature).

Remember to follow validated instructions for use as provided by the medical device manufacturer.

THANK YOU!!

SPSmedical Supply Corp.

Sterilization Products & Services6789 W. Henrietta RoadRush, NY 14543 USAFax: (585) 359-0167Ph: (800) 722-1529

Website: www.spsmedical.com

© SPSmedical Supply Corp.

Certificate is available after viewing by calling SPSmedical

or e-mailing [email protected]

Steam Sterilization Issues: Extended Cycles & Flashing

mailto:[email protected]

Purchasing AAMI Standards

If your organization is not a member of AAMI, you may purchase the Standards directly from SPSmedical at our member discount. The member discount saves you 40-50% depending on the document.

For example:

ORDER CODE: AAMI ST:79List Price: $220 Member Price: $110

References & Resources

Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795703-525-4890 Fax: 703-276-0793 www.aami.org

Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231-5711800-755-2676 www.aorn.org

Canadian Standards Association5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA800-463-6727 Fax: (416) 747-2510 www.csa.ca

Certification Board for Sterile Processing & Distribution2 Industrial Park, Suite 3 Alpha, NJ 08865 908-454-9555 www.sterileprocessing.org

International Assoc. of Healthcare Central Service Materiel Management 213 W. Institute Place, Suite 307 Chicago, IL 60610312-440-0078 Fax: 312-440-9474 www.iahcsmm.org

Documents

STEAM Sterilization Issues (Extended Cycles & Flashing)