1. STEAM Sterilization Issues (Extended Cycles & Flashing)

2. 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

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

4. Standards, Recommended Practices, and Guidelines are also developed by
Association 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 available
and comes in text and CD-ROM.
JCAHO inspects facilities for compliance with best practices.

5. 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.

6. 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

7. 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

8. Sterilization is a patient safety issue and requires a “systems approach”
Surgery
Prepares soiled items for decontamination
Sterile 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

9. Chamberland autoclave built in 1880
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

10. Steam Sterilizers All Class II medical devices are subject to FDA
clearance per a 510(k)
approval.
Sterilization Parameters:
Time
Temperature
Saturated Steam

11. Steam Sterilization There are two (2) different
types of steam sterilizers:
Gravity displacement
Dynamic air removal
Pre-vacuum
Steam-flush-pressure-pulse
Note: Flash sterilization is typically a “shortened cycle” that can usually be run on any type of steam sterilizer.

12. 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)

13. 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.

14. AAMI ST 77 passed November, 2005 (for Mfg’s)
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:
Ergonomics = safer to lift and transport,
Sterilization = use standard exposure & dry times.

15. 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.

16. 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?

17. SYNTHES: Sterilization Parameters
Power Drive PN
Wrapped Temperature Minimum Exposure Time
Pre-vacuum °C/ °F minutes
Gravity Displacement – Not recommended
Unwrapped (Flash) is same as wrapped parameters. 17

18. DePuy a Johnson & Johnson Company
Instruments – Rev. D, Page 2.
Large Bone (Total Hips, Knees, Shoulders, Ankles, Elbows, Wrist)
Sterilization Instructions
Cycle Type Minimum Temperature Minimum Exposure Time / Dry Time
Pre-vacuum º C min. / 20 min. dry time for metal
with 4 pulses or metal/poly trays and 45 minutes
for all poly trays.
º C 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.

19. 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 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.

20. 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?

21. Issues with Extended Cycles
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?

22. Issues with Extended Cycles
4) ANSI/AAMI/ISO 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?

23. 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?

24. 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.

25. FLASH Sterilization Flash sterilization should
not be used as a substitute
for sufficient instrument
inventory.

26. FLASH Sterilization (Examples of typical cycle parameters)
Gravity-displacement sterilizer
270°F/132°C, 3-4 min. exposure for nonporous items
270°F/132°C, 10 min. exposure for porous items
Pre-vacuum sterilizer
270°F/132°C, min. exposure for porous or nonporous items

27. 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:

28. 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.

29. Sterilization & Infection Control
Flash Sterilization Conditions
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.

30. Sterilization & Infection Control
Flash Sterilization Conditions
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.

31. Sterilization & Infection Control
Flash Sterilization Conditions
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.

32. Sterilization & Infection Control
Flash Sterilization Conditions
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.

33. Sterilization & Infection Control
Flash Sterilization Conditions
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.

34. 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!

35. 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

36. 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.

37. FLASH Sterilization
Each sterilization cycle should be monitored to verify that
parameters required for sterilization have been met.
1) Physical indicators:
Time
Temperature
Pressure

38. 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.

39. 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.

40. 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.

41. 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/ CAH
Pass Test Sheet

42. 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.

43. 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.

44. 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

45. 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.

46. 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

47. 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.

48. 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.

49. 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.

50. 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?

51. Conclusion Infection Control, Surgery and Sterile Processing should
work together to comply with sterilization best practices.
Flash only in selected clinical situations,
Avoid flashing implantable devices, and
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.

52. Steam Sterilization Issues: Extended Cycles & Flashing
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Steam Sterilization Issues: Extended Cycles & Flashing
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53. 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:79
List Price: $220
Member Price: $110

54. References & Resources
Association for the Advancement of Medical Instrumentation
1110 North Glebe Road, Suite 220, Arlington, VA
Fax:
Association of periOperative Registered Nurses
2170 South Parker Road, Suite 300 Denver, CO
Canadian Standards Association
5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA
Fax: (416)
Certification Board for Sterile Processing & Distribution
2 Industrial Park, Suite 3 Alpha, NJ 08865
International Assoc. of Healthcare Central Service Materiel Management
213 W. Institute Place, Suite Chicago, IL 60610
Fax: