1. Steam Sterilization: The Process of Choice!

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. Meets in Washington, DC throughout
Association for the Advancement of Medical Instrumentation
Meets in Washington, DC throughout
each year and establishes guidelines
for sterility assurance which become
our American National standards.
Membership includes:
Health care facilities
Health care organizations
Government agencies
Medical device manufacturers
Testing Labs and Consultants
AAMI standards are available in text and on CD-ROM.
ANSI/AAMI ST:79

4. 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

5. NEWS…2008 update available.
Association for the Advancement of Medical Instrumentation
NEWS…2008 update available.
ST79 is the first AAMI standard to be part of the American
National Standards Institute’s “continuous maintenance”
classification. Normally, AAMI standards undergo “periodic
maintenance,” which calls for review (and subsequent
revision, reaffirmation, or withdrawal) of a standard every
five years. With continuous maintenance, AAMI will
consider requests for change at any time.

6. Objectives At the end of this program, participants will be able to…
Understand the history of steam sterilization
Recognize the minimum recommended cycle times for steam sterilization, including gravity displacement, dynamic air removal and flash sterilization
Understand that some instrumentation requires extended steam sterilization cycles to achieve sterilization
Proper loading, unloading and storage of sterilized items
Discuss quality control measures to ensure proper efficacy of each sterilizer
Identify special quality control measures for implant loads

7. Chamberland autoclave built in 1880
Steam Sterilization
Steam sterilization is one of the oldest methods used to sterilize items.
Modeled after the steam pressure cooker which was developed in 1681, the first commercial sterilizer was introduced in the 1800s..
Chamberland autoclave built in 1880

8. Steam Sterilization
Sterilization standards worldwide recommend steam sterilization as the PROCESS of CHOICE, because it’s:
fast,
efficient, and
relatively inexpensive.

9. Steam Sterilization
Steam sterilizers (small and large) are Class II medical devices subject to FDA approval.
They are available in a wide variety shapes and sizes.

10. Steam Sterilization Steam sterilization can be used to process a
wide variety of items
that can withstand moist
heat under pressure at
high temperatures.

11. Steam Sterilization
Of course, not everything can be steam processed due to damage to the device or danger to people. For example, wood products are a problem because during sterilization lignocellulose resin (lignin) is driven out of wood by heat. Lignin is known to cause reactions if it gets into the tissues of a patient.
Additionally, wood products can absorb moisture from the steam, causing superheating and decreasing it’s ability to sterilize other items in the load.

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

13. Gravity Displacement (AAMI - Minimum cycle parameters)
Wrapped instruments
250°F/121°C temperature, 30 mins exposure,
30 mins dry time
270°F/132°C temperature, 15 mins exposure,
275°F/135°C temperature, 10 mins exposure,

14. Dynamic Air Removal (AAMI - Minimum cycle parameters)
Wrapped instruments
270°F/132°C temperature, 4 mins exposure,
30 mins dry time
275°F/135°C temperature, 3 mins exposure,
16 mins dry time

15. FLASH Sterilization (AAMI - Minimum cycle parameters)
Gravity-displacement sterilizer - unwrapped
270°F/132°C, 3 min exposure (nonporous items)
270°F/132°C, 10 min exposure (nonporous & porous)
Dynamic air removal - unwrapped
270°F/132°C, 3 min exposure (nonporous & porous)
Dry times are usually minute.

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

17. URGENT: Medical Device Correction
Letter sent to customers in August, 2008 by SYNTHES®
RE: Power Drive Unit/
Discard all Power Drive User’s Manuals and replace with new literature
Discard all Power Drive/Small Battery Drive Sterilization Guides and replace with new literature
Distribute this information to all departments
Complete verification section of letter and return to SYNTHES

18. DePuya 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 mins / 20 min dry time for metal w/ or metal/poly trays and 45 minutes pulses for all poly trays.
º C mins/ 20 min dry time for metal or metal/poly trays and minutes for all poly trays.
Note: DePuy Moreland Revision Instruments are recommended at 132°C for 18 mins pre-vacuum.

19. Other Examples Mfg/Device Method Parameters
Hand Innovations (all) Gravity 132°C for 20 mins
Pre-vacuum 132°C for 10 mins
Medtronic Midas Rex Gravity 132°C for 25 mins
Pre-vacuum 132°C for 4 mins
Baxter Prosthetic Ring Gravity 132°C for 20 mins
Stryker Spine Sets Pre-vacuum 132°F for 15 mins
Abbott Spine Sets Pre-vacuum 132°F for 15 mins
Scientix SACP System Pre-vacuum 134°F for 18 mins

20. Loading Steam Sterilizers
Steam sterilizers should be
loaded with light items on
top, heavy items on bottom.
Linen packs, basins and
solid trays should be placed
on their sides.
Mesh bottom instrument trays should be placed flat.
Note: Lead/Latex Free Steam Indicator Tape is now available for wrapped items!

21. Loading Steam Sterilizers
Rigid containers should always be placed flat and not stacked unless the mfg. has validated to do so.
Stacked containers are much more difficult to sterilize and may require extended cycle times.
Before loading rigid containers, be sure all filters, data cards and locks are in place

22. Loading Steam Sterilizers
Pouches are designed for lightweight items, and should be placed on edge, facing the same direction.
Inexpensive pouch dividers are available to separate and hold pouches in place.

23. Steam Sterilization Paper/plastic pouches are not recommended to
be placed inside wrapped
sets or rigid containers.
Rationale:
“Placing pouches along with heavy metal instruments can result in inadequate air removal, steam contact and/or drying.”

24. Steam Sterilization
According to 2009 AORN Standards and Recommended Practices, count sheets should not be placed inside wrapped sets or rigid containers.
“Although there are no known reports of adverse events related to sterilized count sheets, there is no available research regarding the safety of toners and/or various papers subjected to any sterilization method.”

25. Steam Sterilization Count sheets – you have two choices:
Tape them on the outside of wrapped trays/ containers,
Cytotoxicity test them to confirm they are safe.

26. Unloading Steam Sterilizers
After drying, the sterilizer cart should be removed and placed in a low traffic area, where it should remain until the load is cool.
Do not place carts near air vents as this can cause condensation to form inside the packs.
Sterile items must not be touched while cooling.
Freshly sterilized items should never be placed on metal or cold surfaces before they have cooled adequately.

27. Inspection
Confirm the Chemical Indicator on each package for proper color change verifying the item has been exposed to the sterilization process.
Packages damaged, wet or opened should not be used.
If you use sterility maintenance bags (dust covers) for added protection during storage, be sure all packs are completely cooled before being placed in the plastic bag.bag.

28. Wet Packs?
If packages are wet at the end of the cycle, the cause(s) must be identified and corrective actions initiated.
Wet packs can be caused by:
condensate collected in / blown out of steam lines
improper drying time
condensate dripping from carriage shelves
metal items on an upper shelf dripping condensate onto items below

29. Wet Packs? Staff can cause wet packs by:
overloading the sterilizer
improper loading
too many instruments in the set
fabrics wrapped to tight
Mechanical problems that can cause wet packs:
obstructed drains
improper steam pressure

30. Sterile Storage Open shelving can be used, but should be:
2” from outside walls
8 to 10” from floor with covered bottom
18” from ceiling fixtures
maintained clean and dry
Care should be taken to avoid crushing, bending, compressing, or puncturing the packaging or otherwise compromising the sterility of the contents.

31. Sterile Storage
Heavy trays should be stored on middle shelves for ease of handling by staff.
Rigid sterile containers may be
stacked; however, wrapped
trays should not be stacked as
this can compromise sterility!

32. Temperature should not exceed 75°F and humidity should not exceed 70%
Sterile Storage
The shelf life of a packaged sterile item is event-related and depends on the quality of the packaging material, the storage conditions, the conditions during transport, and the amount of handling.
Temperature should not exceed 75°F and humidity should not exceed 70%

33. Quality Control Physical monitors must be recorded and maintained
for each sterilizer cycle:
- time
- temperature
- pressure
Sterilizer chart or printout,
should be reviewed and initialed after each cycle.

34. Quality Control Pre-vacuum sterilizers should be tested daily
with a Bowie-Dick test
pack to confirm proper
air removal.
Gravity displacement
type sterilizers do not
require this test.

35. Quality Control Procedure:
Place the test pack over the drain, on the lowest shelf in an empty chamber. Process at 273°F for minutes.
After processing, the chemical indicator sheet inside the test pack must show a uniform color change to pass.

36. Quality Control
Chemical indicators should be used externally and internally for each item processed.
Internal CIs should be Class 3, 4 or 5 depending upon the complexity of the pack and contents.

37. Quality Control AAMI standards define CI’s by six classes:
Class 1 – Process Indicators
Class 2 – Specific Test Indicators
Class 3 – Single parameter Indicators
Class 4 – Multi-parameter Indicators
Class 5 – Integrating Indicators
Class 6 – Emulating Indicators

38. Quality Control
The results of Class 5 integrating indicators may serve as the basis for the release of processed items, excluding implants.
For monitoring wrapped loads, these integrating indicators must be used within an appropriate challenge test pack.

39. What about implants?
Each load containing implantable devices should be monitored with a BI challenge test pack and, whenever possible, quarantined until the results of the BI testing is available.

40. Quality Control
Biological indicators provide the highest level of sterility assurance and should be ran at least weekly, preferably daily and with any load that contains an implant.
CSA = daily, and with implants.

41. Quality Control
A BI inside a Test Pack is used to monitor gravity and dynamic air removal sterilizers processing full loads.
Placement:
The BI test pack should be placed flat on the bottom shelf, directly above the drain with a load.

42. Quality Control
For routine release of loads with an implant, a PCD with a BI and
a Class 5 integrating indicator
should be used.
Whenever possible, the implant
should be quarantined until the
results of the BI are known.

43. Quality Control Flash sterilizers are different
in that the BI and CI are not
placed inside a test pack or a
load, but loose in an empty
tray or rigid container nearest
the drain.
AORN recommends each flash cycle be monitored with a Class 5 integrator.

44. Special Note: Controls
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.
Are you testing each incubator?

45. VA Directive 7176 requires hospitals to grow out the RRBI for 48 hours
Special Note: RRBI
Periodic verification of the early
readout with spore growth should be performed in accordance with the manufacturer’s instructions and facility policy and procedures.
In the event of a sterilizer failure, the sterilizer mfg. may recommend additional and/or alternative BI testing to verify results.
AAMI ST79:2006
VA Directive 7176 requires hospitals to grow out the RRBI for 48 hours

46. Critical Assessments?
Biological indicator challenge test packs should be used during initial installation testing of steam sterilizers after relocation, after sterilizer malfunction, after sterilization process failures, after any major repairs of the sterilizer, and for periodic QA testing of representative samples of actual products being sterilized.
NOTE. A major repair is a repair outside the scope of normal maintenance, such as weld repairs of the pressure vessel, replacement of the chamber door or a major piping assembly, or rebuilds or upgrades of controls.

47. BI Failure?
The Supervisor (and sterilizer Operator) should review proper procedures for sterilizer operation and all testing to determine if the failure was operator error or indeed sterilizer malfunction.
Operator error is failure due to improper loading, wrong cycle selection, fluorescent spotting (RRBI), incorrect BI or BI test pack, etc... Operator error is cause to reprocess the load; whereas, sterilizer failure is cause to recall back to your last negative BI. This is an important distinction!

48. THANK YOU! SPSmedical Supply Corp. Sterilization Products & Services
6789 W. Henrietta Road
Rush, NY USA
Fax: (585)
Ph: (800)
Website:
© SPSmedical Supply Corp.
Steam Sterilization: The Process of Choice!
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49. 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

50. 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: