Flash Sterilization Index Number: OR-0120 Type - Gundersen ...

Flash Sterilization
http://glapps.gundluth.org/apps/policyproc.nsf/bc0155f9ef62e4fd872567dd005e9b5a/00ec7...
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SOP
Subject: Flash Sterilization Index Number: OR-0120
Type:
Section:
Subsection:
Departmental
Operating Room
Outpatient Surgery Center
Original Date:
Last Reviewed:
Next Review:
11/11/2008
12/23/2011
Category: SOP
Dpt. Head: Bryan G Erdmann
Contact:
Miller, Linda M
References
Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2006 –
Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.
Arlington, VA: Association for the Advancement of Medical Instrumentation; 2006.
Recommended practices for sterilization in the perioperative setting. In: Standards, Recommended
Practices, and Guidelines. Denver, CO: AORN, Inc; 2007:673-687.
Recommended practices for cleaning and caring for surgical instruments and powered equipment. In:
Standards, Recommended Practices, and Guidelines. Denver, CO: AORN, Inc; 2007:583-591.
Recommended practices for selection and use of packaging systems. In: Standards, Recommended
Practices, and Guidelines. Denver, CO: AORN, Inc; 2007:607-616.
Employees of the Operating Room (OSC)
Applicable To
Flash sterilization should be used only when there is insufficient time to sterilize an item by the
preferred prepackaged method according to Gundersen Lutheran policy GL-9705 Sterilization and
Sterility Assurance.
SOP
1. The method of transporting the item should be considered to prevent contamination along the
route to the point of use.
2. Exposure times/temperature relationships should follow instrument, container and sterilizer
manufacturer's written instructions.
3. Implants should not be flash sterilized unless necessary for rare emergent cases.
4. Wrappers should not be used in flash sterilization cycles.
5. Loaner instruments/sets being supplied by vendors must be made available to Gundersen Lutheran
OR/OSC prior to the day of surgery or with sufficient lead-time to allow for processing through
standard methods.
Implementation
All materials returned to the dirty workroom area are considered contaminated and potentially
pathogenic and should be reprocessed or disposed of as such. Contaminated items should be contained
during transport from the point of use to the decontamination area. Use a large basin or solid bottom
container to transport contaminated items to the workroom to prevent dripping.

Flash Sterilization
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Cleaning and disinfecting will be performed within the confines of the dirty workroom and ante room
area (room between OR 1 and OR 2). This area is physically isolated from the other divisions of the
OSC department and shall maintain a minimum of 10 air exchanges with 2 outside air exchanges per
hour with all return air directed to the outside.
Ultrasonic washing instruments for flash sterilization
Ultrasonic cleaning provides an intense scrubbing action that leads to unsurpassed cleaning speed and
consistency when compared with simple soaking or immersion with agitation. Refer to CS-7680
Operation of: Ultrasonic Cleaner-Crest. The ultrasonic chamber is cleaned every morning and filled
with Infection Control approved enzymatic cleaning solution by the OCS Surgical Support Technician.
When cleaning heavily soiled items or a large number of items, change cleaning solutions frequently to
avoid recontamination of instruments.
1. Wear appropriate PPE such as masks, goggles or face shields, gloves, and gowns.
2. Try to separate soiled instruments from clean.
3. Use basin or sink with water and Infection Control approved enzymatic cleaning solution.
4. Poole suctions and instruments that can be disassembled are dismantled for hand washing
before being placed in ultrasonic.
5. Use a brush or pipe cleaner to thoroughly clean suctions or cannulated instruments with the
enzymatic cleaning solution.
6. Perform manual cleaning while holding the instrument and the brush under the water.
7. Clean all visibly soiled instruments with soft–bristle brushes, paying attention to ratchets,
serrations and joints. Also open box locks.
8. Place tray or instrument in ultrasonic chamber for pre-set time closing the lid. In ante room
area between OR 1 and OR 2 place lid over ultrasonic. Never operate the ultrasonic without
liquid in the tank, and the liquid level should be one inch from the top of the tank when
operating the unit.
9. Transfer tray or instrument in final rinse and dry chamber for pre-set time closing the lid. In
ante room area between OR 1 and OR 2, rinse instruments with sterile water or RO water.
RO water can be taken from the hose that fills the small ultrasonic.
10. After completion, inspect all instruments for cleanliness and place in pass-through window
for flash sterilization. In ante room area, place instruments into flash sterilizer for
appropriate time. See below for appropriate flash times.
11. Reminder: If any cannulated instruments are going to be autoclaved in a steam sterilizer, the
inner cannula must be moist prior to flash sterilization.
Hand wash instruments for flash sterilization
1. Wear appropriate PPE such as masks, goggles or face shield, gloves, and gowns
2. Hand wash all instruments (i.e., scopes, power equipment, delicate instruments) which
cannot be submerged or go through the ultrasonic.
3. Inspect all components for foreign debris such as blood, fat tissue, bone etc. Disassemble
any components that need to be taken apart.
4. If any foreign debris is found, wash instrument with clean cloth or soft brush soaked with
appropriate enzymatic cleaning solution according to manufacturer's instructions.
5. Cannulated instruments must have a brush, pipe cleaner or equivalent run through until
clean. Pipe cleaners used for cleaning lumens should be discarded at the end of the day, or

Flash Sterilization
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sooner if grossly soiled.
6. Rinse items thoroughly with sterile water.
7. Moisten a clean cloth with an Infection Control approved disinfectant and wipe the cords
thoroughly.
8. Wipe surfaces with a sterile water moistened, lint-free cloth to wipe away any cleaning
solution.
9. Inspect any hand pieces or instruments to assure proper working order and that there are no
loose or missing components.
10. Reminder--- if any cannulated instruments are going to be autoclaved in a steam sterilizer,
the inner cannula must be moist prior to flash sterilization.
11. Inspect for cleanliness and place in pass-through window for flash sterilization. In ante
room area, place instruments into flash sterilizer for appropriate time. See below for
appropriate flash times.
Flash sterilization for non-implants
All tissue, blood and other body fluids must be removed from instruments prior to sterilization. Any
residual debris, such as tissue, may result in incomplete sterilization. Before placing items in flash
sterilizer check manufacturer's instructions for appropriate sterilization method.
1. Make sure instruments have been properly cleaned and are in good working order.
2. Every morning Surgery Support Tech opens and closes valves on top and bottom of Flash
Pak so they are ready for use.
3. Place instrument or tray in Flash Pak with steam chemical integrators in opposing corners of
the Flash Pak.
4. Place Flash Pak in sterilizer as straight as possible.
........Select appropriate cycle and start sterilizer.
........10 minute cycle/270: porous material (includes color-coding tape), instruments
with lumens, and all instruments placed in Flash Pak
5. If instrument or tray is flashed in ante room between OR 1 and OR 2 and used in either of
these rooms, a Flash Pak is not needed. A steam chemical integrator is still placed in load.
6. Items flashed in ante room between OR 1 and OR 2 can be flashed in 2 different cycles
........3 minute cycle/270 for non-porous items without lumens.
........10 minute cycle/270 for porous material (includes color-coding tape), instruments
with lumens; and, if used, all items placed in a Flash Pak.
7. Fill out 2 load stickers and place one in sterilization logbook and one on sterilizer for
patient’s preference card.
8. Legibly fill out load information in the sterilization logbook.
9. At the end of the cycle, and before items are removed from the sterilizer, the operator must
examine the record to verify that cycle parameters were met. Refer to policy GL-9705
Sterilization and Sterility Assurance for sterilization monitors.
10. Legibly fill out unload information in the sterilization logbook
11. Remove Flash Pak from sterilizer and use Flash Pak cart for transporting instruments to the
appropriate OR suite.
12. If items are not in a Flash Pak (OR 1 and OR 2 only) either the Circulator or Scrub Tech
may remove the items from the sterilizer using aseptic technique. Gowned and gloved
personnel may not enter ante room.
13. In the OR suite the Scrub Tech assures that the steam chemical integrators have changed
color appropriately before adding the items to the sterile field. Discard steam chemical
integrators after inspection.

Flash Sterilization
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14. Circulator and Scrub Tech using flash sterilized instruments are responsible for filling out
sterilization logbook.
Note: If the steam chemical integrator has not adequately changed, or if any of the
sterilization parameters have not been met:
• Do not use instruments from the load in question.
• Refer to Gundersen Lutheran policy GL-9705 Sterilization and Sterility
Assurance for appropriate actions.
• Report situation to:
1. Surgery Support Tech
2. Charge Nurse
3. Infection Control
4. Hospital maintenance B#0040 if needed
• Take the instruments back to the dirty workroom and re-clean the instruments.
• Use another autoclave to re-sterilize the load if necessary.
• Circle "not used" in the logbook and fill out adverse event reported to
documentation and incident report.
• If necessary, take the autoclave out of service.
Flash sterilization for Implants
Follow the steps as for non-implants (above) with the following additions:
1. Add an Attest Rapid Readout Biological indicator to the load in addition to the steam
chemical integrators.
2. Use a 10-minute sterilization cycle for all implant loads.
3. When removing the biological from the load, allow the biological to cool for 5 minutes.
Page Surgery Support Tech or Charge Nurse to incubate biological indicator.
4. Write operating room number on biological indicator.
5. "Close, Crush, and Tap" the biological indicator.
6. Place vial into incubator well.
7. Document in 3M logbook for biological indicator in and out time, initials, Mfg. Lot No, and
results. Refer to Gundersen Lutheran SOP CS-8715 Sterilization Monitor and Control.
8. Monitor Biological Indicator for proper readout results. According to the 3M Attest 290
Auto-reader, the final negative readout determination is made in one (1) hour. Scrub Tech
places implant off to the side of sterile field until the BI results are known.
9. Document results in sterilization logbook and place load sticker on patient’s preference
card.
10. Discard biological indicator in regular garbage after use.
11. Fill out Premature Release of Implant Form any time implants are flash sterilized. Make a
copy of the form to send to Infection Control and place the original release form in back of
the sterilization logbook.
12. Biological control is done daily by Surgery Support Tech.
Note: If the Biological Indicator is Positive:
• Do Not use implants and instruments from the load in question.
• Refer to Gundersen Lutheran policy GL-9705 Sterilization and Sterility
Assurance for appropriate actions.
• Place a sign on the autoclave indicating the sterilizer is "Out of Order"

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• Report situation to:
1. Surgery Support Tech
2. Charge Nurse
3. Infection Control
4. Clinical Manager
5. Hospital maintenance B#0040
• Take the instruments back to the dirty workroom and re-clean the instruments.
• Use another autoclave to re-sterilize the load.
• Circle "not used" in the logbook and fill out adverse event reported to
documentation and incident report.
Documentation:
For every flash sterilization cycle, document the following in the sterilization logbook according to
policy GL-9705 Sterilization and Sterility Assurance. The sterilization strip is taped in the sterilization
logbook next to the corresponding load information. The surgical support tech will tape the strips in the
logbook at the end of the day. We will no longer write information on the sterilizer strip. The logbook
and the sterilization strip will contain all 9 areas of needed documentation according to our policy:
1. Cycle start time and date: Automatically recorded on sterilization strip, date also
documented on sterilization log book.
2. Operator initial at load start time: documented on sterilization log.
3. Type of items in the load: documented on sterilization log.
4. Dept ID or OR room number: documented on sterilization log, not used and term added
for items flashed and not used and for items terminally sterilized.
5. Reason instrument was flashed: documented on sterilization log for QI.
6. Operator initial at load completion: documented on sterilization log and also seen as
person checking the sterilizer strip for the adequate temperature and flash time for
sterilization load.
7. Temperature: automatically documented on sterilization strip and also on sterilization log
as a reminder to person unloading the sterilizer that minimal temperature of sterilizer needs
to be 270 or above for load to be considered sterile. "Other_____" also added if temperature
below 270 to track if temperature of sterilizer is below range of 270.
8. Cycle completion time: automatically documented on sterilization strip and documented as
cycle length on sterilization log to track if load was 3min, 10min, or "other_____".
9. Indicator strip results (+) or (-): documented on sterilization log as passed or failed
10. Failed load: documented on sterilization log as Adverse event reported to:
11. Biological Results: documented on sterilization log as negative or positive result (daily
biological run by Surgical Support Tech and biological run with all implant loads)
12. Load sticker with the flash sterilization cycle number will be placed both on the sterilizer
logbook and on patient’s preference card for tracking purposes.
13. Implants in flash load: documented on sterilization log to track implant loads sterilized
and to remind staff that biological also needs to be run with implant load. Also, need to
have a surgical team member fill out Premature Release of Implant Form when implants are
flash sterilized. A copy of the form is sent to Infection Control for patient tracking and the
original is placed in the back of the sterilization logbook.
Related Documents

Flash Sterilization
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CS-7680, GL-9705
Forms Required
Attachments
None
Approver Signatures:
Signed by: Linda M Miller
12/07/2008 10:21:55 PM
Signed by
Signed by Bryan G Erdmann
Signed by
12/23/2008 11:18:53 AM
The following URL will link directly to this policy:
http://glapps.gundluth.org/apps/policyproc.nsf/links/OR-0120
END OF DOCUMENT
Marilyn A Michels
12/08/2008 07:39:42 AM