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# : Environmental Health & Safety
Standard Operating Procedure
Sterilization of Surgical Instruments and Equipment
General Information:
Surgical instruments and equipment are used in a variety of animal operations that can result in contact with biological materials and in many cases, those materials can have infectious properties. The proper sterilization of surgical instruments and equipment after each use is a fundamental way to maintain a sterile work environment without the risk of contamination as well as prevent the transmission of diseases between humans and animals. Below are a series of methods that should be intently followed after each use of any surgical equipment regardless of contact with any infectious materials. This SOP does not advise in the sterilization of medical waste, disposal of which should be in alignment with the Medical Waste Management Plan which includes specific legal requirements for sterilizing medical waste.
Proper Sterilization Procedure:
Instruments that will be reused should be placed in a pouch that can be sealed to maintain sterility after the autoclave procedure. Initial cleaning of surgical instruments must be performed using warm water and a mild detergent or disinfectant before placing the instruments in a clear plastic pouch for autoclaving as this will remove all macro materials such as residual tissues, blood and debris. If macro materials or tissues are known to be infectious, instruments should be soaked initially in a 10% bleach solution for 20 minutes before being washed with a detergent or disinfectant for autoclave prep.
Unlock all surgical instruments and sterilize them in the open position. Hemostats, needle holders and any other equipment that utilizes ratcheting mechanisms or metal-on-metal joints like scissors. Leaving equipment in the locked position or in an orientation that does not allow flexibility will likely result in stress cracks near the hinge due to thermal expansion which will increase the risk of equipment failure during use.
All instruments shall be placed in the autoclave in such a way that the autoclave is not overloaded to allow steam to reach all areas of the instrument.
Safe handling procedures for the autoclave shall be followed at all times and only persons who are trained on proper autoclaving procedures should use equipment. Safe operating procedures shall be posted near the autoclave for review.
A visual indicator should be used to verify the cycle ran to the required specifications. The use of autoclave test strips is recommended as they are calibrated to specific temperatures to visually indicate a successful run.
Indicator strips should be placed inside a clear plastic pouch for autoclaving with the equipment to be sterilized in such a way that the indicator result is clearly visible. Securing the strip to the inside of the pouch with a piece of tape may facilitate the process.
It is recommended that the pouch be sealed with autoclave tape placed over the seal of the pouch. The tape indicates the pouch was autoclaved as well as certifying with a reasonable degree of assurance that the pouch has not been opened since being autoclaved. Should the tape be broken or tape does not indicate autoclaving, the pouch should be substituted for a sterile one.
Strips should be discarded once the pouch is opened to be used. Preserving strips in the autoclave log is not necessary, only an indication that the strip was positive for sterilization.
Every autoclave cycle shall be documented on the autoclave log. The autoclave should also record the cycle history in real time on the autoclave tape. A sample log is available at the end of this document if an existing autoclave log is not available. All records shall be maintained.
The use of biological indicators (BI) should be used on a monthly basis to certify the proper function of the autoclave. In addition to this frequency, a BI should be used when the following occurs:
When a new type of packaging or tray is used,
After undergoing maintenance or repairs to the equipment, and
After any change in the loading procedures.
The BI used to qualify the sterilization process should be consistent with CDC requirements containing Geobacillus or Bacillus species and purchased from a reputable vendor. The BI lot shall be qualified by using a positive control BI to test comparatively to the BI from the sterilized run. The Positive Control should show growth, indicating a healthy BI and the Negative Control should show no growth thus indicating successful sterilization. Results of the BI tests should be documented in the Autoclave Log.
Biological Indicators should be incubated for a period of 3-48 hours in alignment with manufacturer recommendations to determine growth or lack of growth.
A preference should be given to Biological Indicator strips versus liquid-containing glass ampules due to the added sharps risk when breaking the ampule and the risk of spilling the culture or compromising its sterility before incubation.
Incubated controls should be disposed through autoclaving as soon as feasible.
The thermometer shall be calibrated on an annual basis and documented to ensure that the set temperatures are actually achieved. A calibration log is available at the end of this document if an existing calibration log is not available. All records shall be maintained.
Sterilization of surgical equipment using an autoclave should be performed using the following parameters.
121C to 125C
25 PSI
15 Minutes (Exposure Time)
*Note: Medical Waste Laws require autoclaving for 60 minutes. Any waste material must conform to this medical waste requirement. The above procedures only apply to the sterilization of pre-cleaned surgical equipment. 88
Environmental Health & Safety
Operation Log
Autoclaving of Surgical Instruments and Equipment
Department: ____________________ Page _________
Autoclave Manufacturer: _________ ________
Autoclave Model: ____________ ____ Autoclave Serial: ________________________
Date of TreatmentMaximum Temp. Achieved (C)Duration of Maximum Temp. (min)Results of Heat Sensitive Indicator Monthly Results of Biological IndicatorComments or Result of Annual CalibrationSignature of Operator10/1/1412515PosPosN/AJane Doe 88
Environmental Health & Safety
Autoclave Calibration Log
Annual Surgical Instruments and Equipment Calibration
Autoclave being calibrated:
Manufacturer: Date:
Model: Serial Number:
Description:
Test Results:
Test PointAutoclave ReadingTrue ReadingOffset to be Applied
Comments:
Calibrated by:
Signature: Date:
Printed Name:
Company:
DATE \@ "M/d/yyyy h:mm am/pm" 8/29/2019 2:19 PM This document supersedes all previous versions PAGE \* MERGEFORMAT 1 | Page
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