Surgical instruments and equipment used in a variety of procedures may come into contact with biological materials, which in many cases can be infectious. Properly sterilize surgical instruments and equipment after each use, and maintain a sterile working environment free from contamination to prevent the spread of disease between humans and animals. Below is a list of methods that should be carefully followed after each use of surgical instruments, regardless of exposure to any infectious material. This SOP does not recommend the sterilization of medical waste, which should be handled in accordance with a medical waste management plan that includes specific legal requirements for sterilization of medical waste.
Suitable Sterilization Process:
Instruments that will be reused should be placed in a bag that can be sealed to maintain sterility after high pressure procedures. The initial cleaning of surgical instruments must use warm water and a mild detergent or disinfectant, then autoclave the instruments in a clear plastic bag, as this removes all macroscopic contaminants such as residual tissue, blood, and debris . If the macroscopic material or tissue is known to be infectious, the instrument should first be soaked in a 10% bleach solution for 20 minutes before cleaning the autoclave with detergent or disinfectant.
1. Open all surgical instruments and sterilize in the open position. Hemostatics, needle clips, and any other device that utilizes a ratchet mechanism or metal-to-metal connection (like scissors). Leave the device in the locked position.
2. All instruments should be placed in the autoclave so that the autoclave is not overloaded so that the steam reaches all areas of the instrument.
3. Safe operating procedures for pressure cookers should be followed at all times, and only persons trained in proper pressure cooker operating procedures should use the equipment. Safe operating procedures should be posted near the autoclave for inspection.
4. A visual indicator should be used to verify that the cycle meets the required specifications. Autoclave test strips are recommended as they are calibrated to a specific temperature for a visual indication of a successful run.
a. The indicator strip should be placed in a clear plastic bag to be autoclaved with the device so that the indicator results are clearly visible. It will be more convenient to use a piece of tape to secure the tape to the inside of the bag.
b. It is recommended to cover the sealed bag with autoclave tape to seal. The tape indicates that the bag is autoclaved and proves with a reasonable degree of assurance that the bag has not been opened since autoclaving. If the tape is broken or the tape does not show autoclaving, the sterile bag should be replaced.
c. Once the bag has been opened for use, the paper tape should be discarded.
5. Each autoclave cycle should be recorded on the autoclave log. The autoclave should also record the cycle history in real time on the autoclave tape. If an existing autoclave log is not available, a sample log is provided at the end of this document and all records should be kept.
6. A biological indicator (BI) should be used monthly to demonstrate the proper functioning of the autoclave. In addition to this frequency, BI should be used when:
a. When using a new type of packaging or pallet,
b. After maintenance or repair of the equipment
c. After any changes to the loader.
7. The BI used to validate the sterilization process should meet the requirements of the CDC. BI batches should be tested on sterilized BI using a positive control BI. Positive controls should show growth, indicating healthy BI, and negative controls should show no growth, indicating successful sterilization. The results of the BI test should be recorded in the autoclave log.
a. Biomarkers should be incubated for 3-48 hours as recommended by the manufacturer to determine growth.
8. Biological indicator strips should be preferred over liquid-containing glass jars because of the increased risk of sharps when ruptured and the risk of spilling the culture or compromising its sterility prior to incubation.
a. Incubation controls should be processed by autoclaving as soon as practicable.
9. The thermometer should be calibrated annually and recorded to ensure that the set temperature is actually reached. If an existing calibration log is not available, a calibration log is provided at the end of this document. All records should be kept.
10. The following parameters should be used to sterilize surgical equipment using an autoclave.
a.121°C to 125°C
b.25psi
c. 15 minutes (exposure time)
