Cleaning and Sterilization of Instruments and Supplies

Instruments are cleaned as soon as possible after use 
in an enzyme solution so that organic 
material will not dry and cling to the object.  Organic 
materials interfere with the sterilization or disinfecting 
process and must be completely removed before sterilization 
procedures are initiated.
The following is based on Federal Drug Administration 
guidelines, Center for Disease Control and The Association of 
Peri-operating Room Nurses guidelines.
Factors, which interfere with sterilization and disinfecting, 
  1. Organic material, such as mucus, blood, pus, feces, and 
     saliva on uncleaned instruments
  2. Microbial contamination and the nature and number of 
     orgnaisms present
  3. Incorrect dilution (improper mixing) of disinfectant
  4. Inadequate exposure (contact) time between instruments 
     and the sterilant/disinfectant
  5. Excessive dilution of the sterilant/disinfectant, 
     usually from the addition of wet instruments.  Use a 
     solution test strip according to the manufacturer's 
  6. Loss of sterilant/disinfectant strength due to expired 
  7. Inadequate penetration of the sterilant/disinfectant 
     into the instrument, such as into endoscope channels
  8. Incorrect pH or temperature of the disinfectant
  9. Water hardness
 10. Incompatible detergents
 11. Presence of materials such as rubber and plastic
After a pre-soak in an enzyme detergent, instruments should 
then be cleaned manually with detergent and water according to the manufacturer's 
Enzymatic detergent preparations are recommended for a 
pre-soak because they contain various proteinase and 
propylene glycol additives that enhance the cleaning 
procedure in the pre-soak phase.  
  1. Critical instruments, scissors, implants or any 
     instrument which enters sterile areas of the body or 
     vascular system  should have instrument cleaning 
     followed by sterilization 
  2. Semi-critical instruments, endoscopes, endotracheal tubes or instruments which come in contact 
     with intact mucous membranes or non-intact skin should have instrument cleaning followed by steam sterilization
     or high level disinfecting. Endotracheal tubes, if used, are disposed of after use.
  3. Non-critical instruments, stethoscopes, ear syringe 
     tips, tabletops or instruments which come in contact 
     with intact skin should have instrument cleaning 
     followed by low level disinfecting
The nature of the procedures performed at our organization precludes the use of sterile processing. However, the elements of sterilization are included. Staff are not trained in sterile processing. 
  1.  Steam sterilization shall be conducted in accordance 
      with the manufacturer's directions.
  2.  The efficiency of the sterilization process shall be 
      monitored by all of the following methods:
    A.  Sterilizer tape used in securing wrappings on 
        the packs is an indicator of exposure to the 
        sterilant system.
    B.  Chemical indicators placed in the center of each 
        pack indicates that the necessary conditions for 
        sterilization to occur have been reached in that 
        portion of the pack/package.
    C.  Biological monitor (spore testing; e.g. Attest, or
        an out-sourced system) shall be run, at least, weekly
        for the detection of heat resistant spores.  A 
        record of these tests will be kept near the 
        sterilizing equipment.

3.  Any one of the above indicators may be used to denote 
      failure of proper completion of the sterilization 
      process; all loads affected by the failure will be 
      considered non-sterile and will not be used until re-
      processed.  The equipment will be repaired and re-
  4.  Preparing articles for sterilization:
    A.  Instruments and other items for sterilization must 
        be decontaminated and cleaned prior to being laid 
        out for inclusion in the packs.
    B.  Articles to be steam sterilized must be double-
        wrapped or in a peel-pack.  Steam sensitive tape is 
        used to secure each package to be sterilized; a 
        steam indicator is placed inside each package at the 
        thickest portion of the pack.
    C.  Packs should be securely packaged but the contents 
        must not be crowded in the package.
    D.  The size of each package must be appropriate to the 
        manufacturer's recommendations.
    E.  Layers should be cross-hatched to minimize bulk in 
        the pack.
    F.  Rubber tubing should be carefully placed so that no 
        kinks are allowed to form.
    G.  All locking instruments must be left UNLOCKED for 

 H.  Articles must be clean and free of grease.
    I.  Steam must have direct contact with all surfaces of 
        an item.
    If any question exists as to how to sterilize an item, 
    the manufacturer of the autoclave or of the item in 
    question should be consulted.
  5.  Wrapping packages for sterilization:
    A.  All items are to be double wrapped; wrapping 
        material should be clean and free of holes.
    B.  Articles must be completely covered with the corners 
        of wrapper turned in.
    C.  Packages should be loosely packaged and securely 
        wrapped before closing with steam sensitive autoclave
    D.  Peel pack must be large enough to hold the item 
        while allowing for sealing.
    E.  All packs and pouches must contain an internal 
        sterile indicator
  6.  High Level Decontamination Chemical sterilization:
      High-level chemical disinfectants kill most microbes 
      except bacterial spores.  If the contact time is long 
      enough, glutaraldehyde, a powerful disinfectant can 
      achieve complete sterilization (usually 24 hours). 

   Such disinfectants are call 'sterilants' and are 
      approved by the FDA.  Cold sterilization performed at 
      this facility for suture removal instruments only.
Some examples of high-level disinfectants are:
Glutaraldehyde, Cidex OPA, Sodium hypochlorite (bleach)
Gluteraldehyde (2%) requires substantial ventilation.  
Gluteraldehyde can be used to disinfect/cold sterilize a wide 
variety of medical instruments that cannot be subjected to 
heat.  Gluteraldehyde must be prepared and used according to 
manufacturer's instructions.  Thorough rinsing of instruments 
with clean water is imperative to remove potential toxicity 
of Gluteraldehyde residue.
  1. Is toxic, irritating to skin, eyes and nasal passages, 
     and can cause breathing problems.  Employees may be 
     exposed to elevated Gluteraldehyde vapor levels if 
     equipment is soaked in rooms with inadequate 
     ventilation, when spills occur, or where there is an 
     open immersion bath. Therefore monitoring badges must be
     worn periodically; see policy MC.11 in the Infection 
     Control Volume. 
  2. Staff must wear protective clothing, gloves, and eye
     protection when handling.  
  3. Activated Gluteraldehyde is unstable and germicidal 
     potency tends to decrease after storage and use.   
     Manufacture's expiration date should be followed after 
     activation and the solution must be kept in a covered 
     container, and concentrations need to be monitored; 
     utilizing a dip stick and documenting results of 

  4. The placement of a cautionary sign warning pregnant
     women; placed in the area where this product is used is 
     highly recommended.
Intermediate-Level Disinfecting
Intermediate-level disinfectants do not kill large numbers of 
bacterial spores, but can kill most of the surface organisms 
in an exam room.  A 1:100 (1 teaspoon of bleach in 2 cups of 
water) bleach solution or a brand such as Cavicide, germicidal wipes
Envirocide, Madacide can be used to kill surface germs. 
Low-Level Disinfecting
Equipment that does not touch mucous membranes and only 
touches intact skin, e.g., stethoscopes, blood pressure cuffs.
    A.  Articles approved for high level disenfecting  must 
        be chemically disinfected by glutaraldehyde (e.g.,
        Cidex) after having been cleaned, 
        inspected and dried before immersion; time of 
        soaking is per manufacturer's directions (at least, 
        20 minutes at room temperature). 
    B.  The cycle of chemical disinfectants shall be changed 
        per manufacturer's directions.
7.   Flash Sterilization:
     Flash sterilization should be used when there is an 
     immediate need for an instrument item or instrument set.
   Flash sterilization shall be restricted to unplanned or
     emergency situations.  Flash sterilization shall never
     be used as a convenience to compensate for inadequate
     inventories of instruments or implantables.  Flash
     sterilization of implantables shall be restricted to 
     only the most dire circumstances.
     A.  Flash sterilization is used only according to the 
         standards of the equipment manufacturer.Flash 
         sterilization is used only according to the 
         standards of the equipment manufacturer. (usually 3 
         minutes at 270 degrees F at 27 to 28 lbs. of 
     B.  The surgeon is aware of the use of the flash 
         sterilization process.
     C.  Items which are to be flash sterilized shall be 
         cleaned and decontaminated before the sterilization
     D. All items to be flashed whether in a closed 
        container or on a perforated tray must have an 
        indicator placed in the container or on the tray.
     E.  There will be a log kept of items that are flash 
         sterilized in relation to date, time, instrument, 
         patient and case.
The circulating personnel may remove small items and single 
instruments from the sterilizer with care to prevent 

Large instrument trays require the individual to reach over 
the tray  which would preclude the circulating personnel from 
this task.  Also to avoid back injury, the tray needs to be 
carried close to the body. Since circulating personnel are 
not in a sterile gown and gloves this action would 
contaminate the instruments.
Therefore the scrub person must remove the larger trays from 
the sterilizer.  The following should be noted:  
     A. The scrub person should avoid leaving the sterile 
        field when the procedure is in progress, attention 
        should be on the field and assisting with the 
     B. The circulating personnel should accompany the scrub 
        person to the sterilizer to help monitor possible 
        contamination to the scrub person.
     C. The scrub person should avoid accidental contact
        with the doorways, edges of the sterilizer doors, 
        and other equipment.
     D. Traffic in the area leading to the sterilizer and 
        back to the OR should be restricted to the scrub and 
        circulating personnel during the retrieval process.
When the circulator accomplishes the retrieval, the following 
should be noted:  
        i. Avoid reaching over the top of the item while 
           pulling the tray out of the sterilizer

     ii. Do not allow the bottom of the perforated tray to 
           come in contact with the un-sterile tray.
      iii. Traffic in the area leading to the sterilizer and 
           back to the OR should be restricted to the 
           circulating personnel during the retrieval 
  1.  Always check expired dates of sterile supplies.
  2.  Rotate supplies as they are stocked.
  3.  All sterile supplies must be inspected for damaged 
      packaging before opening onto sterile field.
The person responsible for the processing of instruments can 
and should become certified. Please see The CBSPD 
Certification Program – located in the Web Resource Link of 
the Forms Repository.
For further information please see the CDC Guideline for 
Disinfection and Sterilization in Healthcare Facilities.  A 
link to this document is located in the Forms Repository, Web 
Resource Link Section.
Approved By Governing Board    
Control #112.12