“Standards of Practice” to Decontaminate Surgical Instruments Complying with a manufacturer’s instructions for use (IFUs) is an important patient safety issue. Failure to properly follow IFUs can result in a contaminated device being returned to the O.R. where it has the potential to cause a dangerous, painful and costly surgical infection. The first step in every IFU for reprocessing any surgical instrument or reusable device is to decontaminate the device. The Association of Surgical Technologists (AST) publication “Standards of Practice for the Decontamination of Surgical Instruments” is the industry standard for the safe, thorough and effective decontamination of surgical instruments and reusable medical devices. “AST developed the Standards of Practice to support healthcare facilities in the reinforcement of best practices related to the decontamination of surgical instruments in the perioperative setting.  The purpose of the Standards is to provide an outline that the Certified Surgical Technologist (CST) and Certified First Assistant (CSFA) can use to develop and implement policies and procedures for the decontamination of surgical instruments.  The Standards are presented with the understanding that it is the responsibility of the healthcare facility to develop, approve and establish policies and procedures for cleaning and disinfecting surgical instruments according to established healthcare facility protocols.” ¹  There are fourteen “Standards of Practice” listed in the AST publication and each one plays an important role in the complete and thorough decontamination of surgical instruments and devices. The first four “Standards of Practice” are:

1. “The cleaning of instruments should begin during the surgical procedure to prevent drying of blood, soil and debris on the surface and within lumens.” ² The first step in effective decontamination is to place soiled instruments in an instrument tray/container that contains sterile distilled water or an enzymatic cleaning solution. Practically every device manufacturer’s cleaning IFU contains this step so as to moisten the soil and prevent blood, mucus, and other organic debris from drying on the instrument.

2. “The cleaning of instruments should continue at the point of use post-procedure, including sorting and disassembly of instruments, containment and transportation to the decontamination room.” ³ Instruments must remain in a moist environment throughout the transport process to the decontamination/reprocessing room.

3. “Cleaning/detergent agents should be selected that will not damage the cleaning equipment and effectively clean instruments.” ⁴ Always consult with the instrument manufacturers’ IFUs for their recommendations as to the cleaning agents, brushes and detergents that are safe to use on their instruments.

4. “Cleaning may be performed manually, mechanically or a combination of both. The selection of the cleaning method should be based upon the type of device and manufacturer’s recommendations.  However, cleaning alone may not be sufficient to decontaminate items that present a high risk of disease transmission such as surgical instruments and therefore, should undergo a microbicidal process.” ⁵

5. The inability to clean surgical instruments sufficiently to decontaminate them is a major problem that every CS and SPD department faces on a daily basis. As the AST Standard #4 points out, “cleaning alone may not be sufficient to decontaminate items that present a high risk of disease transmission such as surgical instruments and therefore, should undergo a microbicidal process.”

So how do you reduce the risk of disease transmission from instruments that are difficult, if not impossible to thoroughly clean and decontaminate on every reprocessing cycle without conducting a time consuming, labor intensive microbicidal process? You start by using instruments whose cleaning IFUs have been validated by independent laboratory testing utilizing FDA testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time. If you are relying on manufacturer IFUs that have not been validated to ensure that their instruments can be effectively reprocessed and safely reused, then you cannot be sure that the instruments are clean, sterile and moisture-free on every reprocessing cycle. A great “Standard of Practice” to help reduce your patients’ risk of a surgical infection caused by an instrument that wasn’t thoroughly decontaminated starts by only using instruments whose cleaning IFUs have been validated using FDA validation testing protocols. You must insist on instruments with validated IFUs to protect your patients. 1. “Standards of Practice for the Decontamination of Surgical Instruments” Association of   Surgical Technologists (AST) April 2009 2. Op Cite 3. Op Cite 4. Op Cite 5. Op Cite