The complete and thorough decontamination of reusable medical devices and surgical instruments prior to sterilization is an important patient safety issue. Surgical infections have long been, and continue to be, the most frequent cause of morbidity and mortality among hospitalized patients. The Centers for Disease Control and Prevention (CDC) notes that "Microbial contamination of the surgical site is a necessary precursor of a surgical infection."¹ Surgical instruments that remain contaminated with dead, sterile organic debris after reprocessing and sterilization are a major cause of surgical site infections (SSIs).The inability to thoroughly decontaminate surgical instruments during reprocessing is a major challenge that CS and SPD departments face on a daily basis. The decontamination process should always start with a review of the manufacturer’s Instructions for Use (IFUs). Failure to properly follow an IFU 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 medical 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.” ² 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.” ³

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.” ⁴ 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.” ⁵ 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.” ⁶

While all of these steps are important in the reprocessing cycle, almost all manufacturers’ IFUs rely on ‘visual’ inspection to confirm that the instrument is clean and free of biofilm. The problem with visual inspection is that the human eye is incapable of seeing microscopic debris and biofilm. As IAHCSMM points out in its CRCST Self-Study Lesson Plan, Understanding Biofilm, “Even with the use of most visual enhancing tools, microorganisms will still not be seen.” To help solve this problem, tests have been developed to help verify that cleaning quality standards have been attained. These tests include protein tests and adenosine triphosphate (ATP) bioluminescence tests, both of which test for residual soils and which might also be suggestive of biofilm formation. There are also reagent tests that test for protein and hemoglobin, and another 3-in-1 test for lumen devices that is designed to test for blood, protein and carbohydrates, all at the same time. So how do you reduce the risk of organic debris remaining on and/or in instruments that are difficult, if not impossible to thoroughly clean and decontaminate on every reprocessing cycle without conducting a time consuming, labor intensive reagent testing process? You start by using instruments whose cleaning IFUs have been validated by independent laboratory testing utilizing FDA and AAMI validation testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time. 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 . You must insist on instruments with validated IFUs to protect your patients. 1. CDC Publication “Guideline For The Prevention Of Surgical Site Infection” 2. “Standards of Practice for the Decontamination of Surgical Instruments” Association of   Surgical Technologists (AST) April 2009 3. Op. Cite. 4. Op. Cite. 5. Op. Cite. 6. Op. Cite.