News / January 11, 2022
In Part I of this blog (Elmed blog #53) we discussed the fact that over the past year there has been an increased emphasis and a lot more attention placed on pre-cleaning surgical instruments at the point-of-use. The goal is to ensure pre-cleaning of instruments immediately after use and prior to transport to sterile reprocessing. This new, increased emphasis is coming from many sources and organizations, including AAMI, AORN, FDA and the Joint Commission.
Pre-cleaning is the removal of visible soil (e.g., organic and inorganic material) from reusable medical devices. This is normally accomplished manually using sterile water; water with an FDA approved detergent or an enzymatic product (liquid or spray) with a neutral pH (7 or lower).
Thorough pre-cleaning is essential before high-level decontamination and reprocessing because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. The decontamination process is designed to remove pathogenic microorganisms from reusable medical devices so that they are safe to handle during reprocessing.1
Point-of-use pre-cleaning of surgical instruments almost always involves manual cleaning. Manual cleaning is required because most O.R.s and operating suites do not have mechanical cleaning units. Fragile and/or difficult-to-clean instruments (e.g., Kerrison Rongeurs, laparoscopic instruments, etc.) also require manual cleaning.
There are two essential components of manual cleaning, friction and fluidics. Rubbing and scrubbing the soiled area with a brush (friction) is the most recommended, time-honored and dependable method of manual cleaning. Pressurized fluids (fluidics) are used to remove bioburden and biofilm from hard to access spaces (i.e., internal channels, sharp internal corners and dead-spaces). This step is necessary when the instrument’s design does not allow a brush to achieve surface contact through a channel or contact with an internal surface(s).2
Given the importance of pre-cleaning at the point-of-use combined with all of the new emphasis on the procedure in both hospitals and ambulatory surgery centers, what steps should you and your team take at your facility? A good starting point is to consult the instrument manufacturers’ IFUs for their recommendations and requirements.
The first step in every instrument manufacturers’ IFU for reprocessing surgical instruments or reusable devices is to pre-clean the device at the point-of-use. In addition to manufacturers’ IFUs, you should also consult the Association of Surgical Technologists (AST) publication “Standards of Practice for the Decontamination of Surgical Instruments.” This publication 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.”3
There are fourteen “Standards of Practice” listed in the AST publication and each one plays an important role in the complete and thorough pre-cleaning, decontamination, cleaning and sterilization of surgical instruments and devices within your facility. The first four “Standards of Practice” are most applicable to pre-cleaning of instrumentation and devices at the point-of-use. These four standards are:
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.
As was pointed out in Part I of this series “These new recommendations and guidelines for point of use instrument cleaning will mean a process change in the O.R. at many facilities in order to comply with the Joint Commission’s new requirements.” That being said, if O.R. techs get into the habit of cleaning instruments as their surgeon hands the instruments back during the case, then cleaning at the end of the case will be significantly easier, more effective and less time-consuming. Most importantly, the risk of a contaminated instrument getting through the entire reprocessing cycle and potentially harming a patient will be reduced as well.
1 CDC’s “Guideline for Disinfection and Sterilization in Healthcare Facilities” 2008
2 Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013
3 “Standards of Practice for the Decontamination of Surgical Instruments” Association of Surgical Technologists (AST) April 2009
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