Organic material allowed to dry on instruments makes the devices more challenging to clean and can lead to the formation of biofilm. The Association for the Advancement of Medical Instruments (AAMI) and the Association of periOperative Registered Nurses (AORN) clearly state that contaminated items should be kept moist in their transport container. AAMI and AORN note there are various ways to meet that goal: adding a towel moistened with water (not saline) or using a pre-treatment product specifically intended for this use, or placing items inside a package that can maintain moist conditions.
There have been multiple reports of facilities receiving Condition Level Deficiencies (CDLs) from The Joint Commission (TJC) because surveyors insist instruments must be sprayed at the bedside with an enzymatic product. AAMI and AORN do not dictate that an enzymatic be used, or that it should be used at the bedside. In fact, AORN’s Guideline for Environment of Care advises against using spray bottles, which produce aerosols, at the bedside; therefore, if a pre-treatment product is used, it might best be applied in the dirty utility room prior to transporting the items to the decontamination area.
Confusion spurs clarification
TJC citations have caused much confusion and have led to the following question being asked to TJC: “What is meant by pre-cleaning at point of use in decentralized locations for sterilization reprocessing?” TJC stated that “pre-cleaning’ is described as the means of removing visible gross blood, body fluids and/or bioburden to prevent hardening of debris or the development of biofilm due to processing delays. TJC also stated that:
- Pre-cleaning applies to surgical instruments, devices and supplies that, based on manufacturer instructions for use (IFU), are intended to be reprocessed (meaning they are not single-use disposable items).
- When there are delays in the cleaning/decontamination reprocessing steps, gross soil should be removed at the point of use.
- Pre-cleaning at the point of use is required when soiled items cannot be immediately contained and transported to a decontamination area or soiled utility area. “Immediately” is described as “without delay.”
- Pre-cleaning at the point of use requires that visible bioburden is removed from the instruments prior to transport to a decontamination area where pre-cleaning or preparation for transport to a reprocessing area occurs.
- If a product is selected for pre-cleaning purposes, compliance should be based on the manufacturer’s IFU.
- When there are delays in instruments reaching decontamination in CS, items must be pre-cleaned and remain moist while awaiting transport to decontamination.
- Use of a pre-cleaning product or other acceptable method to keep instruments moist applies when there are delays in transporting instruments.
TJC’s response also states that practices should be based on the evidence-based guidelines adopted by the individual organization. TJC surveyors should evaluate compliance based on the guidelines in which the organization has based its policies and procedures. If a product is selected for keeping instruments moist, the organization should follow the manufacturer’s IFU. For example, if the IFU states that hinged instruments are to be in the open position then the surveyors will look for this practice to be consistently followed.
Assessments identify compliance gaps
TJC recommends facilities conduct a proactive risk assessment to examine the process in detail and identify gaps in compliance with evidence-based guidelines and product manufacturers’ IFU. The introductory section of the Leadership (LD) chapter in TJC standards provides an example of a proactive risk assessment model that an organization may use.
TJC concluded its response by sharing examples of professional organizations that publicize nationally recognized guidelines and/or recommendations. Those include: AORN; AAMI; Centers for Disease Control and Prevention (Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. Cleaning, page 73); and Association for Professionals in Infection Control and Epidemiology (APIC).
The bottom line is CS professionals should ensure their facility’s policies reflect whichever standards and guidelines their facility follows, and they should also ensure consistent adherence to those standards. Conducting a routine risk assessment can help to ensure standards adherence and may help facilities avoid a CDL from surveyors.
Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Association of periOperative Registered Nurses. Guideline for cleaning and care of surgical instruments. In: Guidelines for Perioperative Practice. 2018.
Association of periOperative Registered Nurses. Guideline for Environment of Care. In: Guidelines for Perioperative Practice. 2018.
Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST58: 2013. Chemical sterilization and high-level disinfection in health care facilites. 2013
Centers for Disease Control and Prevention. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.
The Joint Commission. Standards FAQ Details, Instrument Reprocessing – Point-of-Use and Pre-Cleaning Expectations.