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Monitoring the Cleaning Process in Sterile Processing Departments

Believe it or not, there was a time when the only quality testing hospitals performed in the sterile processing department was running a biological indicator once a week in the steam sterilizers. But just monitoring the sterilization process is no longer acceptable. A good quality control program requires continuous monitoring of all cleaning and sterilization processes. Quality control should include checking the performance of the mechanical cleaning equipment, manual cleaning processes, and personnel, in addition to measuring soil reduction on medical devices. 

It has only been 20 years since tests for mechanical cleaning equipment became commercially available and 12 years since the standards were updated to recommend performance testing. In 2008, the Association of periOperative Registered Nurses (AORN) updated the standards to include the testing of mechanical cleaning equipment, and in 2009 the Association for the Advancement for Medical Instrumentation (AAMI) followed suit. Since then, the standards have been further updated and currently read that performance testing of mechanical cleaning equipment should be performed when the equipment is installed, each day that it is used, when evaluating or changing cleaning chemistries, and after the equipment undergoes major repairs. When testing washer-disinfectors, all cycles being used should be tested, the standards say. For example, if you are running a cycle for basic instruments and a different cycle for eye instruments, each of these cycles should be tested. The results of the daily cleaning verification tests should be documented and retained per each health facility’s record retention policy.

The one area that is often overlooked but is recommended as part of a good quality control program is the reviewing of the washer-disinfector cycle printouts. AAMI ST79:2017 states that the printouts from the washer-disinfector, if available, should be reviewed and initialed after each load to ensure the washer cycle was acceptable and the washer completed all required phases of the cycle.1 In a busy department it is easy to overlook the cycle completion message on the screen. Reviewing the printout would ensure the parameter is met.

For equipment monitoring, it is important that the quality assurance program include objective indicators that pose a consistent, repeatable challenge to the equipment and provide real-time feedback. Using a standardized test soil or dye is a reliable way to test the functionality of the mechanical cleaning equipment. These tests should be easy to use, easy to read, and validated to ensure that the critical parameters of the process are being measured. For example, the parameters for a washer-disinfector include temperature, time, and presence of chemistry. The parameters for an ultrasonic would include cavitation, time, temperature, and presence of chemistry. It is important to note that it is best practice to test each level of the multilevel rack used in the washer-disinfector. It is possible for a test placed on the top shelf of a multilevel rack to pass while the test placed on the middle shelf fails. Placing tests on each level of a rack helps to troubleshoot the reason for the failure.    

There are many products available today that can quickly detect organic residuals on medical devices. Gone are the days when unaided visual inspection of the instruments is the only means to assess cleanliness and the removal of organic, inorganic, and microbial contamination on medical devices. A comprehensive quality assurance program should also include directly testing individual instruments for residual soils. These tests should be rapid, easy to use, accurate, repeatable, and sensitive to realistic benchmarks such as protein, carbohydrate, hemoglobin, and adenosine triphosphate (ATP) levels. At some interval, individual instruments, especially complex instruments with crevices and lumens, should be checked for residual soil.

In 2014, Michelle Alfa and Nancy Olson published a study comparing the ability of three different commercially available cleaning indicators to detect suboptimal washing conditions. During this study, Alfa identified that even with suboptimal washing conditions, such as a lack of detergent, the instruments looked clean with visual inspection. Visual inspection of instruments without the aid of magnification or a borescope cannot be relied upon to identify inadequate cleaning. Commercially available cleaning indicators are designed pick up inadequate cleaning results because they measure the most critical deficiencies.2  

For cleaning equipment to function properly, it must be maintained properly. It is important to make sure that all mechanical cleaning equipment is inspected and maintained per the manufacturer’s instructions. For washer-disinfectors, sterile processing personnel should be verifying that the spray arms are turning freely and are not clogged, strainer screens are clean, and external surfaces are not soiled. Regular preventive maintenance should be performed, and all records should be retained.

To assess personnel performance, it is important to have defined cleaning policies and procedures based on medical device manufacturers’ instructions as well as published recommendations. Instructions for use should be available to the staff working in the decontamination area for reference. Many of the tracking software available on the market allow for IFUs to be added for direct reference. Auditing staff performance by watching how they are cleaning medical devices and loading the equipment are part of quality control and monitor personnel competencies.  

As you can see, a good quality control program in the sterile processing department, specifically for cleaning processes, should include objective verification methodologies that assess and verify the performance of the mechanical cleaning equipment and check for any residual contaminants on medical devices following the cleaning process.  

We have come along way with quality control in the sterile processing world. Look at the quality assurance program in your institution and make sure it is keeping your process in line with the standards. Don’t take quality assurance for granted. It adds the necessary checks and balances to a process that can be rife with human error.  


  1. ANSI/AAMI ST79: 2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. (n.d.). Arlington, VA.
  2. Michelle Alfa, N. O. (2014). “Comparison of washer-disinfector cleaning indicators: Impact of temperature and cleaning cycle parameters.“ American Journal of Infection Control, 23–26

Linda Condon is the president and CEO of Condon Healthcare Consulting, LLC located in Baltimore, Maryland, USA. She has been in the medical field since 1984 when she graduated from nursing school and took her first job as perioperative nurse. Prior to starting her own consulting company, she was the director of the central sterile processing department at Johns Hopkins Hospital. During her 23-year tenure at Johns Hopkins she actively worked on implementing quality assurance initiatives to include developing measurable metrics for cleaning, assembly, and sterilization processes. She has presented both domestically and internationally to promote safe sterilization practices. She is currently a voting member on several AAMI committees. She holds a master’s degree in business administration and is a published author. 

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