How do You Know Your Automatic Washer is Safe to Use?

February 1, 2006

How do You Know Your Automatic Washer is Safe to Use?


By Stephen M. Kovach

Imagine this scenario: A surveyor for
the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)
asks a central service (CS) manager, How do you know your automatic washer is
working properly? The CS manager replies, My instruments look clean.

It is no longer uncommon for such a question to be posed to CS
staff. Central service has become one of the hospitals most highly technical
areas. Professional organizations that set guidelines and standards for central
service, such as JCAHO, the Food and Drug Administration (FDA), the Centers for
Disease Control and Prevention (CDC), and the Association for the Advancement of
Medical Instrumentation (AAMI), have begun to focus on verifying and monitoring
the cleaning process, and on implementing quality improvement programs (QIPs.)
Their guidelines pertain to ultrasonic cleaners and automatic washers.

The following paragraphs outline the various regulatory
organizations guidelines concerning monitoring the cleaning process. CS
professionals can use these guidelines to answer questions such as:

  • How do I know my automatic washer and ultrasonic cleaner
    are working properly?
  • What am I doing to ensure that these machines are working
    the way they are intended to?
  • How do I ensure that these machines are rending items
    clean and safe for handling by staff and ready for use on a patient?


JCAHO

Darlene Christiansen, director of standards interpretations
and the Office of Quality Monitoring for JCAHO, states, Sterile processing is
an integral part of the care process, so its important to assess that
equipment is being properly maintained, chemicals are being used properly,
infection control and (safety) measures are being applied appropriately, and
that there is proper ventilation, for example.1

Two new JCAHO standards support Christiansens assessment.
Standards EC.6.10 and EC6.20 require organizations to manage the risks of
medical equipment and that equipment be maintained, tested, and inspected on a
prescribed basis. These standards require the organization to have a written plan in place.2


AAMI

AAMI is the primary resource for domestic and international
standards for the medical industry, medical professions, and the government. AAMIs revised TIR 12:2004, 2nd Edition Designing,
testing, and labeling reusable medical devices for reprocessing in healthcare
facilities: A guide for device manufacturers is an excellent resource for
identifying the questions healthcare professionals should ask manufacturers when
considering a product for purchase or when devising a reprocessing protocol for
a product already being used.

This new document is the most proscriptive thus far when it
comes to the monitoring of the cleaning process. It directs device manufacturers
to provide not only specific instructions on how to clean their surgical
instruments, but also how to verify that proper cleaning has occurred.
Suggestions include monitoring water temperature for proper cleaning and
disinfection, employing a specific method to test the cleanliness of an
instrument, or using a suitable analogous device to verify the effectiveness of
the cleaning process.

CS professionals should know that not only does the TIR 12
document direct manufacturers, but also by inference, it empowers the hospital
CS department to insist on receiving proper and complete decontamination
documentation for each and every instrument.

The revised AAMI standard ST 35, 2003 (decontamination
document) recognizes the need for testing and the importance of having a quality
process in place when it comes to cleaning:

  • 7.4.1: Effective cleaning is a multi-step process that
    relies on several interdependent factors: the quality of the water; the quality
    and type of detergent; an acceptable washing method; proper rinsing and drying;
    correct preparation of items to be processed by cleaning equipment; the time and
    temperature parameters and load capacity of the equipment; and operator performance
  • 7.4.2 Cleaning agents: Many types
    of soil could be present on reusable medical devices, but dried blood is
    especially difficult to clean. As a liquid, blood tends to flow over and into joints, hinges,
    grooves, and other difficult-to-clean locations. It then coagulates and dries to
    create a significant challenge to cleaning
  • 7.4.4 Verification of the
    cleaning process: There is an increasing awareness in sterile processing of the
    need to control and standardize the steps taken to ensure a sterile device for
    patient use. With the understanding that disinfection and sterilization cannot
    be ensured unless the cleaning process is successful, it is incumbent upon
    professionals in the field to seek out whatever means are available and
    practical to verify this function. A quality system would call for the
    decontamination processing parameters to be monitored and documented, whether
    the process was accomplished by hand or mechanically
  • 9.2 Quality process:
    Measurements of process performance allow the system to be monitored and the
    results compared to a predetermined level of quality. Evaluation of the findings
    provides a method of identifying problems or shifts in activities, and
    facilitates informed decision-making on policies and procedures. Ongoing auditing provides data to assess the effectiveness of
    the process and make ongoing improvements in performance.


FDA

The FDA document, Class II Special Controls Guidance
Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff
states, The FDA believes that a safe and effective system for cleaning and
disinfecting medical devices is important in protecting the public health.
(Feb. 7, 2002)

The Safe Medical Device Act of 1990 states that each institution
must have processes in place for identifying and implementing the reporting of
incidents related to equipment failure.3 Equipment that fails or is taken out of
service must be reported and documented. Failure of an automatic washer certainly warrants
documentation and follow-up.


CDC

Currently, the CDC is reviewing its Guideline for
Disinfection and Sterilization in Healthcare Facilities. The final guideline
will be published following revisions. The CDCs current recommendations can
be found at its Handwashing and Hospital Environmental Control page: Cleaning
is the necessary first step of any sterilization or disinfection process... If
the surface is not cleaned before the terminal reprocessing procedures are
started, the success of the sterilization or disinfection process is compromised.4


Industry

Companies serving the infection control market are beginning
to supply users with information on how to test their automatic cleaning
equipment. For example, in May 2005, Smith & Nephew updated its Cleaning and
Sterilization Guide for Orthopedic Instruments on its Web page. The new user
guide includes the following recommendations:

  • The quality of water should be carefully considered for
    use in cleaning reusable devices. Water hardness is a concern because deposits left on medical
    devices may result in ineffective decontamination. The use of deionized water
    will reduce the mineral deposits on the devices.
  • Ultrasonic cleaners should be monitored routinely to
    ensure that they are working properly. Recommended monitoring methods are Sonocheck monitoring vials
    from Healthmark Industries Co. which change color when the ultrasonic cleaner is
    supplying sufficient energy and conditions are correct. Getinge also has
    developed a performance-monitoring program that allows users to independently
    verify the key parameters of the automatic cleaning equation under their
    control.
  • On the subject of verifying the cleaning process, Linda
    Clement and Heide Ames of STERIS Corporation state, Now you must investigate
    the entire sterilization process, beginning with cleaning: a) verify that the
    washing equipment is working properly (spray arms arent obstructed and water
    heating element isnt malfunctioning, for example); b) verify that the washing
    equipment monitoring devices are functioning correctly; c) ensure that all
    cleaning chemistries used in the washer are appropriate for the equipment and
    the devices being processed, and that they are being dispensed correctly.5


Why Test in the First Place?

Regulatory agencies and industry are promoting the
implementation of QIPs to monitor the cleaning process. Even with the advent of
such guidelines, some people question the need to monitor. The following
reallife examples illustrate why hospitals should implement QIPs for their
automatic washers and sonic equipment.

  • Switched at Birth: A CS manager implemented a cleaning QIP
    which included the use of a standardized blood soil test. The failed test
    result, which included residual blood soil on the stainless steel coupon,
    indicated that water temperatures were not correct for the various cycles. Upon
    investigation staff discovered that the washer had been installed 10 years prior
    with the cold and hot water delivery pipes reversed. This resulted in excessive
    pre-wash temperatures for the equipment cycle setting.  After the problem was corrected the washer was again tested
    and received a passing mark.
  • How to Save Detergent: Shortly after switching brands of
    detergents for their automated washers, staff at one hospital reported a blood
    odor in the machine after the cycle was complete. The staff followed the recommended QIP, including use of a
    standardized blood soil test. They determined that the new detergent had produced excessive
    sudsing and that the detergent concentration had been set to nearly zero. Although this certainly would have saved the hospital a great
    deal on its detergent budget, the instruments were not getting clean.
  • Im Melting: After implementing a new QIP program for
    the automated washer, a CS department quickly discovered that a plastic supply
    line for the detergent had, for a period of time, been in contact with a
    noninsulated portion of the hot water line. The tube had melted closed, completely eliminating detergent
    supply to one of the washers. No one knew how long this condition had been in place.
  • An Expensive Soaking Tank: A hospitals sonic cleaner
    looked and sounded like it was functioning properly, but when staff used a new
    test designed to detect cavitation energy, the sonic cleaner failed. A follow-up
    visit by an independent service company confirmed that the transducers were not
    working. No one in CS knew how long the cleaner had been malfunctioning; they had simply let the machine run longer (sometimes up to 15
    minutes) until they felt the instruments were clean.
  • True Confessions from the Author: In my own experience as
    CS manager I have seen the need for monitoring the cleaning process. In one case
    I was using a different detergent than what my washer company required. After
    visual inspection we determined that the instruments were not clean. The washer
    company blamed the failure on our use of the wrong detergent, but the detergent
    company defended its product. All I had was a visual assessment; I had no
    independent test that could determine why my instruments were not as clean as
    they had been before. Eventually we discovered it was a dilution problem, but
    only after a lengthy, frustrating investigation that could have been avoided had
    we had a proper test.

I had a similar experience loading trays in my automatic
washer. The hospital where I was working had a problem processing trays; the CS department was very busy and the decontamination area
kept backing up. A representative of the equipment company told me to
double-stack the baskets because the machine could handle it. He also told me I
could put the trays in without rinsing them, which would speed up the process.
After running about five loads this way my staff informed me that the
instruments were not clean. We immediately stopped this process. Had I taken the time to learn more about how my equipment
worked and the impact of all the factors of the cleaning process, I could have
solved my problem more easily and with less frustration. At that time I not only
lacked education and training, I had no real method for monitoring my cleaning
process.

These examples illustrate the frustration CS mangers
experience when cleaning instruments. This is not a new problem, nor has it gone unrecognized by the
public. The following news headlines appearing over the past few years attest to
public concern about monitoring the cleaning process:

  • The process of sterilization should not replace the
    process of cleaning. Soil is still soil, even though it may have been sterilized.6
  • The quality of reusable equipment depends on the
    reliability of cleaning and sterilizing procedures.7
  • Inadequate cleaning of medical or dental instruments
    can threaten the sterilization process.8
  • Surgery halted over dirty instruments, in England.9
  • North Carolina surgeons unwittingly used dirty tools.10
  • In order to sterilize medical devices effectively, all
    organic debris (e.g. blood, tissue, and other bodily fluids) have to be removed
    from the item prior to disinfection and/or sterilization. 11

Concern is growing about the effectiveness of decontamination
techniques for reusable instruments in healthcare facilities. These techniques have a direct impact on patient outcomes.
Studies have shown the ability of sterilization technologies, which under normal
conditions achieve acceptable sterility assurance levels, to be greatly impaired
by the presence of residual soil containing serum and salt.12 Residual organic
debris on processed surgical instruments is a concern, and visual inspection is
not 100 percent accurate.13

The best way a medical facility can determine whether its
equipment is working properly is to implement a quality improvement program. The
QIP should be used daily and after equipment is installed or relocated. It
should also be used after a machine malfunctions, a process fails, or any major
repair is made on the equipment. The QIP should include, but not be
limited to, daily inspection of equipment (cleaning screens, spray arms,
interior of the chamber, etc.), testing via a blood soil type test, and
continuous staff training.


The Future

CS professionals need and are receiving support from
regulatory agency guidelines to implement quality improvement programs to
monitoring the cleaning process. Yet still we must answer to the public who read
the headlines and ask, How do you know your instruments are clean?
Likewise, we may have to answer to a JCAHO surveyor who, as in the opening of
this article, asks, How do you know your automatic washer is working
properly?

It is my experience that if you ask 10 CS managers what
sterilization parameters they use, all 10 will respond, 273 degrees
Fahrenheit for four minutes. When you ask about the parameters used for
cleaning, however, you are lucky if 50 percent know the answer for their
equipment. This lack of knowledge makes it very difficult to optimize the
cleaning process.

Many CS professionals are already taking steps to monitor the
cleaning process. These individuals responded as follows when asked the original
question, How do your know your washer is working properly?

  • Penny Sabrosky, a senior manager at Spectrum Health: We
    currently use the product TOSI to test the efficacy of our washer units on a
    weekly basis and when we discover problems with unusual soil, or rinsing
    problems. We recently signed up for a preventative maintenance program from the
    manufacturer of the equipment and receive quarterly maintenance and service upon
    request for breakdowns. Typically we would run a TOSI test after the service is
    performed for verification of the maintenance.
  • Betty Strickland, director of materials management at Christus St. Joseph Hospital: I use the TOSI daily.
  • Nyla Japp of Banner Health: I know my automatic washer
    is safe to use because I validate my cleaning process in every washer once a
    week and following any needed repairs. I do this by a process called TOSI
    cleaning effectiveness indicators. I log the results as to whether or not they
    pass or fail this challenge. If they do not pass this challenge, the washer
    manufacturer is called in for repairs and the washer is taken out of service
    until it successfully passes the TOSI challenge.
  • Denise Coatsworth, CS manager at Botsford General
    Hospital: (This question) can open up a can of worms. I dont believe a
    visual inspection of instruments defines cleanliness because cleanliness can be
    subjective. As a manager, I would look to CS organizations to establish
    standard protocols for what conditions and testing determine a clean
    instrument. An instrument may appear clean once it comes out of the washer, but
    is there any way that the appearance and condition of that instrument can be
    improved? We also want to ensure that the instrument is safe for handling. As we
    know, an instrument cannot be determined sterile unless it is clean. Standard
    protocols have been established and written for our institution and a routine
    quality test must be run weekly to maintain and document the quality of the wash
    cycle. The TOSI test is an easy and reliable test for the wash cycle, but once
    that test is run and obtains less than optimum results, as the manager I must
    then be willing to take action to get the washer to the optimum level. In good
    conscience, I could not run the test, obtain less than optimum results, and then
    take no action.

The following quotations summarize why CS departments should
monitor their cleaning process.

  • A problem analysis should be completed for any problem
    with any aspect of decontamination that can pose a risk to personnel or
    patients. The problem analysis should define and resolve the problem and the
    system should be monitored to ensure that the problem has been corrected.14
  • Cleaning, not sterilization (or disinfection) is the
    first and most important step in any instrument processing protocol. Without
    first subjecting the instrument to a thorough, validated, and standardized (and
    ideally automated) cleaning process, the likelihood that any disinfection or
    sterilization process will be effective is significantly reduced.15

Ensuring safety and quality is an active practice, not a
passive one. Isnt it time for everyone to understand and monitor the cleaning
process? When monitoring whether manual or automatic occurs, the winners
are both patients and staff.

Stephen M. Kovach,
director of education for Healthmark Industries in St.Clair Shores, Mich., has
worked in the hospital field for more than 30 years. He has held many positions,
including dialysis technician, cardiac catheterization technician, and
perfusionist. For the last 18 years he has held various positions dealing
with central service. He also has been an instructor at the community college
level and published many articles varying in subject matter from perfusion to
the importance of cleaning surgical instruments.


References

1. Hospital Purchasing News. June 2004, page 32.
2. Joint Commission on the Accreditation of Healthcare Organizations. 2004
Standards for Accreditation, Environment of Care Standards EC.6.10,EC6.20.
JCAHO, Oakbrook Terrace, Ill.
3. Food and Drug Administration. Center for Device and Radiological Health. Safe
Medical Device Act of 1990.
4.
http://www.cdc.gov/ncidod/hip/enviro/Enviro_guide_03.pdf
, page 72.
5. Healthcare Purchasing News. September 2005. Page 41.
6. The Central Service Technicians Training and Supervision. IAHCSMM 1975.
7. Leon Hirsch, chairman, ES Surgical. Wall Street Journal, April 1993.
8. Janet Prust, technical services supervisor, 3M Health Care.
9. London Daily Telegraph. November 18, 2000.
10.
http://www.usatoday.com/news/health/2005-06-13-surgery-nc_x.htm

11.
http://www.smtl.co.uk/MDRC/VaginalSpecula/pelican-report.html
Report No:
00/1192/1, Revision: 1.20, November 2000.
12. Alfa, M., et al. Comparison of ion plasma, vaporized hydrogen peroxide, and
100 percent ethylene oxide sterilization to the 12/88 ethylene oxide gas
sterilizer. Infection Control and Hospital Epidemiology, 1996; 17:92-100.
13. AORN Journal. July 1995. Vol. 62, No. 1.
14. Section 9.2 ANSI/AAMIST35 - 2003. Page 23.
15. 510(k) Summary and Overview: Safety, Efficacy and Microbiological
Considerations. The System 83 Plus Washer-Disinfector; Custom Ultrasonics, Inc.
1998, page 7.