Issue 2

issue
THE

Cleaning Reusable Medical Devices: A Critical First Step

Introduction

Over 45 million inpatient1 and 31.5 million outpatient2

surgical and non-surgical procedures are performed

annually in the United States. During these

procedures, patients entrust their well-being to

the medical professionals with whom they come

in contact. They trust that all necessary measures

have been taken to ensure an optimal outcome.

One measure that must be reliably performed is

the appropriate cleaning of the millions of reusable

medical devices which come into contact with

By Susan Shoemake, BA and . patient skin, blood and other body fluids and tissues
Kathleen Stoessel, RN, BSN, MS
each year.3 According to the FDA, a medical device

Table of Contents: is "an instrument, apparatus, implement, machine,

contrivance, implant, in vitro reagent, or other similar

Introduction................................................... 1
or related article.”4 What if reusable devices were not
Risks of Improper Cleaning........................ 2
Components of Cleaning Solutions........... 5 appropriately cleaned after each procedure? What

Common Types of Cleaning Solutions...... 6 impact would that have on patients? This article
Factors for Effective Use............................. 7 discusses the risks associated with improper cleaning
Conclusion . .................................................. 9
of reusable medical devices and provides medical

professionals with the information on the effective use

of cleaning solutions.
 Cleaning Reusable Medical Devices: A Critical First Step

Risks Associated with Improper Cleaning

Following a procedure, a medical device of the proper products and processes
is contaminated with both visible and to assure that all surfaces, internal and
hidden bioburden. This bioburden or soil external, are completely free of bioburden.
may contain hundreds if not millions of Finally, the devices should be thoroughly
potentially infectious organisms. Any soil rinsed to remove all residual bioburden
left on a device following cleaning can and detergent. If the device is not going
pose a risk to the patient. Therefore, it is directly into a washer following this step,
imperative that appropriate steps be taken the device should also be dried. Always
to ensure a thorough cleaning process. remember, if the device is not clean, it
Proper cleaning of medical devices is a cannot be sterilized.
multi-step process (Figure 1). Before a
Significant risks have been associated
medical device reaches the reprocessing
with inadequate or improper cleaning.
area, it is critical to remember that
These risks include healthcare-associated
contaminated devices should be handled
infections (HAIs) due to the presence of
as little as possible following use.
residual soil and/or improper disinfection
Preferably, after use, devices should be
or sterilization, and damage to the medical
soaked or sprayed to keep them moist
device.
during transport. Keeping the devices and
any residual contaminants moist helps Healthcare-Associated Infections
make the cleaning process easier and It has been reported that HAIs have
more effective. accounted for an estimated 2 million
Thorough manual and/or mechanical infections, 90,000 deaths, and $4.5 billion
cleaning is needed for all reusable in excess health care costs in the United
medical devices prior to disinfection or States alone.5 Due to the significance
sterilization. This step requires the use

Figure 1.
Return to Use and
Inventory Contamination

Microbicidal Immediate Handling

Processes at the Point of Use
[disinfection; sterilization]
Reusable Medical
Device Reprocessing
Cleaning Transporting

Sorting and
Presoaking
Disassembly

Proper cleaning is essential to reducing the risks associated with improper or inadequate
medical device reprocessing.


 Cleaning Reusable Medical Devices: A Critical First Step

of this problem, initiatives to monitor accepted cleaning and disinfection

and prevent the occurrence of HAIs have guidelines.8
been developed. As of February 2007, 16
states have enacted legislation mandating
hospitals to publicly disclose HAI rates.
Several other states have legislative
efforts in progress.6 Within the last few
years, initiatives such as the Surgical
Care Improvement Project (SCIP), the
100 Thousand Lives Campaign, and the 5
Million Lives Campaign were developed
to reduce HAIs and to protect patients
from medical harm. Additionally, Pay
Scanning electron micrograph of a Staphylococcal
for Performance (P4P) incentives have
biofilm on the inner surface of an indwelling medical
been established to reward good patient device. Bar, 20 µm. Used with permission of Rodney
outcomes. M. Donlan, Ph.D. and Janice Carr, CDC.
These various initiatives demonstrate Another risk of infection develops from
the increasing legislative and consumer improperly processed devices which allow
interest in HAIs and the Centers for for accumulation of microbial biofilms
Medicare and Medicaid Services (CMS) (collections of bacteria and fungi). These
push toward pay-for-performance (P4P). biofilms adhere to each other and to the
This focus on reducing medical errors has surfaces of medical devices, especially
generated an even greater emphasis on those with lumens, and increase the
standardized and appropriate cleaning of difficulty of thorough cleaning. Cleaning
medical devices. devices immediately after use has the
Improper cleaning has been implicated potential to eliminate this problem of
in patient-to-patient transmission of biofilm contamination.9,10
microbes via contaminated devices Any soil or bioburden remaining on a
such as bronchoscopes contaminated device after cleaning poses a clear risk
with Mycobacterium tuberculosis.3 to the next patient. Unfortunately, this
Documented cases of pathogen incomplete cleaning occurs all too often.
transmission via gastrointestinal (GI) For example, the Pennsylvania Patient
endoscopic procedures have been Safety Authority has received multiple
associated with a breach in accepted reports citing devices contaminated with
cleaning and disinfection guidelines, use bone, tissue, dried fluids and used sutures
of an unacceptable liquid germicide for that were introduced into the sterile field.
disinfection, improper drying or defective Specifically, this contamination included
equipment.7 In a similar case report, bone left in reamers, blood and tissue
the transmission of Hepatitis C virus to found on a drill and suture fragments
patients during colonoscopy procedures remaining on a tunneler.11
was associated with a breach in following


 Cleaning Reusable Medical Devices: A Critical First Step

Improper disinfection or sterilization This situation also wastes valuable time

Another risk associated with improper and increases costs associated with the
cleaning is the resultant improper scheduled procedure.
disinfection or sterilization of medical
devices. All high level disinfection and
sterilization technologies available today
are surface agents. They must have
unimpeded contact with all surfaces of
the device, internal and external, to assure
microbial inactivation. Any residuals left
on the device, including medical soil,
contaminants and detergent residue
can interfere with that direct contact.
Furthermore, interaction of the residuals
with the disinfectant or sterilant could
lessen the efficacy of that disinfectant or
sterilant.3,10,12
Errors in reprocessing which are not identified until
If the error in reprocessing is not
the medical devices have been introduced into the
identified prior to surgery, serious patient
sterile field or are used on a patient can result in
complications may result. For instance,
serious consequences to the facility as well as
there have been reports of sterilized the patient.
medical devices that have remained
Damage to medical devices
contaminated with bacterial endotoxin
A medical device may become damaged
residues. These heat-stable toxins are not
by cleaning solutions or medical soils
destroyed during the sterilization process
that are not removed properly after
and remain a danger to the patient.
the cleaning process.12 Using cleaning
Also, inflammatory reactions have been
solutions that are not compatible with a
reported when detergents, enzymes and
device may cause damage as well.12 Types
tiny particulate matter have contaminated
of damage the device may sustain include
instruments, tubing or the inside of
staining, pitting or corrosion,14 clouding or
irrigating cannulas.13
etching of optics15 and improper function
There may be a delay in detecting due to accumulation of debris.12
reprocessing errors. If an improperly
In order to reduce the risks associated
processed device is introduced into the
with improper or ineffective cleaning
sterile field, it poses not only a risk to
of reusable medical devices, the basic
the patient but may also create cost and
components and types of cleaning
process challenges. The procedure may
solutions, as well as the factors for the
be delayed, causing the patient to remain
effective use of cleaning solutions, must
under anesthesia longer than necessary.
be understood.


 Cleaning Reusable Medical Devices: A Critical First Step

Basic Components of Cleaning Solutions

It is essential that an appropriate cleaning Enzymes increase cleaning efficacy, speed
solution be chosen, and that it be used the cleaning process and help to minimize
correctly, to assure optimal cleaning the need for manual brushing and
of medical devices. To do this, an scrubbing. There are a variety of enzymes
understanding of the basic components of available, each targeting a particular type
cleaning solutions is required. of soil. The most common enzyme found
in solutions used for cleaning medical
Only those cleaning solutions that are
devices is protease, which helps to break
specifically formulated and labeled for
down protein-based soils such as blood
use on medical devices should be used
and feces. Also available are amylase to
in reprocessing. The formulation of each
break down starches like those found
cleaning solution is unique; however, most
in muscle tissue, cellulase to break
will contain some combination of the
down carbohydrates like those found in
following six components (Figure 2 on page 6).
connective fluid and joint tissue and lipase
Water is the most common solvent on to break down fats like those found in
earth and provides the base for most adipose tissue. Any combination of these
cleaning solutions. enzymes may be present in a solution.
Detergent helps to loosen debris from Solutions containing enzymes can often
surfaces. The detergent then acts to hold be used at a more neutral pH and at
the debris in suspension, preventing it lower temperatures than those without
from re-depositing on the device and enzymes.16
allowing it to be easily rinsed away.
Surfactants increase cleaning efficacy by
reducing surface tension thus allowing for
better penetration of the soil.
Buffers provide better compatibility with
materials and inhibit corrosion.
Chelating agents assist with reducing
the potential negative effects of hard
water that may be used when diluting the
solution. They also bind with hard water
minerals to prevent them from depositing
on the device or adversely reacting with
the cleaning solution. It is important to
note that hard water may cause spotting
or leave deposits on the device.


 Cleaning Reusable Medical Devices: A Critical First Step

Common Types of Cleaning Solutions

Medical device cleaning solutions are
made up of various combinations of
the six basic components. The most
common formulation categories of
cleaning solutions are enzymatic and
non-enzymatic. Typically, medical device
cleaning solutions will be simply referred
to as ‘detergents’.

Enzymatic detergents are most

commonly used for manual cleaning and
include single- dual- and multi-enzyme
formulations. Single-enzyme detergents
will most often contain a protease enzyme
while dual- and multi-enzyme detergents
will also contain some combination of
amylase, lipase and/or cellulase. These
solutions are often designed to be used
at room temperature or slightly warmer
and provide rapid action at a neutral pH.
Due to the selectivity of each enzyme,
the enzymatic detergent chosen should
correspond with the type of medical soil(s)
present.

Non-enzymatic detergents are most

commonly utilized in automated washers.
They can be of either a neutral or alkaline
pH and provide effective cleaning at
elevated temperatures.

Figure 2.

Water
Amylase Enzyme
Detergent
Cellulase Enzyme
Surfactant
Lipase Enzyme
Buffer
Protease Enzyme
Chelating Agents

Most cleaning solutions for medical devices are composed of the following: water, detergents,
surfactants, buffers, chelating agents, and one or more enzymes.


 Cleaning Reusable Medical Devices: A Critical First Step

Factors for the Effective Use of Cleaning Solutions

For a cleaning solution to be effective,
a number of factors must be addressed
including:

1. Personnel training

2. Appropriate use of personal protective

equipment (PPE)

3. Proper device preparation

4. Quality of the water used

5. Adherence to guidelines and

manufacturer’s directions for use

Personnel Training
Personnel training is essential for the
effective use of cleaning solutions. It is
critical that personnel with responsibility Appropriate use of PPE is a key factor for the
for any part of device reprocessing be effective use of cleaning solutions.
properly trained and provided with the
tools needed to complete their task Liquid resistant coverings with sleeves,
effectively and safely. surgical face masks and eye protection
should be worn in the decontamination
The training program should include
area. Protective apparel should be changed
education on:
daily and immediately if wet, heavily
■ OSHA Bloodborne Pathogens soiled or visibly contaminated by blood
Standard or body fluids. Surgical head coverings
■ Standard Precautions should completely cover all head and facial
■ Mechanisms of disease transmission hair except for eyebrows and eyelashes.
Clean shoes, designated for facility use
■ Safe handling of chemicals
only, should be skid resistant and durable
■ Reprocessing procedures enough to prevent injury from dropped
■ Device design and component parts items. If shoe covers are selected,
■ Procedures for waste management they should be skid resistant and liquid
■ Maintenance of a safe work resistant or liquid proof. Designated shoes
environment17 and/or shoe covers should be removed
upon exiting the decontamination area.
Appropriate use of PPE
Additionally, general purpose utility gloves
When handling contaminated devices,
should be worn. If gloves become torn,
medical professionals should wear
they should be replaced immediately after
appropriate PPE based upon the degree
appropriate hand washing. Jewelry and
of risk. In the decontamination area, clean
wrist watches should not be worn
uniforms should be donned at the facility.


 Cleaning Reusable Medical Devices: A Critical First Step

in the decontamination area. All PPE

should be removed before leaving the
decontamination area. Special care should
be taken to avoid contaminating clothing
and skin.12

In addition to personal protective

equipment, handwashing is imperative
for minimizing organism transfer among
personnel, patients, and objects. Hands
not visibly soiled should be washed with
soap and water or cleaned with alcohol-
based, waterless, hand hygiene agents. Proper device preparation aids in exposing
Hands that are visibly soiled should be all device surfaces to the cleaning solution.

washed with soap and water. Additionally, the efficacy of the cleaning solution and
hands should be decontaminated after cause spotting on devices. Ideally water
gloves and other PPE are removed in should be filtered through a 0.2 micron
accordance with good personal hygiene filter. Potable tap water may also be used.
practices and departmental policy.12 Filtered water or sterile water is preferable
for rinsing the devices.17
Proper Device Preparation
Prior to cleaning, proper preparation Adherence to Guidelines and
aids in exposing all device surfaces Manufacturer's Directions for Use
to the cleaning solution. This includes It is important to adhere to the
opening scissors, box locks and jaw type manufacturer’s directions for use and
devices, disassembling complex devices applicable guidelines. This will ensure
and pre-cleaning flexible endoscopes. It optimal performance of the solution.
should be noted that “more healthcare- Always refer to the package label for
associated infections have been linked the correct use parameters including
to contaminated endoscopes than to temperature, dilution ratio and soak
any other medical device.”15 Therefore, time, as well as rinsing and drying
endoscopes should be pre-cleaned as per requirements.
the Society of Gastroenterology Nurses &
Typically, a minimum temperature is
Associates [SGNA] Guidelines.3,18
required for the solution to become
To prevent damage to sharp objects and active and to provide adequate cleaning
to protect health care workers from cuts, action. Using water that is hotter than
always isolate sharp objects from other recommended is not advisable as it may
devices. inactivate enzymes contained in the
solution or cause denaturing of protein-
Water Quality
based soils making them harder to
Good quality water is essential. Almost
remove.
all cleaning solutions are packaged as
concentrates; and must be diluted with The dilution ratio needs to be accurately
water. Poor water quality can reduce measured based on the manufacturer’s


 Cleaning Reusable Medical Devices: A Critical First Step

specifications which may include different sterilization is anticipated, devices should

dilution ratios for manual vs. automated be cleaned, rinsed, dried and stored
cleaning. For manual cleaning, it is temporarily.
necessary to measure the volume of the
Thorough rinsing is vital to preparing a
sink or basin being used for cleaning,
device for further processing. Residual
remembering that the container must be
debris or solution can lead to incomplete
deep enough to fully immerse devices
disinfection or sterilization and may also
in the solution. The appropriate amount
cause damage to the device. Always use
of cleaning solution must then be added
enough water to completely rinse the
based on that specific volume of water.
device surfaces, both external and internal
Using less solution than is recommended
with extra attention to lumens, hinges and
may decrease cleaning efficacy. More
crevices.
is not necessarily better as using too
much solution can make thorough Devices should be dried of excess
rinsing difficult; however, heavily soiled moisture prior to disinfection or
devices may require higher solution sterilization. Excess moisture may cause
concentrations. over-dilution of high level disinfectants,
reducing their efficacy below the minimum
It is important to soak the devices for
effective concentration. Excess moisture
the minimum time recommended by the
may also cause cycle cancellation in
manufacturer. This allows the components
some sterilization technologies. Leaving
of the solution to break down the soils
moisture on or in devices for extended
present. Note that the manufacturer
periods, especially in lumens and internal
may recommend a longer soak time for
surfaces, may promote the colonization
heavy or dried-on soil. It is not, however,
of waterborne microorganisms and the
recommended to use cleaning solutions
growth of biofilms.
for storing devices as soaking for
extended periods of time may damage
the devices or allow for microbial growth
in the solution. If a delay in disinfection or

Conclusion
Inadequate or improper cleaning of reusable medical devices puts patients at risk for
healthcare-associated infections. HAIs are a major concern in healthcare today and it
is imperative that all medical professionals do their part to reduce these preventable
infections. One step toward this goal is to ensure adequate and proper cleaning of
reusable medical devices. Cleaning essentials for these devices include a thorough
understanding of the risks associated with improper cleaning, the basic components of
cleaning solutions and the factors necessary for the effective use of cleaning solutions.
With this knowledge, medical professionals will be better equipped to promote optimal
patient outcomes.

Accreditied Education on this Topic:

A CE accredited, speaker facilitated presentation on this topic is available through your
Kimberly-Clark Sales Representative.

 Cleaning Reusable Medical Devices: A Critical First Step

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10
 Cleaning Reusable Medical Devices: A Critical First Step

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11
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