Chapter 5

Decontamination

I. Introduction

Cleaning is the most important part of disinfection or sterilization process. The Critical importance
thorough cleaning has been emphasized by all standard-setting organizations as well as by FDA and
CDC.

Numerous breaches in processing have been reported in the United States. In virtually all cases,
improper cleaning is at the root of the problem.

It is essential that every step in the device manufacturer’s current instructions for use (IFU) be
followed each and every time

If even one step is omitted, the entire disinfection or sterilization process can be ineffective

On September 11, 2015, the CDC & FDA issued a CDC Health Advisory entitled “Immediate Reusable
Medical Devices”

The Purpose of the communication was to alert “healthcare providers and facilities about public
health need to properly maintain, clean and disinfect or sterilize reusable medical devices.

Recent infection control lapses due to non-compliance with recommended reprocessing procedures
highlight a critical gap in patient safety.

Healthcare facilities (e.g. hospitals, ambulatory surgical centers, clinics and doctor’s offices) that
utilizes reusable medical devices are urged to immediately review current reprocessing practices at
their facilities at their facility to ensure them:

1. Are complying with all the steps as directed by the device manufacturers,
2. Have in place appropriate policies and procedures that are consistent with the current
standards and guidelines

The health advisory urged healthcare facilities to review their practices to ensure complete
compliance with manufacturer’s written instruction for use.

The following is also recommended:

 Health care facilities should arrange for a healthcare professional with expertise in device
reprocessing to immediately assess their reprocessing procedures.
 This assessment should ensure that reprocessing is done correctly, including allowing enough
time for reprocessing personnel to follow all steps recommended by the device manufacturer.
Training and competency verification was emphasized among the recommendations were the following:

1. Training should be required and provided:

a. Upon hire or prior to provision of services at the facility.
b. At least once a year
c. When new devices or protocols are introduced including changes in the manufacturer’s
instructions for use during the devices life cycle.
2. Personnel should be required to demonstrate competency with the device reprocessing (i.e
trainer observes correct technique) prior to being allowed to perform reprocessing
independently
3. Healthcare facilities should maintain current documentation of trainings and competencies.
4. If the healthcare facility hires a contractor for device reprocessing the facility should verify that
the contractor has an appropriate training program and that the training program includes the
specific devices that healthcare facility uses.
5. Copies of manufacturer’s instructions for operating and reprocessing each type of reusable
device should be readily available to staff and inspectors. This file should include instruction for
use of chemical disinfectants.

The Health Advisory also recommends that audits of the cleaning disinfection and sterilization processes
be routinely performed to ensure compliances with IFUs and policies and procedures

The national attention to cleaning and compliance with IFUs emphasizes the importance of the cleaning
process.

AS DEFINED BY AAMI (Association for the Advancement of Medical Instrumentation)

Cleaning – is the removal of contamination from an item to extent necessary for further processing or
for the intended use

AS DEFINED BY OSHA (Occupational Safety and Health Administration) in its regulation limiting
occupational exposure to blood borne pathogens

Decontamination – It is the use of physical or chemical means to remove inactive or destroy blood
borne pathogens on a surface or item to the point where they are no longer capable of transmitting
infectious particles and the surface or item is rendered safe for handling, use, or disposal.

Decontamination process involves 2 steps:

1. First and most important step is manual and / or automated, mechanical cleaning.
2. Second step is the application of a thermal or chemical disinfection process.

The disinfection process is used when cleaning alone might not be enough to make the item is safe for
reuse or for further handling without transmitting disease.

The specific types of items processed in the decontamination area vary from institution-to-institution
but the fundamental principles of the process remain the same
Items that are processed or undergo the decontamination process could include:

1. Surgical instrumentation
2. Patient care equipment
3. Other medical devices from all areas of the institution.

Personnel working in the decontamination are constantly exposed to contaminants such as:

1. Blood
2. Body fluids
3. Body tissues
4. Bone fragments

They’re called “Microorganisms on contaminated items” A.K.A. Bio burdens

In many instances, they’re unknown pathogenic (disease-causing) and nonpathogenic organisms

The staff works in a wet environment and is:

 Constantly handling contaminated sharps (like scissors, osteotomes, chisels, needles)

 Working with potentially hazardous chemicals such as detergents and disinfectants.
 Using equipment that operates at high temperatures.

II. DECONTAMINATION AREA

The decontamination area should be set up not only to provide for efficient and effective cleaning but
also to minimize and contain potential environmental contamination.

All items must be handled as if they are represent a significant health risk, because the type and level of
contamination on items to be processed is in most instances, unknown. This practice is referred to as
“Standard Precautions”

Whenever possible the process of decontaminating medical devices should be centralized in one
location to accomplish consistent, effective and efficient processing and containment of bio burden and
for the safety of personnel.

Ideally the area should be physically separated from other areas of the processing department.

Access to this are should be from an outside corridor.

Some important factors that are found in Decontamination are

The Decontamination area should:

 Provide sufficient space to accommodate the type and quantity of supplies, equipment and
instrumentation to be processed.
 Contain the equipment needed for manual and automated mechanical cleaning and
disinfection.
 Allow traffic control and efficient work flow.
 Provide space for storage of PPE
  Provide Space for staff to don and remove PPE
 Include a pass-through window through which manually cleaned items can be passed through to
clean (preparation and packaging area).
 Provide hand-hygiene facilities that are separate from the sinks used for cleaning purposes and
that include conveniently located alcohol-based waterless hand hygiene solution dispensers.
 Allow unobstructed access to eyewash facilities.
 Accommodate the disposal of hazardous substances.
 Accommodate the collection of sharps.
 Provide adequate storage space for supplies.
 Allow temperature and humidity control so that the temperature can be maintained in the
range of 60ᵅF to 65ᵅF and the humidity can be maintained in the range of 30% to 60%.
 Maintain negative air pressure to help contain contaminants inside the decontamination are
with 10 air exchanges per hour.
 Have floors, walls and ceilings with non-porous surfaces that will withstand frequent cleaning
and wet conditions.

Some healthcare facilities are unable to meet the temperature and humidity levels currently
recommended and the PPE being used makes it difficult for the body to release heat:

 One method of promoting employee comfort is the use of cooling vest.

 In addition new fabrics on the market are “Breathable” yet impervious, and could also be used
as PPE
 Because fans are not permitted in SPD other methods of providing for employee comfort should
be employed.

Ambulatory surgery facilities are not always set-up with separate decontamination and prep &
packaging/ sterilization areas. In this situation cross-contamination of already processed devices can
occur.

AAMI recommends that when physical barriers are not available (eg: walls to separate the clean areas
from the dirty areas)

Procedural Barriers should be used

1. Decontamination is done firs. That is soiled activities (like cleaning of devices ) should be
performed 1st )
2. Work areas should be cleaned and disinfected
3. Personnel should remove all PPE and thoroughly wash their hands.
4. Preparation, packaging and sterilization activities may be performed.
5. Decontamination activities should not take place while clean activities (preparation packaging,
sterilization) are being performed.
6. In addition, when only one work space is available, all the clean supplies ( e.g. packaging
materials, BLs, CLs ) must be kept in closed cabinets or covered tote bins to prevent
contamination.

The environmental conditions (like temperature and humidity) should be monitored and maintained
daily
If the temperature or humidity levels are above or below the recommended levels, the discrepancies
should be reported to the SPD manager or supervisor

Environmental Decontamination Prep & Pack Sterilization Sterile Storage

Conditions
Pressure (-) (+) (+) (+)
Air Exchange 10/hour 10/hour 10/hour 4/hour
Temperature 60⁰F-65⁰F 68⁰F-73⁰F 68⁰F-73⁰F 68⁰F-75⁰F
Humidity 30%-60% 35%-60% 35%-60% 35%-70%

Negative pressure – allows air to flow in but not escape from the room, as air will naturally flow from
areas with higher pressure to areas with lower pressure, thereby preventing contaminated air from
escaping the room ( using a ducted exhausted-air ventilation system shall be provided that generated
negative pressure to allow air in)

Because of potentially high levels of contaminants in the decontamination area the ventilation system
should be designed to maintain negative air pressure relative to surrounding areas so that any
potentially hazardous vapors generated by cleaning agents, disinfectants or chemical sterilants used in
decontamination processes will be removed.

(An easy what to check for negative air pressure is to hold a piece of paper in the opened doorway or
pass-through window. The paper should be drawn into the decontamination area)

Air should be exhausted directly to the outside with a special ventilation system not recirculated.

Positive pressure – pushes air out of a room by increasing the rate of flow, fans create a steady flow of
air out of the room and an intake replaces it the air & any particles, are forces out of the room, keeping
contaminants out for as long as the intake is properly filtered.

III. PPE AND OTHER EMPLOYEE SAFETY MEASURES

OSHA’s regulation on occupational exposure to blood borne pathogens requires employers to identify
tasks that might put employees at risk for exposure to blood o other body fluids and to take appropriate
measures to protect them from exposure

These measures include the development of an Exposure Control Plan that identifies:

a) The Tasks that could result in exposure to blood or other hazardous substances
b) The means necessary to protect the employee.

Employees should receive a copy of the Exposure Control Plan and its contents should be covered during
orientation and training.

The exposure control plan should change as new regulations are issued and better control or safety
products become available

The OSHA regulation includes requirements for appropriate PPE

- The type of PPE ( Personal Protective Equipment) might vary according to the tasks to be
performed
 - According to OSHA the PPE selected must “not permit blood or other potentially infectious
materials to pass through or reach the employee’s work clothes, street clothes, undergarments,
skin, eyes, mouth or other mucous membranes under normal conditions of use and for the
duration of time which the protective equipment will be used.

SPD personnel should also wear PPE when working with chemicals (like, detergents disinfectants)

The chemical manufacturer’s IFU and SDS should be consulted for the recommended PPE, which might
differ from the PPE used for protection from blood borne pathogens.

“For Example”

Personnel cleaning up spills of some of the chemicals used in disinfection might need to wear a respirator
and gloves worn during use of certain disinfection chemicals might be made of different materials that
those worn during handling of contaminated items.

The use of PPE is not optional and is regulated by OSHA

CDC recommends when and what type of PPE is required and how the attire is to be used.

It is the employer’s responsibility to:

 Provide the appropriate PPE,

 Ensure that it is used,
 And document and investigate failure to comply.

All employees should be trained in the appropriate protective attire to be worn for the tasks they
perform and in the potential health and disciplinary consequences if they fail to do so.

Training should be documented and routinely verified as part of departmental competencies

PPE must fit the individual user, and it is up to the employer to ensure that all PPE is available in sizes
appropriate for the employees that must be protected

Any Visitors to the decontamination area are required to don PPE. It is responsibility of SPD technicians
assigned to the decontamination area to ensure that all visitors comply with the required PPE.

Failure to comply should immediately be reported to the department supervisor or manager.

The PPE should be located as close as possible to the entrance to the decontamination area (unless
there is a separate room for donning and removing PPE) so that personnel can avoid having to walk
through the area without PPE.

The PPE should be stored in a manner that prevents contamination of the PPE (like plastic in plastic tote
bins or plastic bags).

Eyewash stations must also be available in decontamination area and in areas where disinfectants are
being used.
 IV. PPE FOR DECONTAMINATION PERSONNEL

Because of the potential for soaking of clothing, splashing and the aerosollization of fluids and
contaminants and the consequent need to protect employees from exposure to both microorganisms
and chemicals appropriate PPE in the decontamination area includes the following items:

1. Surgical Scrub attire that is laundered by the facility and changed daily or whenever it becomes
wet or soiled. OSHA requires the wearing of scrubs/PPEs.
2. A long sleeved, impervious ( impenetrable) puncture proof or fluid resistant gown or jumpsuit
( not an apron)
3. Eye and Face Protection, including, but not limited to a full face shield or goggles that prevent
splash fluids from entering from above , below or the sides.
4. Fluid resistant mask must be worn when performing activities that could result in exposures
because of splash or splatter this is in keeping with AAMI recommendations.
5. A head covering that covers all head and facial hair (except eyebrows & eyelashes if earrings are
worn, they must be completely contained within the head covering.

Note: a head covering is not considered PPE but rather part of the required dress code. However it
does not prevent hair and fallout from hair from getting into trays and sets.

6. Fluid Protective Shoe covers with slip proof bottoms. Shoe covers should be removed before
leaving the decontamination area in order to contain microorganisms and other contaminants.
7. Heavy-duty protective gloves with long fitted cuffs that prevent fluid from going between the
gown and the glove during use. The style of glove should protect the wearer from contact with
contaminated water. (For example, a glove that is too short can permit water to enter the glove
when the wearer is moving his or her arms up and down.) A cut-resistant glove liner may be
used beneath the decontamination glove as additional protection. NOTE: on March 21,2016 the
FDA published a proposed ban of the used of powdered gloves in the medical field because of
the health risks associated with powder.

APPLYING PPE (as required by OSHA)

This recommended sequences is based largely on CDC (2004) however this document does not address
shoe covers.

The Sequence follows:

1. Shoe covers should be donned first. Then wash your hands

2. Gown should be donned next.
a. Select appropriate type for the task and proper size.
b. Gown should open in the back. Secure gown at the neck and waist.
3. Mask should be put on next and properly adjusted to fit.
4. Goggles or face shield should be donned next( goggles should feel snug but not tight)
5. Gloves are donned last.
DOFFING PPE (REMOVAL)

To remove PPE safely it is first necessary to identify which sites are considered clean the parts that will
be touched when removing PPE.

1. The inside of the gloves

2. The inside and back of the gown, including the ties
3. And the ties, elastic or earpieces of the mask and goggles or face shield.

In general these are considered contaminated regardless of whether there is visible soil:

 The show covers

 The outside front sleeves of the gown
 The outside front of the mask and goggles or face shield
 The outside of the gloves

As recommended by CDC sequence for removing PPE is intended to limit opportunities for self-
contamination:

1. Shoe covers are considered to be the most contaminated pieces of PPE and therefore removed
1st.
2. Gloves are removed next
3. Goggles or face shield should be removed next
4. Gown should be removed next
5. Mask should be the next thing to be removed
6. As noted earlier the head covering is not considered part of the PPE but it should be removed
last. Before personnel leave the decontaminations area

NOTE: Always remember after REMOVING PPE you should ALWAYS WASH HANDS.

Designated areas for donning and removing protective attire should be provided, and there should be a
trash container readily available for the disposal of single use PPE.

V. JEWLERY AND FINGERNAILS

JEWELRY

Jewelry of any kind (including earrings, necklaces, bracelets and watches) is not permitted in any area of
the SPD

Jewelry should not be worn because it cannot be easily cleaned and can catch on equipment causing
injury.

FINGERNAILS

Fingernails should be kept short (no longer than ¼ in) beyond the fingertip to prevent punctures of
gloves and to facilitate cleaning under the nails.

Punctured or otherwise breached gloves should be changed immediately and personnel should wash
their hands thoroughly before donning new ones.
ACRYLIC NAILS

CDC prohibits the use of acrylic nails because of research indicating that they might support the growth
of microorganisms. (Like fungi) and puncture gloves.

If you notice a hole in a glove you should change it immediately and wash your hands between glove
changes.

Wearing of nail polish is prohibited because it could chip, fall in to trays during processing and end up in
the surgical site.

VI. SHARPS

In 2001 prompted by concerns about the increasing number of incidents involving sharps injuries to
healthcare workers, OSHA revised its blood borne pathogen regulation to include provision
regarding sharps safely.

The new requirements, which went into effect in July 2001 mandate:

1. Sharps be confined and contained in impervious (puncture-proof). Leak proof containers:

2. That each facility establish a Needle stick Safety Committee. Whose job is to monitor accidents
3. Needle LOGS should be maintained
a. To document number of sharps injuries
b. How the injuries occurred
c. Corrective actions taken to improve procedures
d. Prevent future injuries

All sharps injuries that occur in SPD must be reported in accordance with the healthcare facility’s
policy. Sharps containers should be changed before they are full. Most containers now have a fill
line to indicate when the container should be changed to prevent sharp injuries in addition new
safety products are continuously entering the market (like blade removers are now available).

VII. TRANSPORTING CONTAMINATED ITEMS

During the transport of contaminated instruments or equipment there is significant potential for
exposure of many individuals including staff, patients and visitors to potentially hazardous contaminants
and high risk of contaminating the environment.

To minimize those risks:

 Items must be appropriately handled. Confined after use and during transport.
 At the Point of use:
o Contaminated items should be handled as little as possible and only by individuals
wearing PPE appropriate to the task
o The PPE require depends on the exposure risks (like the likelihood of splashing and
soaking of clothing)
o Disposable items should be removed and discarded in the appropriate container
whereas reusable items should be contained in such a way that staff and others will not
be exposed to contaminants during transport of the items to the decontamination area.
Acceptable methods in the transportation of contaminated items include:

 Covered or enclosed carts

 Bins with lids
 Sterilization containers with solid bottoms and covers
 Disposable impermeable bags

If reusable, containment devices should be able to withstand repeated cleaning and disinfection.

Containment devices or bags should be labeled with a Biohazard Label to alert personnel that they
contain potentially bio hazardous materials.

Ideally, soiled items (especially surgical instrumentation) should be transported immediately to the
decontamination area for processing to prevent blood, body fluids and other contaminants from drying
on the surfaces.

Pic-up schedules should be designed to facilitate transport as soon as possible after use and to avoid
high-traffic areas.

Gross soil should be removed at the point of use with a disposable gauze pad or a cloth moistened with
water.

Saline should never be used for this purpose because it can damage the surface of the item

Instruments should be prepared in such a way that organic soils will not dry on surfaces. This can be
accomplished by

 Placing a towel moistened with water (not saline) over the instruments and placing the towel
and instruments inside a package designed to maintain humid conditions
 Using an instrument spray designed for pretreatment. For example the instruments are placed
in an appropriate container and treated with an enzymatic foam or gel designed for this purpose
 The foam or gel adheres to the surface of the contaminated items, breaking down soils. IN
addition the foam or gel will not splash or spill during transport.

Soaking contaminated items in an enzyme solution at the point of use is discouraged because the
solution must be discarded before it is to be transported.

As each item is introduced into the solution the contamination level increases as well as the potential
for cross-contamination of staff & the environment.

Care must be taken to avoid damage to instrumentation and equipment during transport.

All reusable transport containers must be cleaned and disinfected between uses.

Transportation containers and methods must also be designed to prevent potential damage to the times
being transported and to prevent employee exposure to potentially hazardous substance and
conditions.
 VIII. CLEANING VS. DECONTAMINATION

In some instances (like the decontamination of intravenous [IV] pumps sequential compression pumps
and other equipment that does not directly contact the patient). Cleaning alone is sufficient.

In Other cases

Some type of microbicidal process might also be required by the equipment manufacturer

To determine the necessary level of decontamination, consideration must be given to how the item was
used and the type and level of contaminating agents.

IX. INSTRUCTIONS FOR USE

Before any medical device is cleaned, the manufacturer’s written instructions must be obtained

Instructions should include information on specific:

- Cleaning and or disinfecting agents (type of solution)

- Cleaning implements ( tools needed)
- Methods to be used ( How to clean devices)

Whenever possible, these instructions should be reviewed before an item is purchased or at least before
the item is used for the 1st time to ensure that the facility is able to perform the cleaning process
prescribed by the manufacturer.

Manufacturer’s IFUs must also be available for loaned instrumentation.

The importance of obtaining and complying with manufacturers IFUs cannot be emphasized enough

The FDA has developed a guidance document on IFUs (FDS 2015)

The purpose of this document is to provide medical device manufacturers with guidance on creating and
validating reprocessing instructions that if followed will ensure that, if followed will ensure that a device
can be safely used for the purpose for which it was intended.

This document is not regulatory or legally enforceable unless specific regulatory requirements are
mentioned, but IFUs developed under this guidance document are recognized by JC, AAMI and others as
the only way for the user to verify that the device has been safely reprocessed.

IN a ddition to having manufacturer’s IFUs the end user must be able to verify the cleaning process.

According to ANSI/AAMI

“Verification of a cleaning process consists of:”

a) Defining a cleaning process and its critical steps;

b) Ensuring that each step is fully verifiable through personnel training and through observation
and that the process can be followed completely accurately and without variation by all
individuals who perform it and
c) Providing process controls along with validation and verification methodologies that ensure
adequate. Consistent cleaning levels.
In order to define a process.

- The facility must develop written procedures that identify the step-by-step process described in
the IFU and that are based on published and validated recommend practices and or guidelines
- Next. There must be a record of each staff member’s training in the process and compliance
with the procedure
- After initial training there should be a written verification, at a later date of the staff’s ability to
perform the task Depending on the complexity of the device an annual competency assessment
might be necessary.
- Lastly there should be a written plan for the routine verification and documentation of the
ability of the facility’s cleaning equipment to clean and verify the cleanliness of instrumentation
surfaces after manual cleaning/

The Importance of the cleaning process has been acknowledged by JC whose surveyors have been
reported to request the manufacturer’s instructions from the SPD staff and to ask them to demonstrate
and/ or describe the process that they use. In this way the JC can better determine whether proper
procedures and best practices are being followed to ensure the cleanliness and safety of the items.

A manufacture’s IFU should never be modified Additional chemicals (like alcohol, hydrogen peroxide
disinfectant wipes)

Should never be used to “Enhance” the cleaning unless the device manufacturer has specified their use.
Alcohol can be a fixative and make cleaning more difficult.

If cleaning is performed exactly as the manufacturer specifies even if the cleaning is done manually the
device will be safe to handle without PPE in the preparation and packaging area.

X. FACTORS AFFECTING CLEANING

Cleaning. Followed by thorough rinsing. Is the first and probably the most important step in the
decontamination process?

If too many microorganisms are left after cleaning (or if an item is not properly cleaned)

- The process (like disinfection or sterilization ) may not be effective

- May form pyrogenic causing foreign body reactions leading to medical complications for the
patients

PYROGENS – fever producing substances, are dead microorganism in sol or debris left behind on
medical devices after sterilization.

Cleaning is most often associated with “dirty” or “used” instrumentation, but should be noted that

NEW INSTRUMENTS

- As well as individual instruments and sets that were opened but unused. Must be cleaned as
well
- There is now way to ensure that the instruments were not handled with a contaminated glove
or droplets
 - Possible residuals from steam sterilization they can build up and cause discoloration and
stiffness

Disinfection and / or sterilization will not compensate for poor cleaning.

Importance of cleaning cannot be denied and is stressed in all professional guidelines and standards to
disinfection and sterilization

9 FACTORS THA HAS AN IMPACT ON CLEANING:

1. Water Quality
2. Water Temperature
3. Cleaning Activity of the detergents ( also known as cleaning chemistries)
4. Mechanical Action of the cleaning process (like. Ultrasonic energy)
5. Nature and design of the instruments or devices ( simple or complex)
6. Type of soil ( like. Blood vs. fatty marrowy soil)
7. Human factors/ competence (like training compliance with IFUs correct use of processing
equipment)
8. Cleaning verification ( checking and documenting the effectiveness of the cleaning process)
9. Quality Assurance ( monitoring the cleaning process to ensure compliance with all stated
policies , procedures, standards ( like AAMI , AORN and IFUs

When cleaning failures occur, one or more of these factors is involved

Always remember:

DISINFECTION AND OR STERILIZATION WILL NOT COMPENSATE FOR POOR CLEANING. The importance of
cleaning cannot be denied and is stressed in all professional guidelines and standards related to
disinfection and sterilization.

STEPS IN THE CLEANING PROCESS

1. Sorting items to be cleaned i.e.: utensils, basins , sharps, non- immiscible items and powered
equipment’s
2. Disposing of single-use items
3. Pre-rinsing or pre-soaking reusable items to loosen soil on the surface of items. Although
general detergents can be used, enzyme detergents are preferred for this process.
4. Washing, manually and/or mechanically in accordance with the IFU and by a process specifically
designed for surgical instrument.
5. Rinsing, using critical water ( water treated by)
a. Deionization
b. Reverse OSMOSIS [RO]
c. Distillation
6. Drying
7. Inspecting items to ensure that they are, at the very least, visually clean.
CLEANING

1. Sorting – items should be sorted according to type of the item being processed and the method
of cleaning to be used.

As noted in the OSHA regulation limiting occupational exposure to blood borne pathogens.
Personnel should be take care to protect themselves from sharps injuries when removing items
from any container.

To prevent sharps injuries, OSHA prohibits personnel from placing their hands directly into a bin
or other container that contains soiled instruments.

If the instruments are not clearly visible, forceps (e.g. a sponge stick) should be used to pick up
instruments.

IF knife blades are present, they must be removed and disposed of in an appropriate container
before the instrument is processed Devices are commercially available to facilitate blade
removal.

Examples of sorting categories include:

a. Basins and utensils
b. Sharps
c. Non-immersible items
d. Items that require special or handling or disassembly
e. Items that require ultrasonic cleaning
f. Items that can be processed in an automated washer

2. Disposing of Single use Items. – Single use items should be disposed of at the point of use or
placed into a container for a third-party reprocessor.

Single-use items that find their way into the decontamination area should be placed in
appropriate containers for disposal or reprocessing by a third-party reprocessor.

If a healthcare facility uses a third-party reprocessing company, the SPD technician needs to
have the information necessary to comply with the requirements of the reprocessing company.

3. Pre-rinsing or pre-soaking – it is often necessary to presoak items, especially surgical

instruments, to soften and facilitate the removal of soils (specially protein) that have been
allowed to dry on device surface.

Enzyme-based detergents or special pre-soaking solutions are recommended for this process

If instruments are to be pretreated at the point of use, enzymes gels or foams (not solutions)
should be used]
 Items that have been pre-soaked or pre-treated must be rinsed thoroughly before further
cleaning. Because pre-soaking or treatment agent (enzyme, foam, detergent) might not be
compatible with detergents used for cleaning.

4. Washing – Any items with multiple parts must be disassembled according to the manufacturer’s
instruction before it is cleaned.

Items cleaned with small components should be containerized. Small “tea strainer” type
containers that allow the parts to remain together and have contact with the cleaning agent
during mechanical washing.

When disassembling complex instrumentation, personnel should consult the device

manufacturer’s instructions

Some items, such as devices with Lumens, must be washed by hand to ensure that lumen is
clean and free of debris

5. Rinsing – Items that have been presoaked or treated must be rinsed thoroughly before further
cleaning, because the presoaking or treatment agent (enzyme or detergent) might not be
compatible with the detergents used for cleaning.

Lumened items should be thoroughly rinsed with critical water (distilled, deionized, RO water)
to prevent the formation of pyrogens and biofilms

6. Drying – Instruments should never be store wet. Dry the instruments using clean lint-free cloth
or instrument air.

7. Inspecting – Instruments should then be carefully inspected for damage, debris, detergent
residue and completeness. Instruments should be sterilized as soon as possible after cleaning.

SOAKING

Soaking items for prolonged periods should be avoided because of the potential for the formation of
“BIOFILMS”

BIOFILM

The production of thick masses of cells and extracellular materials

Groups or collections of microorganisms that adhere to the surface of any object that comes into
contact with non-sterile water (including distilled or deionized water)

As these microorganisms continue to grow and multiply they form a protective, slimy film that covers
and protects them making cleaning, disinfection and even sterilization ineffective, if not impossible.
Facts about BIOFILMS

- It’s a protective slimy film (can be very resistant to disinfectants)

- Bacteria within biofilm can be up to 1000 times more resistant to antimicrobial agents than the
same bacteria in suspension.
- The longer that surface of an item goes untreated, the greater the potential for biofilm
formation; once formed, the larger and thicker the biofilm becomes, making its removal and
destruction more difficult.
- Can we adhere to any surfaces, but they form more slowly on smooth surfaces than on rough
surfaces.

Items most affected by BIOFILMS

- Lumens – instruments with tubes, scopes ( specially flexible endoscopes)

- Irregular or serrated surfaces
- Difficult-to-reach surfaces

Prevention of BIOFILMS

- Using Critical water to rinse instruments and drying immediately after cleaning.
- Instruments should never be stored wet.
- Instruments should be sterilized as soon as possible after cleaning.

WATER QUALITY

The quality of the water in the department can affect not only how well a detergent will work but also
how much is needed and how well it will rinse off at the end of the cleaning process and the effective
ness of the sterilization process

Water testing should be performed to determine:

- Hardness ( due to inorganic substances)

- pH level
- Organic and inorganic substances

Manual Cleaning - requires low pH level or near neutral (7.1-9 pH)

Mechanical Washers – require higher alkaline detergents (pH 11+) to compensate for the lack of friction
from the manual cleaning technique is lacking.

Hardness – It is determined by the presence of inorganic materials such as calcium that interferes with
the active ingredients

The Higher the mineral content, the Higher the surface tension, the more resistant to friction.

Water hardness can also alter the pH level.

Water Softeners can be added to counter act water hardness, reduce surface tension improve cleaning
activity and facilitate rinsing
Substances found in hard water can:

- Tie up the active ingredients in detergents

- Decrease the detergents effectiveness
- Alter the pH of the detergent
- Impede the rinsing process
- Leave inorganic materials (like iron magnesium and copper) detergent and soil residuals behind
on surfaces.
(These residuals can be corrosive, causing instruments to stick or work improperly and impeded
further disinfection and sterilization.)

CRITICAL WATER is highly recommended

- For the final rinse of all medical devices for either manual or mechanical cleaning (using critical
water might be economically inadvisable for cleaning purposes)
- ADVANTAGES
o Improve the removal of residuals
o Reduce the potential for pyrogens formation and recontamination
o Helps to prevent the formation of biofilm
o Helps prevent mineral deposits.
- Water Quality Testing should be performed routinely and whenever changes are made in
cleaning agents. Most manufacturers of cleaning agents will perform the necessary water
testing before making recommendations on the amount and type of detergent that should be
used for best results.
- AAMI recommends routine monitoring of water quality to ensure that the appropriate water
quality is maintained and does not change over time.
- Failure to continuously monitor water quality could have an impact on processing like the water
used for reprocessing could become heavily contaminated with microorganism or other
contaminants
- Poor water quality can contribute to instrument corrosion, staining, spotting and increased
microbial levels.
- The ultimate responsibility for water quality monitoring and maintenance is with the facility’s
engineering department.
- However SPD technicians need to understand the impact of water quality on the outcome of
cleaning and should be encouraged to monitor any changes.
- Any issues with water quality should be reported to SPD management immediately so that
corrective action can be taken
- Whichever water quality system is chosen, there are parameters that must be monitored daily
to ensure proper function.
SELECTION OF DETERGENTS AND OTHER CLEANING AGENTS

DETERGENTS

- Are synthetic ( man- made from various chemicals into the desired product )
- They are cleaning agents that lower surface tension
- Dislodge soils and dissolving or suspending them in the solution so they can be removed by
washing and rinsing

Additional chemicals include, but are not limited to:

- Agents to soften the water ( chemical agents)

- Enzymes
- Phosphates ( not in limited use because of environmental considerations
- Rust inhibitors

Factors to consider when selecting DETERGENTS

- Quality of the available water.

- Water temperature
- Typeand amount of soil on the item
- Materials the item that is made of
- Manner in which the item will be cleaned (manually or mechanically)

No single Cleaning agent can be used for the removal of all type of soil or is safe on all materials used to
manufacture medical devices. As with most SPD processes, the device manufacturer’s IFU take
precedence in the selection of detergents and cleaning methods.

Detergents must be change frequently

To reduce the bio burden contamination. And to prevent recontamination of cleaned items and the
environment.

Detergents are available in powdered, solid and liquid form

To ensure the efficiency of the detergent and to prevent residuals it is imperative that the detergent be
fully dissolved in the solution, which can sometimes be difficult to achieve with powdered or solid
formulations.

NO matter which type of detergent is selected, the manufacturer’s recommendations on concentration

must be followed.

Using more (too much) detergent than is recommended could:

- Decrease the efficiency of the product.

- Result in harmful residuals

Detergents should be low-sudsing when used in decontamination are.

- To be able to see what you’re cleaning and to prevent aerosollization.

-
Free rinsing to prevent residuals being left on surfaces

- Capable of being removed easily during the rinsing process.

Many devices are available to facilitate the dispensing of accurate amounts of detergents

Devices include but are not limited to the following:

- A simple measuring cup.

- A manual pump that is inserted into and attached to the detergent container and that dispenses
a specified amount of each activation
- Automated centralized pumping stations that are connected directly to sinks or mechanical
cleaning equipment.

No matter which device is used for dispensing detergents it is important that it be maintained
appropriately

Measuring Cups should be cleaned between uses.

Manual Pumps should be cleaned to prevent buildup of detergent at the dispensing spout;

In addition the amount of solution dispensed should be checked routinely to ensure that it has not
changed.

If an automated system is used to deliver the detergent. It should be routinely calibrated and
maintained by the manufacturer.

Types of Detergents

1. Enzymatic (enzyme-based) Detergents – contain organic substances that assist in the

breakdown of protein and blood.

109ᵅF -140ᵅF water temperature is best for enzyme based products

Higher Temperature, can break down or destroy the enzymes within the detergent, making
them less efficient.

Lower Temperature, makes the enzymes within the detergent sluggish reducing their
effectiveness.

Used mostly in Manual Type Cleaning (due to neutral pH level)

Enzymatic detergents can be simple (containing a single enzyme) or complex (containing

multiple types of enzymes).

Examples of enzymes used individually or in combination in the formulation of enzymatic

detergents include:

a. Protease (proteolytic) enzyme which breaks down blood mucus (secretions) feces and
albumin (water soluble protein in blood plasma)
b. Lipase (lipolytic) enzyme which breaks down fat (like bone marrow and adipose tissue).
c. Amylase enzyme: which catalyzes starches and breaks down carbohydrates.
2. Organic Acid Detergents – used to remove severe stains and rust from stainless steel
instruments.

Should not be used routinely because they can be corrosive

Should be washed in slightly alkaline detergents before being used or further processed

The manufacturer of the device being processed should be consulted before and organic

3. High Alkaline Detergents – used in some mechanical washers

Used to replace manual scrubbing which is lacking.

And to reduce the potential for instrumental corrosion, the multistep process in a mechanical
washer consists of:

A. Using high-alkaline wash

B. Followed by a neutralizing acid rinse to clean surgical instrumentation
C. Then the final rinse with critical water

Items NOT compatible:

 Aluminum Rigid Sterilization Containers.

 Rubber
 Lumen Devices
 Some Plastics
 Other Materials

4. Non-abrasive Cleaning Agents – available for removing stubborn soils and stains.

However, they are difficult to remove and must be thoroughly rinsed away

Medical devices that have been cleaned with these agents must be washed with detergent
afterwards.

5. Soaps – are organic compounds, poor cleaners and can be difficult to rinse off
Some device manufacturers recommend that their devices be cleaned with organic soap
because of concern about patient sensitivity (the device material could also absorb the chemical
and cause a patient reaction)
Ivory Snow is not 100% organic, it does not contain bleaches or other chemicals reducing the
chance of an allergic reaction. Some device manufacturers are now recommending that Ivory
bar soap be used for cleaning because it does not contain any chemicals
However soap products should be used only if specified by the device manufacturer.
 6. Pre-cleaning sprays, foams and gels – used when instrument and endoscope cleaning cannot be
performed immediately.

Enzyme based products that are used at the point of use for treating contaminated
instrumentation and endoscope awaiting transport to the decontamination area for cleaning.

The pre-cleaning spray, foam, or gel is applied to contaminated items to keep the instruments
moist, thus preventing bio burden from adhering to surfaces before. Decontamination and
minimizing the formation of biofilm.

In addition, the enzymes in such products immediately begin to break down the blood, fats,
proteins, and carbohydrates on the instruments and endoscopes, thus reducing cleaning time.

The Enzyme spray, gel or foam should be applied to decontaminated items in the area
designated by facility policy

PRINCIPLES OF CLEANING

The manufacturer’s processing instructions for every device must be available and must be followed.
However certain general principles of cleaning apply to any items

- Every surface of the time must come in contact with the Cleaning Solution.
- There must be some type of action that enhances the cleaning process such as friction on the
surfaces.
- All hinged items must be completely open during the cleaning process.
- Whenever recommended and indicated, multipart items must be disassembled for cleaning.
- For large trays being prepared for processing in a mechanical washer, it might be necessary to
disassemble the set into more than one tray to ensure effective cleaning.
- To prevent damage to instruments, delicate items should always be placed on top of heavier
items
- Mixing of different types of metals should be avoided, because electrolysis can occur in any
heated, moist environment.
- To ensure direct contact between the instruments and the detergent and water, all components
such as silicone mats must be removed from trays and washed separately.
- Rigid sterilization container systems must be cleaned before they are re-sterilized and reused
- Overall effectiveness of the cleaning process depends on:
o Appropriate water quantity and quality
o Proper concentration (dilution)
o Type of detergent (or enzymatic agent)
o Used of an acceptable method of cleaning ( as recommend by the device manufacturer)
o Proper rinsing and drying
o Correct preparation of items for an automated. Cleaning process (e.g. opening the
instruments, not covering them with bowls or small metal cups)
o Correct time and temperature in an automated cleaning process
o Adherence to load capacity of the cleaning equipment e.g. not overloading wasters or
ultrasonic cleaners
o Correct performance of procedures and operation of equipment by personnel
MANUAL CLEANING

Manual Cleaning – Might be the only affective method for certain instrumentation, such as:

- Devices with lumens

- Powered equipment that cannot be immersed
- Items that are delicate or of complex design

Manual cleaning might also be performed as a preliminary step before mechanical washing to remove
stubborn stains and soils

In some facilities, manual cleaning might be the only method available

Sinks used for manual cleaning should be deep enough and large enough to contain items and minimize
splashing

The appropriate size and design of sinks are also important to the comfort and safety of the staff who
might work at sinks for long periods and to their ability to easily retrieve items

AAMI recommends that sinks be:

8 to 10 inches deep

36 inches from the floor

Filled up no more than ¾

The width and length of the sink should be determined by measuring the largest tray that will be soaked
in the sink and then add approximately 4 inches to the width to permit lowering the set into the sink by
hand.

Three sinks should be used to accommodate each step of the process:

1. Pre- Soaking/ Washing

2. Preliminary Rinsing
3. Final Rinsing ( should be with critical water)

Always brush or clean devices under the surface of the water (below water level) so devices can be seen
while being cleaned and prevent aerosollization.

Detergent solutions must be changed frequently to reduce the bio burden (contamination) and to
prevent the recontamination of cleaned items & the environment.

Cleaning – is the most important step in the decontamination process

Rinsing – is the most important step in the cleaning process because it removes loosened soils and
debris.

Whenever the detergent solution is changed, the sink or basin should be cleaned and disinfected (with
70% alcohol) before it is refilled.
CLEANING IMPLEMENTS

During manual cleaning, soft bristle brushes of various sizes and lengths and soft, lint-free cloths are
used to create friction on device surfaces

Plastic or nylon brushes are recommended for general cleaning

Metal-bristle brushes are not generally recommended because they can damage the protective layer of
surgical instruments.

Tungsten Carbide – jaws of needle holders are the only item that can be used with metal-bristles
brushes

When considering the type of brush to use, it is important for SPD personnel to look to the
manufacturer for documentation on the safety and limitations of a brush for use on general surgical
instruments.

Brushes used to clean instruments with lumens should be large enough in diameter to achieve contact
with the walls of the lumen but small enough that they do not have to be forced in the lumen3

When selecting brushes for cleaning lumens refer to the instrument manufacturer’s IFU for the correct
diameter needed to perform the task at hand

If the brush diameter is too small, it will not make contact with the wall of the instrument if it is too
large it could damage the item being cleaned because of the excessive force needed to get the brush
through.

Each instrument should be cleaned individually

Brushes should not have porous handles (e.g. wood handles) because they absorb liquids and harbor
bacteria and cannot be adequately cleaned or disinfected

Before a reusable brush is used, its condition should be evaluated

Any brushes that appear worn or that have missing or bent bristles should be replaced

It is imperative that brushes used to clean instruments be designed for use under that circumstances
encountered in the decontamination of surgical instrumentation

Abrasive pads such as steel wool and plastic scrubbies should not be used, because they ill scratch
device surfaces, providing places for bacteria and debris to collect and promoting corrosion

Reusable sponges are not acceptable for use because they harbor bacteria. Cannot be easily cleaned or
disinfected, and break apart during use, leaving small particles in the serrations of instruments

To prevent the formation o biofilms. All cleaning implements should be cleaned after each use and then
disinfected or sterilized at the end of each shift.

Reusable brushes and other cleaning implements should be cleaned or disinfected according to the
manufacturer’s IFU

After cleaning reusable brushes should be hung to dry.

After cleaning items is cleaned, it should be placed in a second sink for an initial rinse with utility water
(tap water) or much better Critical water.

Third sink should contain critical water for the final rinse to prevent spotting and to reduce the potential
formation of pyrogens as the instruments dry

Instruments should then be carefully inspected for damage, debris, detergent residue and
completeness.

The final step is to dry the instruments using a clean, lint-free cloth or instrument air.

MECHANICAL CLEANING

Mechanical cleaning is the use of machines to clean instruments.

Ultrasonic Cleaners

Type of automated cleaning equipment, transmits sound waves through a cleaning solution that create
bubbles that implode ( burst inward) as they contact instruments, drawing soil away from the surface-
called “CAVITATION” process

Very effective in cleaning hard to reach areas (i.e. box locks, serration, ratchets and the teeth on
instruments.

Advantages of ultrasonic cleaning include:

- Efficiency (more efficient than manual cleaning)

- Consistency (can be consistently reproduced)
- Reliability (increases productivity and reliability)

MODELS OF ULTRASONIC CLEANERS:

a) Table-top units ( for small instruments, i.e.: dental or eye instruments)

b) Single-chamber consoles – ( this equipment only cleans)
c) Dual chamber units – (in which instruments are cleaned in one chamber and transferred to the
2nd chamber for rinsing).
d) Three- Chamber consoles - in which instruments are cleaned in one chamber, rinsed in the 2 nd
chamber then dried in the 3rd
e) Ultrasonic lumen Irrigator/ Flushing Units – special machines that clean lumen devices

Because ultrasonic cleaners can be used as cleaning step before mechanical cleaning a single-chamber
model might be at all that necessary.

Sonic Irrigators - are specifically designed for lumened devices (like. Laparoscopic instruments and
flexible reamers)

Combines with manual brushing, has been known to be very effective

Things to remember when using an Ultrasonic Cleaner include the following:

- Consult the manufacturer’s written instruction to ensure that device will not be damaged by
ultrasonic cleaning
 - Change water frequently after every 2 to 3 uses or at the very least every shift.
- Each time the ultrasonic cleaner is drained, it should be cleaned before it is put back into use
- Lid should remain closed during the cleaning process to prevent aerosollization.
- pH level should be near neutral.
- Normal water temperature should be between 100ᵅF - 140ᵅF (Ultra-Sonic Cleaner)
- Degassing (removes the air/oxygen from solution) should be performed as directed by the
manufacturer and with an empty basket inside the cleaner to avoid damaging the chamber
walls.
- To ensure contact with all device surfaces, the instruments to be cleaned should be placed in a
metal tray with a mesh or perforated bottom and perforated sides (to maximize exposure to the
sound waves)
- Hinged instruments should be in the fully open position
- Instruments should not be placed higher than 3 inches inside the basket
- Mist be thoroughly rinsed to remove soils and residual detergent from Device surfaces
- Check for any loosen screws, because of the vibrations to which instruments were subjected
- Should be located in the decontamination area, because it provides a cleaning process
- Mechanical washer disinfector (to disinfect) is used after ultrasonic cleaning is done.

3 TYPES OF DETERGENTS USED IN MECHANICAL WASHERS

1. Neutral Detergents – pH level 7.1-9, items made of plastic and anodized aluminum
2. Moderate Alkaline Detergents – pH level 9.1 – 11, safe for stainless steel but is corrosive to
aluminum , copper and brass.
3. High alkaline Detergents – pH higher than 11, effective in removing heavy organic soils. But
detergents accelerates corrosion and leaves scale deposit.

TYPES OF MECHANICAL WASTERS:

Washer Sterilizers – Wash and rinse cycles use spray arms located at the top, bottom and sometimes,
sides of the chambers.

Final steps in the cycle is the introduction of live steam into the chamber; the steam reaches a
temperature of approximately 290ᵅF (143ᵅC) for an exposure time of approximately one minute

Cycle selection options are extremely limited, and only items that can withstand high temperatures can
be processed in these units

Extensive manual pre-cleaning is required to achieve satisfactory results from washer-sterilizer

Washer decontaminator (also called washer disinfectors) – best results are achieved by processing
instruments through a mechanical washer decontaminator after ultrasonic cleaning

Ultrasonic cleaners do an excellent job cleaning instrumentation, but they do not disinfect the
instrumentation at the end of the process

If instruments do not undergo a disinfection process after ultrasonic cleaning, personnel should wear
gloves when handling the instruments during assembly and preparation for sterilization.
Single-Chamber Washer- decontaminator/disinfectors – have racks at several levels and spray arms
under each rack

Some racks have special connectors for tubing and items with lumens that are appropriate to the device

Multi-Chamber Tunnel/ Indexing Washer – Composed of three to five interconnected chambers each
with a specific task.

- Automatically loaded
- Pre-wash
- Ultras sonic cleaning
- Detergent wash
- Rinse
- Final rinse
- Lubrication
- Drying

LOADING MECHANICAL WASHERS

Correct loading of instruments is critical to successful cleaning

Instruments should be placed into open baskets or into baskets or trays with perforated bottoms.

If multi-level trays are being processed each level should be removed and the contents treated as an
individual tray

All chemical indicators should be removed from the sets

All tamper-evident locks and indicator loads cards should be removed from containers and discarded.

Instruments with box locks should be opened so that all surfaces can be reached by the cleaning
solutions.

When indicated by the manufacturers, instruments should be taken apart to allow for cleaning, small
parts should be contained in small mesh device.

Instruments should not be crowded into the baskets but should be instead spread out to provide for the
greater contact with cleaning and rinsing solutions

Because a single instrument tray might need to be broken down into multiple baskets for cleaning, a
process should be in place to ensure that the baskets are not separated after cleaning and that
reassembly can be accomplished efficiently.

Silicone mats should be removed and washed separately; if they are left in place cleaning can be
ineffective.

Small bowls or emesis basins should not be placed over instruments; otherwise the detergent and water
might not make full contact with the instruments
Basin and other utensil should be washed separately, using a hold-down screen to prevent them from
moving around.

Improper Loading of mechanical washers is a major contributor to cleaning failures.

AUTOMATED ENDOSCOPIC REPROCESSORS (A.E.R)

Designed specifically for the reprocessing of flexible endoscopes like Colonoscopes and Bronchoscopes

Cleans the interior channels of endoscopes as well as the outside surfaces

- If not properly cleaned, it can cause nosocomial infection

Endoscopes are high-level disinfected and are ready for immediate reused at the end of process

General Procedure for using an AER: AER advantages over manual reprocessing:

- Perform any required manual cleaning - Automate and standardize several

or disinfecting steps
- Place the endoscope into the
reprocessor
- Attach all channel connectors according
to the AER manufacturer’s instructions
- Follow the AER manufacturer’s
instructions for running the cycle
important reprocessing steps
- Reduce the likelihood that an essential
reprocessing step will be skipped
- Reduce personnel exposure to high-
level disinfectants or chemical sterilants

CART WASHERS

Used to clean and sanitize metal surgical case carts, supply carts and (with a special loading rack) aeven
rigid sterilization containers

The cart washer provides:

- Wash cycle
- Rinse cycle
- Dry cycle

Cart washers have single or double chambers and usually have tilted floor to help drain water during the
cleaning process.

STEAM GUNS

A steam gun is a powered nozzle on a long stick (wand)

Nozzle can release plain water, water and detergent, and steam

Mainly used to clean case carts and the wheels on patient care equipment

Personnel must war proper PPE, especially heat-resistant gloves and rubber boots to avoid steam burns
POWER NOZZLES

Provide water and/or detergent to flush lumened devise

Can be hooked up to the water in the decontamination area or supplied with a detergent-water mix

Manufacturer’s instruction for use should be followed

ITEMS WITH LUMENS

Must 1st be manually cleaned using a brush of the appropriate size to make direct contact with the walls
of the lumen.

It is critical that lumens be inspected to be sure they are clear and that guide wires ( in the case of
cannulated drills, screwdrivers or reamers) ore debris are not embedded in them

Always brush from smaller end to larger then reverse the flush

ORTHOPEDIC INSTRUMENTATION

Device manufacturer’s instructions should be followed carefully.

Items should be soaked in a lipolytic enzyme solutions that has been prepared in accordance with the
detergent manufacturer’s instructions (or a multi-enzyme solution that contains a lipolytic enzyme)

Ultrasonic cleaning is usually recommended, and many manufacturers recommend extended ultrasonic
cycles.

KERRISON RONGUERS

- Especially problematic
- Kerrisons that cannot be opened for cleaning should be routinely cleaned by an instruments
repair service

LOANER ISNTRUMENTS AND OPENED BUT UNUSED DEVICES

Instruments and devices received from other facility or company or owned and brought in by a surgeon
a for a case must be considered contaminated and should be completely reprocessed

Device manufacturer’s instructions for cleaning and sterilization should be obtained and followed

The sets should not be processed without this information, which should be kept on file

 The names of the instruments sets or trays

 The date and time of receipt
 And the surgeon, company or health care facility from whom they were received

Contents of the sets must be counted (to ensure that sets are complete) and inspected for damage upon
receipt

Sales representatives or facility should be required to provide a count sheet with the tray contents for
each set delivered
Sets should be tracked through he department until they have been completely reprocessed after use,
inspected and counted again to ensure that no items are missing or damaged, and returned to the
lender

Many companies require verification of cleaning and sterilization before the sets are returned

Instruments that are” opened but not used” and returned to SPD from user departments they are also
considered contaminated and should be completely reprocessed.

POWERED EQUIPEMENT

To prevent damage, powered equipment should NEVER:

 Be immersed in a solution
 Come in contact with saline
 Be reprocessed in ultrasonic cleaner

Manufacturers Instructions for disassembly, cleaning and lubrication, and testing should always be
followed.

DEVICES KNOWN OR SUSPECTED TO BE CONTAMINATED WITH PRIONS

Because it is difficult to inactivate prions, special procedures are recommended to process instruments
that have been used on a patient with known or suspected Creutzfeldt - Jakob disease (CJD)

A system for identifying instruments potentially exposed to CJD should be in place

When CJD-contaminated instruments are sent to SPD for reprocessing they should be identified by
means of a form, tag or other label placed inside or outside of the container or basket of instruments

In the United States, posterior eye tissue, brain tissue, and spinal cord tissue are currently considered to
be “high risk” tissues

Instruments with know or suspected CJD should be cleaned 1 st according to the device manufacturer’s
instructions and the facilities procedures

Lumened devices can be difficult to clean; if cleaning cannot be effectively performed, lumened devices
should not be processed

It is not recommend that powered equipment or equipment that requires low-temperature sterilization
be used in procedures involving high-risk tissues, because there is no data on the effectiveness of
cleaning and sterilization procedures used for equipment contaminated by such tissues

LAPAROSCOPIC EQUIPMENT

Must be disassembled for cleaning

Critically important to carefully follow the instrument manufacturer’s instructions for disassembled ( if
indicated) and proper cleaning

All parts should be kept together throughout the cleaning process to ensure that parts are not lost and
that the instrument can be properly reassembled after cleaning
FIBEROPTIC LIGHT CABLES

Should be carefully cleaned using a soft cloth and detergent

Manufacturer’s instructions for use should be followed; some cables cannot be cleaned with enzymatic
detergents.

Cord should be loosely coiled & at least 8 inches in diameter (not tightly)

Instruments should never be placed on top of fiber optic cables because the glass rods inside the cables
could be damaged

Care must be taken during the cleaning process not to stretch the cable in any way or bang the ends on
a hard surface causing damage to the glass rods an interruption of light transmission.

RIGID ENDOSCOPES

Must be cleaned by hand (the vibrations of an ultra-sonic cleaner, could damage the seals, creating
leaks)

Should never be placed under other instruments or mixed with reusable trocars, which can cause
damage

Should be cleaned manually and separately from other instrumentation

Mat or towel should be placed inside the sink to cushion the endoscope and prevent damage

FLEXIBLE ENDOSCOPES

Very difficult to clean because of their numerous small lumens and size (some of these devices are
more than 6 feet long)

Only personnel who have been thoroughly trained, with competencies verified, should be reprocess
flexible endoscopes

Their sophistication and the variety of types and manufacturers of flexible endoscopes make it essential
for personnel performing these activities to have expertise in this process

Instrument manufacturer’s instruction for disassembly cleaning and disinfection should be followed
precisely

5 major steps in the cleaning process after pre-cleaning in the patient room:

 Leak testing to prevent damage

 Cleaning to remove soils and thorough rinsing to remove all detergents residue
 High Level Disinfection
 Rinsing to remove all high-level disinfectant solution
 Drying/Storage
Must always be leak-tested before manual pre-cleaning is performed

If the leak test fails, the endoscope manufacturer should be contacted for instructions on how to return
the endoscope for repair

Leak testing can be performed using either a dry method (with a gauge) or wet method

Wet testing should be performed in tap water (not detergent) so that any air bubbles ( from a damaged
covering) will be visible

The endoscopes must first be insufflated according to the leak tester manufacturer’s instructions

Insufflation before wet leak testing ensures that water will not enter the endoscope during the leak
testing

Manual pre-cleaning is required for flexible endoscopes and the enzymatic cleaner should only be used
for the one endoscope, then discarded.

Reusable cleaning brushes should only be used for ONE endoscope, then cleaned disinfected and dried

After Cleaning and high level-disinfection, the endoscope should be flushed with 70% isopropyl alcohol
to facilitate drying.

To prevent damage to the endoscope the endoscope manufacturer’s recommendation for air pressure
should be followed.

Flexible endoscopes should be processed immediately after use

If reprocessing is delayed beyond one hour, extended soaking or cleaning protocols might be required.

Manufacturer’s instructions for delayed reprocessing should be followed

After processing, the exterior of the endoscope should be dried with a lint free towel

All removable parts should be rinsed and dried so that air can circulate, removable parts should not be
reapplied

Processed scopes should be hanged vertical with no coils in a dust free space well ventilated cabinet – 2
inches space from the bottom of the cabinet

CDC recommend that processed scopes be identified as having been reprocessed. A tag or a similar
method should be used

AORN recommend that endoscopes be stores in a closed cabinet vented for air circulation. The internal
surfaces of the cabinet should be made of cleanable material, the cabinet should be high enough to
allow endoscopes to hang without touching the bottom of the cabinet, and there should be enough
space to store multiple endoscopes without them touching each other.
EYE INSTRUMENTS

TOXIC ANTERIOR SEGMENT SYNDROME (T.A.S.S)

- Is defined as an acute inflammation of the anterior chamber ( segment ) of the eye after
cataract surgery forming endotoxins ( a toxin; a structural component of bacteria)
- This inflammatory response can lead to severe visual impairment if it is not recognized and
treated in a timely manner

Primary issues for TASS are:

- Inadequate cleaning methods

- Inadequate removal (rinsing) of residual detergents
- chemical disinfectants or sterilants

Particular care must be taken in the processing of intraocular surgical instruments to help ensure that
foreign substances or materials associated with the instruments will not be introduced into the anterior
chamber of the eye during surgery

The actual cleaning process does not change and detergents must be used to clean the instrumentation.

AORN and the American Society of Cataract and Refractive Surgeons recommends emphasis placed on
the following steps of cleaning:

- Adequate instrumentation must be available to allow for the proper cleaning and sterilization of
instruments between cases
- A cleaning area and cleaning equipment dedicated for the cleaning of intra ocular surgical
equipment’s should be provided
- To reduce the potential for cross-contamination, intraocular instruments should not be cleaned
with general surgery instruments.

When intraocular instruments are processed in a mechanical washer “gentle” cycle is usually
recommended to avoid instrument damage

Intraocular instruments should not be processed in the same cycle with any general instruments.

Instruments should be pre-cleaned immediately after use. Gross debris should be removed and
instrument lumens should be flushed with sterile distilled water or another suitable agent as
recommended by the manufacturer.

The instruments should be maintained in a moist state before cleaning in order to prevent the drying of
surgical debris onto or within them

IN particular, OVDs (Viscous Solutions used in eye surgery) can dry onto instruments very quickly after
use and resist removal during subsequent cleaning.

Rinsing immediately with sterile water in the OR at the end of the procedure can help remove debris
and prevent the debris from drying before final processing
AORN and the American Society of Cataract and Refractive Surgeons recommends emphasis placed on
the following steps:

- Manufacturer’s instructions for cleaning the instruments must be followed ( only cleaning
agents recommended by the manufacturer should be used)
- Adequate time must be allowed for processing instruments according to the manufacturer’s
instructions
- Detergents used must be of the correct dilution (according to the manufacturer) to avoid the
potential for residuals
- During ultrasonic or manual cleaning, cleaning solutions should be changed after each use. The
solution should not be used for any instruments other than intraocular instruments
- Brushes and other cleaning tools should be cleaned and sterilized as recommended by the
manufacturer at least daily or preferably, after each use.
- Cannulas must be cleaned well, thoroughly rinsed, and carefully inspected
- Rinsing is extremely important because it removes potential residues
- Intraocular instruments must be rinsed multiple times and the final rinse should be with sterile,
distilled, deionized or RO water.
- Much has been written about the importance of thorough rinsing of ophthalmic instruments. Ex:
Phaco hand pieces , cannulas and the relationship between failure to do so and the onset of
TASS
- To facilitate and enhance the rinsing process, the use of an automated instrument rinsing
system is recommended. The use of such a system replaces the use of syringes to rinse
cannulated instruments and devices and ensures consistency of the process as well as the type
and amount of solution used.
- It is important to follow the manufacturer’s IFU regarding connection of the tubing and
decontamination of the unit and tubing
- Cleaning and sterilization equipment should be properly maintained. Otherwise, foreign
materials such as endotoxins or heavy metals could be deposited on the instruments during
processing and induce TASS
- Disinfectants such as activated glutaraldehydes and others should not be used on intra ocular
instruments. Because they can leave a hazardous chemical residue that is difficult to remove

ROBOTIC INSTRUMENTATION

 Robotic Surgery is becoming increasingly popular

 Newer type of robotic instrumentation requires special cleaning protocols to be followed
 EndoWrist instruments are limited multiple-use, fully wristed endoscopic instruments, designed
exclusively for used in intuitive Surgical Da Vinci and Da Vinci S surgical systems ( identified by its
blue color base) Da Vince Si Single Site ( identified by its lime green color base) and the newest
Da Vinci Xi
  EndoWrist Instrument consist of five main components;
o The release Levers
o The Instrument Shaft
o The Wrist
o Tip or End of Effector
o The Instruments Housing
 The instruments have flush ports to facilitate cleaning
 The Manual cleaning process involves multiple steps including
o Scrubbing
o Flushing Priming/ Ultrasonic cleaning
o Rinsing
o Drying
o Lubricating
 To ensure effective cleaning, each step in the manual process must be performed exactly as
described in the manufacturer’s product documentation
 Manufacturer also supplies a flush tube assembly to connect between the instrument flush
ports and the faucet.
 Instruments can also be cleaned using two validated automated ultrasonic lumen cleaning
systems ( manufacturer should be contacted for specific information)
 A Traditional Ultrasonic Cleaner ( Validated to clean surgical instruments) can also be used
 The use of a washer decontaminator, washer disinfector or washer sterilizer is not
recommended

DENTAL INSTRUMENTS

 Depending on its use, dental instrumentation has been classified by the CDC and the American
Dental Association as
o Critical
o Semi critical
o Non Critical
 CDC recommends that critical items and any semi critical items that are not heat-sensitive be
steam sterilized after cleaning
 Heat-sensitive semi-critical items should be cleaned and high-level disinfected, at minimum
 Non-critical items must first be cleaned and then disinfected with an EPA-registered hospital
disinfectant

TRANSESOPHEAGEAL ECHOCARDIOGRAPHY TRANSDUCER PROBE (TEE)

 They’re extremely delicate and must be handled with care. Repairs are very costly
 To prevent damage, the manufacturer’s IFU must be carefully followed
 The control housing, also referred to as the Articulation mechanism, contains the control knobs
and probe connector (that should be checked for damage pins) should never be submerged in
liquid.
 It’s important to pay close attention to protection of the delicate lens at the distal tip during
handling
  Before it is cleaned, the transduces probe should be carefully checked for sign of damage,
including:
o Cuts, bite marks, or holes in the sheath and bending section;
o And lens should be inspected for cracks and chips
 The bending section should be carefully articulated while it is examined for signs of damage.
 A lighted magnifier can be used for the inspection process
 If damage is noted the transducer probe manufacturer should be consulted for further
instructions
 Fluid invasion during cleaning or high-level disinfection can cause failure of the probe during the
procedure and costly damage to the probe.
 An Electrical Leakage test should be performed on the TEE probe each time it is processed
 The leakage text checks the conductivity and leakage current on the probe
 Elevated electric leakage can be dangerous to the heart including micro shock or cardiac
fibrillation
 The inter societal Accreditation Commission (IAC) issued the following statement in its IAC
Standards and Guidelines for Adult Echocardiography Accreditation ( August 2015);
o The manufacturers guidelines must be followed for the appropriate care and cleansing
of the TEE transducers and adhere to the appropriate infectious disease standards to
prevent the transmission of disease.
o Effective Dec. 31, 2015 the structural and electrical integrity of the transducer must be
checked between each use, using an ultrasound transducer leakage tester
o Passed or Failed must be documented in the routine TEE probe cleaning/maintenance
log along with the action taken if “Failed”
 For The Leakage test,
o The Electrical connector of the TEE probe attached to the tester and the TEE probe is
immersed in a solution capable of conducting electricity.
 The leakage tester IFU should be consulted for the appropriate solution, which could be:
o Enzymatic solution
o Saline
o The High-Level disinfecting solution
 A conductivity prove, which is attached to the testing equipment, is placed in the liquid.
 The test results are available within seconds
 IF the test fails, another TEE probe should be tested to be sure that the failure is not with the
testing equipment.

TOSI TESTING DEVICES: Directly correlates to the cleaning challenge of the surgical instruments

TOSI – TESTS CAVITATION

When the ultrasonic cleaner is working correctly SonoCheck will change color. Varying color indicates a
possible bad generator. You can go old school and use a piece of aluminum foil (Green/Yellow >>> BLUE)
VERIFICATION OF THE CLEANING PROCESS

 According to ANSI?AAMI and AORN, the efficacy and efficiency of the cleaning process should be
routinely verified ( weekly)
 Mechanical Cleaning equipment should be tested:
o Upon installation
o Weekly (preferably daily) during routine use
o After major repairs
 Monitoring and verifying cleaning processes should be documented.
 A simple test for ultrasonic cleaners is to place a piece of aluminum foil into the unit
 The size of the foil should be equivalent to the length and width of the sonic chamber so that
the entire surface is covered with the foil
 The test should be performed after the unit has been degassed and preferably without
detergent.
 A cleaning cycle should then be run.
 If the equipment is working properly, the cavitation process will create small pinholes and
numerous creases in the foil.
 Cleaning tests are also available for;
o Cart washers
o Robotic instrumentation
 Careful inspection of items after cleaning is also critical to ensuring cleanliness
 It is especially important that lumens be checked for obstructions or debris before sterilization
 Careful inspection of items after cleaning is also critical ensuring cleanliness
 It is especially important that lumens be checked for obstructions or debris before sterilization
 Verification of cleaning processes involves many activities that in combination, provide
assurance that items are being effectively cleaned
o Written procedures should be developed for the cleaning of instrumentation
o Procedures for the routine monitoring of the cleaning process and for the staff
competency should be developed
o For mechanical cleaning, the operator should verify every cycle by reviewing the
printout (if available) for compliance with cycle requirements and signing the printout
o Accepted level of performance should be specified and compliance should be
documented
o Procedure should be developed to identify the actions that will be taken if established
compliance levels are not met, and those actions should be documented
o Cleaned medical devices should be traceable to the patients on whom they are used

QUALITY ASSURANCE

 There should be a quality assurance process in the place to monitor compliance with all stated
policies and procedures and with manufacturer’s IFUs
 Non-compliance issues should be documented and corrective action taken to prevent
reoccurrences of the non-compliance
 The Cleaning effectiveness testing described in the previous section is an integral part of SPD’s
quality assurance process.
 TRANING AND COMPETENCEIS

 For patient and employee safety, it is essential that SPD staff be thoroughly trained with
competencies verified and documented during orientation, annually and whenever new
products, equipment and a new instrumentation is introduced – for the following ( at a
minimum):
o PPE and dress code
o Cleaning chemicals and their use ( including proper measurements of chemicals)
o Interpretation of SDSs
o Interpretation off use of and compliance with manufacturer’s IFU
o Use of all processing equipment ( like, ultrasonic cleaners , washer-decontaminators
,cart washers)
o Specialty Devices (like loaner instruments)
o Environmental Conditions in the decontamination area
o Use and testing of emergency eyewash equipment’s

SUMMARY

 Cleaning is the 1st and most important step in the decontamination process. Unless cleaning
is carried out properly. Effective disinfection and sterilization are not possible.
 Consideration must be given to the water used in the process how soon the cleaning
process has begun the process itself, the manufacturer’s instructions and the way the items
will be cleaned.
 Because of the potential for contaminated items to spread disease, proper handling and
containment of items during transport and processing, the use of PPE and other proper
design and work flow in the decontamination area are all critical to the safety of patients,
staffs and the environment.
 All of these components of the process are important elements of Achieving successful
outcomes in decontamination as well as disinfection and , ultimately sterilization
 SPAULDING CHART
CRITICAL Sterile areas of the body Sterilization
SEMI CRITICAL Mucosal Membranes HLD
NON CRITICAL Skin or Indirect Contact LLD or Cleaning

Hierarchy of Microorganisms
PRION EXTENDED STERILIZATION
SPORES STERILIZATION
MYCOBACTERIUM HLD
MEDIUM VIRUS HLD
FUNGI INTERMIDIATE LEVEL DISINFECTANT
VEGETATIVE BACTERIA LLD
LARGE VIRUS LLD

Instructions for Use (IFU) DEVICES

DETERGENT STERILANT DISINFECTANT

SAFETY DATA SHEET ( S.D.S)

敖廣