HOSPITAL NAME

INSTITUTIONAL POLICY AND PROCEDURE (IPP)

Department:
TITLE/DESCRIPTION
CLEANING OF MEDICAL DEVICES
EFFECTIVE DATE
REVIEW DUE

Manual:

Section:
POLICY NUMBER

REPLACES NUMBER

NO. OF PAGES

APPROVED BY

APPLIES TO

PURPOSE

To provide clean and sterile supplies for patient care. To define the responsibility for cleaning and disinfecting
patient care equipment.
DEFINITION

General Recommendations:
All objects to be disinfected or sterilized should first be thoroughly cleaned to remove all organic matter (blood
and tissue) and other residue.
All equipment used in patient care shall be kept clean and in proper working condition.
All medical equipment used for patient care must be cleaned and disinfected before use on another
patient.
A hospital grade disinfectant approved by the Department of Healthcare Epidemiology must be used
to disinfect medical equipment.
RESPONSIBILITY

Responsibility for Cleaning

Daily clean in the Intensive Care Unit
- Clinical Equipment Services will clean all medical equipment in the intensive care units on a daily
basis
- Environment Services will clean environmental surfaces in the intensive care units on a daily basis.
- Pulmonary Care Services will clean all respiratory care supplies in the intensive care units on a
daily basis.
- Nursing will clean the environment as needed.
Discharge cleaning in the Intensive Care Unit
- Environmental Services will clean all environmental surfaces and medical equipment in the
intensive care units.
- Pulmonary Care Services will clean and remove all respiratory care equipment in the intensive
care units.
Daily cleaning in the non-ICU environment
- Environmental Services will clean all surfaces in the patients room.
- Nursing will clean the room as needed.
- If the room was used for a patient on Modified Contact Isolation, then Clinical Equipment Services
will be called. They will clean all medical equipment in the room prior to transporting to the CES
department.
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Standards

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- If the room was not used for a patient on Modified Contact Isolation, then the nursing staff calls,

and places the medical equipment in the hall for routine pickup by CES.
CROSS REFERENCES
POLICY

All patient care equipment and medical devices will be cleaned and reprocessed according to these policies..
Critical Items:
Critical medical devices or patient care equipment that enter normally sterile tissue or the vascular system or
through which blood flows should be sterilized before each use (refer to methods of sterilization and
disinfections in this policy).
Semi-critical Items
Objects that come in contact with mucous membranes or skin that is not intact should be free of all
microorganisms except for high numbers of bacterial spores and are called semicritical objects. Intact
mucous membranes are generally resistant to infection by common bacterial spores but susceptible to
other organisms such as tubercle bacilli and viruses. Respiratory therapy and anesthesia equipment,
endoscopes, and diaphragm fitting rings are included in this category, Semicritical items minimally
require high-level disinfections using wet pasteurization or chemical disinfectants.
Non-critical Items
Items that come in contact with skin, but not mucous membranes may only need cleaning or lowlevel disinfections.
PROCEDURE

Wheelchairs and Stretcher

All wheechairs and stretchers must be cleaned and disinfected with a hospital-grade disinfectant when
visibly
soiled and on a routine basis.
Prior to the transport of a VRE patient a clean sheet or other barrier must be placed on the stretcher or
wheelchair. The sheet should be removed once the transportation is completed, and the stretcher or
wheelchair is
disinfected.
Guidelines for Disinfection
Disinfection is a process that eliminates many or all pathogenic microorganisms on inaminate objects
with the exception of disinfection/sterilization should be registered with the Environmental Protection
Agency (EPA). The following agents will be acceptable for disinfection provided that the
manufactures recommendations are followed.
Low Level:
- Ethyl or isopropyl alcohol (70%-90%)
- Phenolic germicidal detergent solution
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Phenolic germicidal detergent solutions will not be acceptable for cleaning bassinets or incubators
Lodophor germicidal detergent solution
Quaternary ammonium germicidal detergent solution
For routine cleaning of most noncritical items, a quaternary ammonium germicidal detergent is
available. Most of the noncritical items can be cleaned with this product between patients and when
soiled. The cleaning agents containing quarternary germicides are effective for routine cleaning but
may be inactivated by organic materials (i.e., cork, cotton, and gauze) and, like several other
germicides, gram-negative bacteria may survive and multiply in these solutions.
Spills of blood and body fluids should be thoroughly wiped up using disposable absorbent material
(i.e., paper towels) which are then discarded into the trash. Next, a hospital-grade disinfectant
(Quaternary Ammonium) should be applied to the area contaminated by the spill. The area should then
be thoroughly rinsed with tap water and dried (see policy: Universal Precautions).

High-Level:
- Glutaraldehyde based formulation (2.5%)
- Glutaraldehyde is used most commonly as a high-level disinfectant for medical equipment, such as
endoscopes, transducers, anesthesia and respiratory therapy equipment, and hemodialysis
proportioning and dialysate delivery systems. All reprocessing using glutaraldehyde must be done
away from the patient areas in a well-ventilated area.
Ortho-phthalaldehyde (OPA)
- OPA is a high level disinfectant used must like glutaraldehyde. It is not a known irritant to the eyes
and nasal passages, does not require exposure monitoring, has a barely perceptible order and requires
no activation. It will stain proteins grey and must be thoroughly rinsed to prevent discoloration of a
patients skin or mucous membranes.
Guides for Sterilization
Sterilization is the elimination or destruction of all forms of microbial life.
- Sterilization may be accomplished in either of the following ways:
- Stream sterilization
- Chemical disinfectants following the manufacturers recommendations.
- Plasma gas sterilization (Sterrad)
- Peracetic Acid (Sterris)
Of all the methods available for sterilization, moist heat in the form of saturated steam under pressure
is the most widely used and the most dependable.
Flash sterilization should only be used in carefully selected clinical situations
(i.e. instrument needed for case falls or floor and no replacement instrument is available)
Implantable medical devices should not be flash sterilized.
Gas plasma sterilization which hydrogen peroxide uses radio frequencies to create hydrogen peroxide
vapor.
Gas plasma is an acceptable method for sterilization. If requires no aeration time and the end products
are not toxic. It cannot be used with cellulose or linen and cannot enter very small lumens.

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Standards

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Recommen-dations for the Reprocessing Area

Items that require high-level disinfection or sterilization should be processed in the Sterile Processing
Department when feasible. Disinfection and sterilization performed elsewhere must comply with the
same guidelines as Sterile Processing Department.
Gross blood, fluid and tissue should not be allowed to dry on any reusable item ( this makes for very
difficult physical cleaning). Therefore, items should be transported to the decontamination area in a
timely manner before processing.
Reusable items shall be placed in a leak-proof bag or container prior to transport to the reprocessing
area.
For those departments that perform high-level disinfection with chemicals, the area for reprocessing
should be separated from the area where items are rinsed and stored.
Reprocessing should be performed away from patient care areas, and the area should be wellventilated. The area must have sufficient air changes to prevent build up of vapor. Noxious levels of
glutaraldehyde vapor are determined by detection badges worn by personnel working in the area.
OPA requires no monitoring badges. Monitoring for concentrations of glutaraldehyde vapor is
overseen by the Chemical Safety Committee
Glutaraldehyde 2.5% and OPA solutions need to be labeled with name of the solution, date of
activation/reconstitution, and of activation/reconstitution, and date of expiration. The instruments
must be fully immersed, hinged instruments opened and the cover closed. High-level disinfection
requires a 20 minutes soak time (see table) for Glutaraldehyde and 12 minutes for OPA.
Glutaraldehyde 2.5% and OPA solutions must be monitored with a chemical test strip and results
documented on a daily basis (or whenever the glutaraldehyde is used).
See attachment for Soaking & Monitoring Instructions.
For those departments who package their won items, physical barriers should separate the
decontamination area from the packaging area. Decontamination and packaging should not be
performed in patient care areas.
Non-critical items (i.e., beds, monitoring equipment, IV poles. etc) may be cleaned in an area
designated for dirty equipment or in non-patient care areas.
Personal Guidelines
All personnel who clean or reprocess equipment should use appropriate protective barriers for the
procedure being performed, (i.e., gowns, gloves, goggles, masks, etc). This may vary according to
the cleaning disinfectant agent or the item being reprocessed.
Ultrasound on Intact Skin
When an ultrasound procedure is done on intact skin, the probe must be cleaned with soap and water
between each patient. A probe cover is not needed.
Ultrasound on non-intact skin
When a ultrasound probe is to be used on a mucous membrane (vaginal, esophageal, etc) or nonintact skin a prove cover (condom) must be used. The scope must also be soaked in glutaraldehyde
for 20 minutes for high level disinfection between each patient (see section above: Recommendations
for the Reprocessing Area).
Recommendations for Packaging Supplies to be Sterilized
They must withstand the physical conditions of the sterilization process chosen for the device.
They must allow for adequate air removal.
They must be easily penetrated by the sterilant.
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 They must be a reliable barrier to dust particles that carry microorganisms.

It must be possible to seal them in such a way that tampering will be evident.
It must be adapt to the size and shape of the item to be packaged.
They must resist tearing and puncturing under ordinary conditions of use.
They must protect the package contents from physical damage.
They must allow aseptic removal of the contents.
See SPD guidelines for packaging.
Chemical Indicator For Sterilized Supplies
External chemical indicators should be placed o n the outside of the packaging material. They may
be used as a form of closure for the package such as indicator tape. If the external chemical indicator
does not demonstrate or show that the package has been in the autoclave, it should be reported to the
manager/director of the Sterile Processing Department with the load control number and the item(s)
should then be reprocessed and sterilized before use.
The appropriate internal chemical indicator should be placed in the center of the package in the
center of the tray when flash sterilizing. If the internal chemical indicator does not indicate that the
item has been sterilized, it should be reported with the load control number to the Manager/Director
of the Sterile Processing Department and the item(s) should be reprocessed and sterilized before use.
Labeling
The contents of the package must be identified before the package is opened. The package must be
labeled correctly and completely.
The label information should include:
- The expiration date
- The identification of the sterilizer and cycle/lot number
- A description of the contents if not visible.
- The technicians initials.
For tape-secured packages that are hand-labeled, felt-tip, indelible-ink markers may be used to
record the necessary information on the tape. Do not write on the wrapper material. Indelible-ink is
necessary so that the marking will not run of fade. Felt-tip indelible-ink markers may also be used
on pouches. For paper/plastic pouches, the label must be on the clear/plastic side. Writing on the
paper side may damage the material, and the ink may bleed through and contaminate the package
contents.
All packages must be labeled prior to sterilization.

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Methods of Sterilization and Disinfection:

Sterilization
High-Level
Critical Items:
Semicritical Items:
Will enter tissue or vascular
Will come in contact
System or blood will flow
with
mucous
Through them
membrane but not
enter
tissue
or
vascular system
Object

Procedure

Exposure
Time (hr)

Procedure
(exposure time 1230 min at 20C) 2,3

Smooth, hard
Surface 1,4

A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G
H
A
B
C
D
E
F
G

MR
MR
MR
10 h
6h
12 m
3-8 h

D
E
F
H
I6

MR
MR
MR
10 h
6h
12 m
3-8 h

D
E
F
H
I6

MR
MR
MR
10 h
6h
12 m
3-8 h

D
E
F
H
I6

MR
MR
MR
10 h
6h
12 m
3-8 h

D
E
F
H
I6

Rubber tubing
And catheters 3,4

Polyethylene
Tubing and
Catheters 3,4,7

Lensed
Instruments4

JCI
Standards

Low-Level
Noncritical
Items:
Will not come in
contact with
mucous
membranes or
skin that is not
intact.
Procedure
(cleaning with
mechanical
friction)
K
L
M
N
O

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Thermometers
(oral and rectal)8
hinged
instruments4

H
A
B
C
D
E
F
G
H

MR
MR
MR
10 h
6h
12 m
3-8 h

D
E
F
H
I6

FORMS
EQUIPMENT
REFERENCES

1. National Standards and Recommended Practices for Sterilization. Association for the Advancement of
Medical Instrumentation, 2nd Edition. Arlington, Virginia, 1988.
2. Perkins, J.J. Principles and Methods of Sterilization in Health Sciences, 2nd Edition, Springfield, Illinois,
Charles C. Scott, 1969.
3. CDC Guidelines for Handwashing and Hospital Environmental Control, 1985. U.S. Department of Health
and Human Services, Atlanta, Georgia.
4. Training Manual for Central Service Technicians. American Society for Hospital Central Service Personnel
of the American Hospital Association, Chicago, Illinois, 1986.
5. Wenzel, R.P. Prevention and Control of Nosocomial Infections, 1987. Baltimore, Md. Williams and
Wilkins.
6. Rutala, W.A., Draft Guidelines for Selection and Use of Disinfectants. AJIC 1989, 17:25a-38a.
7. Rutala, W.A., Antiseptics and Disinfectants Safe and Effective. Infection Control 5:2215- 2218, 1984.
8. American Society for Hospital Central Service Personnel, American Hospital Association, Ethylene Oxide
for Use in Hospital A Manual for Health Care Personnel, 1986, 95-100.
9. Mayhall, C.G. Hospital Epidemiology & Infection Control. Third Edition.
APPROVAL:
Name

Signature

Date

Prepared by
Reviewed by
Approved By
Approved By
Latest Revision Approved By

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Standards

CBAHI
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