Reprocessing: Cleansing,
Disinfection,Sterilization
Cleansing and disinfection:
Cleaning refers to the removal of all visible dirt or contamination of fomotes or the environment. The
most frequently used cleaning agents are detergents. Soap is not used for environmental cleaning anymore
but the cleaning of hands and skin.
Disinfection refers to the elimination of all potential pathogenic microbes. The number of microbes on a
surface or an objects is reduced so far that no infection can occur(reduction of 5 log steps, e.g. by a factor of
100.000 of the initial germ count). Disinfection with sporicidal also kills bacterial spores. For a disinfection
process, it is not required that all microbes are inactivated but that all phatogenic microorganisms are
eliminated.
Therefore, the disinfection aims to break the chain of infection and prevent shedded pathogens to reach a
new infection target (human, food, etc.). To achieve this, disinfection must always be carried out meticulously.
Disinfection is the selective reduction of the numbers of pathogens by physical or chemical inactivation,
so that infection by these objects is not possible. Continuous disinfection of the healthcare environment
prevents the spread of pathogens during the care and treatment of a patient. All surfaces and objects in the
healthcare environment that are contaminated by infectious secretions shed by the patient shouldbe
disinfected. Final disinfection of surfaces and objects has to be carried out when there is a change of patients
in the room.
This Photo by Unknown Author is licensed under CC BY-NC
Classification of
Disinfection • Physical disinfection procedures
Procedures: – Fire or heat
Disinfection procedures are classified – Water
according to their intended practical use in • Thermal disinfection procedures
healthcare according to the sensitivity of
the pathogen: • Actinic disinfection procedures
• Group A—killing of vegetative forms of – Irradiation
bacteria (including mycobacteria) and
fungi
• Chemical disinfection procedures
• Group B—inactivating viruses
– Alcohols
• Group C—killing spores of Bacillus
anthracis – Phenols
• Group D—killing the spores of – Aldehydes
Clostridium perfringens and Clostridium
tetani – Halogens
Disinfection procedures are classified – Oxidants
according to the method of disinfection:
– Heavy metals
Thermal Disinfection:
In order to inactivate the pathogenic microorganisms, heat with sufficient temperature must be transferred to the
germs. It should be noted that the microorganisms can be spared from the heat effect by protection in dirt particles
(e.g. blood, pus, fats, soil) for even long periods and thus no disinfection is achieved. For the disinfection of
thermostable articles (e.g. objects which can withstand heat without being damaged), a thermal process should
always preferred to chemical processes since they have a safer and measurable effect.
Disinfection Using Fire Burning (Incineration)
Incineration is the safest method of disinfection provided that all objects to be disinfected are completely
burned. Incineration is applicable to contaminated wounddressings in a hospital, disposable articles and other
disposable devices with blood residues, waste of a microbiological laboratory, etc.
Annealing
Disinfection of metal instruments, e.g. platinum loops as used in the microbiology laboratories. Scalpels are not
annealed because they get truncated and thus useless.
Flaming
Flaming is limited to fomites or devices that are thermostable. Flaming is usually a process of short
duration. It can be safely applied to metal instruments and objects that conduct heat well because due to
their thermal conductivity, the maximum temperature is reached immediately to kill the germs. But due
to the insecure conducting properties, it cannot be assured that once the required temperature is
reached, it can kill the germs. Therefore flaming is regarded as an uncertain disinfection procedure.
Disinfection Using Boiling Water
Hot Water
Hot water with a temperature of 85–95 °C achieves disinfection. Exposure to hot water
for 3 min disinfects the category groups A and B; exposure for 15 min disinfects the
category groups A, B and C. Disinfection with hot water is performed in dishwashers,
bedpan washer disinfectors and laundry disinfection (categories A, partly B).
Boiling
Boiling in water at temperatures of 99–100 °C achieves disinfection. At 3 min boiling
water disinfects category groups A and B, at 15 minutes boiling the groups A, B and C.
Steam Disinfection
The heat in steam is greater than in hot water. Goods and objects to be disinfected
must be loosely introduced into the steam disinfection device, so that the steam
canpenetrate equally well everywhere.
There are two steam disinfection methods:
• Steam flow method
The air is displaced by saturated steam from the disinfection chamber. The
flowing steam (depending on the air pressure) reaches a maximum of 100 °C. A
time of 5 min is needed to kill the germs from the groups A and B; 15 min are
needed to kill the group C. This method is used to disinfect medical waste.
• Fractionated vacuum process (VDV procedure)
Removal of air is performed by repeated (fractionated) evacuation. Then there is
the inflow of saturated steam. Disinfection temperatures are 75–105 °C. Then a
drying step follows and evacuation of the vapour. Depending on the duration
and temperature, microorganisms of groups A, B or C are killed.
Combined Chemo-thermal Disinfection
Additional chemical disinfectants are added to thermal disinfection (60°C for 10
min = Groups A and B). This is the method of choice for heat-unstable material
(anaesthesia masks, tubing, endoscopes).
Actinic Disinfection
Radioactive rays (beta or gamma rays) and ultraviolet rays (UV rays) can be used for the inactivation of
microorganisms by ionizing radiation. Ionizing radiation is mainly used in industrial and technical contexts. UV
disinfection is commonly used for disinfecting air and water. There are some efforts to use UV disinfection for
medical devices. The back draw is that UV rays do not penetrate solid materials and the so-called areas which
are shadowed from the reach of UV rays may inhibit full disinfection.
Chemical Disinfection
Chemical disinfectants are usually complex formulations of active molecules. The mode of action of these active
molecules is thought to be non-specific; chemical disinfectants dissolve viable parts of microorganisms or
interfere with their metabolism. All chemical disinfectants need to come in contact with microorganisms in order
to act.
Possible Pitfalls of Chemical Disinfection
When submerging medical instruments for disinfection purposes in a chemical disinfectant solution, it is
very important to assure that all surfaces of the medical instruments come in contact with the chemical
disinfectant (open scissors or clamps before submerging them), lumina might be inadequately filled with
disinfectant solution (narrow tubes, needles, etc.), or they could be coated with lipids and therefore
have an increased surface tension. It should also be noted that there may be considerable variation (in
terms of pH, hardness, salinity, etc.) in the solutions surrounding the target microorganisms and the
state in which the latter is present (e.g. isolated bacterium or bacterium included in complex biofilm).
Most Important Chemical Disinfectant Groups
Alcohol
In the hospital setting, monovalent alcohols are mostly being used, especially:
• Ethanol
• Isopropanol
• n-Propanol
Alcohols are bactericidal rather than bacteriostatic against vegetative forms of bacteria; they
also are tuberculocidal, fungicidal and virucidal, but they are not active against bacterial spores.
Their bactericidal activity is based on the fact that alcohols dissolve the bacterial cell wall (but
not those of bacterial spores); they can also act on enzymes and bacterial by-products. The
activity of alcohols depends strongly on their concentration. When diluted below 50%
concentration, alcohols lose their bactericidal activity; their optimum bactericidal concentration
is between 60% and 90% solutions in water (volume/volume). Alcohols are very fast-acting
disinfectants; however they also evaporate rapidly, making extended exposure time difficult to
achieve. It is therefore very important to keep the medical items continuously alcohol wet. Use
ethanol 80 vol%, isopropanol 60–70 vol% or n-propanol 50–60 vol% for hand disinfection.
Alcohol is flammable and consequently cannot be used to disinfect large surfaces! It must be
stored in a cool, well-ventilated area. Main uses: Hand disinfection, instrument disinfection,
Aldehydes
Aldehydes are used for disinfection of medical devices and hospital surface. They are very reliable
disinfectants and gentle regarding instrument longevity Formaldehyde is the main aldehyde used for
disinfection purposes and is used principally as a water-based solution called formalin, which is 35–
40% formaldehyde by weight. Formaldehyde has an allergenic potential on the skin and is therefore
not used for skin disinfection. It has a pungent odour and is a potential carcinogen which is why an
employee exposure standard for formaldehyde has been set that limits an 8-h time-weighted average
exposure at 0.6 mg/m3 ambient air. It should be used for targeted purposes only. Formaldehyde has
good bactericidal activity, and in high concentrations with long exposure times, it shows
tuberculocidal, fungicidal, virucidal and sporicidal activity. For the disinfection of medical devices
(e.g. surgical instruments), formaldehyde is used in its gaseous form (low-temperature steam
formaldehyde sterilization): formaldehyde gas (5 g/m3) in steam (requires high humidity at least
70% room humidity) for at least 6 h. Effective range: A and B For surface disinfection and for laundry
disinfection, formalin can be used. For laundry disinfection the laundry is being exposed for at least 5
h to 3% formalin.
Disadvantages of Aldehydes
Pungent odour, allergenic potential (employee exposure standard: 0.6 mg/m3 air) and high “protein
error” (i.e. the bactericidal activity of aldehydes is decreased in the presence of protein or soil, e.g.
pus, blood serum, etc., due to the fact that the active compound is bound to protein and therefore
not available in a sufficient concentration to act as a disinfectant) A high “protein error” is found for
aldehydes (depending on the compound), quaternary ammonium compounds and oxidants. Alcohols
and phenols have a low 5 Reprocessing: Cleansing, Disinfection, Sterilization 40 “protein error” (i.e.
the presence of proteins does not interfere so much with their bactericidal activity).
Effective Range
Bacteria
• Bacterial spores only when maintaining higher concentrations over longer exposure times at higher
temperatures
• Many viruses (HBV only when using high concentrations and long exposure
times at higher temperatures)
• Fungi (less reliable activity than for bacteria)
Usage
In its gaseous form: Disinfection of medical devices and instruments (special anaesthesia supplies, face masks,
mattresses) using low-temperature formaldehyde and formaldehyde vapour (5 g/m3) in steam (at least 70%
room humidity) for at least6 h. Effective range: A and B
Phenolics
The indication for the use of phenolic disinfectants is therefore limited. One of their important advantages is
their low “protein error” and therefore suitability to dissolve blood contaminations. More important than
phenol itself are phenolic derivate such as diphenylderivates. Diphenylderivates have a very narrow range,
showing mostly bacteriostatic activity against gram-positive bacteria. Its most important representatives are
chlorhexidine and octenidine, used for mucosal and skin decontamination for certain healthcare-associated
gram-positive pathogens.
Halogens and Halogen-Releasing Agents
Chlorine-, iodine- and bromine-containing compounds are highly reactive as oxidizing agents; they show
good bactericidal activity against bacteria, fungi and certain viruses (A, B, partially C). Chlorine is used in
water, linen, and environmental surface disinfection in sanitary and kitchen areas. Iodine shows good
activity against bacteria and bacterial spores, but its virucidal effect is unreliable. Elemental iodine bound to
high-molecular weight surface-active compounds is used as an antiseptic, e.g. as polyvinylpyrrolidone (PVP-
Jod) for mucous membrane disinfection. PVP-iodine preparations should be avoided in neonates, in patients
with thyroid disorders and during pregnancy, as iodine can be resorbed and lead to a systemic increase of
iodine in the organism.
Peroxygens and Other Forms of Oxygen
Oxidizing agents (oxidants) are substances that accept electrons liberated during oxidation. Oxidants are
potent antimicrobial agents. They include substances such as ozone, potassium permanganate or hydrogen
peroxide. Oxidants are very effective antimicrobials showing potent bactericidal, fungicidal and virucidal
activity. Due to their corrosiveness and therefore very restricted material compatibility, their use for
instrument disinfection is limited to corrosionresistant materials. They are mainly used for specified
instruments such as ventilators and infusion pumps and also for surface disinfection. Oxidants, e.g. perform
0.75%, are easy and safe to use for routine disinfection and sanitization purposes in the hospital. Some of
their representatives come in a ready-to-use format, helping to avoid dosage errors. Disadvantages:
Oxidants have a high “protein error” and can therefore only be used on previously cleaned surfaces; they
should under circumstances be used on blood or otherwise protein-contaminated surfaces. In such cases
previous removal of blood contamination, e.g. with phenolics, must precede the use of oxidants.
Metals
Metals used for disinfection are often called “heavy” metals, a term used to qualifymetallic elements with a
greater specific density. The formally frequently used mercury compounds (Mercurochrome, Merfen) are
nowadays obsolete. They are not used anymore due to their toxicity and comparably low disinfectant (only
microbiostatic) activity. 5.1.4.3 Disadvantages
Disadvantages of Chemical Disinfection
• Gaps in effectiveness (spores, HBV) and environmental contamination.
• Chemical disinfectants are concentration-, temperature- and pH-dependent.
• Decomposition and loss of activity.
• Protein error.
• Recontamination potential (if disinfected materials are flushed with water—
against the instructions!)
• Residual chemicals in materials (e.g. in rubber parts).
• Material corrosion.
• Health effects on healthcare users.
Surface Disinfection
There are many surface disinfection products with varying active ingredients on the market. Depending on the
active ingredient, certain factors such as “protein error” and microbicide activity have to be considered when
choosing the correct disinfectant. In the presence of bodily fluids, e.g. there is—from a microbiological-hygienic
Routine Disinfection
We speak about routine disinfection if no contamination of the surface to be treated with blood, other bodily fluids
or microbial cultures is to be expected. Under these circumstances all disinfectants listed as “surface disinfectants”
in the expert register of the ÖGHMP/ASHMPM (Austrian Society for Hygiene, Microbiology and Preventive
Medicine) can be used.
Disinfection of the Hospital Environment of a Known Infectious Patient
In such a case, aldehyde-based disinfectants listed as “surface disinfectants” in the expert register of the
ÖGHMP/ASHMPM (Austrian Society for Hygiene, Microbiology and Preventive Medicine) should be used.
Formaldehyde is the preferred choice if abundant protein residues are expected (e.g. blood, excretions and bodily
fluids) on the surfaces or items to be disinfected.
How to Proceed in Case of Extended Contamination
(E.g. extended blood pool, spilled bacterial culture, etc.)
Step 1: Absorb coarse dirt particles with an absorbent material (e.g. cellulose or similar) and dispose
without contamination (garbage bag for medical waste).
Do consider: Self-protection using gloves and single-use aprons. If liquids are discarded in garbage bags,
always use sufficient absorbent materials to avoid spillage!
Step 2: Spread the absorbent material onto the contaminated surface and carefully soak with disinfectant
solution. Leave as it is for 1 hour, to ensure optimal working conditions for the disinfectant. Clearly
delineate and secure the contaminated area for the entire time of disinfection.
Step 3: Discard the soaked absorbent/covering material in the garbage bag. Finish off with a wipe surface
disinfection.
Mycobacterium Tuberculosis Only use disinfectants with mycotuberculocide activity, and strictly follow
manufacturer’s recommendations regarding concentration and exposure times
Rotavirus Infected patients usually massively shed rotaviruses with the stool and vomit and contaminate
the environment. Therefore routine disinfection measures are not sufficient to eliminate this massive
environmental contamination and interrupt the infectious chain. Additional barrier precautions such as
gloves, nose-mouth mask and single-use aprons are needed (never touch surfaces with unprotected
hands; try to avoid surface contamination). The use of virucidal disinfectants (hand—as well as surface
disinfectants) is mandatory.
Disinfection of Medical Instruments
Disinfection of medical devices is important to avoid transmission of infectious diseases between
patients but also to protect healthcare workers against potential infection risks. Furthermore it is
important for the maintenance and preservation of the medical devices. Medical device
reprocessing comprises different steps from the initial use until the renewed allocation. Medical
devices should be disposed of in a dry manner from the place of use until the reprocessing area
Sterilization
The process of sterilization consists of eliminating all viable organisms including bacterial spores
from a surface or a product.
Sterilization Procedures
Similar to the disinfection methods, we distinguish physical from chemical sterilization
techniques:
I. Physical techniques:
1. Moist heat (steam) sterilization
2. High-temperature dry-heat sterilization
3. High-energy ionizing radiation sterilization
II. Chemical sterilization techniques:
1. Ethylene oxide (EO) sterilization
2. Formaldehyde (FO) sterilization
Moist heat (stem) sterilization is still considered to be the gold standard of sterilization
and should be applied whenever possible. Nevertheless medical diagnostics and treatment options
are increasingly relying on technically complex and at the same time very delicate medical
instruments which are often susceptible to heat, pressure and moisture. Such thermolabile
medical devices cannot be sterilized at high temperatures. For each medical device, appropriate
procedures for the disinfection and sterilization need therefore to be defined. There is currently no
universal sterilization procedure.
Physical Sterilization Techniques
Moist heat (steam) sterilization is currently the most reliable sterilization technique available.
Through condensation of high-temperature steam on surfaces For steam sterilization the following
cycles are widely used: 15 min sterilization at 121 °C (steam pressure 2 bar) or 3 min at 134 °C
(steam pressure 3 bar). Steam sterilization is performed in so-called autoclaves—steam sterilizers.
They consist of chambers shaped depending on their application and capable of withstanding the
required atmospheric pressures for sterilization. In order for steam to also be able to penetrate
hollow lumens, efficient air removal from the autoclave chambers is essential. Selected steps of
the technical time schedule of a steam sterilization cycle inside an autoclave are as follows:
High-Temperature Dry-Heat Sterilization
High-temperature dry-heat sterilization (e.g. 180 °C for at least 30 min) consists of sterilization using hot dry air,
comparable to the use of an oven.
Disadvantages of dry-heat sterilization:
• Slow heat transfer onto the goods to be sterilized
• Higher temperatures and longer sterilization cycles are needed in comparison to other sterilization
techniques.
• Heat is not evenly distributed within the chamber leading to heat stratification with certain areas of the load
remaining cooler than others. Certain goods might therefore not be safely sterilized.
• Loading patterns of the goods have a big effect on the sterilization outcome; overloading can lead to uneven
heat distribution with inadequate sterilization.
• No validation protocols for this sterilization technique are currently available.
• High-temperature dry-heat sterilization should not be used in the hospital setting!
Chemical Sterilization Techniques
Chemical sterilization techniques are low-temperature gas sterilization techniques using broad-spectrum
antimicrobial/biocidal agents as chemical sterilant (e.g. ethylene oxide or formaldehyde) in a closed
system. Only thermolabile medical devices not withstanding steam sterilization should be “gas sterilized”.
Formaldehyde Sterilization
Formaldehyde (FO) is used as a biocide in gaseous form and requires a highly humid environment for its biocidal
activity. FO is used in a low-temperature steam mixture for sterilization purposes. This mixture is neither
flammable nor explosive and is easily removed from the sterilized goods—i.e. rapid aeration over time— after the
sterilization cycle, allowing for its rapid reuse after reprocessing. Formaldehyde gas sterilization achieves
microbicide activity at temperatures between 60 and 75 °C. (Neither saturated steam nor FO alone is sporicidal at
these temperatures; it is the combination of both processes that ensure a sporicidal effect.)
Ethylene Oxide Sterilization
Ethylene oxide (EO) is toxic at relatively low concentrations. Further EO is carcinogenic and considered a
hazardous substance. Safety regulations apply. Advantages of EO sterilization are its good material penetration
abilities and the low sterilizing temperatures needed. On the other hand, to remove residual EO from the load,
adequate aeration times (of up to 16 h) can be required, making EO sterilization inadequate for emergency
sterilization or sterilization of goods with a high turnaround time.
Organization of Hospital Sterilization and Disinfection Units
Central Organization
All goods that need reprocessing (disinfection or sterilization) are transferred to a centralized
reprocessing unit where contaminated goods are decontaminated (validated automated
washing, disinfection followed by packaging and various sterilizing techniques depending on
material compatibility).
Decentral Organization All necessary reprocessing steps are carried out on site in a decentral reprocessing unit.
Requirements for the Sterile Packaging The sterile packaging material must not obstruct the sterilization process and
must ensure sterility throughout the life cycle of the sterile goods. The sterile packaging must be easy to handle, i.e.
removal of the sterilized goods must be possible without recontamination.
In accordance with currently valid standards, the following sterile packaging’s systems are recommended:
• Rigid aluminium container
• Transparent paper-foil combination wraps
• Sterilization paper wrap
Sterilization of CJD (Prion)-Contaminated Medical Devices
Instruments used on patients suspected of having Creutzfeldt-Jakob disease (CJD) cannot be reused. Whenever possible,
disposable single-use neurosurgical medical instruments should be employed. To minimize the possibility of use of
neurosurgical instruments that have been potentially contaminated during procedures done on patients in whom CJD is
later diagnosed, hospitals should consider using the sterilization guidelines for CJD outlined below for all neurosurgical
instruments as prevention measure: steam sterilization at 134 °C with an exposure time of 18 minutes. If this is not
possible, the conventional sterilization cycle at 134 °C with 3 min of exposure time needs to be preceded by a disinfection
of the instruments with sodium hydroxide or 2.5% till 5% sodium hypochlorite solution for 24 h.
Sterilization Monitoring and Control and Documentation
The efficacy of the sterilization process cannot be confirmed by testing the final product. Therefore it is
mandatory to routinely monitor, document and validate each aspect t of the sterilization process. Necessary
requirements for documentation and process control are summarized in the DIN EN 17665 sterilization of
healthcare products—moist heat—Part 1: requirements for the development, validation and routine control of
a sterilization process for medical devices (ISO 17665-1:2006):
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