5.

3 EDUCATIONAL PRODUCT CONSTRUCTION

5.3.1 Material and Sterilization Center and Endoscopy Service

Within the hospital, CME is the sector responsible for the reprocessing
of all materials used in health care and capable of reuse. RDC no. 307 defines
it as a technical support unit (BRASIL, 2002a), because it operates daily
providing materials for care throughout the hospital, having as the largest
consumer unit the Surgical Center due to the volume of materials demanded
for the various surgical procedures.
The MSC reprocesses the materials through standardized processes,
with the objective of providing materials with quality, necessary quantity and
free or partially free of pathogenic microorganisms capable of causing hospital
infection.
CME's work is based on RDC No. 15, regulated on March 15, 2012,
which provides for the requirements of good practices for the processing of
health products and provides other measures.
High-level manual disinfection is an effective alternative when
performed by specialized, well-trained personnel with adequate personal
protective equipment (WORLD GASTROENTEROLOGY ORGANISATION,
2019).
Endoscope reprocessing, specifically, is regulated by RDC No. 6 of
March 10, 2013 (BRASIL, 2013), which orders the training of professionals,
process steps and the physical area. And this reprocessing should be
performed with quality and safety to prevent patients from becoming
contaminated during the examinations, since endoscopic equipment is used in
several patients.

5.3.2 Physical structure for reprocessing

a) Free area of movement of people.

b) Reception and cleaning area of articles, keeping the temperature
between 18 and 24° C.
 c) Sink for cleaning contaminated material.
d) Immersion container, if so, in enzymatic detergent or alkaline
detergent. Neutral detergent can also be used with which
immersion is not required.
e) Container for immersion in disinfectant.
f) Sink cleans for rinsing.
g) Door or window for the output of disinfected material.

Day et al. (2021) warn that the reprocessing room should be free of
occupational risks and risks for patients.
The room must have an exhaust system to protect people from
exposure to toxic fumes.

5.3.3 Use of PPE

Personal Protective Equipment (PPE) is used, fundamentally, so that

professionals do not become contaminated during the activities. In addition,
the gloves have a non-slip function to prevent the material from slipping from
the hands and being damaged during operation (Chart 2, Figure 2).

Table 2 - PPE
EPI Procedure Cleaning Disinfection Drying
Glasses X X X X
Procedure X
gloves
Latex glove X X X
Procedure X X X
mask
Activated X
carbon mask
Long sleeve X X X X
apron
Plastic apron X X X
Ear protector X
Source: Brazilian Society of Nursing in Gastrointestinal Endoscopy (2006).

Figure 2 - Collaborator using all appropriate PPE according to Chart 2

 Source: Collection of the author (2022).

There are several weaknesses and potential deficiencies

in patient care in periendoscopy and endoscope
reprocessing. This includes human and technical error,
characteristics that can be sources of microbial
contamination and transmission of infectious material
(BEILENHOFF et al., 2016).

Therefore, it is essential that the team takes appropriate techniques, is

professionally trained and parapented, so as not to run the risk of becoming
contaminated during the procedure and the reprocessing of the material.

5.3.4 Flexible endoscope equipment

 The flexible endoscope is a high-cost, long equipment, which makes it
difficult to manipulate; and complex conformation, favoring the aggregation of
dirt that can lead to hospital infection after the use of the device (Figure 3).
Figure 3 - Endoscope

Source: Doctor's Portal (2020).

5.3.5 Hospital infection

Hospital infection is that acquired after hospitalization of the patient,

which manifests itself during hospitalization or even after discharge, when it
can be related to hospitalization or hospital procedures performed.
Muscarella (2016) states that between 2008 and 2015, there were, in
the United States and Europe, cases of patients infected after undergoing
endoscope procedures, with about fifteen patients dying in the United States
and sixteen in France. In both countries, contamination was caused by
Carbapenem Resistant Enterobacteria (CRE).
According to the World Gastroenterology Organization (2019), studies
conducted in the United States in 2015 associated reprocessing errors, such
as problems with cleaning, disinfection and drying, as well as hidden defects in
equipment, to outbreaks of infections that same year.
Patients infected or suspected of contamination by Carbapenemases-
Producing Enterobacteria (EPC), highly antibiotic-resistant bacteria, should be
examined last to prevent contamination of other patients. This care is based
on existing outbreaks of infection of patients after flexible endoscopic
procedures in several countries.
This demonstrates the relevance of the adoption of control measures in
the process of disinfection of this equipment within the MSC or sector specific
for endoscopy. Protocols and processes need to be adequate to suppress
hospital infections and the information provided by the equipment
manufacturer should be considered.
The reprocessing of flexible endoscopes is divided into several steps:
cleaning at the point of use; leak test; cleaning; chemical disinfection; drying;
storage and transport.

5.3.6 Process steps

5.3.6.1 Material

Flexible endoscope cleaning brushes cannot be too thick, so as not to

cause the equipment to be abrasioned or too thin, or cleaning will not be
efficient (BRAZILIAN SOCIETY OF NURSING IN GASTROINTESTINAL
ENDOSCOPY, 2006). Cleaning should be done with:

a) Sponges.
b) Enzymatic detergent, neutral detergent, or alkaline detergent.
c) Disinfectant solution.
d) Compresses for drying.
e) Syringe.

5.3.6.2 Pre-cleaning at the point of use

According to the World Gastroenterology Organisation (2019), the

equipment must be processed within 30 minutes so that dirt does not occur,
following the following steps:

a) After removing the patient's equipment, the endoscope should be

cleaned by cleaning the body of the equipment with a compress
 enprinted in water and detergent to remove excess dirt and so that
there is no adhesion of organic material on its surface, making it
difficult to clean.
b) Vacuum the water with detergent (according to the dilution of the
manufacturer) to clean the internal channels of the equipment.
c) Trigger the suction of water for 15 seconds, avoiding obstruction.
d) Remove the appliance from the electrical source and cover the
appliance source so as not to cause damage during the process
(Figure 4).

Figure 4 - Pre-cleaning of the equipment after the procedure (1'04")

Source: Collection of the author (2022).

5.3.6.3 Cleaning area

Area for the reception, separation, and cleaning of materials. In this

location it will also be defined by which type of process the material will pass
through.
The industry needs cleaning equipment and supplies such as
detergents, neutral soap, jet water, heated water, brushes, sponges, and
washers to enhance cleaning. The professionals involved should be properly
paraded and should not move around other areas to avoid cross-
contamination.
5.3.6.4 Receipt of material

When receiving the material, you must hold it firmly, as it is heavy and
has a slippery surface.

5.3.6.5 Watertightness test

a) Adapt the rubber to test the seal of the appliance.

b) Immerse the equipment in the water and check for air bubbles to
flow.
c) With the whole device immersed, perform upward, down, left, and
right movements, watch for the formation of bubbles and/or the
pressure drop of the manometer (Figures 5 and 6).
d) If there is no leakage, continue the process.
e) If the appliance leaks, stop the process, as the air may infiltrate and
damage it further. This should be referred to maintenance
(BRAZILIAN SOCIETY OF NURSING IN GASTROINTESTINAL
ENDOSCOPY, 2006).

Figure 5 - Manometer used for the sealing test.

Source: Collection of the author (2022).

 Figure 6 - Watertightness test (1'10")

Source: Collection of the author (2022).

5.3.6.6 Cleaning

Cleanup is the key point of reprocessing. Material that is not clean

cannot be disinfected – you cannot go to the other steps. Cleaning is the
process of removing organic material and should be carried out judiciously. It
can be manual or automated and a detergent or soap solution (WORLD
GASTROENTEROLOGY ORGANISATION, 2019) should be used (Figures 7
and 8).

Figure 7 - Seal test (26' video)

 Source: Collection of the author (2022).

Cleaning should be done as soon as possible to facilitate dirt removal. If

the material still has organic matter, it will impair the action of the disinfectants
in the later stage. In addition, wet material becomes contaminated with the
possibility of adding biofilm (Figure 9).

The biofilm results from bacteria that bind to a surface and production
of extracellular polysaccharides, allowing organisms to become
trapped and resistant to degradation in future stages of reprocessing.
Additionally, serial cycles of reprocessing generate "accumulated
biofilm", housing layers of protective polysaccharides and many
varieties of microorganisms that are even more resistant (DAY et al.,
2021).

Figure 8 - Rinse 1 (1'55'')

Source: Collection of the author (2022).

Step by step:
 a) Seal the equipment to prevent damage during the process. The
sealing mode depends on the brand of the equipment.
b) Immerse the appliance in an enzymatic solution (at the
concentration recommended by the manufacturer). The enzymatic
solution should be disregarded after each use.
c) Brush the appliance with a suitable brush or sponge for instruments
until all debris is removed.
d) Introduce the enzymatic soaked brush into the channels and
perform friction, ensuring that the tip has also been cleaned.
e) Insert the brush into the suction channel until it leaves the
appliance.

Figure 9 - Biofilm

Menoita fountain et al. (2012).

Detergents with neutral pH are widely used due to their excellent

compatibility with the materials (Figure 10). They are available with or without
enzymatic reinforcements (BEILENHOFF et al., 2016).

Figure 10 - Enzymatic detergent

 Source: Collection of the author (2022).

5.3.6.7 Rinse

Rinsing with water must be abundant and comply with potability

standards. Potability must be regularly monitored in accordance with current
legislation (WORLD GASTROENTEROLOGY ORGANISATION, 2019).

a) Purge water into the channels of the appliance with the help of a
syringe until detergent and water flow through the washbasins.
b) Purge the channels with compressed air to assist the flow of
washing water.

5.3.6.8 Chemical disinfection

Chemical disinfection is the process that aims to remove part of

pathogenic microorganisms. It should be performed in equipment
characterized as semicritical, such as endoscopes and other articles used in
natural orifices (BRAZILIAN SOCIETY OF NURSING IN
GASTROINTESTINAL ENDOSCOPY, 2006).
 Endoscopes are classified as semicritical because they come into
contact with mucous membranes, but not with sterile tissue of the human
organism (CADIME et al., 2021). This classification was created by Spaulding in
1968 to separate health products into critical, semicritical and non-critical,
according to their use and the risk of infection of the patient.
The Spaulding classification guides professionals regarding the best
method for reprocessing the material.

a) Immerse the equipment in solution (some equipment have seals so

as not to damage the control part).
b) Immerse the buttons and valves in solution.
c) Purge the disinfectant solution with the help of a syringe in the
channels of the equipment.
d) Keep the equipment immersed as per the time specified by the
chemical solution manufacturer (Figure 11).

Flexible endoscopes are considered critical articles and should be

sterilized when used for sterile tissue procedures such as laparoscopic
endoscopy, Retrograde Cholangiopancreatography (ERPRE) and Interventional
Endoscopic Ultrasound (EUS) (DAY et al., 2021). In addition, the equipment
used to obtain biopsy samples and perform polypectomy and sphincterotomies
are classified as critical articles.

Figure 11 - Immersion equipment (4'20'')

 Source: Collection of the author (2022).

5.3.6.9 Rinse

a) Remove the material from the solution.

b) Perform new rinsing of the equipment in drinking water abundantly.
c) Introduce water into the channels of the equipment with the aid of a
syringe at least five times (Figure 12).

Figure 12 - Rinse 2

Source: Collection of the author (2022).

5.3.6.10 Drying

a) Perform drying with cloth or dry compress.

b) Rinsar with alcohol 70% in the channels and potentiate drying with
compressed air, which will complement disinfection by its bactericidal
effect.
c) Repeat the same process with loose parts of the appliance (WORLD
GASTROENTEROLOGY ORGANISATION, 2019) (Figure 13).

Figure 13 - Drying (42')

Source: Collection of the author (2022).

5.3.6.11 Storage

a) The appliance must be stored in a cabinet that allows the

maintenance of the temperature between 10°C and 40°C
(BRAZILIAN SOCIETY OF NURSING IN GASTROINTESTINAL
ENDOSCOPY, 2006).
b) Store it without folds, hanging vertically, without moisture and
protected from the light input.
c) The briefcase should not be used for storage.
d) Reprocess the material before use (Figure 14).
 Figure 14 - Material storage cabinet

Source: Collection of the author (2022).

5.3.6.12 Transportation

Use a briefcase provided by the manufacturer only to route the

equipment for maintenance.
Inside the hospital or endoscopy clinic, the equipment must be
transported in a plastic box previously disinfected with 70% alcohol (Figure 15).
If the examination is performed outside the endoscopy sector, reprocess,
and protect the endoscope with clean plastic. When returning it to the sector,
also wrap it in plastic so as not to dirty the box.
 Figure 15 - Equipment case

Source: Collection of the author (2022).

5.3.6.13 Traceability

According to RDC no. 15 (BRASIL, 2012), in art. XXV, traceability

consists of the ability to trace the history of processing and use of products for
health through the registration of information. It is a means of accounting and
monitoring of materials within the CME and when they are being used in
another sector, to avoid losses. Traceability facilitates monitoring with Hospital
Infection Control, which tracks processes in cases of hospital infections, and
can be done manually or automated.
RDC no. 6 (BRASIL, 2013), in its art. 6, talks about the need to register
the exams performed, the complications, the medications, as well as
occupational accidents.

Quality assurance implies that evidence of correct

reprocessing is included in the next patient's file.
Therefore, an interface between electronic documentation
of medical endoscopy reports and reprocessing is
essential to enable data transfer. In cases of suspected
infection, this data exchange is a necessary tool to
 investigate nosocomyal infections (BEILENHOFF et al.,
2016).

Traceability will also serve as a parameter for monitoring the amount of

use and reprocessing of the equipment, to set deadlines for preventive
maintenance and thus avoid the risk of damage to the equipment.
For the quality of traceability, all stages of the process must be properly
recorded.

5.3.7 Monitoring the effectiveness of sanitists.

The most used sanitizes in endoscope reprocessing are enzymatic

detergent, alkaline detergent, peracetic acid disinfectant and glutaraldehyde
disinfectant.

a) Enzymatic detergent: detergent with enzymes, which will facilitate

cleaning by breaking down these enzymes and proteins for the
removal of organic matter. To monitor such a solution, one should
pay close to its color, odor, presence or not of dirt and expiration
date.
b) Alkaline detergent: detergent used in cleaning health products.
Accompany the product a tape for daily pH testing, which should be
from 7 to 14. In addition, the aspect of the solution should be
monitored.
c) Peracetic acid disinfectant: disinfectant with bactericidal and
virucide action used for the disinfection of endoscopes. The dilution,
concentration and expiry date determined by the manufacturer shall
be obeyed. It is also sold with a tape for daily pH monitoring, which
should be from 1 to 7, in addition to monitoring the aspect of the
solution.
d) Glutaraldehyde disinfectant: non-corrosive disinfectant (does not
damage rubber, optics, or plastic materials). It has a broad-spectrum
action, including sporicide, altering RNA, DNA, and protein synthesis
of microorganisms (GRAZIANO; SILVA; PSALTIKIDIS, 2011).
 It is noting point that there are other types of detergents and disinfectants
in the market, however only a few were approached, as well as no emphasis
was placed on the automated reprocessing of endoscopes, since the objective
of the present work is to focus on the learning of the manual technique.

5.3.8 Waste management

RDC No. 222, of September 24 (BRASIL, 2018), regulated by Anvisa,

speaks of the Waste Management of Health Services. The Waste Management
of the Endoscopy Service and the CME is defined in the hospital unit by the
Hospital Infection Control Service with the management of the respective
sectors, and subdivided into groups:

Group A: Infectious waste - materials contaminated with blood and

organic matter.
Group B: Chemical waste - disposal of chemical solutions. Attention
should be given to the disposal of glutaraldehyde, as some brands require it to
be mixed with other solutions so that it is disposed of in a water and sewage
network.
Group C: Radioactive - does not apply to the sector.
Group D: Common waste - disposal of common waste, without organic
matter.
Group E: Sharp cutting - disposal of sharp materials such as needles
and tweezers.

5.3.9 Emergency care

Emergency care in the Endoscopy Service is due to the risks offered

during anesthetic induction to perform the examination. Therefore, it is
necessary to have emergency equipment and medications for the care of the
patient.
 As for occupational risk during reprocessing, it is important to have eye
washer inside the chemical disinfection area in case of an accident, even with
the use of goggles by the whole team. "Eye wash stations are available to
reprocess the team using caustic chemicals. Eye washers are placed near sinks
used to wash or soak dirty endoscopes" (DAY et al., 2021).
It is noteworthy that no recommendation was found on the use of eye
washers in Brazilian legislation.

5.3.10 Audit tool

The bundle is a widely used tool in the hospital area for the audit of
internal processes. It is a support to the manager so that he can identify training
needs and opportunities for improvement stowerses for work, through the
collection of information and the creation of process quality indicators.
According to Beilenhoff et al. (2018), associating hospital infections with
process failures in MSC is an assertive practice when one has the domain and
protocols established for the practices performed in the institution.
In Table 3, it follows a bundle suggestion for the audit of processes within
the Endoscopy Service with a focus on the reprocessing of endoscopes.

Table 3 - Bundle suggestion

Questions C NC IN
Were the canals pre-cleaned after the procedure?
Is there an exclusive room for endoscope reprocessing?
Does manual cleaning occur in an exclusive sink?
Are the solutions prepared according to the manufacturer's
guidance?
Is there a sealing test?
Was drying after immersion?
Is the equipment stored properly?
Are employees trained for the activity?
Do employees use PPE?
Legend: Conforme - C; Non-Compliant - NC; Does Not Apply - NA.