Running Head: STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
Developing a Standardized Dental Sterile Processing Protocol
Name
Instructor’s Name
Institutional Affiliation
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
ABSTRACT
The government and other agencies mandate dental practitioners to have a standard
dental processing protocol. It specifically outlines the requirements necessary for the
transportation, cleaning, sterilization, drying and storage of instruments equipment used in
the practice. Poor sterilization processes expose patients to new infections. An analysis of St.
Paul’s Medical Center indicated that the facility was not at par with the standard protocol.
This project is aimed at creating dental sterile processing protocol at the facility. It will offer
recommendations on what the facility needs to do in order to improve its sterilization process.
The project recommends that the facility trains its staff, redesigns its workflow area and
ensure that there is someone in charge of overseeing processes and taking account of
inventory.
KEY WORDS: Instruments and Equipment, Sterilization. Sterilization Process, Quality,
Standards, Legal and Regulatory, Efficiency
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
Developing a Standardized Dental Sterile Processing Protocol
Introduction
Patients place high expectations on health facilities to ensure that they are reliable and
offer high quality services. Failure Modes and Effects Analysis (FMEA) is a qualitative and
proactive method of ascertaining whether there are any defects. It helps dental practitioners to
anticipate what might go wrong. FMEA reviews steps in the process, what actually could fail,
why the failure would occur and the possible consequences of the failure. In a bid to
determine the compliance of standards, the Joint Commission Leadership standard stipulated
that St. Paul Medical Center carries out risk of failure and harm in processes evaluation. This
evaluation is done in order to ensure that medical facilities detect risky processes so that
intervention measures are created before they occur. A recent FMEA analysis confirmed that
the facility did not have standardized sterile processing of dental equipment protocol. This
research paper will critically explore the methods and techniques St. Paul Medical Center will
use to develop a customary dental sterile processing protocol.
Background
Sterilization refers to an infection process that kills pathogens in various surfaces.
Dentists face a challenge in improving patient safety while at the same time attending to a
huge demographic of patients. A standardized dental sterile protocol involves comprehending
the foundations of infection control and therefore creating infection control procedures
systems that ensures sterilization is done effectively. This includes having well trained staff
in sterilization processes and ensuring that they stay abreast with various infectious diseases
and how they can be managed. Various infectious diseases can be ingested or inhaled through
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
direct contact meaning that it can be passed from one person to another. The infectious
diseases can also be from indirect contact with not properly sterilized equipment or nondecontaminated surfaces.
Standardized dental sterile processing protocol has to be done because dental care is a
profession whose scope is highly susceptible to pathogens (Rutala, Weber, 2013). The result
is that the pathogens might be transferred to patients making them acquire infections that
were non-existent before. St. Paul’s Medical Center was found to be non-compliant with
legal and regulatory frameworks that deal with sterilization process. This project will
therefore recommend strategic interventions that will ensure that sterilizations process so as
to mitigate chances of patients being infected from occurring.
Literature Review
Sterilization of dental instruments is vital in eliminating pathogens from dental
instruments. The sterilization of dental instruments should follow particular protocol so as to
ensure that the outcome of dental processes is of impeccable quality. It also ensures that the
instruments and equipment are handled with extreme precaution and are accounted for.
Precaution must be taken by dental care practitioners in cleaning and sterilizing equipment in
order to ensure they do not negatively affect the outcome of procedures. The standard
effective infection control practices include cleaning used instruments, packaging and
transporting instruments, disposal for instruments that cannot be re-used, sterilization and
storage. Sterilization is an essential step in eliminating the potential of contamination of
dental care instruments and equipment. It helps in ensuring that non-disposable instruments
can be reused without cross-infecting other individuals.
For sterilization to be effective, it is critical that medical health facilities select the
method of sterilization that suits the equipment to be used. Dental health practitioners
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
sometimes use sterilization methods that can be corrosive to the equipment. The
decontamination process is meant to render harmful microbial life powerless. This ensures
that instruments are safe for future handling especially for the reusable instruments. Steps in
the decontamination process includes transportation, mode of dressing, sorting and
differentiating from those that need disposal and those that a reusable, soaking, washing,
inspecting and storing.
Organizational Culture
It is evident that St. Paul’s Medical Center failed to meet standard protocol
requirements due to space constraints associated with an ever increasing demand for dental
care services. The laboratory area was forced to share space with the sterilization room; an
aspect that made it more prone to cross contamination. The sterilizing equipment was limited
and so the staff was forced to overload the sterilizers. The facility began to lose its capability
to sterilize its equipment effectively due to the prevalent challenges. The increase in demand
for dental care services was adding more to the problem an aspect which put a strain on the
efficiency of sterilization processes. The number of patients waiting in line increased due to
the lack of sterilizing equipment and overlap in procedures. After the FMEA analysis, the
medical facility realized that it had to completely overhaul the way it carried out its
sterilization process.
St. Paul’s Medical Center does not have specific individuals in charge of the
transportation, cleaning, sterilization and storage of critical and non-critical equipment. The
lack of someone being in charge of these processes leads to inconsistencies in the sterilization
process. The inconsistencies affect the quality of dental health care as it leads to overlapping
of the process. The overlaps occur due to lack of protocol and due to lack of proper
supervision. Care is therefore not taken to ensure whether the equipment is cleaned, sterilized
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
and dried well. Without the presence of a person in charge, the audit process is poor meaning
that the medical facility is incapable of determining equipment that needs repair replacement
or disposal. The persons in charge of the sterilization process are not aware as to why certain
procedures are adopted. This is a sign of incompetency as it shows that the staff is not welltrained to handle the sterilization process (Hughes, 2008). It shows that the staff underreports
details regarding the latest findings in standards to be met, equipment need and changes to be
adopted. The findings at St. Paul’s Medical Center confirmed that there was poor
communication processes at the facility. The company was unable to address patient safety
due to miscommunication regarding safety protocol. The medical facility realized that in
order to be successful, it had to change as outlined below.
Instrument and Equipment Processing Requirements
It is vital that dental practitioners sterilize instruments and equipment by ensuring that
it decontaminates surfaces that patients cannot directly observe. This is because improper
sterilization is capable of causing grievous harm to both patient and practitioner. The result is
that it will negatively affect the quality of the outcome of the process. The system to be
developed should follow existing standards and recommendations, should consider the nature
of the workflow, the equipment used and the supportive materials so as to determine the
nature of protocol to be developed (Alfa, 2013). It will discourage shortcuts in the
sterilization process that might lead to the creation of errors.
In order to achieve efficiency in the sterilization process, the medical facility should
train its staff so that they are competent to handle arising issues. It should employ one person
preferably a chief nurse to oversee the transportation, cleaning, sterilization, drying and
storage of equipment. The chief nurse should ensure that staffs under him/her have a
checklist on the state of equipment. They should be held responsible for ensuring that
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
equipments and instruments are decontaminated and sterilized according to legal and
regulatory standards. It should regularly take stock of equipment so as to determine the stock
that needs repair and maintenance.
Regulatory and Government Agencies involved in Healthcare Sterilization Processes
The Occupational Safety and Health administration agency outlines how healthcare
workers are can reduce exposure to pathogens. This is stipulated under the Bloopborne
Pathogens rule. Although it does not explain how pathogens are to be handled, it stipulates
how to use personal protective equipment. The Food and Drug Administration (FDA)
regulates the equipment to be used in sterilization of equipment. The Medical Device and
Radiological Health Branch controls manufacture of medical products used in instrument
processing. It mandates manufacturers confirm that they meet specific standards in ensuring
that their devices are effective in the sterilization process. The Centers for Disease and
Prevention Control (CDC) is responsible for the creation of evidence based recommendations
for sterilization processes. The CDC outlines guidelines that ensure that individuals adhere to
disinfection and sterilization procedures in medical centers. Health care facilities especially
dental facilities are required by CDC to ensure that they strictly follow the infection control
requirements of CDC. The regulations outlined by CDC include the minimum expected
standard in ensuring that the sterilization process is successful. Association for the
Advancement of Medical Instrumentation (AAMI) is an organization that advocates for
safety standards while using medical instruments and equipment. AAMI is responsible for
guaranteeing compliance, boosting safety measures and ensuring that medical facilities adopt
stringent protocols. AAMI gives a comprehensive guideline as to the standards of practice in
the sterilization of dental care instruments and equipment.
Objectives
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
The objective of this research paper is to create strategies that will ensure that dental
sterile processing protocol is effective and devoid of errors. The strategies are meant to
improve the efficiency and efficacy in sterilization processes. It will examine the quality
practices that need to be adopted so as to meet Failure Modes and Effects Analysis standards.
It will explore the strategies that need to be implement, the training that employees should
undertake and technological improvements that have to be adopted in order to improve
outcomes.
Research Questions
1. What are the strategies that need to be adopted so as to ensure that St. Paul’s Medical
Center meets the standardized dental sterilization process as stipulated by the law?
2. What are some of the recommendations that the medical facilities should adopt so as
to guarantee quality in its processes?
Protocol Development
Implementation of Strategies
Protocol is critical in ensuring that instruments and equipment are de-contaminated in
an efficient manner so as to eradicate chances of putting patients and dental practitioners in
harm’s way. Protocol should always strive to ensure that it gives sequential procedures in the
sterilization process. They should be consistent with the procedures outlined by regulatory
and government agencies guidelines involved in healthcare sterilization processes.
Preparation: The first step in this procedure is to ensure that the practitioners sort out
equipment depending on how they are used. They should then sort them depending on their
capability to endure the nature of the sterilization process. It should also check to ascertain
whether there are available resources necessary for the process. The instruments can be
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
divided into critical, semi-critical and non-critical instruments. Critical instruments are those
instruments that come into contact with the bone or the bloodstream. Semi-critical
instruments are those instruments that come into contact with the mucous membrane. In
comparison to critical instruments, semi-critical instruments are incapable of penetrating soft
tissues (Cuny, Bednarsh, 2006). They do not come into contact with the bone or the
bloodstream. Non-critical instrument come into contact with the skin.
In dental care, most instruments are categorized in the critical and semi-critical
sector. This is because dental health care is a profession that mostly revolves around coming
into contact with the bone or the bloodstream. They instruments used mostly fall under
Single-use disposable (SUD) products meaning that they should never be used on more than a
single patient. The other category dental care instruments fall under is that of instruments that
are capable of surviving extreme temperatures.
Instrument Processing Area and Work Flow: The instrument processing area should
to ensure that they strictly follow the infection control requirements of CDC. The procedure
should include the disposal of sharp objects, its transportation and subsequent disposal of
wasted especially for Single-use disposable products. The protocol development should
ensure that it then sorts the instruments critical and semi-critical that are highly capable of
surviving extreme temperatures. The next step is to clean the instruments, sterilize them, and
allow them to dry then proceed to store in a dry protected area. The work area should be
designed in a manner that promotes one-directional work flow. This is done so as to ensure
that chances of overlapping of the sterilization process are limited because overlapping of
processes can increase cross contamination (Rutala, Weber, 2008). The work area should be
able to accommodate designate different areas that will facilitate efficient sterilization,
cleaning, transportation and storage.
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
OSHA stipulates that instruments should be first sorted and put in rigid puncture proof
containers before transporting them the sterilization area. The personnel handling the
transportation process should wear heavy-duty utility gloves during the process of receiving,
sorting and cleaning the equipment.
Receiving, Sorting and Cleaning the Equipment: For instruments that cannot be
cleaned immediately, it is vital that to prevent the drying of debris. This is done by ensuring
presoaking them or using an enzymatic spray. They can be externally wiped or cleaned using
ultrasonic baths or instrument disinfectors. The next procedure is to visually examine the
instruments to ascertain whether there is any debris in the instruments. The visual inspection
helps to ascertain whether the equipment is damaged. If damaged, the equipment should be
disposed but if not, the equipment should be cleaned, dried and stored in an appropriate
manner.
Preparation and Packaging: Dental practitioners should package goods and services in
a manner that ensures that strictly adheres to the infection control requirements of CDC. The
packaging material should be able to withstand the sterilization process and should remain
intact during and after the sterilization process. The material should be strong and should not
be susceptible to infectious pathogens. The loading process should be done with caution so as
to ensure that the instruments and equipment are not damaged during the process.
Storage: The storage should be done in a manner that ensures the equipment is
constantly dry. If not handled with caution, dental equipment has a huge shelf life. They are
capable of remaining sterile if not compromised. In order to maintain their sterility, they
should be stored in dry compartments. They can only be removed from the sterilizer once
they have been completely sterilized. Storage should then be done once the equipment is
totally dry and should be stored in areas devoid of moisture.
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
Sterilization Methods to Be Adopted
The various sterilization methods include autoclaving, dry heat sterilization and
chemical vapor sterilization. Steam sterilizations occur when distilled water is steamed at
extremely high temperatures then pressurized to kill pathogens. The main disadvantage of
steam sterilization is that it might corrode the equipment and might subsequently lead to the
rapid depreciation of the equipment. In order for steam sterilization to achieve efficacy, the
air in the chambers must be eliminated. Gravity enforcement enclaves use gravity to
eliminate air in the chambers. Air trapped in chambers limits the performance of autoclaving
and steam sterilization. Dynamic air removal methods uses electronically controlled valves to
displace air from the base of the chamber. Chemiclaves uses water free chemicals to sterilize
dental instruments. Unlike steam sterilization, chemiclaves do not expose instruments to
corrosion. Dry heat sterilizers are applicable for highly heat resistant chemicals since they
operate in extremely high temperatures (Schneider, 2013). Dry heat sterilizers take longer to
sterilize but its merit is that it does not need time to dry since it does not use wet sterilization
methods. The disadvantage of dry heat sterilization is that it is not applicable for equipment
made from plastic.
Role of the Chief Nurse
The chief nurse should be in charge of inspecting instruments and equipment in order
to ascertain whether they have been cleaned and sterilized well. The chief nurse should lay
out the legislation on the procedures to collect, prepare and organize instruments scheduled
for dental practices. He or she should ensure that nurses under them catalogue surgical tools
after usage so as to ascertain whether they are to be disposed or whether they are to be
reused. If they are to be reused, the nurses should know what method of sterilizing is
appropriate for them. The nurses report to the chief nurse on the quality of equipment and
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
whether they need replacement. He or she is responsible for equipment set up so as to ensure
that they are not exposed to harmful pathogens. He or she should provide guidelines that need
to be followed in handling and sterilizing dental care equipment since they are very sensitive
equipment.
Evaluation of Project Implementation and Effectiveness
It is evident that a dental practice can be negatively impacted by poor workflow and
work areas during the process of sterilization. Developing the workflow and work area can
take a minimum of three months to complete. St. Paul’s Medical Center only requires
confirming availability of additional space within the building. In order to ensure that the
project is done in a timely manner, the facility should incorporate team work. It is vital that
the center invests in sterilization equipment that is capable of effectively sterilizing all
instruments depending on how they respond to various sterilization processes. This will
benefit the center as it will minimize chances of overlapping of the process as it makes the
equipment susceptible to cross contamination. In order to improve efficacy, the project
recommends that the sterilization area should be located in the middle of the facility near
where the practice is as opposed to having it at the back of the building. This eases the time
spent for transportation of equipment from the area of practice to the surgical room. The
room should be laid out in a wide area so as to make sorting of equipment less difficult. It
also ensures that the equipment do not combine as a combination will facilitate inter-transfer
of pathogens. The result of adopting the recommendations outlined above is that it will
increase the level of organization at the facility and reduce work stress for the person(s) in
charge of the sterilization process. It will also ensure that new technology that meets legal
and regulatory standards are adopted.
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
The outcome of a well-designed workflow area is that staff is less frustrated and are
more capable of following protocol in the sterilization process. Remodeling and or rebuilding
new work areas guarantees orderly and sequential processes. It ensures a logical flow of
sterilization from the time the equipment reaches the sterilization room to the time it gets
cleaned and sterilized. It ensures that tasks are well coordinated in a bid to boost efficiency
necessary for the safety of both patients and dental care practitioners.
Conclusion
In summary, it is vital to carry out an analysis of the organizational culture of a dental
care practice especially the sterilization process. It exposes the problems at the facility and
how detrimental they can be to the outcome of the quality of care. It helps ascertain the areas
that need to be addressed before they cause grievous harm to both patients and dental care
practitioners. Some of the areas that need to be given top most priority are the design of the
workflow areas. It helps determine the orderliness of the workflow area and how equipment
should be handled from the time they are transported from the operatory area to the time they
are sterilized. It is imperative that the person(s) in charge of the process of sterilization are
well trained and equipped to do so in accordance with standards set by legal and regulatory
entities. Protocol should be strictly adhered to in the process of sterilization.
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STANDARDIZED DENTAL STERILE PROCESSING PROTOCOL
References
Alfa, M. J. (2013). Monitoring and improving the effectiveness of cleaning medical and
surgical devices. American journal of infection control, 41(5), S56-S59.
Eve Cuny, R. D. A., & Helene Bednarsh, R. D. H. Instrument Sterilization in Dentistry.
Hughes, C. (2008). Sterilization: would your facility pass a standards audit?. AORN
journal, 87(1), 176-186.
Rutala, W. A., & Weber, D. J. (2008). Guideline for disinfection and sterilization in
healthcare facilities, 2008.
Rutala, W. A., & Weber, D. J. (2013). Disinfection and sterilization: an overview. American
journal of infection control, 41(5), S2-S5.
Schneider, P. M. (2013). New technologies and trends in sterilization and
disinfection. American journal of infection control, 41(5), S81-S86.
US Food and Drug Administration. US Dept of Health and Human Services. Medical devices
reprocessed single-use devices; requirements for submission of validation data.
Federal Register, 71, 55729-55737.
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Synthesis Project Guidelines
Fall 2017
The synthesis project is a comprehensive project for an organization. This can be a quality
management project or a change project. The project will include statement of the problem,
findings and application, goals and objectives, overview of the organizational culture (including
organizational, environmental, epidemiological, and any other culture-related issues),
implementation, identification of the role of the nurse leader, evaluation of project, and
appropriate references. The project will be presented in written format through a major paper.
Synthesis Project: Presentation
The presentation will be evaluated on how well the 3 criteria of content, power point
presentation, and process evaluation are addressed. In addition, the presentation should be
creative and well organized to initiate discussion. See grading rubric below for details of the
requirements.
Synthesis Project: Presentation Grading Rubric
CONTENT EVALUATION (120 points)
CRITERIA
EXEMPLARY
Project
Project & objectives
description
are completely clearly
and accurately
described. (18-20
points)
Literature review Literature review is
clear, accurate, and
current. (22-24 points)
Organizational
Culture
Implementation
strategies
Role of the Chief
Nurse Executive
Culture is completely
clearly and accurately
described. (18-20
points)
Strategies are clear
and specific. (22-24
points)
Role description is
clear and specific. (1416 points)
Evaluations are clear
and specific. (14-16
points)
Evaluation of
project
implementation
& effectiveness
POWERPOINT EVALUATION (68 points)
CRITERIA
EXEMPLARY
Power point
Presentation
appearance
generates enthusiasm
and stimulates
interest. (14 points)
Clipart and
Supplements and
illustrations
enhances content. (14
points)
Presentation
Colors, font sizes, and
format
formatting are
pleasant in
appearance and
provide easy reading.
(14 points)
References &
Sources are cited
Reference List
accurately throughout
COMPETENT
Project description is
partially accurate
and/or partially
complete. (7 – 8 points)
DEVELOPING
Project description is
not accurate and/or
not complete. (5 – 6
points)
UNSATIFACTORY
Project is not
addressed. (0 – 4
points)
Literature review is
usually clear, accurate,
and current. (8 – 10
points)
Literature review is
sometimes vague,
sometimes accurate,
or not current. (5 – 7
points)
Culture is not
accurate and/or not
complete. (5 – 6
points)
Strategies are vague
or not focused. (5 – 7
points)
Role description is
vague or not focused.
(3 – 4 points)
Evaluations are
vague or not focused.
(3 – 4 points)
Literature review
is not present. (0
– 4 points)
DEVELOPING
Some slides are not
clear or have
inaccurate details. (710 points)
Detracts from
content. (7-10
points)
Detracts from
content. (7-10
points)
UNSATIFACTORY
Poorly developed
presentation. (0 –
6 points)
Sources are
minimally cited
Not present in
presentation
Culture is partially
accurate and/or
partially complete. (8 –
8 points)
Strategies are usually
clear and specific. (8 –
10 points)
Role description is
usually clear and
specific. (5 – 6 points)
Evaluations are usually
clear and specific. (5 –
6 points)
COMPETENT
Presentation is clear
with accurate details.
(11-13 points)
Present. (11-13 points)
Colors, font sizes, and
formatting are
appropriate. They could
be improved with
attention to readability.
(11-13 points)
Sources are usually
cited throughout
Culture is not
addressed. (0 – 4
points)
Strategies are not
evident. (0 – 4
points)
Role description is
not evident. (0 – 2
points)
Evaluations are
not evident. (0 – 2
points)
Not present. (0 –
6 points)
Colors, font sizes,
and formatting
make reading
difficult. (0 – 6
points)
presentation & in a
reference list. (14
points)
All slides are
mechanically
(punctuation, spelling,
capitalization) &
grammatically correct.
(12 points)
PROCESS EVALUATION (12 points)
CRITERIA
EXEMPLARY
APA format
References are cited
correctly in APA 6th. (6
points)
Slides are usually
mechanically &
grammatically correct.
(9-11 points)
throughout
presentation and/or
in a reference list. (710 points)
Slides are sometimes
mechanically &
grammatically
correct. (6-8 points)
COMPETENT
References, are usually
cited correctly in APA
6th. (4-5 points)
DEVELOPING
References are
poorly cited. (2-3
points)
Length of
presentation
Length is 45 slides or
more. (4-5 points)
Length is 34 slides or
less. (2-3 points)
Grammar &
Spelling
Length is 35 to 45
slides. (6 points)
TOTAL POINTS – 200 points possible
presentation and/or in
a reference list. (11-13
points)
and/or no
reference list. (0 –
6 points)
UNSATIFACTORY
APA format is not
used for
presentation. (0-1
points)
Presentation is
incomplete. (0-1
points)
Many slides are
not mechanically
& grammatically
correct. (0-5
points)
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