Positive Thinking to Improve Personality Development as an SPT

Martin Li, MA, CRCST, CER, CIS, CHL

Positive thinking is a vital component for Sterile Processing Technicians (SPTs) who aim to develop a resilient and proactive personality. In the high-pressure environment of sterile processing, where the stakes are always high, maintaining a positive outlook can make a significant difference. Positive thinking begins with self-talk, the internal dialogue that shapes how you perceive and respond to challenges. By transforming negative thoughts into constructive ones, SPTs can better manage stress, which not only improves their well-being but also enhances job performance and satisfaction.

Positive thinking also fosters a cohesive team dynamic within the SPD, as optimism can be contagious. For example, instead of viewing a challenging task as insurmountable, a positive mindset sees it as an opportunity to learn something new. This proactive approach is essential for SPTs, who must constantly adapt to new procedures and technologies in their work. As research shows, maintaining a positive outlook leads to better mental health, greater job satisfaction, and a more supportive work environment [1; 2; 3].

Practicing positive thinking daily, especially in moments of stress or self-doubt, can gradually shift your mindset from pessimism to optimism. This shift is not just beneficial for the individual but also for the entire team, as a positive attitude can inspire and uplift others in the department.

References

1.           mayoclinic.org - Positive thinking: Stop negative self-talk to reduce stress

2.           verywellmind.com - Positive Thinking: Definition, Benefits, and How to Practice

3.           ncbi.nlm.nih.gov - Proactive Personality as a Predictor of Career Adaptability

Positivity in the Sterile Processing Department: A Catalyst for Cultural Change

 

Martin Li, MA, CRCST, CER, CIS, CHL

Introduction

The Sterile Processing Department (SPD) is a high-pressure, fast-paced environment where interactions are varied and constant. It is a setting where the consequences of a lapse in focus or a negative mood can ripple throughout the department, affecting not only the individual but the entire team's performance and morale. In such a demanding environment, fostering a positive culture is essential for ensuring both the physical and mental well-being of SPD technicians. This article explores the role of positivity in the SPD, drawing parallels between the spread of positivity and the transmission of infections, and highlights how cultivating a positive mood can lead to significant cultural changes within the department.

The Importance of a Positive Environment

In the sterile processing environment, the concept of cleanliness and the prevention of contamination are paramount. Just as bioburdens can multiply and spread if not properly managed, so too can negativity if left unchecked. A lack of point-of-use cleaning or the failure to use enzymatic detergents can lead to the development of complex bioburden growths that require considerable effort to remove. Similarly, in an environment where stress and negativity are allowed to fester, it can become increasingly difficult for technicians to maintain their morale and effectiveness.

A positive environment, on the other hand, allows SPD technicians to thrive. In the right conditions, technicians can experience better physical and mental health, which directly impacts their performance. Confidence, a sense of security, and the ability to contribute opinions without fear of retribution are all critical components of a healthy workplace. These elements create opportunities for bonding and growth among team members, fostering a culture of inclusion and belonging. Just as infection prevention is essential to the work of an SPD, spreading positivity is crucial to creating a resilient and effective team.

Positivity as a Contagious Force

Positivity, much like biological contagion, has the power to spread rapidly throughout a department. Consider the example of a yawn in a room full of people; one person yawns, and soon, the entire room is yawning. This phenomenon is a simple illustration of how emotions, whether positive or negative, can be contagious. In the context of the SPD, the mood of a single technician can influence the entire team.

At the start of a shift, it is not uncommon to see a variety of emotions on the faces of the team members gathered for the morning huddle. The challenge of maintaining a positive mood in such an environment varies for each individual. Factors such as personal experiences, genetic predispositions, and the overall atmosphere in the department all play a role in shaping a person's mood. For instance, an orthopedic screw caddy falling to the floor during assembly can quickly sour the mood of even the most resilient technician. The negative emotions generated by such an incident can quickly spread, infecting the rest of the team.

The Science of Emotional Contagion

The spread of emotions within a team is not just anecdotal; it is supported by scientific research. A 2022 study conducted in a German medical facility surveyed 200 employees about their workplace stress and coping strategies. The study identified three main categories of coping strategies: high energy and positivity, positive reframing and social coping, and evasive coping such as avoidance. The study found that those who actively engaged in positive reframing and other social coping strategies were better equipped to handle stress and maintain a positive mood, which in turn had a positive impact on their colleagues (Catalino, 2014).

Neurological studies further support the idea that emotions are contagious. Research has shown that viewing a smiling face can trigger areas of the brain that cause the observer to mirror the emotions they see. This automatic response means that positivity can spread from one person to another, much like a pathogen. In the SPD, this means that a single individual who arrives at work in a good mood can influence the entire team, helping to create a positive atmosphere that benefits everyone (Mayo Clinic, 2023).

The Chain of Infection and Positivity

The spread of positivity in the SPD can be likened to the chain of infection, a concept well-known to those in the healthcare field. The chain of infection consists of six links: the infectious agent, the reservoir, the portal of exit, the mode of transmission, the portal of entry, and the susceptible host. Each link in this chain must be present for an infection to spread. Similarly, the spread of positivity in the SPD can be understood through this framework.

1. Infectious Agent: In this context, the infectious agent is the positive technician who brings energy, humor, and a good attitude to the workplace.
2. The Reservoir: The reservoir is the environment in which the technician operates, in this case, the SPD. This environment is where positivity is cultivated and nurtured.
3. Portal of Exit: The portal of exit refers to how the positivity is transmitted from the technician to others. This can be through body language, spoken words, or physical gestures such as a pat on the back or a high-five.
4. Mode of Transmission: The mode of transmission is how the positivity spreads through the department. This could be through direct interactions, such as conversations or shared tasks, or indirectly, through the overall atmosphere of the department.
5. Portal of Entry: The portal of entry is how other technicians receive positivity. This could be through being open to positive comments, physical touch, or simply being in the presence of a positive individual.
6. Susceptible Host: The susceptible host is the technician who is open to receiving positivity. This could be someone who is already in a decent mood and is therefore more likely to be influenced by the positivity of others.

Breaking the Chain of Negativity

Just as healthcare professionals work to break the chain of infection to prevent the spread of disease, so too must SPD leaders work to break the chain of negativity. Negativity, like a pathogen, can spread rapidly if not contained. However, by focusing on spreading positivity, SPD leaders can create an environment where resilience, effectiveness, and collaboration thrive.

Interventions to break the chain of negativity can take many forms. For example, promoting a culture of open communication and feedback allows technicians to express their concerns without fear of retribution. Encouraging teamwork and recognizing the contributions of all team members helps to build a sense of belonging and inclusion. Providing opportunities for professional development and personal growth ensures that technicians feel valued and supported in their roles.

The benefits of spreading positivity in the SPD are clear. Positive emotions not only improve the mental and physical well-being of individual technicians but also enhance the overall functioning of the department. Teams that are resilient in the face of stress and adversity are better equipped to handle the challenges of the job. By fostering a culture of positivity, SPD leaders can create a department where everyone has the opportunity to thrive.

Conclusion

The sterile processing environment is one where precision, focus, and teamwork are critical to success. In such a setting, the mood and attitude of each technician can have a significant impact on the entire team. By cultivating a positive environment, SPD leaders can ensure that their teams are resilient, effective, and collaborative. Positivity, like an infection, can spread rapidly throughout a department, leading to lasting cultural changes that benefit everyone. Just as bioburdens must be carefully managed to prevent contamination, so too must negativity be addressed to prevent it from undermining the work of the SPD. In contrast, fostering a positive mood in the SPD can lead to better outcomes, both for the technicians and for the patients they serve.

References

1.   Lahnna I. Catalino, et. (2014). Prioritizing Positivity: An Effective Approach to Pursuing Happiness https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5533095/

2.   Mayo Clinic, (2023). Positive thinking: Stop negative self-talk to reduce stress https://www.mayoclinic.org/healthy-lifestyle/stress-management/in-depth/positive-thinking/art-20043950

 

Ensuring Another Safety in SPD: The Essential Guide to Food-Grade Plastics in Healthcare

 

Martin Li, MA, CRCST, CER, CIS, CHL

Figure 1 Plastic Resin ID Codes https://www.palmetto-industries.com/safe-food-grade-plastic/

Introduction

In the Sterile Processing Department (SPD), safety is paramount. Plastics are identified by the Resin Identification Code, which is any number between 1 to 7 stamped between a triangle made by arrows. The following are the types of plastics and their codes.

#1 PET (Polyethylene Terephthalate)

#2 HDPE (High-Density Polyethylene)

#3 PVC (Polyvinyl Chloride)

#4 LDPE (Low-Density Polyethylene)

#5 PP (Polypropylene)

#6 PS (Polystyrene)

#7 Polycarbonate

Figure 2 Plastic Signs

The choices we make regarding the materials used for storing and handling medical tools directly affect patient outcomes. As SPD educators, it is essential to ensure that our teams understand which materials are safe and compliant with health standards. Food-grade plastic resins offer a reliable solution for reducing contamination risks while maintaining hygiene.

Key Food-Grade Plastics Used in Healthcare

1. High-Density Polyethylene (HDPE) - #2

High-density polyethylene is indispensable in healthcare. Its strength, chemical resistance, and non-toxic properties make it ideal for various applications, from storing sterile instruments to packaging medical products. HDPE is safe for contact with medical devices as it resists leaching chemicals, ensuring patient safety. It’s also durable and moisture-resistant, which enhances its utility in medical settings [3].

2. Polypropylene (PP) - #5

Polypropylene's heat and chemical resistance makes it perfect for medical trays, containers, and autoclaved items. It’s also food-safe, which means it doesn’t release harmful substances when it comes into contact with medical devices. As SPD educators, it's crucial to communicate the benefits of using PP in maintaining sterility and preventing contamination [1].

3. Low-Density Polyethylene (LDPE) - #4

Low-Density Polyethylene is a flexible, yet robust plastic often found in medical tubing and sterile wraps. LDPE’s non-reactivity and moisture resistance are vital in protecting medical devices from bacterial growth. Its food-grade designation makes it a reliable material for environments requiring the highest hygiene standards [3].

Figure 3 Food Grade Plastic Types

Educating SPD Technicians on Safe Material Use

SPD educators play a critical role in promoting the correct use of food-grade plastics. [2].By choosing these materials, we reduce the risk of chemical exposure and contamination, safeguarding both healthcare workers and patients. Understanding the characteristics of different plastic resins ensures that SPD technicians maintain a safe and compliant environment in all operations, contributing to better patient outcomes.

References

1. https://www.palmetto-industries.com/safe-food-grade-plastic/
2. Dix, k (2005). Educating SPD Staff. https://www.infectioncontroltoday.com/view/educating-spd-staff
3. https://www.acmeplastics.com/content/the-ultimate-guide-to-food-grade-and-food-safe-plastics/

Failure is Not an Option in Sterile Processing: The Role of Education and Certification in Ensuring Competence

Martin Li, MA, CRCST, CER, CIS, CHL

Introduction

In the healthcare industry, the Sterile Processing Department (SPD) plays a critical role in patient safety and care. The effectiveness of the SPD directly impacts the outcome of surgeries and procedures by ensuring that instruments and devices are properly cleaned, sterilized, and ready for use. As SPD educators, our task is monumental: we must ensure that staff are competent, that their knowledge is current, and that the resources to maintain competency are available. Failure in this domain should not be an option.

Addressing Knowledge Deficits: A Consistent Challenge

One of the most significant challenges facing SPD educators is the disparity in knowledge levels among staff members. Knowledge deficits vary from one facility to another, making it difficult to standardize training. These gaps can stem from differences in geographical location, access to resources, or the specific demands of the institution. It is essential that we, as educators, remain innovative, embrace technology, and seek unconventional approaches to ensure that every area of SPD training is covered, no matter the facility's location or size.

Knowledge deficits among SPD practitioners cannot be pinpointed to a single subject or category. Every individual comes with varying degrees of understanding of critical concepts, which makes it challenging to establish a one-size-fits-all solution. What can be done, however, is to push for consistency in knowledge through mandatory certification. Standardized certification ensures that every SPD professional meets a measurable benchmark of competence. Additionally, certification mandates that practitioners continue their education through Continuing Education Units (CEUs), keeping their skills sharp and up to date [1].

Certification as a Pathway to Excellence

Mandatory certification is a critical step in driving educational consistency and ensuring a baseline level of competency across the board. Currently, only some states require central sterile personnel to be certified. However, a nationwide mandate for certification would elevate the profession, ensuring that all SPD staff members meet the same rigorous standards. Certification not only ensures that practitioners are well-trained but also requires them to continue their education and stay current with advancements in technology and best practices [1].

The certification process, including the maintenance of certification through CEUs, functions almost like an accountability system—"Big Brother," so to speak—ensuring that professionals stay engaged with the latest developments in sterile processing. As technology evolves, so must the knowledge base of SPD professionals. This continuous education ensures that staff can confidently and competently operate new sterilization equipment, follow updated protocols, and avoid the pitfalls of outdated practices [2].

Innovative Approaches to Education: Online Learning and Beyond

To meet the educational needs of SPD professionals, especially those in rural areas, innovative approaches to learning have become increasingly vital. While urban and suburban communities have easier access to hands-on training and medical libraries, those in rural areas often struggle to secure the education necessary to pass certification exams. This is where technology comes in. Organizations like IAHCSMM, in collaboration with Purdue University, offer online training programs for central service technicians. These programs provide a comprehensive curriculum with online discussions, mentor support, and forums where participants can connect with others in the field [2].

Online courses offer a unique and modern solution to the challenge of training in rural and underserved areas. They allow practitioners to engage in educational activities without the need for frequent travel or disruption to their daily routines. Furthermore, self-learning CD-ROMs and other digital resources have become an integral part of ongoing education. These resources enable practitioners to learn at their own pace and focus on areas where they may need additional support [2].

The Importance of Hands-On Training and Conferences

While online and digital resources are valuable, hands-on training remains irreplaceable in the sterile processing profession. Seminars, conferences, and regional educational meetings provide CS professionals with the opportunity to network, discuss challenges and solutions with their peers, and learn from experts in the field. These gatherings foster a sense of community and shared purpose, while also helping SPD professionals accumulate the CEUs required for recertification [2].

However, budgetary constraints in hospitals often restrict attendance at these events. Despite these challenges, organizations like IAHCSMM have stepped in to offer regional educational meetings, ensuring that SPD professionals still have access to critical learning opportunities. By bringing education closer to the technicians who need it most, these regional meetings play a crucial role in maintaining the competency of SPD staff, even in the face of financial limitations [3].

Surgical Instrumentation: The Greatest Knowledge Gap

Of all the areas where knowledge deficits exist, surgical instrumentation remains the most significant gap for SPD professionals. Sterile processors must be familiar with every instrument, unlike operating room personnel who may specialize in one area. With continuous advancements and changes in surgical instrumentation, the learning curve remains steep. The lack of specific training materials tailored for central sterile staff further exacerbates the issue [4].

This gap is not simply a matter of memorization—it requires critical thinking and the ability to interpret manufacturers’ instructions correctly. Many SPD professionals face an additional challenge: English may not be their first language, which can complicate the interpretation of technical instructions. Failure to follow manufacturers' guidelines can result in improper processing of devices, posing legal risks and endangering patient safety [4].

The Need for Acknowledgment and Proper Compensation

Sterile processors often feel undervalued and treated like second-class citizens. For years, the attitude towards SPD professionals has been one of indifference—"just do your job." However, the importance of their work cannot be overstated. Proper training ensures that SPD staff can operate all equipment, including sterilizers, confidently and competently. Managers should not need to oversee every step; with adequate training, staff can handle special sterilization cycles without supervision [5].

Changing the perception of sterile processors is crucial. Once the importance of their work is acknowledged, the profession will gain the respect it deserves, including salaries that reflect the immense responsibility they carry. Administrators, hospital staff, and even CEOs need to understand that the success of surgeries and patient outcomes depends on competent, well-compensated SPD professionals. Sterile processors are not directly in the operating room, but their work is just as essential to patient care as the work of surgeons and nurses [5].

Moving Forward: The Role of HR and Language Competency

Human Resources (HR) departments play a vital role in recruiting competent SPD staff. A standardized salary survey, clear job descriptions, and a career ladder can help attract a higher caliber of candidates. Additionally, language competency should be a requirement in job descriptions. While English as a second language courses can be offered, proficiency in reading, interpreting, and speaking English fluently is crucial for effective communication with surgeons and other medical staff [4].

Learning the necessary information to become proficient in sterile processing is time-consuming, and it is unrealistic to expect SPD professionals to know every surgical instrument immediately. Basic training, which includes both classroom and clinical time, may take up to six months. However, with proper training and support, sterile processors can gradually build the knowledge and skills required to excel in their roles [4].

Conclusion: Failure is Not an Option

In sterile processing, failure is not an option. The safety of patients, the success of surgeries, and the reputation of healthcare facilities depend on the competence of SPD professionals. Mandatory certification, ongoing education, hands-on training, and the acknowledgment of sterile processors' importance are all critical steps toward ensuring that failure never occurs. The future of the SPD profession lies in the hands of educators, administrators, and healthcare leaders who recognize the essential role that sterile processing plays in patient care and are committed to investing in the education and compensation of SPD professionals.

References

1. https://www.steris.com/healthcare/knowledge-center/sterile-processing/spd-staffing-training-education
2. https://www.infectioncontroltoday.com/view/educating-spd-staff
3. https://consteril.com/sterile-processing-mistakes/
4. https://www.steris.com/healthcare/knowledge-center/sterile-processing/what-is-sterile-processing
5. https://www.linkedin.com/pulse/why-i-love-being-spd-educator-carol-corso-b-s-cspdt-csis/

 

Duodenoscopes and Infection Control: The Role of SPD in Enhancing Duodenoscope Safety

 

By Martin Li, MA, CRCST, CER, CIS, CHL

 

 

Introduction

A duodenoscope is a hollow, flexible, lighted tube that allows doctors to see the top of a patient’s small intestine, known as the duodenum. These specialized scopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. During ERCP, doctors insert the duodenoscope through the mouth, passing it through the throat, stomach, and into the duodenum. This procedure provides direct access to the bile or pancreatic ducts, allowing treatment for conditions like gallstones, inflammation, tumors, or cancers [1]. Duodenoscopes are invaluable tools in modern healthcare, particularly in procedures such as endoscopic retrograde cholangiopancreatography (ERCP), where they play a critical role in diagnosing and treating conditions related to the pancreas, bile ducts, and gallbladder. These flexible, lighted tubes allow physicians to access the duodenum and perform intricate procedures that would otherwise require invasive surgery. Despite their importance, duodenoscopes have been at the center of several infection outbreaks over the past decade, primarily due to design flaws that complicate the reprocessing procedure. As Sterile Processing Department (SPD) educators, it is crucial to understand these challenges and the necessary infection control measures to mitigate risks associated with these devices.

The Critical Role of Duodenoscopes in ERCP Procedures

 

ERCP procedures are among the most common therapeutic endoscopic procedures performed in the United States, with an estimated 500,000 to 700,000 procedures conducted annually. These procedures are less invasive alternatives to traditional surgery for diagnosing and treating conditions such as acute and chronic pancreatitis, gallstones, pancreatic pseudocysts, and tumors in the bile ducts and pancreas. The precision and effectiveness of ERCP are largely due to the advanced design of duodenoscopes, which allow direct visualization and access to the bile and pancreatic ducts [2].

Design Challenges and Infection Risks

 

The sophisticated design of duodenoscopes, while beneficial for medical procedures, presents significant challenges for reprocessing. Unlike standard endoscopes, duodenoscopes are equipped with a complex elevator mechanism that helps manipulate accessories used during procedures. This mechanism, along with the scope’s numerous small parts and intricate channels, creates multiple areas where organic material and bacteria can accumulate. Despite rigorous cleaning and sterilization efforts, these design elements have led to several cases of residual contamination, which in turn has caused outbreaks of antibiotic-resistant infections, commonly referred to as “superbugs” [3].

One of the most significant risks associated with duodenoscopes is the potential for contamination with carbapenem-resistant Enterobacteriaceae (CRE), a group of bacteria that are resistant to most antibiotics and can cause severe, often life-threatening infections. The elevator mechanism has been identified as a critical point of failure in the cleaning process. Even when following the manufacturer’s instructions for use (IFU) and adhering to standard reprocessing protocols, residual bacteria can remain trapped in the elevator channel, leading to cross-contamination between patients [4].

The Impact of Design Flaws on Patient Safety

The impact of these design-related infection risks became glaringly evident in the 2010s, when several hospitals across the United States reported outbreaks of multidrug-resistant organisms (MDROs) linked to duodenoscope use. Investigations by the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and a U.S. Senate Committee revealed that the complexity of duodenoscope reprocessing contributed significantly to these outbreaks. Between 2012 and 2015, over 190 cases of superbug infections were reported in the United States and Europe, all traced back to contaminated duodenoscopes. The infections were severe, with some resulting in patient fatalities [5].

The design flaws in duodenoscopes not only endanger patient safety but also place a heavy burden on healthcare facilities, which must balance the need for these critical devices with the imperative to prevent infection. The risks associated with duodenoscopes have led to numerous lawsuits, particularly against Olympus, the leading manufacturer, which controls approximately 85% of the U.S. market. These legal challenges underscore the need for ongoing scrutiny of device design and reprocessing practices [6].

Infection Control Strategies in SPD

Given the inherent risks associated with duodenoscopes, effective infection control in SPD is crucial. The following strategies are essential for mitigating the risks of contamination and ensuring patient safety:

1. Strict Adherence to Reprocessing Protocols: SPD professionals must meticulously follow the reprocessing protocols outlined in the IFU. This includes manual cleaning, high-level disinfection, and sterilization of all duodenoscope components, paying particular attention to the elevator mechanism and other areas prone to contamination. Where possible, automated endoscope reprocessors (AERs) should be used to enhance the consistency and effectiveness of cleaning and disinfection processes.
2. Enhanced Surveillance and Monitoring: Routine surveillance for signs of contamination and infection outbreaks is critical. This includes regular microbiological testing of reprocessed duodenoscopes to detect any residual bacteria. Any signs of contamination should trigger immediate reprocessing and investigation to prevent patient exposure.
3. Implementation of Single-Use Duodenoscopes: In response to the infection risks associated with traditional duodenoscopes, some manufacturers have developed single-use duodenoscopes. These disposable devices eliminate the need for reprocessing and significantly reduce the risk of cross-contamination. Healthcare facilities should consider incorporating single-use scopes into their practice, particularly for high-risk procedures or patients.
4. Education and Training: Continuous education and training of SPD staff are vital for maintaining high standards of infection control. Staff should be well-versed in the latest reprocessing techniques, understand the risks associated with duodenoscopes, and be able to recognize potential signs of contamination. Regular training sessions should also include updates on new technologies and best practices in scope reprocessing.
5. Collaboration and Communication: Infection control is a multidisciplinary effort that requires close collaboration between SPD, infection prevention teams, and healthcare providers. Open communication channels should be established to ensure that any concerns or issues related to duodenoscope reprocessing are promptly addressed. This collaborative approach is essential for maintaining a culture of safety and continuous improvement in infection control practices.

Moving Forward: The Role of SPD in Enhancing Duodenoscope Safety

The challenges associated with duodenoscopes underscore the critical role that SPD plays in protecting patient safety. As SPD educators, it is our responsibility to ensure that our teams are equipped with the knowledge, skills, and tools necessary to effectively reprocess these complex devices. This includes staying informed about the latest developments in scope design, reprocessing technology, and infection control guidelines.

Moreover, SPD must advocate for continuous improvement in device design and reprocessing protocols. This can be achieved by participating in industry forums, collaborating with manufacturers, and contributing to research efforts aimed at enhancing the safety and efficacy of duodenoscope reprocessing. By taking an active role in these initiatives, SPD can help drive innovation and ensure that patient safety remains at the forefront of healthcare practice.

Conclusion

Duodenoscopes are indispensable tools in the diagnosis and treatment of serious gastrointestinal conditions, yet their complex design poses significant infection control challenges. The outbreaks of superbug infections linked to these devices highlight the critical need for rigorous reprocessing protocols, enhanced surveillance, and ongoing education within SPD. By implementing best practices in infection control and advocating for continuous improvement, SPD professionals can mitigate the risks associated with duodenoscopes and ensure the safety of the patients they serve.

References

1.https://www.drugwatch.com/duodenoscope/

2.fda.gov - Infections Associated with Reprocessed Duodenoscopes

3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7671768/

4.cambridge.org - A prospective, multicenter, clinical study of duodenoscope contamination after reprocessing

5.https://journals.lww.com/ctg/fulltext/2020/08000/infection_control_in_endoscopic_retrograde.7.aspx

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8697464/

Sterilizer Diagnostic Tests: Leak Test vs. Bowie-Dick (Air-Removal) Test and Sterility Assurance Tests

By Martin Li, MA, CRCST, CER, CIS, CHL

 

 Introduction

In the intricate and high-stakes environment of the Sterile Processing Department (SPD), ensuring the sterility of medical instruments is paramount. The reliability of steam sterilizers is central to this mission, and various diagnostic tests are employed to validate the proper functioning of these critical devices. Among the most important of these tests are the Leak Test and the Bowie-Dick (Air-Removal) Test. Understanding the distinct purposes and processes of these tests, along with the role of sterility assurance tests like biological and chemical indicators, is crucial for SPD professionals. These tests are not interchangeable but complementary, each providing unique insights into the performance and integrity of steam sterilizers.

Understanding the Leak Test

The Leak Test is a diagnostic tool designed to verify the integrity of the sterilizer pressure vessel and its plumbing outside the chamber. This test is typically pre-programmed into the sterilizer cycle. It is vital to ensure that there are no leaks that could allow air to enter the chamber during the sterilization process. Air leaks can compromise the effectiveness of steam sterilization, as the presence of air pockets can prevent steam from reaching all surfaces of the instruments, thereby jeopardizing sterility.

During a Leak Test, the sterilizer is pressurized, and then the pressure is monitored for any unexpected drops, which would indicate a leak. The test results provide a numerical value that can be tracked over time, allowing SPD staff to monitor the sterilizer's integrity and address any issues before they lead to sterilization failures. Regular Leak Tests are essential for maintaining the reliability of the sterilization process and ensuring that the equipment operates within safe and effective parameters [1].

The Bowie-Dick (Air-Removal) Test: Ensuring Effective Air Removal

The Bowie-Dick Test, also known as the Air-Removal Test, is another critical diagnostic tool used in steam sterilization. This test is specifically designed for pre-vacuum steam sterilizers, which rely on a vacuum system to remove air from the chamber before steam is introduced. The removal of air is crucial because any remaining air can create pockets that steam cannot penetrate, leading to incomplete sterilization.

The Bowie-Dick Test uses a specially designed test pack, typically consisting of porous materials arranged in a specific pattern. When the test is run, the vacuum system attempts to remove air from the pack, and the steam is introduced. The pack contains a chemical indicator that changes color if air removal and steam penetration are effective. The result is a visual representation, usually in the form of a color change pattern, which confirms whether the sterilizer's vacuum system is functioning properly.

This test is conducted daily, before the first load is processed, or at the same time each day. It is a critical check to ensure that the sterilizer can achieve the necessary vacuum levels to effectively sterilize instruments. However, it is important to note that while the Bowie-Dick Test verifies the vacuum system's performance, it does not test for leaks in the sterilizer. Therefore, it should be used in conjunction with the Leak Test to ensure comprehensive monitoring of the sterilizer's performance [2].

The Role of Sterility Assurance Tests

Beyond the Leak and Bowie-Dick Tests, sterility assurance tests play a vital role in confirming that the sterilization process has been effective. These tests typically involve the use of biological indicators (BIs) and chemical indicators (CIs), each serving a distinct function in the sterilization process.

Biological Indicators are considered the gold standard in sterility assurance. They contain highly resistant bacterial spores(Geobacillus stearothermophilus spores for steam or H2O2 sterilizers, or Bacillus atrophaeus spores for ETO sterilizer) which are placed inside the sterilizer along with the instruments. After the sterilization cycle is complete, the BI is incubated to determine whether any spores survived the process. A successful sterilization cycle will kill all the spores, resulting in a "pass" result. If any spores survive, it indicates a failure in the sterilization process, necessitating immediate corrective action. BIs provide a direct measurement of the sterilization process's effectiveness and are an essential component of a robust sterility assurance program [3].

Chemical Indicators, on the other hand, provide a quicker, though less definitive, assessment of sterilization conditions. CIs are placed both inside and outside of instrument packs and contain chemicals that change color when exposed to specific sterilization parameters, such as temperature and steam presence. External indicators confirm that the pack has been exposed to the sterilization process, while internal indicators provide additional assurance that sterilant has penetrated inside the pack. CIs are useful for real-time verification at the point of use, but they do not replace the need for BIs, as they do not directly measure the microbial kill process [3].

Complementary Roles: Why All Tests Are Necessary

Running a Bowie-Dick Test or a Leak Test does not replace one another, just as sterility assurance tests cannot be substituted for diagnostic tests. Each of these tests serves a unique purpose in the overall sterilization process, and together, they provide a comprehensive assessment of the sterilizer's performance and the effectiveness of the sterilization process.

The Leak Test ensures that the sterilizer's pressure vessel and plumbing are intact, preventing air from compromising the sterilization process. The Bowie-Dick Test confirms that the vacuum system is effectively removing air from the chamber, ensuring that steam can reach all surfaces of the instruments. Meanwhile, sterility assurance tests like BIs and CIs provide the final confirmation that the sterilization process has been successful in killing any potentially harmful microorganisms.

By using these tests in combination, SPD professionals can have confidence that their sterilizers are functioning correctly and that the instruments processed are truly sterile and safe for patient use. Neglecting any of these tests can lead to gaps in the sterilization process, potentially resulting in the use of non-sterile instruments and putting patient safety at risk.

Best Practices for SPD Professionals

For SPD professionals, understanding the distinct roles of these tests is essential for maintaining high standards of infection control and patient safety. Best practices include:

1. Daily Testing: Conduct the Bowie-Dick Test daily before the first load is processed, or at the same time each day, to ensure the vacuum system is functioning properly.
2. Regular Leak Tests: Perform Leak Tests regularly, according to the sterilizer manufacturer's recommendations, to monitor the integrity of the pressure vessel and plumbing.
3. Routine Sterility Assurance Testing: Incorporate BIs and CIs into routine sterilization cycles to provide ongoing verification that the sterilization process is achieving the required microbial kill rates.
4. Documentation and Trend Analysis: Maintain thorough records of all test results, including numerical values from Leak Tests and color change patterns from Bowie-Dick Tests. Use these records to track trends over time and identify any potential issues before they lead to sterilization failures.
5. Continuous Education and Training: Ensure that all SPD staff are well-trained in the proper execution and interpretation of these tests, as well as the importance of each test in the overall sterilization process.

Conclusion

In conclusion, the Leak Test, Bowie-Dick Test, and sterility assurance tests each play critical roles in ensuring the reliability of steam sterilizers and the sterility of medical instruments. These tests are not interchangeable, and each provides unique insights into different aspects of the sterilization process. By understanding and properly implementing these tests, SPD professionals can help maintain the highest standards of sterility assurance, ultimately protecting patient safety and supporting the effective operation of healthcare facilities.

References

1. https://consteril.com/autoclave-steam-sterilization-cycle-bowie-dick-test/

2. https://www.sterislifesciences.com/-/media/files/lifesciences_com/pdf/tech-lab/mitigating-risk-with-autoclave-air-removal-tests.ashx

3. https://erd-us.com/bowie-dick-biological-leak-tests-in-steam-sterilization/

Understanding the Purpose of a Quality Management System in Healthcare Sterile Processing: Differentiating Between Quality Assurance, Quality Control, and Quality Culture

 

Martin Li, MA, CRCST, CER, CIS, CHL

Introduction

In the world of healthcare, Sterile Processing Departments (SPD) serve as the backbone of infection control and patient safety. Every instrument, device, and piece of equipment that passes through the hands of an SPD technician must be meticulously cleaned, inspected, and sterilized before being used in patient care. The importance of this role cannot be overstated, as the consequences of a lapse in sterility can be dire. To ensure the highest standards of safety and efficiency, a Quality Management System (QMS) is essential in any healthcare SPD.

A QMS in SPD is designed to ensure that all processes involved in the decontamination, inspection, assembly, packaging, and sterilization of medical instruments meet the required standards. However, understanding the full scope of a QMS involves differentiating between three critical components: quality assurance, quality control, and quality culture. Each of these elements plays a unique role in contributing to the overall effectiveness of SPD operations and the safety of patient care.

Quality Assurance: The Foundation of Consistency and Reliability

Quality assurance (QA) in the context of SPD refers to the systematic processes and procedures put in place to ensure that all operations meet predetermined standards. QA is a proactive approach that focuses on preventing errors and defects in the first place, rather than merely detecting and correcting them after they occur.

In SPD, QA involves establishing standardized protocols for every step of the reprocessing cycle—from the initial decontamination of instruments to their final packaging and sterilization. These protocols are based on guidelines from regulatory bodies, manufacturer’s instructions for use (IFU), and industry best practices. For example, the correct dilution of detergents, the appropriate temperature for sterilization cycles, and the specific inspection criteria for various instruments are all part of QA standards that must be consistently followed.

The importance of QA in SPD cannot be overstated. It ensures that every instrument processed meets the same high standards of cleanliness and sterility, regardless of who is performing the task or when it is being done. This consistency is crucial in preventing healthcare-associated infections (HAIs), which can have severe consequences for patients [1].

Quality Control: The Mechanism of Verification and Validation

While QA focuses on establishing and maintaining standards, Quality Control (QC) involves the testing and verification processes used to ensure that these standards are being met. QC is a reactive approach that identifies any deviations from the established standards and takes corrective action when necessary.

In SPD, QC activities include routine monitoring and testing of sterilization equipment, such as biological and chemical indicators that confirm the effectiveness of sterilization cycles. For example, a biological indicator (BI) test might be conducted to ensure that an autoclave has reached the necessary temperature and pressure to achieve sterility. If the BI shows that sterilization was not achieved, QC protocols dictate that the entire batch of instruments be reprocessed before use.

QC also involves the inspection of instruments for cleanliness, functionality, and damage after decontamination and before packaging. For instance, an instrument with residual bioburden or a damaged surgical tool must be identified and removed from circulation to prevent potential harm to patients [2].

The role of QC is critical in ensuring that the QA processes are working as intended. It provides the necessary feedback loop that allows an SPD to identify and correct issues before they result in compromised patient safety. By verifying that each step of the reprocessing cycle has been executed correctly, QC helps maintain the integrity of the sterilization process and the safety of the instruments used in patient care [3].

Quality Culture: The Heartbeat of Continuous Improvement

Quality culture refers to the collective commitment of an organization’s staff to uphold and continuously improve quality in every aspect of their work. In SPD, fostering a quality culture means that every technician, supervisor, and manager is dedicated to maintaining the highest standards of practice and is continuously looking for ways to improve processes.

A strong quality culture in SPD is characterized by open communication, ongoing education, and a shared sense of responsibility. For example, technicians should feel empowered to speak up if they notice a potential issue, such as a deviation from standard procedures or a malfunctioning piece of equipment. They should also be encouraged to participate in regular training sessions that keep them updated on the latest best practices and technological advancements in sterile processing [4].

Moreover, quality culture involves a commitment to continuous improvement. This can be achieved through regular audits, staff feedback, and the implementation of new technologies or processes that enhance the efficiency and effectiveness of SPD operations. For instance, the introduction of automated instrument tracking systems can help reduce the risk of human error and improve the traceability of instruments throughout the reprocessing cycle.

A strong quality culture ensures that QA and QC processes are not just seen as checkboxes to be ticked but as integral components of a broader commitment to excellence. It fosters an environment where quality is everyone’s responsibility, and where continuous improvement is the norm rather than the exception. This cultural shift is essential for achieving long-term success in SPD and for ensuring that patients receive the highest standard of care [5].

The Synergy of Quality Assurance, Quality Control, and Quality Culture

While QA, QC, and quality culture each play distinct roles in an SPD’s QMS, they are most effective when working together in synergy. QA sets the standards and provides the roadmap for achieving consistent results. QC ensures that these standards are being met through rigorous testing and validation processes. Meanwhile, a strong quality culture creates an environment where everyone is committed to upholding and continuously improving these standards.

The synergy of these three elements leads to better outcomes in SPD by minimizing the risk of errors, improving the efficiency of reprocessing cycles, and ensuring that all instruments meet the required standards of cleanliness and sterility. This, in turn, reduces the likelihood of HAIs, enhances patient safety, and supports the overall goals of the healthcare facility.

Moreover, the integration of QA, QC, and quality culture contributes to greater staff satisfaction and retention. When technicians feel that their work is valued and that they are part of a team committed to excellence, they are more likely to take pride in their work and stay engaged in their roles. This positive work environment is crucial for maintaining high standards in SPD, where the stakes are always high [4].

Conclusion

In conclusion, the purpose of a Quality Management System in healthcare Sterile Processing is to ensure that all instruments and devices used in patient care meet the highest standards of cleanliness and sterility. By differentiating between quality assurance, quality control, and quality culture, SPD professionals can better understand how each element contributes to the overall effectiveness of their operations. QA provides the foundation of consistent standards, QC ensures these standards are being met, and a strong quality culture fosters a commitment to continuous improvement.

Together, these elements create a robust framework that supports the safety and well-being of patients while enhancing the efficiency and effectiveness of SPD operations. As SPD educators and leaders, it is our responsibility to instill these principles in our teams and to cultivate a culture of quality that will drive better outcomes for our healthcare facilities and the patients we serve.

References

1.           History of infection prevention and control https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151947/

2.           ncbi.nlm.nih.gov - Infection Control

3.           Infection prevention and control GLOBAL (who.int)

4.           https://www.physio-pedia.com/History_of_Infection_Control_Guidelines

5.           https://en.wikipedia.org/wiki/Infection_prevention_and_control