As the world of medicine advances, the role and responsibilities of Sterile Processing departments have become more critical than ever before. From ensuring surgical instruments are free of contaminants to optimizing workflows, every step in an SPD’s process is dedicated to providing safer patient outcomes. In this “Better, Faster, Safer” educational series, we will explore key concepts and best practices to better understand the breadth and depth of SPD efficiency. This is not just about surgical instruments or devices, it’s about the processes and the people that ensure they are primed and patient ready for every procedure, every time!
As new technologies emerge, we have both the opportunity and the obligation to harness them for improved efficiency and, most importantly, enhanced safety. It’s not just about being faster, it’s also about being better without compromising on safety. By the end of this series, we aim for each participant to embody the essence of a “Better, Faster, Safer” technician, equipped with the know-how and motivation to drive transformative change in the industry.
Join us on this journey of innovation, efficiency, and the relentless pursuit of patient safety!
New Technology & Reprocessing Efficiency
The True Scope of SPD Efficiency
Efficiency in a Sterile Processing department goes beyond being a trendy catchphrase; it is the driving force behind the success of any healthcare facility. The significance of measuring efficiency plays a critical role in ensuring the safety of our patients, maintaining high-quality standards, and achieving operational excellence.
When looking at the true scope of Sterile Processing efficiency, we must factor in the following dimensions:
- Purpose: Every action in an SPD has a clear intent—to produce instruments that are safe for instruments. Each step in the reprocessing cycle, whether cleaning, disinfecting, or sterilizing, is adding value to those instruments to be ready for a patient. Steps along the way that do not add value (i.e. handling the tray multiple times in staging) should be removed. Each action should move the instrument set closer to being patient ready.
- Workflow Efficiency: The seamless connection and flow of tasks can make all the difference between smooth operations and encountering bottlenecks. Streamlining tasks means that instruments do not come through the workflow in giant batches. Instead, instruments smoothly move from one task to the next in a “one piece flow.” This consistent flow of instruments reduces equipment bottlenecks, staff inefficiencies, and helps ensure instruments ready and available for patient procedures.
- Data: Having the right data available helps the department pinpoint opportunities for performance improvement, anticipate future instrument needs, and plan for emergencies. Having accurate and timely data ensures they’re always ahead of the curve.
- Communication: By creating an environment where team members can openly voice concerns, share insights, and collaborate on solutions, departmental leaders can cultivate innovation and continuous improvement in their SPDs. It’s through these critical discussions that best practices can emerge and evolve.
- Standard Operating Procedures: With established protocols and regular training, leaders ensure that every aspect of their SPD is “under control.” This ensures consistency, reduces errors, and guarantees that the highest standards are always met.
As the “heart of the hospital”, Sterile Processing departments play a crucial role in the daily success of our healthcare facilities. By understanding the true scope of their efficiencies—from workflow to control—SPD’s can optimize their operations and consistently deliver on their promise to deliver safe, quality care for every patient, every time.
Water & the Instrument Death Cycle
Water, though sometimes overlooked, plays a crucial role in determining the lifespan and durability of your department’s surgical instruments. It’s important to note, the way your department’s water is treated and managed can make all the difference between sustaining your instrumentation or propelling them into a premature ‘death cycle.’ When exposed to poor water quality, stainless steel instruments can prematurely rust and form irreparable pitting corrosion, causing them to need to be replaced. In addition to the cost of instrument replacement, instrument damage due to water increases operational costs, as time is diverted from instrument sterilization to looking for replacements for damaged instruments.
To prevent the pre-mature damaging of your instruments, consider these key elements of an effective water quality program in Sterile Processing:
- Standards Compliance: Sterile Processing professionals should advocate for water quality that aligns with the rigorous standards set by AAMI TIR 34, a comprehensive framework for water quality in healthcare facilities. Reference these guidelines for the specific water quality requirements of utility and critical water, including water hardness, pH, total organic carbon, conductivity, and others.
- Water Quality Management Program: Water quality management is not a task that can be done once and then left alone. Water quality changes for a variety of reasons: changing seasons, new water sources from the utility company, and construction, to name a few. Because water quality is dynamic, it needs to be actively managed. Partner with your facilities management team to for a water committee that can monitor water quality in compliance with recommended guidelines in AAMI TIR34.
- Utilize Critical Rinse Water: There are 2 “categories” of water needed in Sterile Processing: utility water and critical water. Utility water comes from the tap and is used for general flushing, washing, and rinsing. Critical water is extensively treated to remove organic and inorganic materials from the water. Critical water should be used for the final rinse of your manual washing process, as well as the final rinse of your automated washers. This critical water rinse helps remove impurities from the instruments that may have been left over from their wash in utility water. Critical water rinsing is one of the most significant steps you can take for protecting your instruments from premature corrosion, staining, and rust.
In the quest for sterilization safety, water plays a pivotal role in maintaining the integrity of surgical instruments. By understanding the significance of water in the reprocessing cycle, SPD’s can uphold the integrity of their instruments, enhance patient outcomes, and maintain the highest standards of healthcare excellence.
Surrounded by Chemistries
Sterile Processing professionals have an arsenal of cleaning agents at their disposal armed and ready to fight dirty. These chemistries go beyond the mere act of cleaning and fighting off bioburden. They also work to protect the integrity and longevity of the instrumentation they are sworn to clean. The most common cleaning chemistries you will find in your SPD are:
- Enzymatic Cleaners
- Non-enzymatic Detergents
- Pre-cleaner Sprays & Foams
- Descalers & Stain Removers
- Lubricants
- Cart Cleaners & Drying Agents
- Disinfectants
The significance of these chemistries in our SPD’s cannot be overstated. Each solution is specifically designed to address the unique needs during each step-in instrument reprocessing. Whether it’s enzymatic cleaners breaking down organic matter or rust and stain removers rejuvenating instruments, every cleaning agent plays a vital role in upholding the highest standards of Sterile Processing excellence. By meticulously following the established standards and guidelines and leveraging the scientific knowledge behind these chemistries, you can elevate your Sterile Processing Department for safer outcomes for both employees and patients. To get started, make a “master list” of all the chemicals in your department, and make sure all of them are being used according to their labeled instructions!
Point of Use and Technology
Why should you advocate for point-of-use treatment in your healthcare facility?
The answer is simple. Point-of-use treatment is the first line of defense in the battle against biofilm and bioburden. From the moment an instrument is used, the clock starts ticking. Blood, tissue, and other bioburden start to form and dry on the instrument, making it harder to achieve optimal cleaning. Beginning the cleaning of an instrument right at the point-of-use will significantly reduce the risks of microbial growth and the potential transmission of infections.
As soon as possible after instruments and equipment are used, gross soil should be removed from the device, and it should be kept moist until further cleaning can take place in decontamination. There are a myriad of options to keep the instruments moist, from using a wet towel, to applying a spray or gel to wet the instruments during transport. Some of these products also include enzymes to begin the cleaning activity during transport, as well as anti-corrosives to prevent damage to the instruments.
On of the biggest challenges Sterile Processing Departments face related to point-of-use treatment is partnering with clinical areas to improve compliance. Digital Tracking systems can be used to help collect data for compliance with point-of-use treatment protocols. That data can be used to benchmark performance, set goals, and achieve a safer workflow to prevent soils from drying on surgical instruments.
Brushes: Right, Wrong, and Why
Just as a surgeon carefully selects the ideal tool for a procedure, choosing the right brush is instrumental (pun intended) during the manual cleaning process. With varying sizes, bristle stiffness, and purposes, manual cleaning brushes are designed to meet the individual needs of the instruments they clean.
It is a common misconception that you should approach brushes as a one-size-fits-all solution, and that just isn’t the case. The first step in selecting your cleaning tool of choice is to understand what you are cleaning. Each brush is designed to do specific tasks, and choosing the wrong brush could lead to instrument damage, improper cleaning, and infection risks.
The most common brushes found in you will find in decontamination are:
- Channel Brushes
- General Brushes
- Burr Brush
- Valve & Port Brushes
- Reamer Brush
So how do you know what type/size is correct for your instruments? Best practice is to refer to the manufacturer’s IFU for detailed cleaning directions. Remember, choosing the right brush isn’t just about getting the job done; it’s about doing it right!
A Clean You Can See
Can you really see clean? The initial answer might seem straightforward: a clean instrument looks clean, but the reality is much more complex. While an instrument may look free of blood and tissue, microscopic residues and biofilm can easily go undetected by the naked eye. Let’s take a closer look at the tools helping Sterile Processing professionals “see clean” more clearly.
Lighted Magnification: When inspecting an instrument under a lighted magnifier a technician can critically inspect areas of the instrument that are not easily seen with the naked eye. Magnification acts as a bridge between what we see and what we need to see.
Borescopes: For instruments with internal channels or hard-to-see areas, a borescope is a game-changer during instrument inspection. This optical tool can navigate through the internal channels of your department’s toughest instruments/devices and relay real-time video images. It’s like giving SPD professionals the ability to see the unseeable.
Soil Detection Tests: Even the best magnifiers or borescopes are not going to help a Sterile Processing technician see a biofilm or some residual protein. In addition to the visual aid of magnification, technicians can employ a chemical test to check for the presence of ATP, proteins, hemoglobin, or other soil markers. These soil detection tests are intended to be used intermittently to help evaluate the cleaning process, and they must be used according to the manufacturer’s directions. Often these tests require the instrument to be recleaned after testing, regardless of the result.
Our next post will highlight the sterility assurance tool that ensures instruments are declared “sterile” and ready for patient use.
Investigating Biological Indicators
We can’t talk about better, safer, and faster reprocessing efficiencies without discussing the most important sterility assurance tool used in Sterile Processing. That’s right, it’s time to talk about Biological Indicators (BIs).
Biological Indicators play a critical role in ensuring the efficacy of the sterilization processes. These specifically designed test systems contain viable bacterial spores resistant to the specific sterilization method being tested. Biological Indicators are an important tool during the sterilization process because they provide a high level of confidence that sterilization parameters have been met and that instruments have been exposed to a lethal sterilization process.
Biological Indicators come in many shapes and sizes, but the most common type found in Sterile Processing departments are Self Contained Biological Indicators (SCBI). These tests include both the bacterial spores and a growth medium in a single vial, making it simple to combine them following sterilization. Once sterilized, the technician activates the BI, combining the growth medium with the bacterial spores, and incubates the test according to the manufacturer’s directions. If the BI indicates no bacterial growth, then the test has passed, indicating sterilization was successful.
The modern emergence of super rapid biological indicators has revolutionized the way sterilization processes are monitored. Super Rapid BIs have trimmed down the incubation time of biological indicators down to just minutes. This allows Sterile Processing professionals to receive more immediate feedback on the efficacy of sterilization, and can potentially detect a sterilization issue before the instruments have been released from the department for use.
Wrapped Sealed or Locked? Packaging 101
Sterile packaging plays a crucial role in safeguarding the medical instruments we use daily. This multifaceted landscape has seen many changes and improvements over the years. Let’s delve into four significant types of packaging, each with its unique features, advantages, and disadvantages.
Muslin, a lightweight cotton cloth with 140 threads per square inch, was once a commonly used material for wrapping surgical instruments. While economical and reusable, Muslin has fallen out of favor due to the labor involved in laundering and inspecting the linen wraps, as well as its limitations as a barrier against microbial penetration.
Surgical Wraps
Disposable surgical wraps have become an industry standard, offering a versatile and effective barrier for various instruments. They are non-woven materials, often bonded together into 2 layers, and they make an excellent microbial barrier. The advantages include suitability for various instruments and an effective barrier when used correctly. However, the wrapping technique can be time consuming, and the packaging is vulnerable to punctures and tears.
Peel Pouches
Peel Pouches, made from paper and plastic for steam sterilization or Tyvek for hydrogen peroxide sterilization, are an ideal, user-friendly option for smaller instruments. They are convenient and allow for direct visualization of the packaged instrument thanks to their transparent design. On the downside, since they are limited to smaller, individual items, they are an impractical solution for large-scale instrument use. They also are vulnerable to damage from punctures and tears.
Rigid Containers
Rigid Containers are the oldest of the modern sterilization packaging systems, originating in the 1890s. Rigid containers offer a secure, long-lasting, and environmentally friendly option for sterilizing surgical instruments. They provide excellent protection against physical damage, but their initial cost of implementation may be higher. They require careful inspection for wear and tear and should be maintained to ensure they are in optimal working condition.
The Cutting Edge of Rigid Technology
The latest rigid container technology has brought about a significant change in sterilization workflows. Certain modern containers eliminate the need for a dry time in steam sterilization, saving sterile processing departments significant time in the sterilization process. Moisture in these containers is considered to be normal and expected, as the container is able to keep the instruments sterile for the duration of its shelf life.
Conclusion
The field of sterile packaging is as diverse as it is essential. From the historical use of Muslin to the innovative rigid containers of today, each method has its unique attributes and challenges. Understanding these aspects helps in choosing the right packaging for different surgical instruments, contributing to improved efficiency and safety in healthcare. Whether wrapped, sealed, or locked, these packaging techniques continue to shape the world of medical devices, illustrating a continuous path of innovation and adaptation.
A Sterile Processing FYI on the FDA
Understanding the FDA’s role in our industry empowers Sterile Processing professionals to make informed decisions, ensuring the highest standards of patient care. Let’s take a closer look at how the FDA weaves its regulatory web in our industry.
- The FDA rigorously vets and clears medical devices and instruments to make sure they meet stringent safety and performance benchmarks before reaching the market.
- All sterilizers undergo thorough design, performance, and safety testing before they are made available to SPD’s.
- In order for medical devices to receive FDA approval they must go through the 510(k) clearance process.
- In the realm of healthcare regulations, it’s important to clarify that the only regulatory body vested with the authority to grant clearance to items is the FDA. This power is not held by the Department of Health (DOH), accreditation organizations, or the Centers for Medicare & Medicaid Services (CMS). Understanding this distinction is crucial, as FDA clearance signifies adherence to rigorous safety and efficacy standards, underscoring its unique role in ensuring the quality and reliability of healthcare products and equipment.
- The FDA’s rigorous process is a testament to its commitment to patient safety.
The IFU Sterilization Decision Tree
Sterilization is not a one-size-fits-all process. It’s a complex and tailored process that requires a thorough understanding of the various IFUs (Instructions For Use) involved. Navigating the intricacies of each IFU is essential when selecting the appropriate IFU to follow. Three IFUs to keep in mind include:
Sterilizer IFU: Details the operation, maintenance, and validation of the sterilization equipment. Each sterilizer model has specific cycles, temperatures, weight capacities, and other operational metrics, and following these guidelines is crucial for effective sterilization.
Medical Device IFU: Provides device-specific instructions, including decontamination practices, assembly instructions, and sterilization guidelines. Since medical devices vary in complexity, this IFU ensures each device is sterilized without compromising its integrity or functionality.
Packaging IFU: Covers directions for ensuring the integrity of the sterile packaging chosen. Selecting the appropriate packaging system, whether its blue wrap, pouches, or rigid containers, has specific guidelines to ensure sterility during storage and transport. Because dry time is a factor of sterility maintenance, not achieving sterility, the sterile packaging IFU should dictate the dry time for the sterilization cycle.
So, with these three IFUs in play, how do we decide which one to follow? The reality is that all three of these IFUs should be consulted when sterilizing an instrument. Think of these three documents as the three legs of a stool, on which the sterilization process stands.
Event or Expiry? A Need to Know
What are the differences between Event Related Sterility (ERS) and Expiratory Dating Practices? Here are the key things you need to know:
Event Related Sterility determines an item’s sterility based on the conditions it has been exposed to rather than a predetermined time frame.
- Items are considered sterile unless compromised by an external event (e.g., moisture, tears in the packaging).
- Event Related Sterility reduces waste and allows for flexibility in inventory management.
- It is important to note, regular inspection of sterile items is crucial, and any items suspected of being compromised should be reprocessed immediately.
Expiratory Dating is the predetermined shelf-life of an item, based on the manufacturer’s clearance for shelf life. A facility is not free to choose any date they wish; the expiry date must be selected based upon the manufacturer’s clearance.
- Items are considered non-sterile once they reach the expiration date and must be reprocessed or thrown out.
- This process requires careful tracking and managing, especially in larger healthcare facilities.
- Expiratory Dating can lead to unnecessary reprocessing and waste.
You might be asking yourself, which practice is better? The answer depends on your facility’s volume, turnover requirements, storage capabilities, and tracking systems. Ultimately the goal is the same, ensuring the safety and efficacy of sterilized items in the pursuit of better, safer patient care.
Aiming for Efficiency Hyperdrive
The field of Sterile Processing is integral to the healthcare industry and constantly evolving. Aiming for efficiency is essential for the delivery of safe and effective patient care. This article outlines four key strategies for Sterile Processing professionals to enhance efficiency within their departments.
1). Have Purpose, Be Competent, and Continue Life-Long Learning
The cornerstone of efficiency in Sterile Processing starts with a clear sense of purpose and an unwavering commitment to competence. Understanding the rationale behind protocols and procedures fosters a more meaningful connection to the work. Continuing education and professional development opportunities are not merely advisable but essential to maintaining the highest standards of care.
2). Continually Reassess and Innovate Your Workflows with Alternatives
Efficiency in Sterile Processing requires a willingness to regularly reassess and innovate existing workflows. Evaluating current practices and considering alternatives that could optimize them is fundamental. This process does not undermine established procedures but aims to refine and improve upon them, ensuring they align with best practices within the industry.
3). Stay Up to Date on the Latest Processes, Products, and Technology
The rapid advancement of technology within the Sterile Processing sector necessitates an ongoing commitment to staying abreast of the latest developments. This includes understanding new processes, products, and technologies that can enhance workflow efficiency. Engagement with professional organizations, industry publications, and peer collaboration can foster an environment of continuous improvement.
4). Embrace New Technologies in Your Department
Adopting new technologies is a vital aspect of driving efficiency within Sterile Processing departments. From the integration of advanced biological indicators to the implementation of cutting-edge sterilization techniques, embracing these innovations supports the provision of the highest quality care. Resistance to change can impede progress, so a willingness to explore and implement new technologies is essential.
Remember, efficiency in Sterile Processing is a marathon, not a sprint. As you aim for excellence in your Sterile Processing department, it is important to find the balance in your hyperdrive, push boundaries that can lead to new innovations, and continue to set higher standards for better, safer, and faster sterilization efficiencies.
The Better Faster Safer Technician
Sterile Processing professionals are the unsung heroes of patient care. As the guardians of instrument reprocessing, they shoulder the immense responsibility of providing safe, patient-ready instrumentation for every surgical procedure, every time. By applying the concepts from this “Better, Faster, Safer” series to their daily operations, frontline professionals can transform their skill sets and take their careers to the next level.
So how do we start?
The best place to begin is to establish a solid foundation during employee onboarding. Orientation introduces new technicians to your department’s mission and the expectations you have in your SPD. First impressions last, so take the time to give a thorough tour of your SPD, introduce current staff to their new coworkers, and encourage mentor-mentee relationships between new and experienced technicians.
Providing continuing education and training opportunities for staff is essential to the success of your Sterile Processing department. When you encourage your technicians to stay up to date on industry standards and best practices, you are fostering an environment of collaboration and Sterile Processing excellence.
The next question is, how do you achieve Sterile Processing excellence on the day-to-day? You start by creating an environment where technicians are free to collaborate, share their feedback, and have the freedom to troubleshoot challenges collectively. This will help technicians think on their feet and prepare for real-world challenges.
The goal of this series isn’t just to create Sterile Processing professionals who are better and faster, it’s to also establish champions of safety in Sterile Processing. The journey to the “Better, Faster, Safer” is ongoing and we are here to support you on your own journey to reprocessing efficiency!
Series Wrap Up
As you have seen throughout this series, creating “Better, Faster, Safer” reprocessing efficiencies goes far beyond mere workflow improvements. It’s about empowering Sterile Processing professionals with the cutting-edge knowledge, tools, and passion they need to drive meaningful change in our industry. Embracing new technology isn’t just a trend; it’s a call to action.
We hope this program not only educates but also challenges you to think creatively and innovate fearlessly. It’s a challenge to not only make your department more efficient and productive but also to be pioneers in the adoption of technology that makes processes faster, better, and never compromises on safety.
Let this series be a catalyst for you to explore, question, and embrace the new technologies that are shaping our industry’s future. Don’t forget to take a moment to review each section of this program before completing the CE quiz.
Your journey towards excellence starts with a willingness to take that bold step towards innovation. Thank you for learning with us, and more importantly, thank you for being part of this exciting and transformative movement!