On This Page On This Page Download the eBook Cleaning Surgical Instruments: What Healthcare Facilities Need to Know Written by: Bill Warren Ensuring the sterility of surgical instruments and other medical equipment is paramount to patient safety in hospitals, ambulatory surgical centers (ASCs), and other healthcare facilities, preventing cross-contamination and reducing the risk of healthcare-associated infection (HAI). But patients aren’t the only ones who benefit. By maintaining a rigorous surgical equipment cleaning process, healthcare facilities can maintain equipment integrity, reduce operating costs, and comply with medical device standards and regulations. As the volume of outpatient surgical procedures in the U.S. continues to rise, particularly in ASCs and hospital outpatient departments (HOPDs), the need for reliable and efficient cleaning and sterilization processes is more urgent than ever. Key Terms: The Difference Between Cleaning, Disinfection & Sterilization Though the terms “cleaning,” “disinfection,” and “sterilization” are often used interchangeably, they have different meanings and applications. It’s imperative that healthcare professionals understand the distinctions between these terms to ensure patient safety and follow proper procedure when cleaning surgical instruments and other medical devices. Cleaning Cleaning is the first step in the decontamination process, and involves removing any visible dirt, debris, or organic matter from medical equipment. Surgical instruments are often cleaned using water, detergents, or enzymatic products. While cleaning removes physical contaminants from instruments, it does not eliminate all microorganisms present on their surface. Disinfection Disinfection goes beyond cleaning, destroying most pathogenic microorganisms on inanimate objects. However, it does not necessarily kill all microbial life forms, such as bacterial spores. Most medical facilities use chemical agents or physical methods, such as UV light, to disinfect equipment, with varying levels of disinfection — low, intermediate, or high — depending on the microorganisms present and the intended use of the items being disinfected. Sterilization Sterilization is the most rigorous form of decontamination and is designed to destroy all forms of bacterial life present on surgical instruments, including bacterial spores. Common sterilization methods include steam under pressure (also known as autoclaving), ethylene oxide (EtO) gas, hydrogen peroxide plasma, and dry heat. Autoclaving is often the preferred method of sterilization for sterile processing departments (SPDs) due to its efficiency, cost-effectiveness, and ability to penetrate fabrics and complex instruments. Standards for Cleaning Surgical Instruments There are various organizations that set strict requirements for cleaning surgical instruments to maintain the highest levels of hygiene and safety in healthcare settings. These organizations and their respective standards and regulations include: Association for the Advancement of Medical Instrumentation (AAMI): In partnership with the American National Standards Institute, AAMI developed ST79, a comprehensive guide that outlines best practices for the sterilization of healthcare products. ST79 covers a wide range of topics, including sterilization equipment, process validation, quality control, and staff training to ensure the sterilization procedures are consistent and effective, thereby minimizing the risk of HAIs and protecting patient safety. Centers for Disease Control and Prevention (CDC): The CDC sets infection control guidelines, including those for cleaning and sterilizing surgical instruments and other medical devices. These guidelines include requirements for pre-cleaning instruments, recommendations for choosing the appropriate cleaning agents, and procedures for disinfecting and sterilizing equipment according to risk. World Health Organization (WHO): The WHO offers global guidelines for infection prevention, including the sterilization of medical devices. The WHO’s guidelines, which are intended to help even resource-limited facilities maintain high standards of instrument hygiene, emphasize point-of-use (POU) cleaning, consistent decontamination, and appropriate staff training. Association of periOperative Registered Nurses (AORN): AORN’s Guidelines for Perioperative Practice are a comprehensive resource for safe perioperative patient care and cover every aspect of surgical instrument handling, from POU cleaning to sterilization. AORN’s guidelines are essential for nurses and surgical technologists and are considered the gold-standard in evidence-based recommendations. International Organization for Standardization (ISO): ISO sets international standards for products, services, systems, and processes, including medical device sterilization. ISO 17664 specifies the information medical device manufacturers must provide for processing reusable medical devices, while ISO 17665 sets requirements for developing, validating, and controlling steam sterilization processes for medical equipment. What Is Point-of-Use Cleaning? Point-of-use cleaning is the initial step of the surgical instrument decontamination process and takes place immediately after use. POU cleaning involves removing gross contaminants, such as blood and tissue, at the site of use before instruments are transported to the SPD for more thorough cleaning and sterilization. POU cleaning prevents the formation of biofilm — “clusters of microorganisms that stick to non-biological surfaces” — by removing organic material immediately. Biofilm can harbor and protect bacteria, making subsequent cleaning and sterilization more challenging. Additionally, early removal of contaminants reduces the microbial load on instruments, enhancing the efficacy of later disinfection and sterilization processes. Prompt cleaning at the point of use also helps maintain the condition and functionality of surgical instruments, prolonging their lifespan and ensuring their performance during critical procedures. Cleaning Medical Instruments: A 12-Step Process By meticulously following these steps, healthcare facilities can make certain that surgical instruments are safe, sterile, and ready for use, thereby protecting patients from potential HAIs and improving overall health outcomes. Point-of-use Cleaning: Instruments should receive initial cleaning immediately after a surgical procedure to prevent blood, bodily fluids, and other contaminants from drying on them and forming biofilm. During POU cleaning, it’s best to wipe instruments down with a sterile, damp cloth or sponge and use a pretreatment spray, foam, or gel to keep organic matter moist. For heavily soiled instruments, soaking them in a container filled with an enzymatic detergent solution can help break up organic matter, making them easier to clean. Transportation: When transporting instruments from the surgical site to the SPD, be sure to place them in leak-proof, puncture-resistant containers clearly labeled with biohazard symbols to minimize the risk of contamination or damage. Manual Cleaning: Manual cleaning involves physically scrubbing surgical instruments with soft-bristled brushes, lint-free cloths, and detergent to remove visible soil. This step of the surgical instrument cleaning process is essential to eliminate all organic and inorganic material before mechanical cleaning. When performing manual cleaning, pay close attention to any joints, crevices, lumens, or other intricate parts to ensure that there’s no remaining debris or residue. Finish by rinsing with a distilled or deionized water to remove any residual cleaning agents. Mechanical Cleaning: Mechanical cleaning, which is typically performed in an ultrasonic cleaner or washer-disinfector, further removes any remaining debris from surgical instruments using high-frequency sound waves or automated washing cycles. When using either an ultrasonic cleaner or washer-disinfector, it’s important to properly load instruments so that they are fully exposed to the cleaning process. It’s also important to select the appropriate cycle settings based on the manufacturer’s Instructions for Use (IFU) to maintain equipment integrity and to regularly test and maintain mechanical cleaning equipment for optimal performance. Sterilization: Perhaps the most important step in the cleaning process, sterilization eliminates all forms of microbial life, including bacterial spores, biofilm, and protozoa. There are numerous sterilization methods, including ethylene oxide gas, hydrogen peroxide plasma, dry heat, and steam sterilization; when selecting the appropriate sterilization method, be sure to follow the manufacturer’s IFUs. Rinse: If you used ethylene oxide to sterilize instruments, be sure to rinse them afterward using a distilled or deionized water to remove any residual EtO, which can be toxic. Drying: If you used steam sterilization or EtO gas to sterilize instruments, give them time to either cool or aerate, and then thoroughly dry them using a lint-free towel or compressed air. This step of the process maintains the integrity of instruments, especially metal instruments, which can rust and corrode if packaged while wet. Lubrication: Lubricating the hinges and joints of surgical instruments with moving parts helps to maintain their functionality and prolong their lifespan. It’s best to use a medical-grade, water-soluble lubricant, applied sparingly and according to the manufacturer’s IFUs. Inspection: Inspect each instrument for cleanliness, functionality, and integrity before packaging. Use magnification to inspect for cracks, chips, or other damage and ensure that instruments with moving parts move smoothly and correctly. Remove and reprocess any instruments that do not meet cleanliness or functionality standards. Packaging: Packaging surgical instruments after cleaning maintains their sterility until use. Be sure to use the appropriate packaging materials for each instrument, such as sterilization wraps, pouches, or containers, and tightly seal to prevent possible contamination. Finally, label packages with the date of sterilization, their contents, and any relevant batch numbers for traceability. Storage: To maintain their sterility, clean surgical instruments should be stored in a clean, dry, temperature-controlled environment, placed on shelves rather than the floor, and kept away from direct sunlight. Implement a first-in, first-out system to ensure that older items are used before newer ones. Documentation: Maintain detailed records of the entire sterilization process, including the date and time, sterilization method used, cycle parameters, and operator information. Additionally, keep maintenance logs and records of biological indicator testing results (including failures). Maintaining this documentation — and making sure it is accessible and organized for audits and inspections — is critical to ensuring traceability and compliance with industry standards. 12 Common Points of Failure When Cleaning Surgical Instruments There are several potential points of failure that can compromise the effectiveness of the surgical instrument cleaning and sterilization process. Here are some key things for SPD technicians to watch out for: Failure to Clean Instruments Immediately After Use: When cleaning surgical instruments, time is of the essence. When bioburden, such as blood, tissue, and other bodily fluids, is allowed to dry on instruments, it can form biofilm. Not only is biofilm significantly harder to remove, but it can shield bacteria and other pathogens from the cleaning and sterilization process, increasing the risk of HAIs. POU cleaning both maintains the integrity of instruments and guarantees a higher standard of hygiene. Incorrect Disassembly Prior to Cleaning: Instruments that are not properly disassembled prior to cleaning can harbor residual debris and microorganisms in joints, hinges, and other hidden areas. If left unaddressed, these residuals can compromise the sterilization process. Prior to cleaning, be sure to take each instrument apart according to the manufacturer’s guidelines to expose all surfaces to cleaning agents. Inadequate Manual Cleaning: Manual cleaning is a crucial step in the decontamination process, and inadequate techniques can leave behind organic material and other contaminants. Examples of inadequate techniques include using the wrong tools, such as still brushes, which can damage instruments, or failing to scrub all surfaces — especially joints, hinges, and lumens — thoroughly. Incorrect Cleaning Solutions: Using the incorrect cleaning solutions can result in ineffective removal of bioburden or biofilm and potential damage to instruments. Some cleaning agents may be too harsh, causing corrosion or pitting, while others may not be effective enough to break down organic material. Therefore, it’s essential to choose cleaning solutions specifically designed for medical instruments and compatible with the materials from which they are made, as recommended by the manufacturer. Failure to Follow Manufacturer’s IFUs: Every surgical instrument comes with specific Instructions for Use provided by the manufacturer that detail proper cleaning, handling, and sterilization procedures. Failure to adhere to these instructions can result in inadequate cleaning and potential damage to instruments, which is why it’s vital to follow them to the letter. Insufficient Rinsing After Cleaning: Thoroughly rinsing instruments after cleaning is essential to remove any residual cleaning agents or debris. Failure to do so can leave chemical residue, which can cause irritation or adverse reactions in patients, as well as contribute to corrosion and degradation of instrument materials. Improper Sorting or Handling During Transportation: Improper sorting and handling of instruments when in transit from the surgical site to the SPD can lead to contamination, damage, and mix-ups. Always place instruments in leak-proof, puncture-resistant containers prior to transport and sort them according to their type and cleaning requirements. Proper labeling can also eliminate potential confusion. Inadequate Staff Training: Technicians responsible for cleaning and sterilizing surgical instruments must be thoroughly trained in proper cleaning protocols and techniques to prevent improper handling, compromised equipment, and potential risks to patient safety. Continuous education and training programs are necessary to ensure that all personnel are up-to-date with the latest guidelines and best practices for surgical instrument processing. Lack of Quality Control Measures: Quality control measures are essential to guarantee the effectiveness of surgical instrument decontamination. Without proper quality control, there is no assurance that instruments are being cleaned and sterilized to the required standards, and inadequate inspection can lead to the use of damaged or contaminated instruments. Implementing rigorous quality control procedures and thorough inspection protocols helps identify and address any issues before instruments are used in patient care. Overloading Ultrasonic Cleaners, Washer-disinfectors, or Autoclaves: Overloading cleaning and sterilization equipment prevents instruments from being fully exposed to cleaning agents and sterilizing conditions. When instruments are packed too tightly or otherwise loaded improperly, it can obstruct the flow of water, detergent, and other sterilizing agents, compromising the sterilization process. Again, when loading instruments, be sure to follow the manufacturer’s IFUs. Improper Cycle Selection: For facilities that use autoclaves to sterilize surgical instruments, selecting the appropriate cycle type is essential to ensure comprehensive sterilization. Choosing the wrong cycle — that is, the correct parameters for steam sterilization, such as temperature, pressure, and exposure time — can not only leave instruments contaminated and unsafe for use, but can also damage them, rendering them unusable in the future. Equipment Malfunction: Equipment malfunctions can lead to incomplete cleaning and sterilization, posing a risk to patient safety, while unexpected equipment downtime can lead to surgical backlogs. Scheduling routine maintenance and continuously monitoring SPD equipment mitigates the risk of equipment failure at critical moments and ensures consistent performance. Best Practices for Cleaning Medical Instruments When cleaning surgical instruments and other medical devices, observe the following best practices to achieve best results: Begin the cleaning process immediately after use. Starting the cleaning process as soon as possible is crucial to prevent biofilm from forming on instruments, which can be challenging to remove later on in the process and can prevent certain cleaning methods from being effective. Not only does POU cleaning reduce the risk of contamination, it also enhances the overall efficiency of the decontamination process. Always refer to the manufacturer’s IFUs. IFUs provide specific guidelines tailored to each instrument’s material and design, ensuring that the cleaning process does not damage the equipment while achieving the necessary level of sterility. Strictly adhering to these instructions both maintains the functionality and longevity of instruments and safeguards patient and staff safety. Keep contaminated and clean items separate. While it might seem obvious, it’s imperative to clean and decontaminate instruments in a dedicated area separate from where you handle clean items. This separation minimizes the risk of spreading contaminants from soiled instruments to sterilized ones, and maintaining distinct zones for different stages of the cleaning and sterilization process ensures a controlled environment, enhancing the efficacy of infection control measures. Require SPD technicians to wear personal protective equipment (PPE). Wearing PPE is mandatory for any personnel involved in cleaning surgical instruments to protect them from exposure to potentially infectious materials and harmful cleaning agents. Appropriate PPE includes gloves, gowns, masks, and eye protection. Consistent use of PPE reduces the risk of occupational exposure to pathogens and chemical irritants, creating a safer working environment for healthcare workers. Remove soiled or defective instruments for reprocessing or repair. During the inspection process, immediately remove any instruments you deem soiled or defective from service. These instruments must either be reprocessed to achieve proper sterility or sent for repair if they are damaged. This practice ensures that only fully functional and sterile instruments are available for use in surgical procedures, maintaining the highest standards of patient care and safety. Ensure that all SPD technicians receive proper training. Regular training and competency assessments are essential to maintaining high standards of practice. Ongoing education ensures that SPD technicians are up-to-date with the latest protocols, techniques, and regulatory requirements, while competency assessments identify areas where additional training may be required, fostering a culture of continuous improvement. Implement strict quality control measures. Quality control measures, such as routine checks and validating cleaning and sterilization equipment, support optimal equipment functioning and performance. Routine testing and maintenance provide opportunities to flag potential issues before they result in equipment failure, as well as ensure that cleaning and sterilization processes consistently meet the required standards. Avoid stacking or overcrowding instruments during transportation or storage. Preventing damage to sterilized surgical instruments requires careful handling during transportation and storage. Stacking or overcrowding instruments can cause physical damage, such as bending, breaking, or scratching, which can compromise their functionality and sterility. Consolidated Sterilizer Systems specializes in manufacturing state-of-the-art autoclaves for hospitals, ASCs, and other medical facilities, ensuring patient safety and supporting positive outcomes. Whether you’re building your SPD from the ground up or are looking to invest in additional equipment, check out our in-depth autoclave buyers’ guide for medical professionals. Frequently Asked Questions Q: What are the risks associated with improperly cleaned surgical instruments? A: When instruments are not adequately sterilized, they can harbor residual blood, tissue, and other organic materials that provide a breeding ground for harmful microorganisms. These contaminants can result in surgical site infections, which are associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. In addition to infections, the presence of biofilm can interfere with instrument functionality, potentially compromising the success of procedures and patient safety. Q: How does improper cleaning impact patient safety and healthcare costs? A: The improper cleaning of surgical instruments increases the risk of HAIs, which can lead to severe complications, extended recovery times, and even mortality. These adverse outcomes not only affect patient health and safety but can also inflate healthcare costs. Treating HAIs and managing complications requires additional medical interventions, extended hospital stays, and increased use of antibiotics, all of which contribute to higher expenses. Moreover, facilities may face legal liabilities and damage to their reputation, undermining trust in the healthcare system. Q: What are the most common methods of sterilizing medical instruments? A: Common methods for sterilizing medical instruments include: Steam sterilization, or autoclaving, which involves exposing instruments to high-temperature steam under pressure Ethylene oxide sterilization, which uses EtO gas to penetrate materials and eradicate microorganisms Hydrogen peroxide plasma sterilization, which uses oxidative processes to sterilize instruments at low temperatures Dry heat sterilization, which is used for materials that can withstand high temperatures without moisture Q: What is the best sterilization method for stainless steel instruments? A: Steam sterilization is highly effective and widely recognized for its ability to thoroughly sterilize stainless steel instruments without causing damage. Stainless steel’s durability and resistance to moisture makes it ideal for this method. Additionally, autoclaving is efficient, cost-effective, and has many applications beyond steel instruments, making it the preferred sterilization method for many SPDs. Sources: Research and Markets, “US Outpatient Surgical Procedures Market by Surgical Procedure Type, Patient Care Setting – US Forecast to 2023, https://www.researchandmarkets.com/reports/4746620/us-outpatient-surgical-procedures-market-by.” Consolidated Sterilizer Systems, “Decontamination, Disinfection & Sterilization: What You Need to Know, https://consteril.com/disinfection-vs-sterilization/.” Centers for Disease Control and Prevention, “Cleaning, https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/cleaning.html.” Consolidated Sterilizer Systems, “Sterilization vs. High-Level and Low-Level Disinfection [a 3-Point Comparison], https://consteril.com/high-level-vs-low-level-disinfection/.” Consolidated Sterilizer Systems, “Medical Device Sterilization: 4 Alternatives to Ethylene Oxide, https://consteril.com/medical-device-sterilization-eto-alternatives/.” Association for the Advancement of Medical Instrumentation, “ANSI/AAMI ST79, https://www.aami.org/standards/featured-standards/ansi-aami-st79.” Centers for Disease Control and Prevention, “Disinfection and Sterilization Guideline, https://www.cdc.gov/infection-control/hcp/disinfection-and-sterilization/index.html.” World Health Organization, “Decontamination and reprocessing of medical devices for health-care facilities, https://www.who.int/publications/i/item/9789241549851.” Association of periOperative Registered Nurses, “Guidelines for Perioperative Practice, https://www.aorn.org/guidelines-resources/guidelines-for-perioperative-practice.” International Organization for Standardization, “ISO 17664-1:2021, https://www.iso.org/standard/81720.html.” International Organization for Standardization, “ISO 17665:2024, https://www.iso.org/standard/80271.html.” Nature Reviews Microbiology, “Bacterial biofilms: from the Natural environment to infectious diseases, https://www.nature.com/articles/nrmicro821.” Occupational Safety and Health Administration, “Ethylene Oxide, https://www.osha.gov/ethylene-oxide.” Consolidated Sterilizer Systems, “What Are Biological Indicators (Spore Tests)?, https://consteril.com/autoclave-biological-indicator-guide/.” Consolidated Sterilizer Systems, “Top 13 Sterile Processing Mistakes in Hospitals, https://consteril.com/sterile-processing-mistakes/.” Infection Control Today, “The Importance of Following Manufacturers’ IFUs, https://www.infectioncontroltoday.com/view/importance-following-manufacturers-ifus.” Consolidated Sterilizer Systems, “The Top 8 Hospital Sterilization Cycles for CSSDs & SPDs, https://consteril.com/central-sterile-supply-department-sterilization-cycles/.” World Health Organization, “Infection prevention and control, https://www.who.int/teams/integrated-health-services/infection-prevention-control/surgical-site-infection.” 17 Questions to Ask Before Buying Your Next Autoclave We created this 17-question eBook as a framework to help you explore and discover the exact type of autoclave best suited to your needs. Get eBook Tweet Like Share
Cleaning Surgical Instruments: What Healthcare Facilities Need to Know Written by: Bill Warren Ensuring the sterility of surgical instruments and other medical equipment is paramount to patient safety in hospitals, ambulatory surgical centers (ASCs), and other healthcare facilities, preventing cross-contamination and reducing the risk of healthcare-associated infection (HAI). But patients aren’t the only ones who benefit. By maintaining a rigorous surgical equipment cleaning process, healthcare facilities can maintain equipment integrity, reduce operating costs, and comply with medical device standards and regulations. As the volume of outpatient surgical procedures in the U.S. continues to rise, particularly in ASCs and hospital outpatient departments (HOPDs), the need for reliable and efficient cleaning and sterilization processes is more urgent than ever. Key Terms: The Difference Between Cleaning, Disinfection & Sterilization Though the terms “cleaning,” “disinfection,” and “sterilization” are often used interchangeably, they have different meanings and applications. It’s imperative that healthcare professionals understand the distinctions between these terms to ensure patient safety and follow proper procedure when cleaning surgical instruments and other medical devices. Cleaning Cleaning is the first step in the decontamination process, and involves removing any visible dirt, debris, or organic matter from medical equipment. Surgical instruments are often cleaned using water, detergents, or enzymatic products. While cleaning removes physical contaminants from instruments, it does not eliminate all microorganisms present on their surface. Disinfection Disinfection goes beyond cleaning, destroying most pathogenic microorganisms on inanimate objects. However, it does not necessarily kill all microbial life forms, such as bacterial spores. Most medical facilities use chemical agents or physical methods, such as UV light, to disinfect equipment, with varying levels of disinfection — low, intermediate, or high — depending on the microorganisms present and the intended use of the items being disinfected. Sterilization Sterilization is the most rigorous form of decontamination and is designed to destroy all forms of bacterial life present on surgical instruments, including bacterial spores. Common sterilization methods include steam under pressure (also known as autoclaving), ethylene oxide (EtO) gas, hydrogen peroxide plasma, and dry heat. Autoclaving is often the preferred method of sterilization for sterile processing departments (SPDs) due to its efficiency, cost-effectiveness, and ability to penetrate fabrics and complex instruments. Standards for Cleaning Surgical Instruments There are various organizations that set strict requirements for cleaning surgical instruments to maintain the highest levels of hygiene and safety in healthcare settings. These organizations and their respective standards and regulations include: Association for the Advancement of Medical Instrumentation (AAMI): In partnership with the American National Standards Institute, AAMI developed ST79, a comprehensive guide that outlines best practices for the sterilization of healthcare products. ST79 covers a wide range of topics, including sterilization equipment, process validation, quality control, and staff training to ensure the sterilization procedures are consistent and effective, thereby minimizing the risk of HAIs and protecting patient safety. Centers for Disease Control and Prevention (CDC): The CDC sets infection control guidelines, including those for cleaning and sterilizing surgical instruments and other medical devices. These guidelines include requirements for pre-cleaning instruments, recommendations for choosing the appropriate cleaning agents, and procedures for disinfecting and sterilizing equipment according to risk. World Health Organization (WHO): The WHO offers global guidelines for infection prevention, including the sterilization of medical devices. The WHO’s guidelines, which are intended to help even resource-limited facilities maintain high standards of instrument hygiene, emphasize point-of-use (POU) cleaning, consistent decontamination, and appropriate staff training. Association of periOperative Registered Nurses (AORN): AORN’s Guidelines for Perioperative Practice are a comprehensive resource for safe perioperative patient care and cover every aspect of surgical instrument handling, from POU cleaning to sterilization. AORN’s guidelines are essential for nurses and surgical technologists and are considered the gold-standard in evidence-based recommendations. International Organization for Standardization (ISO): ISO sets international standards for products, services, systems, and processes, including medical device sterilization. ISO 17664 specifies the information medical device manufacturers must provide for processing reusable medical devices, while ISO 17665 sets requirements for developing, validating, and controlling steam sterilization processes for medical equipment. What Is Point-of-Use Cleaning? Point-of-use cleaning is the initial step of the surgical instrument decontamination process and takes place immediately after use. POU cleaning involves removing gross contaminants, such as blood and tissue, at the site of use before instruments are transported to the SPD for more thorough cleaning and sterilization. POU cleaning prevents the formation of biofilm — “clusters of microorganisms that stick to non-biological surfaces” — by removing organic material immediately. Biofilm can harbor and protect bacteria, making subsequent cleaning and sterilization more challenging. Additionally, early removal of contaminants reduces the microbial load on instruments, enhancing the efficacy of later disinfection and sterilization processes. Prompt cleaning at the point of use also helps maintain the condition and functionality of surgical instruments, prolonging their lifespan and ensuring their performance during critical procedures. Cleaning Medical Instruments: A 12-Step Process By meticulously following these steps, healthcare facilities can make certain that surgical instruments are safe, sterile, and ready for use, thereby protecting patients from potential HAIs and improving overall health outcomes. Point-of-use Cleaning: Instruments should receive initial cleaning immediately after a surgical procedure to prevent blood, bodily fluids, and other contaminants from drying on them and forming biofilm. During POU cleaning, it’s best to wipe instruments down with a sterile, damp cloth or sponge and use a pretreatment spray, foam, or gel to keep organic matter moist. For heavily soiled instruments, soaking them in a container filled with an enzymatic detergent solution can help break up organic matter, making them easier to clean. Transportation: When transporting instruments from the surgical site to the SPD, be sure to place them in leak-proof, puncture-resistant containers clearly labeled with biohazard symbols to minimize the risk of contamination or damage. Manual Cleaning: Manual cleaning involves physically scrubbing surgical instruments with soft-bristled brushes, lint-free cloths, and detergent to remove visible soil. This step of the surgical instrument cleaning process is essential to eliminate all organic and inorganic material before mechanical cleaning. When performing manual cleaning, pay close attention to any joints, crevices, lumens, or other intricate parts to ensure that there’s no remaining debris or residue. Finish by rinsing with a distilled or deionized water to remove any residual cleaning agents. Mechanical Cleaning: Mechanical cleaning, which is typically performed in an ultrasonic cleaner or washer-disinfector, further removes any remaining debris from surgical instruments using high-frequency sound waves or automated washing cycles. When using either an ultrasonic cleaner or washer-disinfector, it’s important to properly load instruments so that they are fully exposed to the cleaning process. It’s also important to select the appropriate cycle settings based on the manufacturer’s Instructions for Use (IFU) to maintain equipment integrity and to regularly test and maintain mechanical cleaning equipment for optimal performance. Sterilization: Perhaps the most important step in the cleaning process, sterilization eliminates all forms of microbial life, including bacterial spores, biofilm, and protozoa. There are numerous sterilization methods, including ethylene oxide gas, hydrogen peroxide plasma, dry heat, and steam sterilization; when selecting the appropriate sterilization method, be sure to follow the manufacturer’s IFUs. Rinse: If you used ethylene oxide to sterilize instruments, be sure to rinse them afterward using a distilled or deionized water to remove any residual EtO, which can be toxic. Drying: If you used steam sterilization or EtO gas to sterilize instruments, give them time to either cool or aerate, and then thoroughly dry them using a lint-free towel or compressed air. This step of the process maintains the integrity of instruments, especially metal instruments, which can rust and corrode if packaged while wet. Lubrication: Lubricating the hinges and joints of surgical instruments with moving parts helps to maintain their functionality and prolong their lifespan. It’s best to use a medical-grade, water-soluble lubricant, applied sparingly and according to the manufacturer’s IFUs. Inspection: Inspect each instrument for cleanliness, functionality, and integrity before packaging. Use magnification to inspect for cracks, chips, or other damage and ensure that instruments with moving parts move smoothly and correctly. Remove and reprocess any instruments that do not meet cleanliness or functionality standards. Packaging: Packaging surgical instruments after cleaning maintains their sterility until use. Be sure to use the appropriate packaging materials for each instrument, such as sterilization wraps, pouches, or containers, and tightly seal to prevent possible contamination. Finally, label packages with the date of sterilization, their contents, and any relevant batch numbers for traceability. Storage: To maintain their sterility, clean surgical instruments should be stored in a clean, dry, temperature-controlled environment, placed on shelves rather than the floor, and kept away from direct sunlight. Implement a first-in, first-out system to ensure that older items are used before newer ones. Documentation: Maintain detailed records of the entire sterilization process, including the date and time, sterilization method used, cycle parameters, and operator information. Additionally, keep maintenance logs and records of biological indicator testing results (including failures). Maintaining this documentation — and making sure it is accessible and organized for audits and inspections — is critical to ensuring traceability and compliance with industry standards. 12 Common Points of Failure When Cleaning Surgical Instruments There are several potential points of failure that can compromise the effectiveness of the surgical instrument cleaning and sterilization process. Here are some key things for SPD technicians to watch out for: Failure to Clean Instruments Immediately After Use: When cleaning surgical instruments, time is of the essence. When bioburden, such as blood, tissue, and other bodily fluids, is allowed to dry on instruments, it can form biofilm. Not only is biofilm significantly harder to remove, but it can shield bacteria and other pathogens from the cleaning and sterilization process, increasing the risk of HAIs. POU cleaning both maintains the integrity of instruments and guarantees a higher standard of hygiene. Incorrect Disassembly Prior to Cleaning: Instruments that are not properly disassembled prior to cleaning can harbor residual debris and microorganisms in joints, hinges, and other hidden areas. If left unaddressed, these residuals can compromise the sterilization process. Prior to cleaning, be sure to take each instrument apart according to the manufacturer’s guidelines to expose all surfaces to cleaning agents. Inadequate Manual Cleaning: Manual cleaning is a crucial step in the decontamination process, and inadequate techniques can leave behind organic material and other contaminants. Examples of inadequate techniques include using the wrong tools, such as still brushes, which can damage instruments, or failing to scrub all surfaces — especially joints, hinges, and lumens — thoroughly. Incorrect Cleaning Solutions: Using the incorrect cleaning solutions can result in ineffective removal of bioburden or biofilm and potential damage to instruments. Some cleaning agents may be too harsh, causing corrosion or pitting, while others may not be effective enough to break down organic material. Therefore, it’s essential to choose cleaning solutions specifically designed for medical instruments and compatible with the materials from which they are made, as recommended by the manufacturer. Failure to Follow Manufacturer’s IFUs: Every surgical instrument comes with specific Instructions for Use provided by the manufacturer that detail proper cleaning, handling, and sterilization procedures. Failure to adhere to these instructions can result in inadequate cleaning and potential damage to instruments, which is why it’s vital to follow them to the letter. Insufficient Rinsing After Cleaning: Thoroughly rinsing instruments after cleaning is essential to remove any residual cleaning agents or debris. Failure to do so can leave chemical residue, which can cause irritation or adverse reactions in patients, as well as contribute to corrosion and degradation of instrument materials. Improper Sorting or Handling During Transportation: Improper sorting and handling of instruments when in transit from the surgical site to the SPD can lead to contamination, damage, and mix-ups. Always place instruments in leak-proof, puncture-resistant containers prior to transport and sort them according to their type and cleaning requirements. Proper labeling can also eliminate potential confusion. Inadequate Staff Training: Technicians responsible for cleaning and sterilizing surgical instruments must be thoroughly trained in proper cleaning protocols and techniques to prevent improper handling, compromised equipment, and potential risks to patient safety. Continuous education and training programs are necessary to ensure that all personnel are up-to-date with the latest guidelines and best practices for surgical instrument processing. Lack of Quality Control Measures: Quality control measures are essential to guarantee the effectiveness of surgical instrument decontamination. Without proper quality control, there is no assurance that instruments are being cleaned and sterilized to the required standards, and inadequate inspection can lead to the use of damaged or contaminated instruments. Implementing rigorous quality control procedures and thorough inspection protocols helps identify and address any issues before instruments are used in patient care. Overloading Ultrasonic Cleaners, Washer-disinfectors, or Autoclaves: Overloading cleaning and sterilization equipment prevents instruments from being fully exposed to cleaning agents and sterilizing conditions. When instruments are packed too tightly or otherwise loaded improperly, it can obstruct the flow of water, detergent, and other sterilizing agents, compromising the sterilization process. Again, when loading instruments, be sure to follow the manufacturer’s IFUs. Improper Cycle Selection: For facilities that use autoclaves to sterilize surgical instruments, selecting the appropriate cycle type is essential to ensure comprehensive sterilization. Choosing the wrong cycle — that is, the correct parameters for steam sterilization, such as temperature, pressure, and exposure time — can not only leave instruments contaminated and unsafe for use, but can also damage them, rendering them unusable in the future. Equipment Malfunction: Equipment malfunctions can lead to incomplete cleaning and sterilization, posing a risk to patient safety, while unexpected equipment downtime can lead to surgical backlogs. Scheduling routine maintenance and continuously monitoring SPD equipment mitigates the risk of equipment failure at critical moments and ensures consistent performance. Best Practices for Cleaning Medical Instruments When cleaning surgical instruments and other medical devices, observe the following best practices to achieve best results: Begin the cleaning process immediately after use. Starting the cleaning process as soon as possible is crucial to prevent biofilm from forming on instruments, which can be challenging to remove later on in the process and can prevent certain cleaning methods from being effective. Not only does POU cleaning reduce the risk of contamination, it also enhances the overall efficiency of the decontamination process. Always refer to the manufacturer’s IFUs. IFUs provide specific guidelines tailored to each instrument’s material and design, ensuring that the cleaning process does not damage the equipment while achieving the necessary level of sterility. Strictly adhering to these instructions both maintains the functionality and longevity of instruments and safeguards patient and staff safety. Keep contaminated and clean items separate. While it might seem obvious, it’s imperative to clean and decontaminate instruments in a dedicated area separate from where you handle clean items. This separation minimizes the risk of spreading contaminants from soiled instruments to sterilized ones, and maintaining distinct zones for different stages of the cleaning and sterilization process ensures a controlled environment, enhancing the efficacy of infection control measures. Require SPD technicians to wear personal protective equipment (PPE). Wearing PPE is mandatory for any personnel involved in cleaning surgical instruments to protect them from exposure to potentially infectious materials and harmful cleaning agents. Appropriate PPE includes gloves, gowns, masks, and eye protection. Consistent use of PPE reduces the risk of occupational exposure to pathogens and chemical irritants, creating a safer working environment for healthcare workers. Remove soiled or defective instruments for reprocessing or repair. During the inspection process, immediately remove any instruments you deem soiled or defective from service. These instruments must either be reprocessed to achieve proper sterility or sent for repair if they are damaged. This practice ensures that only fully functional and sterile instruments are available for use in surgical procedures, maintaining the highest standards of patient care and safety. Ensure that all SPD technicians receive proper training. Regular training and competency assessments are essential to maintaining high standards of practice. Ongoing education ensures that SPD technicians are up-to-date with the latest protocols, techniques, and regulatory requirements, while competency assessments identify areas where additional training may be required, fostering a culture of continuous improvement. Implement strict quality control measures. Quality control measures, such as routine checks and validating cleaning and sterilization equipment, support optimal equipment functioning and performance. Routine testing and maintenance provide opportunities to flag potential issues before they result in equipment failure, as well as ensure that cleaning and sterilization processes consistently meet the required standards. Avoid stacking or overcrowding instruments during transportation or storage. Preventing damage to sterilized surgical instruments requires careful handling during transportation and storage. Stacking or overcrowding instruments can cause physical damage, such as bending, breaking, or scratching, which can compromise their functionality and sterility. Consolidated Sterilizer Systems specializes in manufacturing state-of-the-art autoclaves for hospitals, ASCs, and other medical facilities, ensuring patient safety and supporting positive outcomes. Whether you’re building your SPD from the ground up or are looking to invest in additional equipment, check out our in-depth autoclave buyers’ guide for medical professionals. Frequently Asked Questions Q: What are the risks associated with improperly cleaned surgical instruments? A: When instruments are not adequately sterilized, they can harbor residual blood, tissue, and other organic materials that provide a breeding ground for harmful microorganisms. These contaminants can result in surgical site infections, which are associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. In addition to infections, the presence of biofilm can interfere with instrument functionality, potentially compromising the success of procedures and patient safety. Q: How does improper cleaning impact patient safety and healthcare costs? A: The improper cleaning of surgical instruments increases the risk of HAIs, which can lead to severe complications, extended recovery times, and even mortality. These adverse outcomes not only affect patient health and safety but can also inflate healthcare costs. Treating HAIs and managing complications requires additional medical interventions, extended hospital stays, and increased use of antibiotics, all of which contribute to higher expenses. Moreover, facilities may face legal liabilities and damage to their reputation, undermining trust in the healthcare system. Q: What are the most common methods of sterilizing medical instruments? A: Common methods for sterilizing medical instruments include: Steam sterilization, or autoclaving, which involves exposing instruments to high-temperature steam under pressure Ethylene oxide sterilization, which uses EtO gas to penetrate materials and eradicate microorganisms Hydrogen peroxide plasma sterilization, which uses oxidative processes to sterilize instruments at low temperatures Dry heat sterilization, which is used for materials that can withstand high temperatures without moisture Q: What is the best sterilization method for stainless steel instruments? A: Steam sterilization is highly effective and widely recognized for its ability to thoroughly sterilize stainless steel instruments without causing damage. Stainless steel’s durability and resistance to moisture makes it ideal for this method. Additionally, autoclaving is efficient, cost-effective, and has many applications beyond steel instruments, making it the preferred sterilization method for many SPDs. Sources: Research and Markets, “US Outpatient Surgical Procedures Market by Surgical Procedure Type, Patient Care Setting – US Forecast to 2023, https://www.researchandmarkets.com/reports/4746620/us-outpatient-surgical-procedures-market-by.” Consolidated Sterilizer Systems, “Decontamination, Disinfection & Sterilization: What You Need to Know, https://consteril.com/disinfection-vs-sterilization/.” Centers for Disease Control and Prevention, “Cleaning, https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/cleaning.html.” Consolidated Sterilizer Systems, “Sterilization vs. High-Level and Low-Level Disinfection [a 3-Point Comparison], https://consteril.com/high-level-vs-low-level-disinfection/.” Consolidated Sterilizer Systems, “Medical Device Sterilization: 4 Alternatives to Ethylene Oxide, https://consteril.com/medical-device-sterilization-eto-alternatives/.” Association for the Advancement of Medical Instrumentation, “ANSI/AAMI ST79, https://www.aami.org/standards/featured-standards/ansi-aami-st79.” Centers for Disease Control and Prevention, “Disinfection and Sterilization Guideline, https://www.cdc.gov/infection-control/hcp/disinfection-and-sterilization/index.html.” World Health Organization, “Decontamination and reprocessing of medical devices for health-care facilities, https://www.who.int/publications/i/item/9789241549851.” Association of periOperative Registered Nurses, “Guidelines for Perioperative Practice, https://www.aorn.org/guidelines-resources/guidelines-for-perioperative-practice.” International Organization for Standardization, “ISO 17664-1:2021, https://www.iso.org/standard/81720.html.” International Organization for Standardization, “ISO 17665:2024, https://www.iso.org/standard/80271.html.” Nature Reviews Microbiology, “Bacterial biofilms: from the Natural environment to infectious diseases, https://www.nature.com/articles/nrmicro821.” Occupational Safety and Health Administration, “Ethylene Oxide, https://www.osha.gov/ethylene-oxide.” Consolidated Sterilizer Systems, “What Are Biological Indicators (Spore Tests)?, https://consteril.com/autoclave-biological-indicator-guide/.” Consolidated Sterilizer Systems, “Top 13 Sterile Processing Mistakes in Hospitals, https://consteril.com/sterile-processing-mistakes/.” Infection Control Today, “The Importance of Following Manufacturers’ IFUs, https://www.infectioncontroltoday.com/view/importance-following-manufacturers-ifus.” Consolidated Sterilizer Systems, “The Top 8 Hospital Sterilization Cycles for CSSDs & SPDs, https://consteril.com/central-sterile-supply-department-sterilization-cycles/.” World Health Organization, “Infection prevention and control, https://www.who.int/teams/integrated-health-services/infection-prevention-control/surgical-site-infection.” 17 Questions to Ask Before Buying Your Next Autoclave We created this 17-question eBook as a framework to help you explore and discover the exact type of autoclave best suited to your needs. Get eBook Tweet Like Share
8.14.24 Cleaning Surgical Instruments: What Healthcare Facilities Need to Know → Ensuring the sterility of surgical instruments and other medical equipment is paramount to patient safety in hospitals, ambulatory surgical centers (ASCs), and other healthcare facilities, preventing cross-contamination and reducing the risk of healthcare-associated infection (HAI). But patients aren’t the only ones who benefit. By maintaining a rigorous surgical equipment cleaning process, healthcare facilities can maintain […]
8.13.24 What Is a Process Challenge Device? → Ensuring that sterilization equipment is effective and performs as intended is crucial for any lab or sterile processing department. To determine sterilizer efficacy, technicians rely on a process called validation, in which tools known as process challenge devices are used to measure their machines’ abilities to sterilize loads. In this blog post, we’ll take a […]
7.10.24 Top 10 Surgery Center Architecture Firms → Building a new ambulatory surgery center (ASC) from the ground up is no simple task. From choosing the right location and setting budgets to drawing up building plans and managing construction, there are many moving pieces to keep track of. As a more specialized project, there are certain parameters that must be met to ensure […]
