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 equipment integrity, reduce operating costs, and comply with medical device standards and regulations.

ASCs alone are projected to see 22% volume growth by 2033. As the volume of outpatient surgical procedures in ASCs and hospital outpatient departments (HOPDs) continues to rise, the need for reliable and efficient cleaning and sterilization processes is more urgent than ever.

Key Takeaways

• Cleaning, disinfection, and sterilization are distinct processes with different applications. Understanding the difference between the three is vital to patient safety.
• Point-of-use (POU) cleaning is the most time-sensitive step in the process, as biofilm begins forming within minutes of instrument use.
• Proper surgical instrument reprocessing follows a multi-step sequence, from POU cleaning through documentation.
• The most common points of failure in SPDs, including inadequate manual cleaning, overloaded equipment, and insufficient staff training, are all preventable.
• ANSI/AAMI ST79, CDC guidelines, AORN’s Guidelines for Perioperative Practice, and ISO 17664/17665 are the primary standards governing surgical instrument reprocessing in the U.S.

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.

How Quickly Does Biofilm Form?

The window for effective POU cleaning is narrow. Many professional organizations recommend that instrument processing begin within 30 minutes of use to prevent organic soils from drying, and some manufacturers specify even tighter timeframes in their IFUs. Once dried bioburden hardens on instrument surfaces, it becomes more difficult to remove, which can increase turnaround times in already-busy SPDs.

If you can’t clean biofilm off instruments immediately after use, ANSI/AAMI ST79 recommends keeping them moist using a damp towel or an enzymatic solution applied at the surgical site before transport. However, don’t soak instruments in open containers, as this raises the risk of cross-contamination. The goal is to prevent drying, not to begin full decontamination in the OR.

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.

A Note on Complex & Minimally Invasive Instruments

Standard reprocessing protocols were designed with conventional surgical instruments in mind, but modern SPDs increasingly handle devices that present additional cleaning challenges, such as laparoscopic instruments with long narrow lumens, robotic surgical components, arthroscopic shavers, and power tools with internal channels. These instruments require special attention at several points in the cleaning process.

Instruments with lumens must be manually flushed through internal channels during both manual and mechanical cleaning, as ultrasonic cleaners and washer-disinfectors may not adequately penetrate narrow bores without dedicated flushing adaptors. Manufacturers’ IFUs should flag instruments that cannot be fully disassembled as requiring specific mechanical cleaning equipment capable of channel irrigation. ANSI/AAMI ST79 and AORN both recommend that facilities verify mechanical cleaning efficacy for complex instruments through periodic soil challenge testing rather than assume a standard washer cycle will achieve the same results across all instrument geometries.

Device manufacturers’ IFUs also dictate reprocessing for robotic surgical instruments and may specify cycle parameters, cleaning agents, and drying protocols that differ from standard SPD procedures. Failure to follow these IFUs exactly can void manufacturer warranties and, more critically, leave contamination in inaccessible internal components.

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.

Which Sterilization Method Is Right for Your SPD?

Steam sterilization is the best method for the vast majority of surgical instruments processed in hospital and ASC sterile processing departments. It’s the most cost-effective sterilization method, has the shortest cycle times, produces no toxic residuals, and is validated for the widest range of instrument types, including stainless steel instruments, wrapped sets, and porous loads. For SPDs building or expanding their sterilization capacity, an autoclave is a foundational investment.

There are, however, some exceptions. A small subset of instruments, including certain flexible endoscopes and instruments with electronic components, cannot tolerate the moisture of steam sterilization. In these situations, facilities may turn to:

• Ethylene oxide, which is used for heat- or moisture-sensitive instruments, including flexible endoscopes, powered devices, and instruments with electronic components. EtO penetrates packaging and complex geometries effectively, but cycle times are significantly longer (often 10–16 hours including aeration), and EtO is a regulated carcinogen subject to Occupational Safety and Health Administration exposure limits and Environmental Protection Agency emissions requirements. Facilities using EtO must comply with ventilation, monitoring, and worker safety requirements.
• Hydrogen peroxide plasma, which is used for heat- or moisture-sensitive instruments where EtO’s long cycle time is a throughput problem. Cycle times are shorter than EtO, there are no toxic residuals, and no special ventilation is required. The biggest limitation with hydrogen peroxide plasma is load compatibility; cellulose materials such as paper and linen, liquids, and instruments with very long or narrow lumens may not be compatible.
• Dry heat sterilization, which is used for moisture-sensitive materials that can tolerate extended high temperatures. This method is less common in hospital and ASC SPDs and more typical in dentist and laboratory settings.

If you’re uncertain which sterilization method you need, be sure to consult the manufacturer’s IFU for the device or instrument you intend to sterilize.

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: The risks associated with improperly cleaned surgical instruments include surgical site infections, cross-contamination, and equipment damage. 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: The most common methods for sterilizing medical instruments are:

• 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 the best method for stainless steel instruments. Stainless steel’s durability and resistance to moisture means autoclaves can sterilize these instruments without damaging them. Additionally, autoclaving is efficient, cost-effective, and has many applications beyond steel instruments, making it the preferred sterilization method for many SPDs.

Q: What does ANSI/AAMI ST79 require for surgical instrument cleaning?

A: ANSI/AAMI ST79 requires that:

• Surgical instruments receive point-of-use cleaning immediately after use to prevent bioburden from drying
• Manual cleaning precede any mechanical cleaning cycle
• Facilities verify the effectiveness of their cleaning and sterilization processes through documented quality control measures, including biological indicator testing

ST79 also establishes requirements for SPD facility design, staff training and competency, packaging, and sterile storage.

Q: What is the difference between a washer-disinfector and an ultrasonic cleaner?

A: The differences between a washer-disinfector and an ultrasonic cleaner are the cleaning mechanism and the outcome.

A washer-disinfector uses automated thermal or chemical wash cycles, similar to a commercial dishwasher, to clean and thermally disinfect instruments. It is generally the preferred mechanical cleaning method for most standard surgical instruments because it also achieves a level of disinfection that makes instruments safer to handle.

An ultrasonic cleaner uses high-frequency sound waves to generate microscopic cavitation bubbles that dislodge debris from instrument surfaces, including from joints, hinges, and complex geometries that manual brushing may not be able to reach. Ultrasonic cleaners are often effective for delicate or intricate instruments but do not achieve the same level of disinfection as a thermal washer-disinfector. For this reason, many SPDs use the two in sequence — ultrasonic cleaning followed by washer-disinfector processing.

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