What is Sterile Processing

Understanding its Importance

Sterile Processing is the systematic method of cleaning, decontaminating, inspecting, sterilizing and storing of medical instruments and devices. This comprehensive process is vital in healthcare settings to ensure that all surgical instruments are safe for patient use and reduces the risk of healthcare-associated infections.⁴ Effective sterile processing is essential for protecting patients from complications that may arise from contaminated instruments. Hospitals must comply with stringent sterile processing guidelines and standards set forth by multiple bodies, including The Joint Commission (TJC), the Centers for Disease Control and Prevention (CDC), and the Association for the Advancement of Medical Information (AAMI). Additionally, SPDs comply with guidance created by the Association of Perioperative Registered Nurses (AORN) and the Society of Gastroenterology Nurses and Associates (SGNA). 

The importance of sterile processing also extends to the financial implications for healthcare systems. Surgical site infection (SSIs) cost the U.S. healthcare system $3.5 to $10 billion annually, increase the risk of readmission, and yet it is estimated that half of SSIs are preventable.^2,3 The Centers for Medicare and Medicaid Services (CMS) have started penalizing hospitals with high rates of SSIs and other healthcare-associated conditions, making infection prevention a top priority to improve patient outcomes and control costs.² Therefore, investing in the Sterile Processing Department (SPD) not only enhances patient safety but also proves to be a financially sound decision for healthcare institutions.

The Sterile Processing Department 

The SPD plays a pivotal role in any healthcare facility by managing the decontamination, inspecting, sterilization, and storage of surgical instruments. The SPD is essential for maintaining patient safety, as it ensures that instruments are reprocessed correctly according to the manufacturers’ instructions for use (IFUs) and are free from contaminants before reaching the operating room. The efficiency of SPDs directly impacts surgical schedules and patient care; delays in instrument reprocessing can lead to rescheduled surgeries and increased wait times for physicians and patients.

SPDs typically consist of designated areas for decontamination, preparation, sterilization, and storage of instruments.¹ The structure and organization of SPDs are critical for maintaining efficient workflows, documentation, and ensuring that instruments are reprocessed in a timely manner. Proper staffing and training within the SPD are equally important to handle increasing workloads while maintaining sterile processing protocols.  An adequately staffed SPD can significantly reduce turnaround times for surgical instruments, leading to on-time surgeries and overall operational efficiency.

The Role of Manual Cleaning

Proper decontamination of surgical instruments begins at the point of use, as dried biological matter becomes significantly harder to remove.¹ Before high-level disinfection or sterilization can be performed, instruments must first undergo thorough cleaning to remove organic and inorganic debris.¹ Any residual contamination can compromise the effectiveness of subsequent reprocessing steps.¹ The cleaning phase involves eliminating visible and microscopic residues using water and specialized detergents or enzymatic solutions such as ENZOL™ Enzymatic Detergent or CIDEZYME™ XTRA Multi-Enzymatic Detergent. Adherence to the manufacturer’s IFU for detergents and other aspects of the cleaning and decontamination process can help avert damage to devices and prolong their use life.¹ Thorough cleaning is essential for ensuring instruments are properly prepared for disinfection and sterilization while reducing the risk of cross-contamination in healthcare settings.

The Purpose of Disinfection

Disinfection is a process that kills pathogenic and other microorganisms by physical or chemical means on inanimate objects. Disinfection may not destroy all microbial forms, such as bacterial spores. Disinfection processes do not ensure the margin of safety associated with sterilization processes.¹
Disinfection is categorized into three levels:

• High-level disinfection: The destruction of all viruses, vegetative bacteria, fungi, mycobacterium, and some, but not all, bacterial spores.⁵
   
• Intermediate-level disinfection: Eliminates mycobacteria, vegetative bacteria, fungal spores, and some nonlipid viruses, but does not destroy bacterial spores.⁵
   
• Low-level disinfection: Effective against most bacteria (excluding mycobacteria and bacterial spores), most viruses (except some nonlipid viruses), and certain fungi.⁵ 

Manual high-level disinfection is used to reprocess heat-sensitive, reusable semi-critical medical devices intended for patient use when sterilization is not feasible.⁶

Selecting an appropriate high-level disinfectant is crucial to ensuring effective microbial reduction. The disinfectant should provide the necessary antimicrobial activity suited for the specific reusable device (e.g., CIDEX™ OPA Solution*). Always follow the device manufacturer’s labeling and IFU documentation to ensure proper application.

Healthcare facilities can perform high-level disinfection of flexible endoscopes with a biocide, through manual soaking or automated reprocessing using an Automated Endoscope Reprocessor (AER) System, such as the ASP AEROFLEX™ AER or EVOTECH™ Endoscope Cleaner and Reprocessor (ECR)**. While all AERs automate disinfection, some also include automated cleaning and leak testing, improving efficiency and consistency. 

ANSI AAMI ST91:2021 Flexible and Semi-Rigid Endoscope Processing in Health Care Facilities recommend monitoring biocide Minimum Effective Concentration (MEC) Solution or Minimum Recommended Concentration (MRC) every cycle; MEC and MRC testing is typically performed with a manual test strip.⁶ Both the EVOTECH™ ECR and ASP AEROFLEX™ AER have integrated systems that eliminate the use of test strips, reducing healthcare exposure to chemicals and human error. 

Common Sterilization Methods 

Healthcare facilities utilize various sterilization methods, each suited for different applications and microbial elimination needs. Steam sterilization is commonly used for heat- and moisture-stable instruments due to its effectiveness in eliminating microorganisms, including bacterial spores. However, for heat- and moisture-sensitive medical devices, low-temperature hydrogen peroxide sterilization is a preferred solution, ensuring effective reprocessing without exposure to high temperatures or excess moisture. 

Among low-temperature sterilization options, hydrogen peroxide gas plasma systems are increasingly recognized for their ability to safely reprocess complex medical devices, including flexible endoscopes. The STERRAD™ Systems provide effective sterilization for instruments that require low-temperature processing. Recently, ASP received FDA clearance for the ULTRA GI™ Cycle on the STERRAD™ 100NX Sterilizer with ALLCLEAR™ Technology, specifically designed for reprocessing hydrogen peroxide-compatible duodenoscopes^† using advanced gas plasma sterilization.

Understanding these sterilization methods is essential for sterile processing technicians to select the best approach based on instrument compatibility, longevity, and infection control requirements.

Quality Assurance in Reprocessing

Quality assurance in sterile processing ensures that every step of the instrument reprocessing workflow – from cleaning and disinfection to sterilization and storage – is performed correctly and consistently. This includes:

• Routine audits to ensure compliance with established protocols.
• Ongoing staff training to maintain best practices.
• Accurate documentation to meet regulatory requirements.

A robust quality assurance program enhances patient safety and improves operational efficiency by ensuring consistency in sterile processing practices.

Sterility Assurance and Validation

Sterility Assurance Level (SAL) of 10-6 indicates there is less than or equal to one chance in a million that a single viable microorganism is present on a sterilized item.1 Process Challenge  Devices (PCDs), Biological Indicators, and Chemical Indicators play a crucial role in verifying sterilization efficacy.

• PCDs simulate the most challenging sterilization conditions to verify cycle performance.¹
•  Biological Indicators provide direct evidence that sterilization has effectively inactivated resistant bacterial spores.¹
• Chemical Indicators react to specific sterilization parameters, such as time, temperature, or the presence of sterilant, providing immediate confirmation that the sterilization process has met predefined conditions.¹

By performing advanced sterility assurance methods after every load, healthcare facilities can ensure greater confidence in sterilization validation, support compliance efforts, and contribute to patient safety.

Best Practices in Sterile Processing

Regularly reviewing and updating sterile processing procedures is essential for maintaining compliance with industry standards and ensuring the highest level of patient care. A proactive approach to quality improvement includes ongoing staff education, process audits, and the adoption of new technologies that enhance sterilization validation and workflow efficiency.

By staying informed on emerging best practices and integrating advanced sterility assurance tools and protocols, healthcare facilities can reinforce their commitment to safe, effective, and consistent instrument reprocessing.