Understanding and implementing the Spaulding Classification System for Reprocessing Healthcare Surgical Instruments: An SPD Educator's insights

 

By Martin Li, M.A., CRCST, CER, CIS, CHL

Introduction

In 1939, Earle H. Spaulding devised a rational approach to the disinfection and sterilization of patient care items and equipment, significantly influencing the methods and standards used today in the reprocessing of healthcare surgical instruments. His deep study of disinfection and sterilization refined the classification of appropriate treatment of medical devices based on their use. The Spaulding Classification System is pivotal for ensuring patient safety and includes three categories for medical devices: critical, semi-critical, and non-critical. This system helps healthcare professionals determine the level of disinfection or sterilization required for each type of device. 

This article offers a comprehensive understanding of the Spaulding Classification System from an SPD educator's perspective emphasizing the importance of proper reprocessing techniques to ensure patient safety and high-quality care in healthcare settings.

Figure 1 Examples of the three classes

The Spaulding Classification System

The Spaulding Classification System is based on the degree of risk involved in the use of medical devices. Understanding this system is crucial for healthcare professionals, particularly those in Sterile Processing Departments (SPD), to ensure that all devices are processed correctly and safely.

Critical Items

Critical items are those that penetrate the skin or enter sterile tissue or the vascular system. These items include surgical instruments, cardiac or urinary catheters, implants, and ultrasound probes. Due to their nature, critical items require sterilization. Sterilization methods can include steam, ethylene oxide, hydrogen peroxide gas plasma, or other appropriate techniques to ensure the elimination of all microorganisms, including spores.

Semi-Critical Items

Semi-critical items contact mucous membranes or non-intact skin. Examples include respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades, esophageal manometry probes, and cystoscopes. At a minimum, these items require high-level disinfection (HLD) using chemical disinfectants such as glutaraldehyde, hydrogen peroxide, ortho-phthalaldehyde( OPA), or peracetic acid with hydrogen peroxide. Given the complexity of some devices, sterilization may also be recommended for certain semi-critical items.

Non-Critical Items

Non-critical items are those that contact intact skin and pose the least risk for infection transmission. Examples include blood pressure cuffs, stethoscopes, bedpans, and crutches. Cleaning followed by disinfection with an Environmental Protection Agency (EPA)-registered, hospital-approved disinfectant is usually sufficient for processing these items.

Importance of Device Classification and IFU Adherence

Understanding device classification is crucial for healthcare professionals in SPDs to comprehend the “why” behind the Instructions for Use (IFU). The IFU reflects the device classification and outlines the procedures for handling, disassembling, inspecting, and processing the item.

Manufacturer's Role in IFU Updates

Manufacturers regularly update their IFU and issue customer notifications to alert users to changes, concerns, or new information about their products. These updates are essential for ensuring that devices are used and processed correctly and safely. SP leaders must ensure that all technicians have access to and understand these updates, ensuring compliance with the latest standards, guidelines, and best practices.

Communication with Vendors

Effective communication with vendors is vital. When vendor representatives visit the department for education or support, it is prudent to inquire about any important updates or changes. If IFU updates have been missed or overlooked, request a copy of the revised material. SP leaders can also ask vendor representatives to provide targeted education to address any concerns and ensure that all technicians understand the recommendations.

Ensuring Compliance with IFU

Healthcare organizations are responsible for ensuring their patients receive the safest, highest quality care. This responsibility includes managing and processing devices according to each manufacturer’s current IFU. Patients expect clean, sterile, safe, and well-functioning devices, and clinicians expect instruments and equipment from the SPD to meet these critical expectations. Following IFU precisely and seeking guidance from the manufacturer whenever recommendations are unclear are among the best ways to ensure device safety.

The Role of SP Leaders

SP leaders play a crucial role in ensuring that devices and equipment are processed correctly. They must ensure that technicians are trained and understand the importance of following the IFU. This includes making sure that all shifts have access to and are aware of any updates to the IFU. Continuous education and training are essential for maintaining high standards in device reprocessing.

Conclusion

The Spaulding Classification System is a foundational framework for the disinfection and sterilization of medical devices. It categorizes devices based on their use and the associated risk, guiding healthcare professionals in determining the appropriate level of reprocessing. Adherence to the IFU, regular communication with manufacturers, and ongoing education are critical components for ensuring the safe and effective use of medical devices. By following these principles, SP professionals can significantly contribute to patient safety and the overall quality of healthcare.

References

1. Centers for Disease Control and Prevention. (2019). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Retrieved from https://www.cdc.gov/infectioncontrol/guidelines/disinfection/
2. Association for the Advancement of Medical Instrumentation. (2017). Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2017). Arlington, VA: Author.
3. Rutala, W. A., Weber, D. J., & Healthcare Infection Control Practices Advisory Committee. (2019). Disinfection and sterilization: An overview. American Journal of Infection Control, 47(7), A3-A9. https://doi.org/10.1016/j.ajic.2019.01.014
4. Spaulding, E. H. (1939). Chemical disinfection of medical and surgical materials. In S. S. Block (Ed.), Disinfection, sterilization, and preservation (5th ed., pp. 881-917). Philadelphia: Lea & Febiger.
5. ANSI/AAMI. (2015). ANSI/AAMI ST58:2013/(R)2018 Chemical sterilization and high-level disinfection in health care facilities. Arlington, VA: Author.
6. Tschudin-Sutter, S., Frei, R., Dangel, M., Stranden, A., & Widmer, A. F. (2012). Rate of transmission of extended-spectrum β-lactamase-producing enterobacteriaceae without contact isolation. Clinical Infectious Diseases, 55(11), 1505-1511. https://doi.org/10.1093/cid/cis770
7. Rutala, W. A., & Weber, D. J. (2013). Disinfection and sterilization in health care facilities: An overview and current issues. Infectious Disease Clinics of North America, 30(3), 609-637. https://doi.org/10.1016/j.idc.2016.04.001
8. U.S. Food and Drug Administration. (2020). Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling

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