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
- 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/
- Association for the Advancement of Medical
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sterility assurance in health care facilities (ANSI/AAMI ST79:2017).
Arlington, VA: Author.
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A3-A9. https://doi.org/10.1016/j.ajic.2019.01.014
- Spaulding, E. H. (1939). Chemical disinfection of
medical and surgical materials. In S. S. Block (Ed.), Disinfection,
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& Febiger.
- ANSI/AAMI. (2015). ANSI/AAMI ST58:2013/(R)2018 Chemical
sterilization and high-level disinfection in health care facilities.
Arlington, VA: Author.
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- 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