Maintaining Sterile Processing Departments: Key Strategies for Preventing Infections and Downtime
Safeguarding patient safety and preventing healthcare-associated infections (HAIs) starts with regular maintenance checks on sterilization equipment in the sterile reprocessing department. Proper sterilization of medical instruments is essential for infection prevention. Equipment malfunctions can lead to inadequate sterilization, exposing patients to harmful microorganisms.
Effective sterile processing goes beyond having the right equipment in place; it requires thoughtful planning, regular maintenance protocols, and sufficient resource allocation to make certain equipment functions correctly. Many sterile processing departments face challenges, such as unpredictable equipment downtime, which can disrupt operations and compromise patient safety [1]. Implementing preventive maintenance programs, proper planning, and organizing workflows help minimize contamination risks and reduce the likelihood of equipment malfunctions. This strategic approach not only facilitates operational efficiency but also supports consistent adherence to sterilization standards, helping to protect patient safety and avoid costly errors [5]. Addressing equipment-related challenges is also critical to avoiding lapses in sterilization processes that could lead to healthcare-associated infections (HAIs).
Industry standards provide clear guidance on how to maintain sterilization equipment effectively. The Association for the Advancement of Medical Instrumentation (AAMI) emphasizes the need for routine maintenance and validation of equipment to validate it operates at optimal levels. For instance, AAMI ST79 highlights that all sterilization and reprocessing equipment, including sterilizers and washers, must follow the manufacturer’s maintenance instructions. Regular preventive care—such as inspections, testing, and calibration—helps to identify and resolve potential issues before they compromise equipment performance or sterility [3].
Building on this, AAMI ST91 recommends healthcare facilities to establish a comprehensive maintenance program. This includes daily inspections, periodic testing, and annual validation to verify that sterilization processes remain effective over time [2]. The guidelines also emphasize the importance of detailed record-keeping, aligning with FDA regulations, which mandate maintaining logs of all maintenance activities. These logs should document inspections, repairs, tests, and the personnel responsible for ensuring traceability and compliance [4].
By implementing a comprehensive quality management system and adhering to strict equipment maintenance guidelines, healthcare facilities can reduce operational downtime, enhance the reliability of sterilization processes, and significantly improve infection prevention strategies. This establishes a safer environment for both patients and staff while promoting efficiency within sterile processing departments.
Please note that this publication is based on the United States perspective and research.
Sources and further readings
Data on file with Olympus (2024). A blind survey, sponsored by Olympus and conducted by a third party, was sent to 25 SPD-related personnel in January 2024.
Association for the Advancement of Medical Instrumentation (AAMI). (2021). ANSI/AAMI ST91:2021 Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities.
Association for the Advancement of Medical Instrumentation. (2017). ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI.
U.S. Food and Drug Administration. (2023). Quality and Compliance for Medical Devices. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices. Accessed September 2024.
Infection Control Today. (2021). How to Successfully Plan for Space, Equipment, Staff, and Workflows in Sterile Processing Departments. Retrieved from https://www.infectioncontroltoday.com. Accessed September 2024.