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Sterilization: Ensuring Quality Care in Surgical Facilities

June 14, 2024 9:00 AM
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    The Importance of Sterilization in Surgical Facilities

    To reduce the risk of infection and help ensure patient safety, ambulatory surgery centers (ASCs) and hospitals must take all appropriate measures to preserve sterility of the operating field, including the proper sterilization of surgical instruments and other medical devices.

    Sterilization is defined as a process of complete elimination or destruction of all forms of microbial life (i.e., both vegetative and spore forms) carried out by various physical and chemical methods.1

    Note that there is a distinction between sterilization and disinfection. The latter is defined as a process of complete elimination of vegetative forms of microorganisms, except the bacterial spores, from inanimate objects.1

    So, what’s the main objective of sterilizing surgical instruments and other medical devices?

    The primary goal of cleaning, disinfection, and sterilization is to reduce the number of microorganisms on the surgical instrument or medical device to a level where the probability of transmission of infection will be zero.1

    Failure to carry out this critical aspect of care not only jeopardizes patient health and violates public trust but can have harmful consequences for the healthcare facility. Repercussions may come in the form of financial costs, legal issues, and damage to reputation.

    Sterilization Standards for Manufacturers of Certain Types of Medical Devices

    The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) maintains an online database of voluntary consensus standards to which the FDA will accept a declaration of conformity from a medical device manufacturer regarding sterilization.2

    Medical devices are sterilized in a variety of ways, including via the use of moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.3

    The CDRH, which notes that the sterilization of medical devices is vital to help prevent serious infections, oversees these processes to ensure they are effective and used in amounts that are safe for patients and healthcare professionals.2

    Now let’s look at the responsibilities of ASCs and hospitals in respect to sterilization of medical devices.

    Healthcare Facility Responsibilities and Best Practices

    Surgical instruments and medical devices intended for reuse come with reprocessing and sterilization instructions from their manufacturer ― ASCs and hospitals are expected to reprocess and sterilize the  devices or instruments per these instructions.4

    sterilization-instructions-1

    Ambulatory surgery centers and hospitals should strive to adhere to relevant guidelines published or advocated by regulatory bodies, certifying organizations, and the national health protection agency.

    For instance, the Centers for Disease Control and Prevention (CDC) publishes a guideline that addresses a range of topics pertinent to disinfection and sterilization in ASCs and hospitals, such as sterilization methods, sterilizing practices, and the effect of cleaning on sterilization efficacy.5

    The CDC document, titled Guideline for Disinfection and Sterilization in Healthcare Facilities, also contains a number of category-specific recommendations for quality control, some of which are summarized here:5

    • Provide comprehensive and intensive staff training
    • Compare the reprocessing instructions from the instrument manufacturer and the sterilizer manufacturer and then resolve any discrepancies by communicating with both manufacturers
    • Conduct infection control rounds periodically in high-risk reprocessing areas
    • Ensure reprocessing instructions are up to date, accurate, and correctly implemented, documenting all deviations from policy
    • Record and retain records of each sterilization cycle, including sterilizer type, cycle used, load identification number, load contents, exposure parameters, operator, and results of monitoring
    • Prepare and package items to be sterilized so that sterility can be achieved and maintained to the point of use
    • Review policies and procedures for sterilization periodically
    • Have qualified personnel perform preventative maintenance on sterilizers, guided by the manufacturer’s instructions

    Multiple references from the scientific literature for each of the items listed above, along with greater detail and the agency’s full set of recommendations, can be found in the aforementioned CDC guideline.

    Note that the Association of periOperative Registered Nurses (AORN) also publishes a guideline for sterilization, which was approved by the AORN Guidelines Advisory Board and became effective in 2018.6

    Preventing Surgical Site Infections

    Sterilization standards and guidelines help the healthcare community reduce the risk of contamination that may lead to surgical site infections (SSIs). As illustrated by the data presented below, beyond the many deleterious effects these post-operative infections can have on individual patients, they also have a significant negative impact on healthcare systems.

    In 2022, Journal of Patient Safety published a retrospective study analyzing data from the Agency for Healthcare Cost and Utilization Project’s 2016 National Inpatient Sample, the largest all-payer U.S. inpatient database.7

    The study analyzed data surrounding catheter-associated urinary tract infections, catheter- and line-associated bloodstream infections, surgical site infections, ventilator-associated pneumonias, and infection with Clostridioides difficile.7

    According to the study’s findings, the most common healthcare-associated infection (HAI) among admissions with primary HAI diagnosis was surgical site infections, at a cost of 3.7 billion USD.7

    The cost of infections is steep. If you are interested in learning more about sterilization standards, guidelines, and best practices, an array of helpful resources can be found on the FDA, CDC, TJC, and AORN websites.

    References:

    1. Mohapatra S. Sterilization and Disinfection. Essentials of Neuroanesthesia. 2017:929–44. doi: 10.1016/B978-0-12-805299-0.00059-2. Epub 2017 Mar 31. PMCID: PMC7158362.
    2. “CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization.” U.S. Food and Drug Administration. www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-new-standards-recognition-support-innovation-medical-device-sterilization. Content current as of 07/24/2023. Accessed 02/27/2024.
    3. “Sterilization for Medical Devices.” U.S. Food and Drug Administration. www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices. Content current as of 02/27/2024. Accessed 02/27/2024.
    4. “Ensuring critical instruments and devices are appropriate for reuse.” www.jointcommission.org/-/media/tjc/newsletters/quick-safety-64-reuse-of-critical-instruments-2-14-22-final4.pdf. Quick Safety | Issue 64 | February 2022. The Joint Commission. Accessed 02/27/2024.
    5. “Disinfection and Sterilization.” Centers for Disease Control and Prevention. www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html. Page last reviewed: 05/24/2019. Accessed 02/27/2024.
    6. “Sterilization.” AORN eGuidelines+. https://aornguidelines.org/guidelines/content?sectionid=173737535. Accessed 02/27/2024.
    7. Forrester JD, Maggio PM, Tennakoon L. Cost of Health Care-Associated Infections in the United States. J Patient Saf. 2022 Mar 1;18(2):e477-e479. doi: 10.1097/PTS.0000000000000845. PMID: 33881808.

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