The 2008 “Guideline for Disinfection and Sterilization in Healthcare Facilities,” authored by William Rutala, PhD, MPH, David Weber, MD, MPH, and the Healthcare Infection Control Practices Advisory Committee (HICPAC), was finally issued in November following a significant delay caused by disagreement over several issues, including the recommended exposure time for achieving high-level disinfection with greater than 2 percent glutaraldehyde.
“This delay has occurred even though the Centers for Disease Control and Prevention (CDC) guidelines are evidence-based and there are greater than 30 peer-reviewed publications that demonstrate the effectiveness of greater than 2 percent glutaraldehyde at 20 minutes and 20 degrees Celsius provided cleaning precedes disinfection,” says Rutala. “In addition, all professional organizations such as SHEA, APIC, ASGE, ACG, AGA, SGNA, AORN, and The Joint Commission that have a recommendation on this subject, recommend 20 minutes and 20 degrees C for greater than 2 percent glutaraldehyde.”
Rutala explains that HICPAC accepted the guideline for publication in February 2003; however, the Food and Drug Administration (FDA) had not cleared the guideline because it makes a recommendation that is contrary to an FDA-cleared label claim (45 minutes at 25 degrees C for greater than 2 percent glutaraldehyde). “This disagreement persists even though the guideline states that if the user selects exposure conditions that differ from those in the FDA-cleared labeling for high-level disinfection, the user assumes liability for any injuries resulting from off-label use. In addition, because the FDA-cleared label claim is based on a test that does not allow cleaning, is conducted in the presence of horse serum (i.e., protein load), and uses an extremely high number of mycobacteria (100,000 to 1,000,000), an extended immersion time and elevated temperature are necessary to inactivate 100 percent of the mycobacteria. When cleaning is performed, the time to achieve high-level disinfection is reduced. While this issue of glutaraldehyde use at 20/20 was supposed to have been resolved on several occasions it remained why the guideline was not published.”
The guideline presents evidence-based recommendations on the preferred methods for cleaning, disinfection and sterilization of patient-care medical devices and for cleaning and disinfecting the healthcare environment. The guideline reviews cleaning methods — since the proper removal of organic and inorganic materials facilitates the effectiveness of disinfection and sterilization – and discusses chemical disinfectants including alcohols, glutaraldehyde, formaldehyde, hydrogen peroxide, iodophors, ortho-phthalaldehyde, peracetic acid, phenolics, quaternary ammonium compounds and chlorine. The sterilization methods discussed in the guideline include steam sterilization, ethylene oxide (ETO), hydrogen peroxide gas plasma and liquid peracetic acid.
The guideline notes, “The choice of disinfectant, concentration, and exposure time is based on the risk for infection associated with use of the equipment and other factors discussed in this guideline. When properly used, these cleaning, disinfection, and sterilization processes can reduce the risk for infection associated with use of invasive and noninvasive medical and surgical devices. However, for these processes to be effective, healthcare workers should adhere strictly to the cleaning, disinfection, and sterilization recommendations in this document and to instructions on product labels.”
The guideline seems to emphasize the need for healthcare workers to properly interpret the significant amount of science presented within the document.
“I think there is always a risk of improper interpretation of the science and evidence behind a recommendation or guideline which is one reason why users must remain informed and current and open to questioning what may not be completely understood,” says Cynthia Spry, MsEd, MSN, RN, MA, an independent consultant serving the healthcare industry. “For example if a professional organization makes a recommendation for use of a product that differs from a product label claim cleared by the FDA the user must question why, must understand the rationale and use critical thinking skills to determine how to best use that product. Once the science and the rationale for various recommendations are understood the decision on how to proceed can be fairly easy.”
While the guideline may serve as an essential roadmap for the technical processes of disinfection and sterilization, the complexity of these processes require preciseness and proper implementation in order to uphold patient safety. Collaboration between infection prevention stakeholders is vital to ensuring this guideline’s recommendations are understood and observed correctly.
“There is absolutely no question that cooperation between infection control, the sterile processing department (SPD) and the operating room (OR) is critical to ensuring quality practices and processes that support patient safety,” Spry concurs. “It’s like a three-legged stool – if one leg is missing, there is huge risk that sitting on the stool will cause it to collapse. Each of these departments brings specialized expertise to sterilization and disinfection. In my experience I have found that when these departments work together, understand each others’ needs, appreciate each others’ expertise and commit to working as a team, they will be among the most successful. Each department should be represented at meetings that impact all three. For example, a representative from SPD and infection control should attend the OR committee meetings. Another way to foster teamwork is to select a CQI project that involves all three departments. In order to better understand each department’s needs, priorities and function I believe new hires should be assigned at least one day in each department assigned to tail a chosen individual. There are many, many ways to bring these departments together, but that is a seminar in itself.”
In addition to updated recommendations, the guideline addresses many new topics, including inactivation of antibiotic-resistant bacteria, bioterrorist agents, emerging pathogens, and bloodborne pathogens; toxicologic, environmental, and occupational concerns associated with disinfection and sterilization practices; disinfection of patient-care equipment used in ambulatory settings and home care; new sterilization processes, such as hydrogen peroxide gas plasma and liquid peracetic acid; and disinfection of complex medical instruments, such as endoscopes.
The 158-page document is a wealth of information, but Spry cautions that it is “not a stand-alone document.” She explains, “For example, anyone responsible for processing flexible endoscopes must also be familiar with the SGNA guidelines. Anyone who practices flash sterilization must be familiar with AORN guidelines, etc. The CDC guidelines do an excellent job of explaining new and existing technology and products, identifying scientific studies related to the guidelines, and describing inactivation of microorganisms. It is an excellent resource but it does not provide all the answers a practitioner needs to carry out sterilization and disinfection and makes no claim to be all inclusive. It is important that practitioners also refer to their respective professional organization’s recommended practices and standards and to the Association for the Advancement of Medical Instrumentation (AAMI) guidelines as well. In addition, guidelines from AAMI and professional organizations tend to be updated frequently. Sterilization and disinfection technology is rapidly evolving, new issues and concerns such as extended cycles, the significance of cleaning and water quality are being discussed, and scientific evidence is constantly evolving. This information must be made available to users in a timely manner. Frequent updates to sterilization and disinfection guidelines are critical. The last CDC guideline was many published many years ago but hopefully updates will occur more frequently in the future.”
One important set of recommendations to which the HICPAC guideline is a companion document is the AAMI standards. Spry reports that AAMI met in mid-December, with the steam sterilization working group approving approximately 25 updates to the ST 79 document, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.” Spry notes, “These recommended updates must now go the AAMI standards board and if approved will be published and disseminated to anyone who currently has ST79. Because ST 79 is in a three-ring binder format the user will be able to simply remove the old pages and replace with the new ones. Also, AAMI is planning on providing some educational programs for committee members regarding Class 6 indicators, with the goal that guidelines for its use will be included in a future update.”