This complex question is made even more confusing by the directions commonly found on disinfectants. Most low or intermediate level disinfectant labels carry language stating they are not intended for use on medical instrumentation. This statement is designed to inform users that the product is not to be used to sterilize instruments directly for use in surgery. Yet, in many cases, these disinfectants are suitable for use as an intermediate step prior to a high level disinfectant or sterilization. Further, many of these products are commonly called disinfectant/detergents, leaving the user with a false impression that the product can do everything in a single step. As both cleaning and disinfection are required for any soiled surface, these products may be used once to clean, then again to disinfect the surface. To help clarify, a product’s label will typically state that visible soil needs to be removed prior to disinfection, particularly when blood and other body fluids are present.

The Centers for Disease Control and Prevention (CDC) along with the Association for Professionals in Infection Control and Epidemiology (APIC) has identified the level of disinfection needed after decontamination and prior to patient use for medical instrumentation.3 Included in these guidelines are recommendations for environmental surfaces in a healthcare facility. For instrumentation and other items that come into contact with patients, the three Spaulding categories are applicable: critical, semicritical, and noncritical devices. These categories allow healthcare professionals to evaluate the object’s potential risk to patients and determine the appropriate decontamination and sterilization procedure.

Noncritical devices may be subjected to low level disinfection as they do not come in contact with skin that is not intact. However, with both critical devices (objects that enter sterile tissue) and semicritical devices (those that contact mucous membranes or non intact skin), it is important to not only consider the final method of sterilization or high level disinfection, but also to consider the steps that should be taken to make the instrument safe to handle for sterile processing employees. It is unacceptable not to know whether an instrument has been properly decontaminated to protect the workers wrapping and prepping the item for further high level disinfection or sterilization.

There are many types of low and intermediate level disinfectants available to the sterile processing community. Common liquid chemical disinfectants contain active ingredients such as alcohols, phenols, quaternary ammonium compounds, chlorine compounds, hydrogen peroxide and peracetic acid. These actives might be used individually or in combination with others, and end users should evaluate their characteristics to determine the best solution for their situation.

For example, some products may have material compatibility concerns, be less efficacious or be more difficult to remove from surfaces. The water quality used to dilute the product or even the application method may have a negative impact on the product’s efficacy. The Occupational Safety and Health Administration (OSHA) requires that any disinfectant used to disinfect blood spills is efficacious against Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV). Some facilities require even more aggressive products shown to be effective against Mycobacterium tuberculosis (TB). OSHA considers products that are effective against TB to also be effective against HIV and HBV. The consumer needs to assess the application, the materials of construction for the instrumentation, and the efficacy requirements for the process when evaluating a detergent.

Most of the information needed to evaluate a disinfectant is found on the product label. The first critical step in evaluating a disinfectant label is to locate the U.S. Environmental Protection Agency (EPA) product registration number. To ensure that claims are accurate and the product is produced under the appropriate controls, only disinfectants with an EPA registration number should be used. The label will also contain a list of the active ingredients, dilution or activation instructions, safety equipment requirements (i.e., appropriate PPE and ventilation requirements), and may list the organisms against which the product has been proven to be effective. The label will also provide contact times and concentration levels required for the product to be efficacious against the organisms listed on the label. Practitioners have raised the concern that the time constraints of today’s sterile processing world make many of these contact times difficult to achieve. The CDC and infection control experts have recently acknowledged these concerns and are evaluating the performance of disinfectants in applications with reduced contact times to be recommended in the updated guidelines for disinfection, sterilization and antisepsis. Until reduced contact times are recommended by the appropriate authorities and registered by the EPA, users should continue to carefully follow label claims and use timers or other tools to ensure soaking requirements are met.

Sterile processing professionals today are frequently left to try and sort this out on their own. Their infection control practitioner can assist, but should that be standard practice? AAMI ST 79: 2006 states "The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized."1 This information should be provided in written form to the user to ensure the procedures are carried out correctly. But what if those directions do not contain a disinfection step prior to sterilization? Many times the burden of compatibility then falls on the chemical company supplying a disinfectant to determine whether the materials of construction are compatible with the disinfectant. To further complicate matters, not all instrument manufacturers are able to disclose lists of the materials of construction due to proprietary knowledge protection. Users can help bridge this gap by requesting the cleaning and disinfection recommendations directly from the device manufacturer, and by requesting the materials of construction when that information is missing.

References:

1 Association For the Advancement of Medical Instrumentation. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. ANSI/AAMI ST79:2006. AAMI, 2006. American National Standard.

2 Occupational Safety and Health Administration. Bloodborne Pathogens. Code of Federal Regulations, Title 29, 1910.1310.