Infection Preventionist Starter Kit: Cleaning, Disinfection, and Sterilization

Dwell time (also known as contact time or kill time) is the length of time a disinfectant must remain wet on a surface in order to effectively kill germs. The dwell time of a product should be listed on the container.

 IP tip: In a health care facility, all disinfectants should be approved by the Environmental Protection Agency (EPA). The EPA ensures that products used for disinfection are safe and effective.

Manufacturers’ instructions for use (IFU) is the guidance provided by the device manufacturer that includes how to properly clean, disinfect, and sterilize them. The guidance is based on rules from the U.S. Food and Drug Administration (FDA).

Medical device instructions for use should include what kind of disinfectant is acceptable to use. It’s important to follow these directions to both kill targeted pathogens effectively and to protect devices from damage if an inappropriate disinfectant product is used.

IFUs for each device in your facility should be current and readily available in all locations where that device is reprocessed. Remember that single-use devices should not be reprocessed, except at an FDA-approved entity (such as an FDA-registered third-party reprocessor registered for the specific device in question). Facilities must keep documentation from the third-party reprocessor confirming FDA registration.

Not all patient or resident care items require sterilization. Therefore, facilities must be able to identify what type of reprocessing is needed based on the item’s intended use. The Spaulding Classification is an approach to disinfection and sterilization of patient care equipment informed by the degree of infection risk involved with using the items.

Under the Spaulding Classification, equipment is categorized as critical, semi-critical, and non-critical:

• Critical items are items that enter sterile tissue or the vascular system such as surgical instruments.
• Semi-critical items are items that come into contact with non-intact skin or mucous membranes such as flexible endoscopes.
• Non-critical items are items that come into contact with intact skin but not mucous membranes such as blood pressure cuffs.

There are different types of sterilization:

• Steam: This is the preferred type of sterilization for devices that are not damaged by heat, steam, pressure, and moisture.
• Immediate Use Steam Sterilization (IUSS): Formerly known as “flash sterilization.” This is a method for sterilizing instruments without packaging. Items must be properly cleaned prior to IUSS, and monitoring of the sterilizer with mechanical, chemical, and biological monitors is required. IUSS should never be used for implantable devices (unless there is an emergency that necessitates it), as a way to decrease reprocessing time, or because the facility does not have an adequate supply of instruments.

There are three types of techniques for monitoring that are used to ensure that sterilizers are operating properly. They all work to demonstrate that parameters for appropriate sterilization have been met during the sterilization cycle.

• Physical or mechanical: Monitors the sterilization cycle’s time, temperature, and pressure. This is typically done via gauges that are visible on the sterilizer. This type of monitoring could be done by using a printed paper that shows the time, temperature, and pressure results. Physical/Mechanical monitoring should be done during every sterilization cycle.
• Chemical: There are many different types of chemical indicators that can be used to monitor sterilization cycles, such as indicator tape or labels that are placed on the package. They typically change color when the proper parameters have been met. Chemical indicators should be used during every cycle.
• Biological: A biological indicator includes a live, highly resistant microbial organism. These are placed into the sterilizer and provide evidence that the sterilizer is capable of killing microbial life when the indicator demonstrates no microbial growth after undergoing the sterilization cycle. Used at least weekly and with every load that includes an implantable device.

Sterile items must be stored in a way that protects them against damage from moisture, pests, and dirt or dust. Closed cabinets within a well-ventilated room may provide a safe space for storage of these items.

The shelf life of sterilized items can be either time-based or event-based. This is a decision made by the facility, and the decision should take into account multiple factors, such as the type and quality of wrappers utilized, the storage conditions, and the amount of handling of the sterilized items.

• Time-based sterility means that each item must be labeled with an expiration date. After that date passes, the items inside must be reprocessed.
• Event-based sterility means that items are considered sterile unless or until the integrity of the package is compromised, such as becoming torn or wet.

Identify what products are currently being used in your facility. You may also want to consult with staff who regularly use the products. Do staff understand contact time, and can they tell you the correct contact time of the product they are using? Do they know what type of personal protective equipment (PPE) is appropriate when using these chemicals? Use the Cleaning and Disinfection Product List, F-02705 (PDF) to help keep track of disinfection processes.

Review disinfection and sterilization resources from organizations such as CDC. Consider presenting the resources to staff in your facility that are responsible for disinfection, if appropriate.

Evidence-based guidance could be sourced from CDC, American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI), Society of Gastroenterology Nurses and Associates, Inc. (SGNA), and Association of periOperative Registered Nurses (AORN). If you are unsure, you can check with the manager of this area. Develop your own audit tool, based upon which evidence-based guideline your facility is following.

Key places might include an endoscopy area (GI endoscopes) and the imaging department (transvaginal ultrasound probes). Follow along with your facility’s policy and procedure as staff reprocess these items and stores them. Are there gaps in the process that your facility can work to achieve? Can you congratulate the staff on a job well done?

This will typically be called the central sterilization area and may be located close to the operating room if you have one. Ask questions about what types of sterilizers are utilized, what type of personal protective equipment (PPE) is worn and when, what types of chemicals are utilized in the area, and how are competencies evaluated and documented for staff performing sterilization?