By Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS

The Association for the Advancement of Medical Instrumentation (AAMI) has released its Technical Information Report (TIR) 68:2018 Low-and intermediate-level disinfection in health care settings for medical devices and patient care equipment and sterile processing environmental surfaces. Because the selection and use of disinfectants can be complex, TIR 68 provides guidance on the selection and use of low- and intermediate-level disinfectants and disinfection processes for safe and effective use.

TIR 68 is intended to serve as a reference for all health care personnel who perform low- and intermediate-level disinfection processes on patient care medical devices and medical equipment and their accessories, and for those who oversee cleaning and disinfecting environmental surfaces in medical device processing areas. Included in this TIR is information regarding the prevalence of antibiotic-resistant infectious organisms and environmental pathogens. Prior to this publication, AAMI standards only addressed medical devices that were sterilized or high-level disinfected.

Items requiring low- or intermediate-level disinfection are typically classified (per the Spaulding Classification) as non-critical patient-contacting medical devices, non-critical patient care equipment, and environmental surfaces; those devices and instruments contact only intact skin and do not penetrate it (e.g., blood pressure cuffs, stethoscopes and skin electrodes). During patient care, other surfaces that don’t come in direct patient contact can become contaminated with microorganisms and organic soil such as body fluids, even though they may not be visibly contaminated. Examples of this type of equipment and surfaces include patient care equipment, patient beds, keyboards and light cords.

Key factors for consideration

Low and intermediate chemical disinfectants are classified as biocidal solutions and should be applied to inanimate objects such as medical devices and environmental surfaces. TIR 68 describes the different categories of chemical disinfectants, along with performance characteristics and considerations for use. Chemical disinfectants are available in a range of formulas, including liquids, impregnated wipes, sprays, concentrated powders, and gases or vapors. There are several factors to take into consideration when selecting the correct disinfectant for the task, including: the degree of microbicidal activity required, the characteristics of the item to be disinfected, the device manufacturer’s written instructions for use (IFU), the disinfectant manufacturer’s written IFU, and the cost and ease of use of the available products.

The new TIR addresses how chemical disinfectants can be impacted by numerous factors, such as the presence of organic soil, design of the device, disinfectant dilution, contact time and temperature, mode of action, and microbial load in reusable solution. User knowledge of the proper use of a disinfectant is critical for rendering the item safe for patient care.

It is interesting to note that many of the low- to intermediate-level disinfectants used for medical device processing are under dual regulation by the Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA). The FDA regulates chemical disinfectants used for liquid chemical sterilization or high-level disinfection or sterilization of reusable medical devices, the sterilant or disinfectant chemistry, and the related systems. The EPA regulates the products as antimicrobial pesticides.

Safe and effective use of these chemicals requires appropriate personnel training. TIR 68 includes recommendations for such training and education. Other personnel considerations are addressed, such as using the correct personal protective equipment (PPE), and a health and hygiene section discusses vaccinations and appropriate steps to take in the event of an exposure.

Specifically, TIR 68 includes information on the following:

  • Cleaning and disinfection of non-critical patient care items, devices and patient care equipment and accessories, electronic accessories for devices, and other non-critical devices (e.g., magnetic resonance coils, magnetic resonance/computed tomography tables, X-ray detector plates, neonatal intensive care incubators, cables, smaller console equipment, intravenous infusion pumps and poles);
  • Processes for categories of items that are terminally processed with low- or intermediate-level disinfection. A table is presented for quick and easy reference.
  • Chemical disinfection of items, making them safe to handle through low- or intermediate-level disinfection to proceed to further processing (e.g., critical medical devices that will be terminally sterilized or semi-critical items that will be high-level disinfected);
  • Recommendations for cleaning and disinfection of environmental surfaces in the sterile processing area; and
  • Guidance on the use of disinfectants and disinfection processes intended for medical devices that:
  1. Undergo final processing prior to reuse;
  2. Medical devices that undergo processing to be made safe to handle prior to high-level disinfection or sterilization; and
  3. Environmental surfaces in medical device processing areas.

Additionally, a section is included on how to read and interpret labels.

Risk assessment prudent

There is always a risk when using chemicals; therefore, it is recommended to perform a risk assessment to determine potential risks to both patients and staff. A risk assessment involves an interdisciplinary team to develop policies and procedures and identify the risk of inadequate or improper use of disinfectants that could cause a disinfection failure or other weakness in the processing practice. A risk assessment helps identify potential problems and allow actions to be taken to reduce the overall likelihood of a problem occurring.

TIR 68 is available at www.aami.org.

– Susan Klacik, BS, CRCST, CHL, CIS, ACE, FCS, serves as an IAHCSMM Clinical Coordinator and has also served as the IAHCSMM representative to the Association for the Advancement of Medical Instrumentation since 1997.