Strategies to Mitigate Cross Contamination of Non-critical Medical Devices

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Acknowledgments

This issue brief was researched and written by members of the 2021 APIC Practice Guidance Committee in collaboration with members of the 3M clinician research team. The Association for Professionals in Infection Control and Epidemiology (APIC) gratefully acknowledges the following individuals for their valuable contributions.

Objective and Scope

This issue brief addresses high-level themes regarding contamination of multiple-use, non-critical medical items frequently used across patient care settings. The goal is to shed light on best practices for minimizing infection risk from these types of items. The brief covers non-invasive, non-critical medical devices such as blood pressure cuffs, oxygen saturation monitors, and stethoscopes, as well as therapy toys and other multiple-use items that come in contact with intact skin, such as medical tape. It does not cover contamination of semi-critical or critical medical devices.

The brief addresses mitigation of cross contamination for pediatric and adult patient populations across the continuum of care. However, certain patient populations who are at increased risk of infection from contaminated medical devices/items, such as immunocompromised individuals, are excluded from the population scope.

Background

Preventing healthcare-associated infections (HAIs) requires a comprehensive infection prevention program that encompasses all potential reservoirs in the chain of infection (Figure 1),¹ including environmental surfaces, shared medical devices, and other fomites (inanimate objects or surfaces that can be contaminated with pathogens). The program must have effective policies and procedures for appropriate cleaning and disinfection of reservoirs that can be cleaned and disinfected, as well as clear guidance for the safe handling and storage of all equipment and basic items used in the delivery of healthcare.

Strategies to Mitigate Cross Contamination of Non-critical Medical Devices - APIC (3)

Non-invasive portable clinical items shared among patients are part of the patient’s immediate surroundings and may pose a threat of pathogen transmission.² These items are not typically assigned to a specific patient and may be overlooked when establishing routine disinfection practices. Micro-organisms can live on these items’ surfaces for long periods, with the micro-organisms’ life spans depending in part on the material of the surface, the ambient air temperature and humidity, and the presence of organic material.^3-5 The occurrence of infection from contaminated environmental surfaces and non-critical medical devices has been documented in the literature.^6-8 In a 2015 literature review of research on contamination of non-invasive portable clinical items and HAIs, Livshiz-Riven and colleagues² found that between 23% and 100% of the items investigated in 13 qualifying studies were contaminated; up to 86% of items were contaminated with pathogenic organisms; and multi-drug resistant organisms (MDROs) were found on up to 25% of items. The authors concluded that inappropriate disinfection practices increase the risk of HAIs transmitted from such items.

Current Challenges

Misconceptions about “Non-critical” Items

The literature shows that some of the most-overlooked sources of contamination in healthcare settings are items deemed “non-critical.”² For example, non-critical items used in patient rooms, such as call buttons, infusion pumps, lead wires and oxygen flow meters, are touched throughout the day, but they may not be cleaned and disinfected until a patient is discharged. Thus, such contaminated non-critical items can become a critical source of pathogen transmission, particularly if hand hygiene is poor. When items are labeled “non-critical,” they will be perceived as such—and the importance of cleaning and disinfecting these items will likely be a low priority. For this reason, Livshiz-Riven and coauthors² have argued that “the concept of ‘non-critical item’ is inappropriate and is an unfortunate term that needs to be changed.”

Cleaning and Disinfecting Medical Equipment

It is difficult to ensure that medical equipment is cleaned and disinfected appropriately. Factors that play a significant role in medical equipment disinfection include the compatibility and effectiveness of disinfectants, variations in disinfectant applications and wiping methods, interactions between disinfectant products and equipment, disinfectant storage requirements, the cleanability of specific items, and the roles of human behaviors and workflows in cleaning and disinfection.

The effectiveness and safety of each disinfectant must be evaluated before such products are approved for use in a healthcare setting. Disinfectants work in two different ways—growth inhibition (bacteriostatic and fungistatic) and lethal action (sporicidal, bactericidal, fungicidal, tuberculocidal, and virucidal effects)—and it is important to select products that will work as needed for particular applications.

The Occupational Safety and Health Administration’s (OSHA’s) bloodborne pathogens standard, 29 CFR 1910.1030,⁹ requires that items and surfaces contaminated with blood or other potentially infectious materials be decontaminated with an appropriate disinfectant. OSHA does not provide its own definition of an “appropriate disinfectant”; instead, OSHA defers to the U.S. Environmental Protection Agency (EPA), which states, “EPA-registered antimicrobial products may not make efficacy claims against pathogens unless the Agency has reviewed data to support the claim and approved the claim on the label.”¹⁰ Use of the various product lists published by the EPA¹⁰ can assist in selection of an appropriate disinfectant for the needs of the healthcare setting.

Other considerations when selecting disinfectants include their flammability, corrosiveness, stability, and required contact time.¹¹ Contact time, also known as “wet time” or “kill time,” is the amount of time the surface must stay wet to ensure efficacy of the disinfectant. Contact time is determined by the manufacturer through rigorous testing using EPA-approved standards; it can range from 15 seconds to more than 10 minutes.,³ Staff and patient safety during disinfectant application is not to be neglected.

Once a compatible and appropriate disinfectant is selected for use, the staff responsible for disinfection must understand and execute the correct technique for the disinfectant application as explained in manufacturer’s instructions. For example, disinfectant wipes and sprays are commonly used to disinfect medical equipment because they are easy to use and can perform reliably. However, improper use of these products can diminish their effectiveness.¹¹ There is potential to transfer micro-organisms to other parts of the equipment depending on the bactericidal activity of the disinfectant and the application technique. The contact time of the disinfectant must also be understood. If staff are unfamiliar with the contact times of specific disinfectants, they may not disinfect equipment appropriately. Another risk is inappropriate storage of disinfectant wipes with the lids open, which results in dry and ineffective wipes.

The instructions for use for every piece of medical equipment must be reviewed by the user to ensure the compatibility of disinfectants with the equipment. Infection preventionists are a good resource for assistance in understanding the instructions for use. This required review can be cumbersome and detailed. However, if it is not done, it can result in damaged equipment or—worse yet—transmission of infection because proper disinfection was lacking. In some instances, medical equipment may have small crevices or surfaces that make appropriate cleaning and disinfection difficult to complete.

Cleaning and Disinfecting Toys and Books

Cleaning and disinfecting shared toys and books is also important. According to Ibfelt and coauthors, “toys are among the fomites with the highest pathogen load, but their role in disease transmission is unknown.”¹² Toys shared in healthcare settings should be easy to clean and disinfect. Stuffed animals and other toys that have cloth, fur, or other surfaces that cannot be disinfected or cleaned should be avoided. Instead, select toys that can be washed with soap and thoroughly rinsed with tap water or cleaned with 70% alcohol wipes.¹³ Some plastic or vinyl toys can also be cleaned and disinfected in a dishwasher with bleach detergent on the hottest setting (check with the toy manufacturer for guidance).

Although there is limited research related to contaminated books and their risk of transmission of pathogens, there are a few studies related to waiting room magazines. In a study by Charnock,¹⁴ the front pages of 15 magazines from 11 general practice surgeries in Norwegian cities were swabbed and analyzed for total and specific bacteria. The results showed that all of the magazines were contaminated with bacteria, including α-hemolytic streptococci (Streptococcus mitis and S. sanguinis) and two colonies of Staphylococcus aureus. The study suggests that magazines may be a pathogenic risk, but the generalizability of the findings for infection prevention and control policy is limited by the study’s small sample size and the exclusive focus on bacterial contamination. Facilities should undertake a risk assessment to determine whether shared books should be avoided altogether, or if a cleaning and disinfection process should be put into place.

Handling and Storage Considerations

The routine handling and storage of non-critical medical devices present opportunities for contamination, particularly because there are very few guiding principles or recommended practices addressing how to manage them. Medical tape is one example of a non-critical medical device that could be an overlooked infection reservoir. Though medical tape is widely used in both routine and critical applications, it does not fall into a category with instructions for use to minimize infection risk. Furthermore, when tape rolls are not individually packaged (as is often the case), they are not protected during storage and handling prior to use or between uses. Tapes cannot be cleaned, disinfected, or reprocessed, but they are frequently stored unpackaged in areas without cleaning protocols, left on counters or in drawers, used for care of multiple patients, and not discarded after a single use. In a 2021 literature review of 42 publications on tape and cross contamination as a cause for HAIs, Bernatchez and Schommer⁸ reported that 29 different microbial species, including Staphylococcus epidermidis, Bacillus sp., Escherichia coli, and coagulase-positive staphylococci, have been found on tape during its life cycle, including between patient uses. The literature reviewed by Bernatchez and Schommer included several case studies where reports of bacterial or fungal infections occurred under tapes used to secure various devices. One of these case studies described a patient in India with a healthcare-associated case of mucormycosis (formerly known as zygomycosis), a potentially fatal fungal infection, that was likely transmitted from contaminated adhesive tape.¹⁵ Bernatchez and Schommer noted in their article that medical tape has been a suspected vector of infection transmission for decades, and yet the storage and handling of the product has not changed substantially.⁸

Stethoscopes, which are also considered non-critical items, provide another example of a commonly used item required to provide quality care that is also an overlooked reservoir for pathogens. The Centers for Disease Control and Prevention (CDC),¹⁶ Society for Healthcare Epidemiology of America,¹⁷ and Infectious Diseases Society of America¹⁸ recommend the use of dedicated patient stethoscopes for patients on transmission-based precautions; however, according to a single-use stethoscope manufacturer, 74% of clinicians reported using their personal stethoscopes in isolation.¹⁹ A literature review of 28 studies found that the mean rate of stethoscope contamination was 85% (range 47% to 100%); study design did not permit conclusions about associations between contamination and infection transmission.²⁰ In an anonymous survey at a pediatric hospital,²¹ over 75% of clinicians reported that they did not disinfect their stethoscope between patient encounters.

Knowing how to handle and manage non-critical medical items can be difficult when the only guidance from institutions such as the CDC³ and WHO²² is to provide low-level disinfection when items are visibly soiled or on a regular basis. Perhaps the best guidance is found in “Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals”²³ from the US Food and Drug Administration (FDA). This document clearly addresses storage and handling risks and should be considered when implementing infection prevention and control policies and procedures in facilities. The FDA guidance specifies that single-use devices are to be considered disposable and notes the importance of ensuring they are used on one patient during a single procedure as intended. If an item does not come with reprocessing instructions, the FDA states it should be considered a single-use item and disposed of appropriately after one use.²³ If facilities follow this FDA guidance, that may help drive manufacturers to provide products that better enable clinicians to reduce these cross-contamination risks. HAIs present a significant challenge for the healthcare sector, and the increased emphasis on prevention will likely propel significant demand for disposable medical supplies in the future.²⁴

Human Factors and the Healthcare System

Current recommendations and guidelines to prevent HAIs from the CDC^25,26 and WHO^22,27 (for example) focus primarily on the most notable infection risk factors, such as inadequate hand hygiene and contaminated environmental surfaces. However, despite efforts to minimize obvious risks, non-critical patient care items still frequently serve as reservoirs for multi-drug resistant organisms (MDROs) such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and Clostridioides difficile, as well as other pathogens.^28,29 Given the current state of the healthcare system, we may need to consider less obvious and potentially overlooked environmental risks for HAIs, including the specific role of human factors, or how humans interact with their environment and the impact that has on how care is provided.

The Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality³⁰ notes that despite the best of intentions, healthcare personnel “can be set up for mistakes by poorly designed products, uncoordinated care processes, and fragmented systems.” To avoid such errors and improve compliance with infection prevention and control policies, healthcare organizations must recognize how healthcare personnel and patients interact with the specific facility’s environment and strategically address environmental obstacles. For example, instead of basing a policy for safe handling of medical tape on the assumption that staff will always remember what they should do and will always perform their tasks with single-minded focus, it is preferable to consider how systems can be set up to minimize handling errors given that humans can be forgetful, multitasking, or tired, and generally have limited attention spans.

The workloads, responsibilities, and priorities of healthcare workers have always affected clinical outcomes. Despite hospitals having environmental service teams, high-touch areas and the items within them that are frequently handled are not always cleaned and disinfected. When responsibilities are not clearly delineated and workloads are demanding, these areas may be overlooked by both environmental services and nursing. If cleaning and disinfecting responsibilities fall to the clinical staff, the likelihood of missed opportunities increases because clinicians typically lack the time to do this work. Increasing workload is associated with compromised infection control activities—when clinicians must choose among priorities, patient care comes first.³¹

Little has been written about healthcare providers’ infection prevention behavior during daily care, and we need more information about their risk behaviors when they are in contact with patients and equipment. In a 2017 study of several medical wards in two different hospitals, Lindberg and coauthors³² used evidence-based standards as well as recommendations for preventing organism transmission as a framework to help identify risk behaviors of healthcare personnel. In 39 hours of observation, the investigators identified 497 errors related to preventive hygiene, which means a risk for organism transmission occurred approximately every 5 minutes. Additionally, many of the noted risk behaviors in this study involved the use of non-critical items. For example, when nurses removed an intravenous needle, they used rolls of tape they had stored in their pockets to adhere a bandage over the site; similarly, a nurse went to a supply cart, retrieved a roll of tape, placed it on a bedside table, removed a cannula, and taped a bandage over the site. There were also incidents of clinicians using scissors that had not been disinfected prior to use to cut dressing material that was subsequently placed over a cannula. In other studies,^20,33 investigators observed healthcare personnel using equipment such as blood pressure cuffs and stethoscopes on multiple patients without the equipment being disinfected between uses. Based on these types of findings, Lindberg and coauthors³² argue that healthcare providers seem to have a false sense of security that materials are microbiologically clean when they are visually clean. They urge healthcare providers to presume that surfaces are “unclean” rather than “clean.”

Recommendations

Risk Assessment

A healthcare organization’s policy and procedures for cleaning and disinfection of non-critical, non-invasive medical devices should be grounded in the risk of pathogen transmission. Therefore, the CDC³⁴ recommends the use of a risk assessment approach to determine the frequency of cleaning and disinfection of such medical devices. This risk assessment approach has three primary considerations: the contamination factor, the vulnerability factor, and the exposure factor. The first consideration is that the more contaminated an item can become, the more frequently and rigorously it will need to be cleaned and disinfected. The second consideration is that items used in areas where highly vulnerable patients are located may require more frequent and more rigorous cleaning and disinfection than comparable items used in areas with less vulnerable patients. Third, the exposure factor classifies noncritical items as high touch versus low touch, with high-touch items having a broader scope of potential exposure and requiring more frequent and more rigorous cleaning and disinfection. Examples of high-touch non-critical items include non-invasive devices used to touch patients (eg, stethoscopes), items frequently touched by healthcare workers and patients (eg, poles for intravenous devices), and items shared between patients.³⁴

Specialized patient care areas are departments or units where highly vulnerable populations are encountered. Examples of these specialized areas include the following:

Areas that care for high-dependency patients (eg, intensive care units)
Units offering services for immunosuppressed patients (eg, treatment areas for recipients of bone marrow transplants or chemotherapy)
Areas in which patients undergo invasive procedures (eg, operating rooms)
Areas in which patients are regularly exposed to blood or body fluids (eg, labor and delivery or burn units)

Because the probability of contamination is high in specialized areas and the patients tend to be highly prone to infection, these areas have a higher infection risk than general patient areas.³⁴

A combined assessment of the contamination, vulnerability, and exposure factors for non-critical patient care items can help facilities determine policies regarding the frequency of cleaning and disinfection, as well as the cleaning and disinfection methods and the personnel who are responsible for these tasks. Unlike cleaning and disinfection of critical or semicritical equipment, cleaning and disinfection of non-critical patient care items could be the shared responsibility of clinical and non-clinical staff. Because of this possibility for delineation of work, it is best practice to clearly define cleaning and disinfection responsibilities for all equipment, including stationary and portable items.³⁴

Disinfection Guidelines

In 2008, the CDC published guidelines³ for disinfection and sterilization in healthcare settings. These guidelines, which were last updated in 2019, highlight the importance of performing low-level disinfection for non-critical patient-care surfaces (eg, bedrails, over-the-bed tables) and equipment (eg, blood pressure cuffs, stethoscopes) that touch intact skin (Category II evidence). The CDC guidelines³ also emphasize the importance of disinfecting non-critical medical devices with an EPA-registered hospital disinfectant and ensuring that, at a minimum, non-critical patient care devices are disinfected when visibly soiled and on a regular basis (between patients or once daily or weekly).

Rutala and Weber⁶ have presented a bundled approach for disinfecting non-critical items that has five components: (1) creation of policies and procedures; (2) appropriate selection of cleaning and disinfecting products; (3) staff education, particularly for those working in environmental services, patient equipment, and nursing; (4) monitoring of compliance with feedback; and (5) implementation of “no touch” room decontamination technologies—including appropriate disinfection of non-critical environmental surfaces—for spaces housing patients on Contact Precautions or Enteric Precautions.

The use of newer technologies such as adenosine triphosphate (ATP) and fluorescent marking have been effective tools for compliance monitoring and feedback.³⁵ Additionally, hydrogen peroxide and ultraviolet light are newer technologies to consider for patient equipment disinfection.^36,37

Additional Storage and Handling Policies

It is important to acknowledge that not all non-critical medical devices have instructions for use or guidance on how to properly handle them once they become contaminated. Additionally, some multiple-use non-critical devices simply cannot be decontaminated by traditional cleaning and disinfection methods. Comprehensive clinical practice guidelines for storage and handling are often lacking, yet these devices remain high-touch and widely used.⁸

In the absence of more robust guidelines for non-critical medical and patient care items, policymakers should consider the FDA guidance on single-use items mentioned previously.²⁴ Consideration should be given to using single-patient, single-use items where available; identifying simple solutions for these frequently handled products, including packaging of items such as tape that traditionally do not have that extra layer of protection; and reviewing internal policies at facilities to address cleaning, disinfecting, handling, and storage of non-critical patient care items where applicable.

Human Factors–Oriented Solutions

More than 2 decades have passed since the Institute of Medicine published To Err Is Human,³⁸ which focuses on how human factors-oriented approaches and solutions can help improve outcomes related to safety, usability, or improving an entire process or organizational structure. However, many healthcare organizations are not yet taking full advantage of human factors–oriented solutions, which, as the Armstrong Institute notes, “make it ‘easy to do things right and hard to do things wrong.’”³⁰ Healthcare organizations can help minimize infection risk from shared non-critical medical equipment and devices by better understanding the range of human factors that affect how such equipment and devices are used—including the physical environment and the tasks, tools, and technologies involved in handling, cleaning, disinfection, storage, and other critical tasks—and using that understanding to evaluate and redesign workloads and workflows to improve patient safety and healthcare team performance.

Summary

This issue brief highlights the importance of cleaning and disinfection of non-critical items for patient safety and addresses additional safe handling and storage strategies when cleaning and disinfection guidance is lacking. A multi-pronged approach involving risk assessment, application of current disinfection guidelines, human-factors solutions, and consideration of newer technologies and non-traditional safe handling methods is recommended to help ensure the safety of patients in healthcare settings.

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Additional Resources

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