SHARON WARD-FORE, MS, MT(ASCP), CIC, FAPIC, is an infection prevention consultant located in North Carolina. She is a member of 

®’s Editorial Advisory Board. Her videos can be found on YouTube. One example is https://www.youtube.com/watch?v=0jtR465SdcY .

Sharon was the winner of the 2023 Infection Control Today's Educator of the Year award. 

By Sharon Ward-Fore, MS, MT(ASCP), CIC, FAPIC

Figure 1 The plate count is the most common method to determine the number of living bacteria on a surface, with results expressed in colony-forming units (CFUs) per surface area tested.

The environment plays a significant role in the transmission of health care-associated pathogens. Environmental cleaning is essential in reducing microbial contamination on hospital surfaces and contributes to the prevention of health care-associated infections (HAIs). Patients infected or colonized with pathogens frequently contaminate their surroundings, which can contribute to the transmission of pathogens by serving as a source that may contaminate the hands or gloves of health care personnel (HCP).

 This can potentially result in cross-contamination of other patients, other patient care items, and other environmental surfaces, as well as self-contamination and possible infection if you touch your face, mouth, or eyes.

In 2003, the CDC “Guidelines for Environmental Infection Control in Health care Facilities—Environmental Surfaces” recommended that hospitals clean and disinfect ‘‘high-touch surfaces.’’ A later CDC guideline 

 recommended that hospitals ‘‘monitor (ex supervise and inspect) cleaning performance to ensure consistent cleaning and disinfection of surfaces near the patient and likely to be touched by the patient and health care professionals.’’ As a result of these recommendations, the 2007 revised Center for Medicare and Medicaid Services (CMS) Interpretative Guideline for its infection control standard now 

 that hospital infection prevention and control programs ‘‘must include appropriate monitoring of housekeeping activities to ensure that the hospital maintains a sanitary environment.’’

Reference: diagram-https://www.cdc.gov/hai/prevent/environment/surfaces.html CDC website: Reduce Risk from Surfaces

In 2010, the CDC identified 4 science-based methods for evaluating environmental hygiene, including effective surface cleaning. They are direct practice observation, adenosine triphosphate (ATP) bioluminescence, fluorescent markers, swabs, and agar slide cultures.

More than thirty years ago, the food industry was the first to standardize cleaning methods by choosing ATP testing to assess cleanliness.

 The food industry is highly regulated by the FDA and USDA, as well as other agencies, with specific guidance and established facility cleanliness standards. Besides the food industry, ATP testing has been implemented in other areas, including education, the pharmaceutical industry, electronics manufacturing, and health care.In health care, ATP testing is used to detect residual contamination on hard, non-porous surfaces in the environment, providing an estimate of the presence of organic matter, including microbiological contamination.

 Unfortunately, unlike the food industry, no specific agency or regulatory requirements exist for what constitutes a “clean” surface in health care.

How Does ATP Bioluminescence Technology Work?

ATP is a compound used in the metabolic processes of cells, so it is present in all organic material. ATP bioluminescence technology measures the presence of ATP in organic matter from various sources - living microbes, dead microbes, soil bioburden, and natural materials. The detection of ATP in bioburden is due to an enzymatic reaction resulting in bioluminescence. This reaction utilizes ATP, luciferin, and firefly luciferase, an enzyme that produces light in the firefly's tail.

 During the reaction, luciferin is oxidized and emits light. The light produced during this reaction is related to the amount of ATP in the sample and is reported as “relative light units” (RLU). A device called a luminometer is used to “read” the reaction. However, ATP bioluminescence detection is non-specific. RLU results cannot distinguish between live or dead bacteria, fungi, viruses, or any other intracellular source of ATP, like food or soil residual remaining on a surface.

https://www.cdc.gov/hai/toolkits/appendices-evaluating-environ-cleaning.html

ATP Bioluminescence Pass/Fail Determination

The manufacturers of ATP test systems state that testing does not have one pass number that can apply to every facility and every surface. The amount of ATP on a surface after cleaning and the acceptable RLU limits depends on several factors: 1) the surface material, 2) the surface age, 3) what touched that surface, 4) how often the surface was cleaned, and 5) the cleaning procedure and cleaning elements of including time, temperature, and cleaning chemicals.

To have a robust assessment of the equipment or surfaces being evaluated, rigorous testing with ATP swabs should only be done after a deep cleaning the test surfaces. The testing should be done in several pre-selected testing points as this testing aims to produce data for a defined period (eg 2 to 3 weeks or 10-30 cleaning cycles).

 An analysis of the results should identify a reasonable pass/fail limit for the surface or equipment tested. Each facility should set pass/fail limits based on its own data and risk tolerance for each surface. 

There are no specific standards or regulatory limits on RLU to define what is considered “clean,” a significant limitation of ATP bioluminescence test systems. RLU is not a standardized unit of measurement—different ATP systems have other limits in sensitivities, reagent formulations, swabs, and light detection systems. Every ATP device manufacturer has its own RLU arbitrary scale based on their pre-existing curve of ATP luminescence for that instrument, and all measurements are made relative to that specific system. Because each manufacturer uses a different scale, RLU values should not be used to compare other ATP monitoring systems. This limits comparing data between different ATP units.

When deciding on an evaluation method to monitor a cleaning program, it is essential to consider whether the cleaning process or the actual cleanliness of surfaces is the goal. According to the CDC, direct observation and fluorescent gel systems directly evaluate adherence to the cleaning process. In contrast, swab/culture methods and ATP bioluminescence systems have the 

 to assess cleanliness by monitoring the effectiveness of cleaning procedures.2 Cleanliness, defined by the Oxford Dictionary, is “the state or quality of being clean or being kept clean.” However, no defined level of microbial contamination correlates with cleanliness in a clinical setting.

 This lack of a standardized threshold or benchmark for determining the level of cleanliness or “Safe” post-cleaning RLU for specific surfaces, equipment, or patient care areas could lead to a feeling of false confidence in the level of contamination on the tested surface.

ATP bioluminescence detects ATP from bacteria (RLU) in addition to all other biological sources of ATP, so it is not a measure of the number of bacteria on a surface, only a measurement of the material present on the surface. The plate count is the most common method to determine the number of living bacteria on a surface, with results expressed in colony-forming units (CFUs) per surface area tested. CFU and RLU values are detected using different test methods and measure other substances. RLU values do not consistently correlate to CFUs when evaluating an environmental surface. Six studies have shown that various pathogens exhibit different RLU readings.

Microbial tests verify the disinfectant is doing its job. Disinfectant efficacy is confirmed by the Environmental Protection Agency (EPA) when a disinfectant meets the criteria to be an EPA-registered disinfectant. ATP bioluminescence testing cannot be trusted to evaluate the disinfection of a health care surface. It should also not be used as a tool to compare the effectiveness of disinfection between different disinfectants. Luminometers have limitations in detecting the actual number of organisms on a surface, which can lead to false confidence in surface disinfection.

Residual detergents and disinfectants can either increase or decrease RLU readings.

 Additionally, high concentrations of bleach can potentially decrease ATP bioluminescence, reducing RLUs. More research is needed to understand how bleach-based disinfectants impact the use of the ATP test system. Be aware if a bleach-based disinfectant is used, the surface must be dry before testing with ATP. Fortunately, many commercial bioluminescence detection kits contain neutralizers to combat the effect of detergents/sanitizers

Contaminants other than bacteria can also interfere with RLU readings. Inconsistent ATP measurements may be caused by microfiber products, manufactured plastics, stainless steel, any organic substrate, or even the material of surfaces being cleaned.

 ATP does not consistently detect bacterial spores. Testing for viral contamination with ATP luminometers is not helpful because viral cells do not contain or produce ATP molecules on their own, raising another concern about the limitations of the ATP bioluminescence technology in health care. Despite these limitations, ATP bioluminescence testing is one of the most common methods used in health care to monitor the effectiveness of environmental cleaning.

When evaluating a method to assess surface cleanliness, understanding the pros and cons of each method should be considered. ATP bioluminescence testing has gained popularity as a method to assess surface cleanliness. However, there are many limitations to this method. ATP performs better than visual inspection but not as well as fluorescent markers.

 There is no correlation between CFU and RLU because ATP does not differentiate between living and dead organisms.

 It only determines the presence of organic material, including dirt and debris. Consider viable plate counts if you want to know the number of viable bacteria on a surface. As mentioned earlier, ATP does not detect viruses or spores consistently.

RLU ranges and sensitivity between commercially available systems vary. ATP testing requires robust testing of surfaces in your facility to generate data so you can set facility-specific pass/fail limits based on facility data and risk tolerance for each surface. However, there are no specific standards or regulatory limitations on RLUs or standards for what is considered “clean.”

Residues of detergents and disinfectants on surfaces, microfiber, and the surface itself can interfere with RLU readings, either increasing or decreasing them.

 ATP bioluminescence testing should not be used to evaluate disinfection of a health care surface. It should not be used as a tool to compare the effectiveness of disinfection between different disinfectants.

ATP bioluminescence testing should be used as a tool to provide education to environmental services and health care personnel on cleaning processes. It can also be used to identify surfaces that might have been missed during a cleaning regimen based on data obtained to determine RLU baselines, but again, there is no standard for what is “clean.” ATP and any other surface cleanliness evaluation method should always be used with good infection control practices, including environmental services education and compliance with cleaning practices and protocols. It is advisable to be aware of the limitations of ATP to use it effectively.

Amodio E, Dino C. Use of ATP bioluminescence for assessing the cleanliness of hospital surfaces: A review of the published literature (1990–2012). DOAJ. March-April 2014. 7(2). 92-98. Doi.org/10.1016/j.jiph.2013.09.005

https://www.sciencedirect.com/science/article/pii/S2772431X22000338?via%3Dihub

Carling P, Bartley J. Evaluating hygienic cleaning in healthcare settings: What you do not know can harm you patients. AJIC. June 2010. 38 (5). 41-50.DOI.org/10.1016/j.ajic.2010.03.004 https://www.ajicjournal.org/article/S0196-6553(10)00406-2/fulltext

Powitz R. ATP Systems Help Put Clean to the Test. Food Safety Magazine. June 2007. Accessed April 1, 2023. https://www.food-safety.com/articles/4080-atp-systems-help-put-clean-to-the-test

APIC Practice Guidelines Committee (PGC) Position Statement on Adenosine Triphosphate (ATP) Testing of Reusable Textiles in Healthcare Facilities. August 15, 2012. https://www.apic.org/Resource_/TinyMceFileManager/Position_Statements/APIC_position_ATP_and_reusable_textiles_082012.pdf

3M Food Safety News. How clean is it? What ATP can tell you about the safety of your food handling areas. 2023. Accessed April 3, 2023.https://food-safety-news.3m.com/fsn/how-clean-is-it-what-atp-can-tell-you-about-the-safety-of-your-food-handling-areas/

3M Clean-Trace Hygiene Management System. ATP, RLUs and CFUs. 3M™ Clean-Trace™ Hygiene Management System website. 2010. Accessed April 2, 2023. https://multimedia.3m.com/mws/media/686753O/clean-trace-atp-rlus-and-cfus.pdf

Montgomery A, Hammer K, Dubert G, Lo T. Evaluation of adenosine triphosphate bioluminescence-based system in rooms occupied by patients with methicillin-resistant 

. IMJ. September 2022.1(3) doi.org/10.1016/j.imj.2022.08.002 https://www.sciencedirect.com/science/article/pii/S2772431X22000338

Omidbakhsh N, Ahmadpour F, Kenny N. How Reliable Are ATP Bioluminescence Meters in Assessing Decontamination of Environmental Surfaces in Healthcare Settings? IMJ. June 18, 2014. doi.org/10.1371/journal.pone.009995. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0099951#s4

Tetro J, Sattar S. The Application of ATP Bioluminescence for Rapid Monitoring of Microbiological Contamination on Environmental Surfaces: A Critical Review By Jason "The Germ Guy". Infection Control.tips. November 10, 2021. Accessed April 3, 2023. https://infectioncontrol.tips/2021/11/10/atp-critical-review

Options for Evaluating Environmental Cleaning. Appendix B. CDC. Updated May 16, 2019. Accessed April 4, 2023. https://www.cdc.gov/hai/toolkits/appendices-evaluating-environ-cleaning.html

Rutala W, Kanamori H, Gergen M, Sickbert-Bennett E, Huslage K, Weber D. Comparative Analysis of Four Major Hospital Cleaning Validation Methods. 

. 2017. 4(87)doi.org/10.1016/j.ajic.2017.04.087https://www.ajicjournal.org/article/S0196-6553(17)30405-4/fulltext

Best Practices for Environmental Cleaning in Healthcare Facilities: in Resource-Limited Settings. CDC. 2019. Version 2. Accessed April 10, 2023. https://www.cdc.gov/hai/pdfs/resource-limited/environmental-cleaning-RLS-H.pdf

Articles

In 2003, the CDC recommended hospitals to clean and disinfect frequently touched surfaces. Later, they advised hospitals to closely supervise cleaning procedures near patients. This article explains what IPC personnel need to know about ATP testing. 

Adenosine Triphosphate (ATP) Bioluminescence Testing and Performance

According to the Surgical Site Infection Guidelines published in 2017 by the American College of Surgeons and Surgical Infection Society, the most common and costly type of health care–associated infections (HAIs) are surgical site infections (SSIs), accounting for 20% of all HAIs. SSIs occur in an estimated 2% to 5% of patients undergoing inpatient surgery and up to 25% of major surgical procedures.

 Annual incidence of SSIs in the United States is between 160,000 and 300,000, costing from $3.5 billion to $10 billion annually. On average, an SSI increases a patient’s length of stay by 9.7 days, yet approximately half of all SSIs are preventable when evidence-based prevention strategies are implemented.

Infection preventionists (IPs) are vital in supporting the perioperative team by sharing the most current, evidence-based surgical infection prevention strategies to help improve SSI prevention. The operating room (OR) is a challenging environment, with various surgical personnel and medical devices coming together to help improve patients’ lives. Covering surgical services as a novice or even a seasoned IP can be intimidating. In addition to the basic environment of care items, the OR has unique infection prevention challenges. Surgical attire, or OR scrubs (the special surgical clothing required for personnel within the OR suite), is intended to promote cleanliness and reduce microbial contamination in the surgical suite to prevent SSIs.

The human body is a significant source of bacterial contamination in the surgical environment. SSIs have been traced to bacteria from surgical personnel’s hair, scalp, and skin.

 However, maintaining a clean surgical space and reducing microbial contamination wasn’t always a consideration. Through the timeline of surgical attire (

), one can begin to see the development of a better understanding of infection and organism transmission through the changes in clothing.

Surgical attire was initially known as surgical greens because of their color, then were later referred to as scrubs because they’re worn in a scrubbed environment. In 1894, Dr Hunter Robber said, “It is safer and better that all should put on a complete change of costume rather than simply don a sterilized coat and pair of trousers over ordinary clothing.”

 He also suggested that the clothing be made white so they could easily be washed.

When electricity was discovered and electric lights were used in the OR instead of windows and skylights, the combination of bright lights and white attire led to significant glare. “There was a green ghosting effect when shifting gaze from bloody red innards to white backgrounds,” Hunter said.

In 1914, Harry Sherman, MD, FACS, believed that a color scheme might evolve from the red of blood and tissues. He recommended green, a color “less wearisome to the eyes, and [one that] minimized reflection.” He also said green “keeps the surgeon’s eye acute to red and pink.”

 Sky blue became popular for surgical apparel in the 1950s when color television began to be used for videotaping and closed-circuit teaching.

 Today, our surgical scrubs are primarily jade green or misty blue, depending on the vendor’s name given to the color.

Surgical attire has come a long way, but it is—and will probably always be—a hot-button issue due to the variety of organizations and agencies providing input as well as the difficulty of creating and enforcing policies designed for patient and staff safety. The guidance and recommendations are plentiful, which is why it’s vital for IPs covering the OR and the perioperative team to know what the surgical attire policies are as well as the sources used to develop them. Some of the regulatory agencies and professional organizations that have provided recommendations, guidelines, or position statements include the following:

Association of periOperative Registered Nurses (AORN)

Centers for Medicare & Medicaid Services (CMS)

Occupational Health and Safety Administration

Association for Professionals in Infection Control and Epidemiology



To further complicate the surgical attire issue, some states have established their own surgical attire dress code requirements or have adopted a version of AORN or other guidelines. Your local health department may also have further information about state-specific surgical attire requirements, so be sure to contact them as you develop your surgical attire policy.

If your health care facility participates in the CMS programs, you’ll need to follow their surgical attire requirements to be in compliance. They have their own Hospital Infection Control Survey Worksheet that includes a section on surgical procedures with specific surgical attire elements to be assessed by surveyors.6 You’ll need to follow these or risk getting cited. In some instances, they do differ from AORN. Some medical devices and equipment also include manufacturer instructions for use (MIFU) that require wearing specific surgical attire. Check those devices and equipment MIFUs carefully.

Ensure your health care facility’s surgical attire policy complies with the state and local agencies, MIFU, and CMS (if applicable). If none of these are relevant, then the health care facility’s chosen surgical attire, evidence-based guidelines, and consensus statements can be used to develop policies. If your health care facility does not have specific state or local surgical attire requirements, does not have MIFUs that mandate specific surgical attire, is not a CMS participant, and a Joint Commission standard does not explicitly require your facility, then you can choose which evidence-based guidelines or consensus statements to develop your surgical attire policies.

 Surveyors, like The Joint Commission, will survey your specific surgical attire policy. As you know, they don’t make the policy; they confirm that you are following your surgical attire policy.

Most facilities follow AORN’s surgical attire guidelines or incorporate parts of them into their facility-specific surgical attire policies. AORN recently updated the 2015 guidelines on surgical attire in 2019, published in 2020. IPs, including me, have struggled with issues that are addressed in these updated guidelines, including head coverings, arm coverings, beards, shoes, and scrubs outside the surgical suite. What’s not discussed in AORN’s 2020 surgical attire guidelines are patient clothing or linens used in the OR, masks as personal protective equipment, and the use of masks at the sterile field. If you want this information, refer to the AORN Guideline for Sterile Technique

 and the AORN Guideline for Transmission-Based Precautions.

addresses wearing rings, bracelets, watches, nail polish, artificial nails, and other nail treatments.

The rationale for AORN’s 2020 Guideline for Surgical Attire

 includes recommendations for selecting, wearing, and cleaning surgical attire. They are based on the highest-quality evidence available. Recommendations are rated as regulatory requirement, recommendation, conditional recommendation, or no recommendation. These categories are based on the level of evidence, an assessment of the benefits vs harms of implementing specific interventions, and consideration of resources required to implement the interventions

Regulatory requirement: Perioperative team members must implement the recommendation.

Recommendation: Perioperative team members should implement the recommendation unless there is a clear and compelling rationale for an alternative approach.

Conditional recommendation: Perioperative team members may implement the intervention, although the degree of implementation may vary depending on the benefit-harm assessment for the specific setting.

No recommendation: Perioperative team members will need to evaluate whether to implement the practice issue.

AORN states that the guidelines’ recommendations are intended to be achievable and represent what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and clinical situations that determine the degree to which the guideline can be implemented. AORN recognizes the “many diverse settings in which perioperative nurses practice; therefore, this guideline is adaptable to all areas where operative or other invasive procedures may be performed.”

 AORN recognizes that one size does not fit all, and not every organization or professional specialty will use or agree with these guidelines. However, the document does provide evidence-based guidance on surgical attire that can serve as a credible resource to help health care facilities develop perioperative policies and procedures while also considering guidance from professional organizations, state and local agencies, MIFU, and CMS (if applicable).

Development of policies and procedures for surgical attire should be a team sport, ensuring input from all the disciplines (eg surgeons, anesthesia, nursing, infection prevention, environmental services, sterile processing, nurse educator) that contribute to providing quality patient care based on the most up-to-date, evidence-based best practices, with SSI prevention at top of mind.

APIC Implementation Guide: Infection Preventionist’s to the OR. Association for Professionals in Infection Control and Epidemiology. Accessed March 12, 2023. 

https://apic.org/Resource_/TinyMceFileManager/Implementation_Guides/APIC_ImplementationPreventionGuide_Web_FIN03.pdf

Owens CD, Stossel K. Surgical site infections: epidemiology, microbiology and prevention. 

. 2008;70(suppl 2):3-10. doi:10.1016/S0195-6701(08)60017-1

AST standards of practice for surgical attire, surgical scrub, hand hygiene and hand washing. Association of Surgical Technologists. Accessed March 12, 2023. 

https://www.ast.org/uploadedfiles/main_site/content/about_us/standard_surgical_attire_surgical_scrub.pdf

From formalwear and frocks to scrubs and gowns: a brief history of the evolution of operating room attire. American College of Surgeons.Accessed March 13, 2023.

https://www.facs.org/media/0ypjk2ki/01_formalwear_and_frocks.pdf

Does Joint Commission require that organizations follow specific requirements for operating room dress/surgical attire? The Joint Commission. Updated on November 30, 2021. Accessed March 13, 2023. 

https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/leadership-ld/000002266/

Hospital infection control worksheet. Centers for Medicare & Medicaid Services. Accessed March 12, 2023. 

https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/SC15-12.02.FY%202015%20Hospital%20Infection%20Control%20Worksheet%20-%20Public.pdf

Guideline for surgical attire. Association of periOperative Registered Nurses. Updated July 1, 2019. Accessed March 13, 2023. 

https://pdihc.com/wp-content/uploads/2019/10/AORN-Guideline-for-Surgical-Attire.pdf

Kennedy, Lynne. (2013). Implementing AORN Recommended Practices for Sterile Technique. AORN journal. 98. 14-26. 10.1016/j.aorn.2013.05.009.

The guideline for transmission-based precautions - association of peri. Aorn.org. Accessed April 14, 2023. 

https://www.aorn.org/article/2019-10-09-Transmission-Based-Infection-Guideline

Periop today - 5 new hand hygiene practices to reduce infection - asso. Aorn.org. Accessed April 14, 2023. https://www.aorn.org/article/2022-10-10-New-Hand-Hygiene-Practices

Human bodies, especially surgical personnel's hair, scalp, and skin, are a major source of bacterial contamination in the surgical environment and a major cause of SSIs. Yet, not it hasn't always been a consideration.

Surgical Attire: Policy Development Resources

Cleaning and disinfection are critical and will always be an essential focus as health care professionals work to mitigate the spread of health care–acquired infections (HAIs). Yet, as new advances in disinfectants and disinfection technology continue to emerge, an overlooked issue continues to intensify and must be addressed.

Surface material and product damage caused by surface disinfection incompatibility impedes effective cleaning and disinfection, costs health care facilities millions of dollars annually, and creates dangerous safety issues for patients and health care personnel. There are many different materials and textiles within a health care facility, and they cannot all be cleaned and disinfected the same way. When they are, damage occurs. First, at a microscopic level, and then it continues until the damage is clearly visible.

It is impossible to deal with a microbial issue at a macro level. We all know microbes can’t be seen. Visual inspections following disinfection do not provide information about what remains on and in surfaces at a microbial level. Surface damage caused by incompatible disinfection methods—cracks, fissures, and pits—provides microscopic reservoirs for microbial attachments, colonization, and biofilm formation. This provides pathogens a potential safe harbor away from the biocides used to disinfect the surfaces, placing patients and health care personnel at risk for contracting infections.

Many factors influence microbial attachment. It is critical to have a basic understanding of what can remain on surfaces after cleaning and disinfection. Well-documented research provides insight into the role surfaces play in acquiring and transmitting microbes that cause deadly infections. In a February 2021 

, Zheng et al describe in detail how microbes attach to surfaces.

Surface damage can support microbial attachment, colonization, and ultimately, biofilm formation. Biofilm is a complex matrix of extracellular polymeric substances that protect against environmental adversities. Once biofilm is formed, killing the bacteria or removing the biofilm that protects them is extremely difficult, as is disinfecting damaged surfaces where microbial reservoirs have been created. The selection of surfaces that are compatible with disinfectants used in the health care setting is critical during the design of products or the built environment.

A Case Study on Surface Disinfection Incompatibility

Because of the complexity of this problem, many facilities pay high costs for repair, replacement, and ongoing maintenance for medical equipment. In many cases, the cause of the problem is overlooked. In a jointly released case study,

 the Healthcare Surfaces Institute (HSI) and the Association of Healthcare Value Analysis Professionals conducted a deep-dive analysis to understand the root cause of damage to a medical device.

A large midwestern hospital, with approximately 700 licensed beds and over 1.2 million patient encounters yearly, purchased several hundred state-of-the-art, noninvasive optical sensor medical device monitoring systems. There was visible damage to the monitoring systems within 2 years because of chemical exposure during the disinfection process. Such damage is susceptible to unreachable microbial reservoirs that inhibit disinfection, creating severe liability and costs for the hospital and manufacturer.

The Challenges and Gaps That Were Identified

The medical device company identified a lack of understanding and discussion about infection prevention products and guidelines used within the hospital. Although the medical device company met with many key decision makers, there was no central point of contact for them to work through, resulting in a breakdown of communication and the lack of involvement of critical experts during the evaluation process. Also, health care experts were excluded from initial meetings before the damage occurred; had they been consulted, it is possible some issues could have been avoided.

The case study also provided a clear example of the lack of guidelines and testing requirements for surface materials and products. When the medical device company applied for US Food and Drug Administration (FDA) 510(k) clearance, which is a process that evaluates a device’s safety against comparable legally marketed devices, they had testing done for surface disinfection and compatibility. The company was left to determine which cleaning agents to recommend for testing. Only 1 disinfectant was tested. The case study found that the hospital’s infection prevention and control guidelines did not support the use of the only disinfection method prescribed by the medical device manufacturer. The hospital was left to find an alternative for disinfection after purchasing the devices.

The fact that there are no guidelines or minimum testing requirements to validate surface disinfection compatibility is a problem. Minimum testing should require all categories of US Environmental Protection Agency (EPA)-registered hospital-grade disinfectants. There are hundreds of proprietary disinfectant products on the market in addition to no-touch technologies, and it would be cost prohibitive to test all disinfectants. However, by testing the categories of disinfectants, foundational information can be gained. Going beyond the minimum testing and working with the disinfectant companies from which hospitals purchase products will be essential.

Also discovered during this investigation were conflicting instructions for use (IFU) and care and maintenance manuals. The IFU provided information for the possible use of 2 other disinfectants. However, in small print was a warning against the use of the alternative disinfectant selected by the hospital, as there was concern that it may cause corrosion. Unfortunately, the small print was not noticed until the damage had occurred.

It was also determined that not all health care personnel were trained for cleaning and disinfection, such as their nursing staff disinfecting part of the device during patient care. They did not have access to the information they needed and were not offered the basic training.

Materials were not tested or evaluated for cleanability during the surface material selection process and before product development. It is currently not common for raw material manufacturers to test their materials for surface disinfection compatibility before selling them to manufacturers, which is missing a vital step. Product designers must have this information to support that the product’s design can be cleaned and disinfected without damage.

It was noted that medical suppliers benefit from having coordinated access to clinical staff for feedback on successes and potential device improvements. It is important to include critical information about the cleaning and disinfecting agents and processes used within the hospital. The information gained will support the manufacturer as they identify disinfectants for testing.

Before purchasing the monitoring device, the hospital’s evaluation and selection process would have benefited from active participation from a diverse group of health care professionals responsible for infection prevention, including environmental service, infection prevention, biomedical, nursing, and clinical professionals. All these professionals evaluate products differently, and the combined knowledge and discussion provides valuable insight into potential challenges and successes.

In the past 6 months, several medical device manufacturers faced FDA recalls for surface disinfectant incompatibility issues that caused risk to patients. Each of the recalls resulted in a requirement to do additional testing for surface disinfection compatibility and the rewriting of IFUs. Recalls are costly and could be avoided if guidelines and minimum testing recommendations were identified and followed.

Infection preventionists can help drive more awareness about surface disinfection compatibility. We can start with collaboration with health care personnel, biomed, raw material suppliers, device manufacturers and designers, and disinfectant manufacturers. We can bring together all the different groups working on surfaces to help health care facilities understand the importance of surface disinfection compatibility, surface disinfectant testing, IFUs, and how they are all tied together. We must work together to achieve the following:

Develop a minimum standard for surface disinfectant compatibility that tests categories of disinfectants instead of proprietary products.

 If categories of disinfectant chemistries are tested rather than specific brand names, this helps simplify and clarify IFUs. This allows health care facilities to determine whether the products they already use are compatible with their equipment and medical devices. HSI has developed minimum testing standards, using 7 categories of EPA-registered, hospital-grade disinfectants. By bringing this issue to the forefront and addressing the issue at a microbial level, we will begin to see sustainable solutions to mitigate the spread of HAIs.

Designate a single point of contact within a health care organization to facilitate collaboration between manufacturers and health care professionals and to communicate important matters to all parties.

 Health care facilities and systems have equipment and medical devices that are damaged or placed out of service for reasons not always known to staff. Having 1 “point person” to report equipment and device issues to, such as damage from cleaning products, would be invaluable.

Establish a greater understanding of real-life challenges health care professionals face when working to mitigate the spread of infections within the health care setting. 

Medical device designers and manufacturers and disinfectant manufacturers do their best to create products that help keep patients and staff safe. However, sometimes there is a disconnect between the users and the vision research and development had in mind. A product with multiple nooks and crannies—although helpful in the design and build of a device—can pose a nightmare for cleaning and disinfection.

­­­­Build awareness around the selection of surface materials during the design phase by medical device manufacturers based on surface disinfection compatibility.

 Raw materials must meet minimum standard requirements. The number of different types of medical devices and equipment is overwhelming. When you consider all the possible surface material components, such as plastics, metals, and coatings, it’s not hard to see how easily surface disinfection incompatibility can happen.

Create guidelines for product reviews before purchase, as well as checklists for health care selection teams within the health care setting that provide essential information for product value analysis professionals.

 Infection preventionists already have guidelines or checklists to help evaluate disinfectants. They also need tools for assessing surface disinfection compatibility to determine whether a surface material or product can be safely cleaned and disinfected without causing damage that can harbor and transmit dangerous pathogens.

Medical device suppliers should provide maintenance training, including a review of cleaning and disinfection for all users of their equipment or devices.

The lack of attention paid to surface disinfection compatibility with patient care equipment and devices results in damage, failure, and recalls of expensive—and sometimes critical—patient care equipment. Addressing the issue of surface disinfection compatibility can help prevent these financial losses. However, understanding how critical the issue of surface disinfection compatibility is to protect patients and keep health care personnel safe when handling patient care equipment and devices is more important. Infection preventionists can help drive the change needed to address surface disinfection compatibility in health care.

Zheng S, Bawazir M, Dhall A, et al. Implication of surface properties, bacterial motility, and hydrodynamic conditions on bacterial surface sensing and their initial adhesion. 

. 2021;9:643722. doi:10.3389/fbioe.2021.643722

Surface disinfection incompatibility with medical devices creates potential patient risks. Healthcare Surfaces Institute. September 2021. Accessed March 11, 2022. https://www.healthcaresurfacesinstitute.org/case-studies/surface-disinfection-incompatibility-with-medical-devices-creates-potential-patient-risks/

The surface material and product damage caused by new advances in disinfection technology must be addressed for patient safety.

Surface Disinfection Incompatibility Does Not Support Effective Cleaning and Disinfection

hen all states fully reopen, long-term care facilities (LTCFs) must balance the needs of residents against the potential for additional deadly COVID-19 outbreaks. COVID-19 uncovered deep flaws in nursing homes that have been worsening for decades. Nursing home is a generic term for a facility for a patient who can no longer remain at home because they require 24-hour nursing care and monitoring, also known as a skilled nursing facility (SNF), long-term care facility (LTCF), or extended care facility (ECF).

 For this article, LTCF will be used to refer to these 3 types of facilities.

Seventy percent of LTCFs are for-profit operations, a factor that’s been linked to the spread of COVID-19.

 Unlike hospitals, most LTCF residents live in these facilities permanently, although some are admitted for shorter periods of rehabilitation after a hospital stay. Although these facilities are designed to be comfortable for long-term emotional, social, and physical well-being, they also are perfect incubators for viruses and bacteria. Their layouts increase person-to-person contact. Most residents share bedrooms, bathrooms, activity rooms, and dining rooms—and staff usually share a break room. Although group spaces encourage socializing and are designed partly to cut costs, they also help spread infectious diseases.

 Residents are generally older, frail, and often have comorbidities that make them more susceptible to severe infections such as COVID-19. Many need help performing basic activities of daily living such as eating, dressing, or bathing, increasing the chances of being infected by the staff who help them or passing the virus along to their caregivers.

When mortality rates at facilities struck by COVID-19 were compared with ones that were spared, the more the virus spread through a facility, the greater the number of deaths recorded for 

. In facilities where at least 30% of residents had the virus, the rate of death for reasons 

 the virus was double what would be expected without a pandemic. This implies that the care of those who didn’t contract the virus may have been negatively affected as the staff were overwhelmed attending to residents with COVID-19 or were left short-handed as employees became infected.

Many LTCFs lack the necessary resources to protect seniors from COVID-19. News articles describe LTCF staff as generally underpaid, often living in crowded conditions at home, traveling on public transportation, and working jobs in multiple homes to make ends meet.

 Statements from staff and administrators mentioned that staff feared exposure to COVID-19 and other infectious diseases, along with fear of bringing home infections to their family members; some lacked accessible child care; some had competing family obligations. Many staff don’t receive health insurance or paid sick leave, leading some to work even when they are experiencing symptoms. The facilities they work in may have insufficient personal protective equipment (PPE) and training on how to use it. Many facilities lack COVID-19 testing for staff and residents.

The other issues that make LTCFs so vulnerable—chronic underfinancing, inadequate clinical services, and fragile staffing—seem to be endemic to the LTCF industry. Before COVID-19, this sector endured widespread economic and operational problems. Since the initial COVID-19 surge, LTCFs have lost occupancy and utilization, have lower revenues, and face immense staff retention and recruitment obstacles.

Public opinion on LTCFs has been further eroded by the human toll from the pandemic. According to AARP, “the American nursing home industry exists as it does today because of federal laws and regulations that go back 85 years. The infrastructure these laws created, no matter how well intended, didn’t anticipate the future, nor could it foresee a health storm of this magnitude, speed, and deadliness.”

The Centers for Medicare & Medicaid Services (CMS), an agency within the US Department of Health and Human Services (HHS), is responsible for ensuring the approximately 15,500 LTCFs, with 1.4 million residents nationwide, meet federal quality standards.

LTCFs must meet standards to protect residents. These standards were 

Hiring enough quality staff to provide adequate care

Protecting residents from physical and mental abuse

Establishing and maintaining an infection prevention and control program.

Under the CMS umbrella, state survey agencies are expected to conduct inspections once a year and can inspect facilities more often if the facility is performing poorly or if there are complaints or facility reported incidents. Inspectors also review the residents’ clinical records and interview residents, family members, caregivers, and administrative staff. The inspection team looks at many aspects of life in the LTCF including as follows:

The care of residents and the processes used to give that care

The infection prevention and control program

Infection control inspections are an abbreviated type of inspection that allow the team to focus specifically on LTCF infection control policies and practices. These inspections can identify serious risks to resident health and safety through the spread of communicable disease. They review areas such as:

Performance of hand hygiene including hand washing and the use of alcohol-based hand sanitizers

Staff education, monitoring and screening for infection control

Appropriate cleaning and disinfection of surfaces

Not surprisingly, infection prevention and control deficiencies were the most common type of deficiency cited in surveyed facilities, with most facilities having an infection prevention and control deficiency cited in 1 or more years prior to the pandemic. Infection prevention and control deficiencies can include items such as staff not regularly using proper hand hygiene or failure to implement preventive measures during an infectious disease outbreak. Isolating sick residents and using masks and other PPE are critical to preventing the spread of infectious diseases from multidrug-resistant organisms and respiratory viruses.

A US Government Accountability Office report found that from 2013 through 2017, 82% of all surveyed LTCFs were cited. In each individual year, approximately 40% of surveyed LTCFs had infection prevention and control deficiencies, which continued in 2018 and 2019. Approximately half (48%) of LTCFs with an infection prevention and control deficiency had this same deficiency cited in multiple consecutive years from 2013 through 2017.

 This indicates persistent problems that existed long before the onset of the pandemic. The safety of the residents, who often are in frail health and live in close proximity to one another, was brought to the attention of the world during the COVID-19 pandemic.

Most critics of the LTCF industry agree that it was dealt a nearly impossible hand during the pandemic, left to take the brunt of public anger over the large number of deaths at LTCF facilities. The American Health Care Association, a not-for-profit federation of affiliated state health organizations that represents more than 14,000 not-for-profit and for-profit LTCFs, states that “the failure of public health services at all levels to prioritize [long-term care facilities] for both testing and personal protective equipment left the industry unequipped to stop the spread of the virus.”

But there are some data that show a link between LTCF quality and COVID-19 cases. Investigators found that facilities that had lower quality ratings from regulators before the pandemic were more likely to have outbreaks.

 And the New York Times found that residents in top-rated facilities were as likely to die from COVID-19 as those in facilities ranked near the bottom.

LTCFs do have protocols to handle outbreaks such as influenza, but the COVID-19 pandemic arrived so quickly and the SARS-CoV-2 virus was so contagious that many facilities were caught unprepared. The reasons vary from state to state and facility to facility. In general, when SARS-CoV-2 reared its head, many LTCFs did not have enough PPE on hand or adequate staff trained to use it to sustain the volume of patients with COVID-19.

They couldn’t institute mandatory use of PPE for staff in order to protect them or offer PPE to visitors. They couldn’t provide testing for staff and residents to help them and their families make good decisions regarding working ill and visitation. Instead, hospitals were prioritized over LTCFs in terms of emergency assistance, even though elderly adults and individuals with disabilities, who make up the vast majority of LTCF residents, are at highest risk for serious illness and death from COVID-19.

An article by the John A. Hartford Foundation sums up how some view LTCFs: “Unfortunately, the situation in LTC [long-term care] with COVID-19 is consistent with how America treats LTC. We prefer these essential facilities and their residents and staff to be out of sight and out of mind. We place the sickest, frailest, and most vulnerable people in 1 spot and then pay less than minimum wage to those who will be caring for them, despite the difficult nature of their jobs. LTCF staff provide care for many individuals who have profound dementia, complex chronic diseases, and decreasing function and ability to eat, bathe, or move around on their own.”

The COVID-19 pandemic emphasized LTCF patient and staff safety and infection control practices as critical public health issues. The impact of the pandemic on residents and staff in LTCFs called for reexamining the relationship between the physical environment and the factors of infection control, quality of life, and overall resident and staff safety.

 Yet even now these facilities continue to be a major source of US COVID-19 cases.

Investigators at UCLA and Yale University found that LTCF aides who worked in multiple facilities in order to make more money contributed to the spread of COVID-19. They found restricting workers to a single facility had the potential to reduce COVID-19 infections by 44%.

An LTCF aide can be responsible for more than 20 residents on a shift. The job is physically and emotionally demanding, and the average wage is approximately $13 an hour. Requirements for the job vary by state. In most states, workers complete a hands-on training course and a certified nursing assistant (CNA) program, which is approximately 75 hours of training over 3 months. Surprisingly, state requirements to gain a hairstylist license are more demanding than those for a CNA, says Lori Porter, cofounder and CEO of the National Association of Health Care Assistants.

 Now that COVID-19 restrictions have limited CNAs to working at just 1 facility, many are now unable to afford basic living expenses. Without increased pay and benefits, coupled with the mandated vaccine, LTCFs will remain short-staffed.

Cell phones, tablets, and other videoconferencing devices have been invaluable in helping reduce isolation and loneliness in LTCFs. Virtual visits were linked to a 50% lower risk of depression compared with emails, social media, or instant messaging.

“Social isolation was a mental and physical health problem in nursing homes long before COVID-19,” says Bei Wu, PhD, director for research at the Hartford Institute for Geriatric Nursing at New York University. Lack of connection is associated with a 50% higher risk of dementia, 29% higher risk of coronary heart disease events, and a 32% higher risk of stroke.

Physical contact is also important. The creation of spaces where LTCF residents and family members could meet and hug demonstrated the importance of incorporating safe areas for in-person visits. These are spaces made out of plastic sheeting with holes cut into it to allow protected physical contact. Moving forward, there could be plexiglass walls, a sound system, antimicrobial surfaces, and perhaps a “hug wall” made of flexible material for germ-free embraces.

Telehealth increases patient engagement, reduces costs, and saves time. Telehealth enables patients to be more engaged in their own health and well-being. During the pandemic, Medicare authorized payment for telehealth services to residents in any health care facility and in their home.

 Clinicians who were able to virtually assess LTCF residents via video monitoring were more likely to catch health issues sooner and then treat patients where they were, rather than having to admit or readmit them to a hospital. Avoiding unnecessary trips to the hospital can promote better health outcomes for patients and benefit LTCFs by reducing lost revenue when a patient is in the hospital. Clinicians were better able to assess and provide care while avoiding risk of exposure to SARs-CoV-2.

LTCFs that had the resources and staffing to anticipate and prepare for the pandemic fared much better than those that didn’t. These facilities shared what they learned: Stock up on cleaners, disinfectants, and PPE and masks for workers and residents; screen everyone who walks in the door for symptoms; hire more staff to clean bathrooms and common areas; educate everyone on best practices for containing the virus—wash hands, avoid close contact, keep an eye out for fever or cough; lock down the facility and isolate infected residents.

Having an infection preventionist on site or as a consultant to lead infection prevention and control training makes a difference. The ability to screen, isolate, or group patients can save lives. Ongoing testing of residents and staff is critical, as is vaccination of residents and staff to keep the virus under control.

LTCFs should stockpile PPE, not just for COVID-19 but also for other contagious events. Even more safety improvements and changes may be necessary. Not just because another pandemic may be around the corner, but because the aging US population demands them to stay independent and safe. By 2030, every baby boomer will be at least 65 years old, with Generation X and the millennials aging right behind them.

Although infection prevention is a critical component for patient and staff safety, critics think the LTCF system needs attention beyond what infection prevention practices can provide. It may be time to rethink what LTCFs should look like based on what was learned from the pandemic. Too often, LTCFs look, feel, and function like hospitals. Besides looking at creating smaller LTCFs, familylike household facilities may be a better option.

“Making nursing homes the de facto choice for older Americans in need of care set the stage for the ravages of the pandemic,” says Patricia McGinnis, JD, executive director of California Advocates for Nursing Home Reform. “LTCFs are not good places for anyone except for short-term rehab. I would hope this is a wake-up call that the system isn’t working.”

Advocates for alternatives to LTCFs include AARP and the Green House Project. AARP, a nonprofit, nonpartisan organization dedicated to helping older Americans achieve lives of independence, dignity, and purpose, has more than 33 million members.

 They have been outspoken on behalf of their members, urging LTCF reform.

The Green House Project is an innovative, nationally recognized model in LTCFs that creates small homes that recognize the individuality of residents and respect their autonomy, choice, privacy, and dignity, yet are also affordable. Founded in 2003, the Greenhouse model has key features that provide infection mitigation, including private rooms, more access to outdoor spaces, open floor plans that allow for social distancing, and a staffing model that limits the number of people with whom each resident interacts.

 There are approximately 300 Green Houses in 32 states. These homes house only 10 to 12 residents that live in a housing center and share an open kitchen, dining room, and living room. Specially trained CNAs work exclusively in 1 house—making meals, doing laundry, socializing, helping residents pursue their interests, and looking for early signs of health issues.

Having an infection preventionist on site or as a consultant to lead infection prevention and control training makes a difference. The ability to screen, isolate, or group patients can save lives. Ongoing testing of residents and staff is critical.

By Sharon Ward-Fore, MS, MT(ASCP), CIC, FAPIC

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