Linda Lybert Featured in Infection Control Today on the 2018 Healthcare Surfaces Summit

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A new article published in Infection Control Today by Matthew Hardwick, PhD; Debra Harris, PhD; Linda Lybert; and Amber Mitchell, DrPH, MPH, CPH, on the 2018 Healthcare Surfaces Summit, “Unprecedented Collaboration to Eliminate Infection and Illness Caused by Contaminated Surfaces in Healthcare Environments.” (Re-printed below)

 

Unprecedented Collaboration to Eliminate Infection and Illness Caused by Contaminated Surfaces in Healthcare Environments

By Matthew Hardwick, PhD; Debra Harris, PhD; Linda Lybert; and Amber Mitchell, DrPH, MPH, CPH

Originally published September 13, 2018 by Infection Control Today

In a world full of conflict and complexity, we seek solidarity and simplicity. In an age of globalization of travel and medical tourism, we need the delivery of healthcare to make common sense for all who access it. A healthcare facility must be a safe place designed for health and healing. If its surfaces cannot be effectively cleaned, disinfected and/or sterilized, it is not a healing environment.  

A design cannot just be created, initiated and executed by architects, designers, engineers, builders, without input from clinicians, specialists, scientists, manufacturers, advocates, and educators. The problem we continue to see is that manufacturers often develop new products to solve a specific problem without input from healthcare professionals that will be responsible for the care and maintenance of them. In particular, those who are in daily contact with patients and personnel have a different level of understanding and knowledge of infection prevention as it relates to surfaces. Ensuring all key stakeholders are at the table for all discussions provides invaluable insight and knowledge of protocols and process for cleaning and disinfection. 

The Healthcare Surfaces Summit (HSS) is just that -- a collaboration of stakeholders adamant about making healthcare environments and the delivery of healthcare free from harm. 

HSS is a collaboration between infection preventionists, epidemiologists, infectious disease experts, scientists, laboratorians, engineers, occupational health and safety experts, and architects working in healthcare, manufacturing, academic, entrepreneurial, government, standards setting, and non-profit organizations. All are focused on creating measures, metrics, standards, research, outreach and education to reduce preventable infections by interrupting the transmission of surface-related pathogens in healthcare in support of community health.

Readers of Infection Control Today well know that 1 out of 25 patients will acquire an infection while being treated for something else.1 This statistic is unacceptable. We also know that this is not just an issue for patients, but that healthcare personnel also experience increased incidences of illness and infection and are continually at risk.2 Exposure to pathogenic microorganisms that can cause morbidity and mortality in patients and personnel, also carry risk to the public and impact overall global public health.3 This is not just the case in crowded, heavily occupied healthcare facilities.  In fact, it may potentially be more pertinent -- especially with hearty environmental microorganisms like Clostridium difficile -- in regular, everyday settings like moderately occupied acute care hospitals and outpatient clinics.4

Together, HSS is pulling together all science, research, and resources necessary to create meaningful tools and resources for the healthcare industry.  HSS is working to ensure that healthcare surfaces – including items such as countertops, toilets, sinks, patient care items, machines and appliances, textiles, upholstery and medical devices – become less of a culprit for harboring pathogens and contaminants that cause infection and illness in patient and personnel.

To best identify where we need to go, it is important to identify where we have been and what the science tells us.  As a result, the HSS has commissioned an extremely robust literature review and meta-analysis. The purpose of the literature review is to develop collaborative strategies to design, specify, maintain and use surface materials that contribute to a solution to reduce the risk of healthcare associated infections (HAI). Often, research focuses on the cleaning process, but not the material being cleaned. Similarly, studies focus on transmission via healthcare practitioner and hand washing strategies without controlling for contact with surfaces prior to patient interaction. 

Understanding the contributing factors to the selection, maintenance, and use of environmental surfaces in healthcare facilities is the foundation to identifying successful processes and innovating new solutions to mitigate infection and illness. This study utilizes a peer-reviewed assessment method and ranking system for published journal articles and will conduct meta-analysis to evaluate the evidence and identify gaps where additional research is needed. By systematically reviewing the literature and investigating practice processes, collaborators across interested disciplines can work together to define best practices, develop guidelines and standards, and provide educational opportunities to increase compliance and reduce infections and illness.

We know that to tackle an issue so complex and wide-reaching, that there needs to be focused efforts in several different and distinct arenas.  As part of HSS, there has been ongoing, focused work among and between four initiative workgroups with the following missions:

- Research: Evidence-based efforts to demonstrate the connections between HAI transmission and healthcare surfaces and provide best practices guidance to accelerate the adoption of new innovations and interventions for surface decontamination.
Standards and Utilization: Evaluate and implement objective measurement tools for disrupting pathogen transmission. Review products and technology for decontaminating surfaces 

- Surface Disinfection and Compatibility: Develop testing guidelines for surface disinfection incompatibility by evaluating disinfection process, products and protocol to understand the relationship between surface damage and microbial acquisition and transmission.

- Education: Create and disseminate tools, resources, educational material, and other critical information for providers, patients, and the public to reduce transmission of surface related pathogens.  A range of materials including infographics, presentations, checklists, training parameters, and educational curricula will be developed to target individuals at all levels of awareness to improve their knowledge, skills, and ability to act as agents of change.  

Historically, infection prevention research focuses largely on handwashing and antibiotic stewardship. There is also a vast body of research that indicates the primary role of healthcare surfaces in the transmission of pathogens. Much of the current surface research examines the bacterial-reducing efficacy of specific interventions, but it fails to provide any evaluation of the surface materials used to construct healthcare facilities and how they can or cannot support microbial growth and movement. Additionally, surface materials used for healthcare products such as furniture, medical equipment and medical devices are typically made of multiple surface materials that cannot all be cleaned, disinfected or sterilized in the same way or with the same disinfectant products. When these surfaces are damaged during the cleaning process, the question remains: How is microbial growth and ultimately the acquisition and transmission of microbes affected? 

While this oversight may seem inconsequential, several disinfectants are known to compromise both hard and soft healthcare surfaces. The HSS Research Initiative is performing research to identify incompatibilities between current disinfectants, both physical and chemical, and existing healthcare surfaces. To this end, we are currently studying the impact of disinfectants and various wiping techniques on bacterial reduction on a variety of healthcare surfaces. This data will inform development of modernized cleaning techniques, incompatibility issues between disinfectants and surfaces, and highlight the need for more collaboration between the research community and disinfectant manufacturers, as well as healthcare environment designers. While the work of the HSS Research Initiative is largely independent, much of our work will be a collaborative effort with industry groups. After all, reduction of HAIs is a global need and requires the input of all stakeholders.

There is a great deal of fragmentation within oversight and standards setting groups for healthcare surfaces that can impact the transmission of infections and illness in healthcare facilities. This is especially true as it pertains to protocols for surface testing, materials compatibility, cleanability, contamination rates, durability, testing methods, and outcome and intervention measures. For years, consensus, specification, performance, and testing standards organizations like AAMI, ASTM, ISO and others have built and published parameters to designers, manufacturers, and oversight organizations for commercialization of products – medical devices, personal protective equipment, textiles, chemicals, and their subsequent components.  These groups set standards for all sorts of processes, procedures, and products including diagnostic testing, materials compatibility, safety, shelf life, packaging, sterility, quality measures, biocompatibility, and electrical, physical, and flammability parameters. However, there are no standards set for the selection on surface materials used to manufacturer these products. 

In addition, regulatory, licensing, and accreditation institutions like the Joint Commission and State Departments of Health and Public Health, OSHA, EPA, FDA, and many more incorporate consensus standards into their regulations, standards, and guidance.  It is then that professional and trade associations and member organizations -- the alphabet soup of AHA (American Hospital Association), ANA (American Nurses Association), AMA (American Medical Association), APIC (Association for Professionals in Infection Control and Epidemiology), ACHA (American College of Healthcare Architects), ASM (American Society of Microbiology), ASCLS (American Society for Clinical Laboratory Science), ABSA (The Association of Biosafety and Biosecurity), IAFF (International Association of Fire Fighters), SHEA (Society for Healthcare Epidemiology of America), AdvaMed, PhRMA, and so many more - craft “evidence-based” standards and best practices for adoption among their members and clients.  These standards are often only available to paying members in good standing or to the public for a fee. Open, free access to timely, accurate, and succinct information is simply not happening. A widely adopted standard does not currently exist. 

The HSS and its stakeholder members are dedicated to joining forces to make this a common practice. They are creating an evidence-based consensus standard to serve as a foundation to manufacturers, architects, engineers, and construction trades in healthcare to balance the specifications needed for healthcare surfaces that are safe and safely able to be cleaned, disinfected, and/or sterilized. The HSS workgroups will collectively provide information to achieve this goal.  It will be determined at a future time, what standards-setting organization would provide the best platform for publication and dissemination of such a standard.

Many areas of work that need to be completed and the need for collaboration have been identified. The challenge is bringing people together for discussion and testing and developing a clear understanding of what systems can be put together that provide sustainable solutions. Ultimately, the end goal we all share is reducing risk and mitigating the spread of pathogens that cause infections and illness. A new project for HSS is the development of an incubator. Much like a business incubator that helps new and startup companies develop services, HSS will utilize this concept to develop a testing site.

Working through the Initiative Groups, we will look at all aspects of the problem and test solutions as a system. Manufacturers will have the opportunity to interact with many healthcare professionals to understand what they do and how they operate. They may also gain input from them on innovative new ideas and solutions. 

References:
1. CDC. HAI Data and Statistics. https://www.cdc.gov/hai/surveillance/index.html
2. van Vugt, JLA, Coelen RJS, van Dam DW, et al. Surgical Infections. April 2015.
3. Mitchell A, Spencer M, Edmiston C Jr. Role of healthcare apparel and other healthcare textiles in the transmission of pathogens: a review of the literature. J Hosp Infect. 2015 Aug;90(4):285-92.
4. Mahshid Abir, MD, MSc, Jason Goldstick, PhD, Rosalie Malsberger, MS, et al. The Association of Inpatient Occupancy with Hospital-Acquired Clostridium difficile Infection. Journal of Hospital Medicine. Web June 27, 2018.

A Critical Step Missed During Design!

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Recently, I read a great article in the Wall Street Journal's May 29th issue, titled “The Operating Room of the Future.” The article highlighted the expanded operating room with more technology (such as imaging equipment) that allows for minimally invasive treatments – or when necessary, more invasive surgeries – without the need to move the patient and team to a different OR. The additional technology allows physicians to tap into big data during and after procedures to get guidance and analysis in real time. I'm sure everyone agrees that these current trends of minimally invasive outpatient surgeries, faster recovery times and fewer complications are benefits to both patients and the medical teams treating them. I'm even more certain that healthcare facilities are very supportive of increasing the number of patients that take advantage of this technology and new way of treatment. 

No silver bullets.

I want to urge all members of the design team to add more healthcare professionals to the discussion BEFORE construction begins. There is more to evaluate. Operating rooms are critical areas that turnover quickly from one case to the next. Typically, those responsible for doing this work to get the time down to around 9 or 10 minutes. Pathogens can’t be seen and a quick turnover between patients leaves potential risk for the next. To ensure this can be disinfected and prepared effectively and efficiently requires evaluation. BEFORE construction begins. Manufacturer partners, environmental services, infection preventionists, and facilities professionals must evaluate the time it takes to effectively clean, disinfect and when necessary sterilize equipment before the next patient.

Pathogens can’t be seen and harbor on handles, on cords, in cracks, creaves, and damaged surface areas. In many cases, the disinfectants used in this environment can damage equipment. Within the article, there are only two minimal references to infection prevention – the terrazzo floor and a photo caption stating, “…it aims to be more versatile, reduce infection risks, and improve the surgical team’s views and workflow.”  How is it going to reduce infection risk? A terrazzo floor is not a silver bullet solution, and there is so much more to infection prevention.

According to a recent report from the Center for Disease Control (CDC), Surgical Site Infections (SSI) were the most common healthcare-associated infections (HAI), representing 31% of all HAIs among hospitalized patients.  This means someone from Infection Prevention needs to be at this table. Now. Before it’s too late.

Cleaning is only step one.

Cleaning, disinfecting and sterilizing surfaces within the operating room environment are absolutely critical. Invasive procedures leave patients at higher risk of infection. This should not be taken lightly! Look at and think about the many different surface materials, textiles, and assemblies in this environment. Medical devices, carts, cords, supply carts, X-ray equipment, lights, walls, floors, countertops just to name a few. Looking at this environment with the requirement for cleaning/ disinfecting and sterilizing BEFORE finalizing the design and during the mock-up evaluation phase is critical so you have a clear picture of what will be required to provide a sterile environment for the next case.  So, before construction begins, the below question needs to be forefront in everyone’s mind:

Can this OR, with all of this technology, be cleaned, disinfected and sterilized (microbes killed and removed) quickly in the 10–20 minutes allotted between cases?

Manufacturers can provide answers to these questions:

  • What disinfectant products are required? (Not all surface materials and products can be cleaned and disinfected in the same way with the same products.)
  • What are the manufacturer warnings for disinfectant products?
  • Are they all compatible with the combined surface materials used on any one product?
  • Was a surface disinfection compatibility testing performed in conjunction with the specific disinfectant products currently being used in the facility? Can the product be required?

Infection Prevention experts must evaluate and make recommendations for:

  • Changes to products, processes, or protocols may be required to provide a safe, sterile environment for the next patient based on this new technology and configuration.
  • Testing protocols to validate infection prevention effectiveness that includes a microscopic evaluation of surface integrity.
  • Specific roles for each team member to support effective infection prevention.
  • Comprehensive plans to ensure the safety of every single person in that OR.

Everyone has the goal to mitigate HAI’s and ultimately save lives. A proactive approach not only includes the development of technology and the design of the OR space. It also must include an understanding of what infection prevention process, products, and protocol will be required.  The only way to do that is to bring in the teams to test and validate before construction, and again before the OR opens to patients.

Required Manufacturer Testing

A step in the right direction

The recent requirement imposed by the FDA for scope manufacturers to test their products is a step in the right direction and hopefully, testing requirements won’t be limited to just scopes. The next step is to develop clear testing requirements, which will provide indisputable evidence that products can be cleaned, disinfected and sterilized properly, and that manufacturers can provide recommendations that coincide with infection prevention requirements and strategies.

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There are several ways manufacturers may test their products:

  • In-house, often using some recognized testing protocol such as ISO and ANSI
  • Professional associations representing product manufacturers often provide testing
  • Third party independent laboratories

All options provide data and information about specific products. However, third party independent laboratory testing is unbiased. All products or materials in any given category are tested using the same protocol, providing an “apples to apples” comparison.  Often testing data is available online in the same format as other manufacturer results.

Testing Standards and Requirements

Testing standards and requirements need to be developed and put in place that take into consideration current infection control requirements and recommendations. Conflicts occur when manufacturer recommendations don’t coincide and those responsible for cleaning, disinfection, and sterilization step outside required and existing protocol. Potential risk and liability exist for everyone. If manufacturer recommendations are not followed warranties may be voided, leaving healthcare facilities vulnerable.

There is obviously a microbiology component of testing. Data may show that a specific product can be effectively cleaned or sterilized using a given process, but does this process effectively destroy or eliminate microbes and the potential for cross contamination? When establishing testing protocol this data must be collected as well.

Assemblies

Product testing often is done on individual components or parts rather than on complete assemblies. Characteristics and the ability to effectively clean, disinfect and sterilize changes once components are put together as a final assembly. It is important to have a clear understanding of how the assembly needs to be cleaned before the product enters the market.

Human Behavior

Product testing will provide data that shows if and how a product can be effectively disinfected/sterilized to destroy harmful microbes. What is not tested is human behavior. This is a great subject for a future blog, but felt it important to mention. Despite testing, we still must recognize that human behavior impacts the success or failure of the disinfection/sterilization process.

Don’t know what they don’t know

Silos play a key role in the current problem. Over the years, I have come to learn that manufacturers don’t know what they don’t know about infection prevention and control. Within the healthcare facility there are many different specialized silos that often conflict on the subject of infection prevention. If and when manufacturers or anyone for that matter, seek to learn something they receive many opinions.

The ultimate goal is to mitigate the spread of infection, save lives and provide a safe environment. Reaching this goal will also help reduce the financial loss healthcare facilities experience. I am pretty sure most people will agree this can’t be achieved by focusing on only one aspect of the problem.

Establishing testing standards and requirements will require communication, education and a clear understanding about the data that is necessary from all perspectives.

Enforcement

We certainly can’t stop by simply establishing standards and protocol. We need to establish who is going to enforce product testing and who will hold accountability and responsibility to verify all data has been collected.

There is so much more to do, but a big step in the right direction has been taken. Let’s make sure steps continue to be taken to reduce the spread of infection and risk to patients, healthcare workers and the general public.

Antimicrobial Surfaces are NOT “Self-Cleaning”

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During a community tour of a new critical access hospital, I was shocked to see carpet leading from the main entry of the hospital, up the stairs and throughout the entire patient care area. Hallways and nursing station areas all carpeted. This was not continuous carpet, it was carpet tiles with visible seams and edges. Perfect sites for microbes to harbor. I am thrilled to say that the patient rooms were not carpeted!

When I asked about the ability to effectively clean the carpet, the exchange went like this:

“It is antimicrobial.”

“Oh, okay. What exactly does that mean?”

“It is continually disinfecting.”

The answer was given in such a way that everyone believed, with every step we took, the microbes from our shoes were being destroyed instantly.

No such thing

Recent conversations with healthcare professionals have also caused me to stop to catch my breath. The belief that surfaces are “self-cleaning” can lure people into a false sense of security. ATTENTION: There is no such thing as a self-cleaning surface!

Every surface in every healthcare facility must be thoroughly cleaned and disinfected regularly!

Today there are many different antimicrobial products on the market. All work in different ways. Some need water, some need light, some need to be free of any kind of coating, some need to be reapplied on a regular basis. Understanding how the antimicrobial surface works and how it can be cleaned and disinfected is extremely important.

Is there a chance that a surface may be overlooked or the due diligence necessary to effectively clean the surface will not be followed because staff members believe antimicrobial surfaces are “self-cleaning?” Will we see an increase in the number of infections as a result of this misunderstanding? Remember, the goal is to mitigate the spread of infection.

After asking a series of questions in countless interviews with manufacturers of antimicrobial products, not one representative has ever claimed that a surface was capable of cleaning itself continuously, even though that was the initial impression given when the conversation started. Asking the right questions is key, since misunderstandings happen quickly.

Digging deeper

My first question is always “What do you mean by antimicrobial?” Here are just a few of the responses I have heard:

  • We use pine and linseed oil in our manufacturing process. Both of these products have natural antimicrobial properties
  • The surface slows down the bacteria
  • The antimicrobial properties of this product provide a backup to regular cleaning and disinfection procedures, so you don’t need to clean it as often
  • The savings come from not having to clean this material as often
  • Since our product is non-porous, it is naturally anti-bacterial. (Hmm, anti-bacterial or antimicrobial?) Bacteria can’t survive on the surface.

Another important question that is often not asked has to do with quantifying efficacy. Has this antimicrobial product reduced the number of infections within a healthcare facility? By how much? The majority of antimicrobial surfaces show a 99.999% reduction of microbes over time in a testing laboratory. But does this reduction in a controlled laboratory environment translate into a measurable reduction in a real world active healthcare environment?

I believe there are good products on the market that can be an effective part of a multimodal solution. However, I am concerned that some people believe that “self-cleaning” surfaces actually exist. This will likely lead to reduced attention on required cleaning and disinfection protocols, setting facilities up for failure.

View Surfaces as an Assembly

Virtually all healthcare surfaces are difficult, if not impossible, to clean. That is a very scary thought considering research shows surfaces are active in the spread of healthcare-associated infections (HAIs).

We continue to learn about emerging diseases and the microbes that survive on surfaces for days and weeks, even after they have been cleaned and disinfected. It is time to look at how surfaces support the spread of infection.

Surfaces are made of different materials and textiles. Soft, hard, porous and non-porous materials that cannot all be cleaned the same way. The selection of materials typically is made based on a “standard” that is established for a specific area. How they look and what they cost are always considered.

Not evaluated, not considered

What is not evaluated effectively, if at all, are the manufacturer’s recommendations for cleaning and disinfecting their product and the warning labels related to disinfectants and cleaning products. Not considered are the ways surface materials are put together, as an assembly, and connected to other surface materials. Soft and hard surface materials have seams and connect or rest on other materials. This has an effect on how effective the cleaning and disinfection process can be.

With the goal to have surfaces that are easy to clean and leaving minimal room for human error when cleaning, we need to look at surfaces in a completely different way.

In high touch, high turnover areas, the need to quickly and effectively disinfect surfaces is critical. It is important to understand who is tasked with room turnover. In some high turnover areas such as an emergency department, staff with primary patient care responsibility (i.e. nurses) may also be required to perform cleaning and disinfection of the area. Identifying these areas and selecting materials that support this process is extremely important. Here are a few things to take into consideration:

  • Identify surfaces that are located in:
    • High traffic
    • High contamination
    • High touch
    • Quick turnover areas
  • How are the surface materials assembled and combined with other types of surfaces and surfacing materials? Are they compatible?
  • Which cleaning and disinfection products can be used on these surfaces without causing damage? (Remember that damage often cannot be seen with the naked eye.)
  • Who is responsible for cleaning and disinfecting this area?

A hard surface example

The hand washing station pictured is located in a 900-bed hospital in a large metropolitan area. They serve everyone and are recognized for serving the underserved. This particular station is located in the emergency department, just outside one of the patient care bays. This area is characterized by high traffic, high contamination and high touch, which clearly results in a high potential for cross-contamination if not cleaned and disinfected often and effectively.

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Set up for failure

In this very small area there are:

  • Five different surface materials, layered one on top of the other, all requiring different cleaning products and processes to be effectively disinfected
  • Four different surface textures, some of which provide sheltered areas for microbes, contributing to the development of biofilm and formation of colonies
  • Ten different surface areas needing disinfection, making it very easy for those responsible for disinfection to miss ledges, seams and textured surfaces that can harbor microbes

I wish I would have stepped back further to take this photo. You would see that the paper towel dispenser is located on the left side of the faucet, about three inches above the ledge created by the thick vinyl wall protection. As people reach for paper towels, water drips onto the wallpaper and down the back side of the wall protection. There is great potential for mold to become an issue.

While this area really is very attractive and pleasant to be in, there are serious surface issues. This area is difficult, if not impossible, to clean and disinfect effectively. This combination of surfaces provides multiple areas that support microbial growth that can contribute to the spread of infection.