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HSI Announces Creation of the Healthcare Surfaces Certification Program
By Linda Lybert and Caroline Etland, PhD, MSN
Note: This article was originally published in the October 2019 issue of Healthcare Hygiene magazine.
The Healthcare Surfaces Institute is 501c3 non-profit organization with a mission: To reduce preventable infections through the collaboration of industry, academia, science, regulatory, and service sectors by interrupting the transmission of surface-related pathogens in healthcare in support of community health.
In 2018, the Institute commissioned the University of Baylor to conduct a comprehensive literature review to gain a clear understanding of what research, test methods, product validation, standards, resources, guidelines, and training programs currently exist which would provide direction for the work of the Institute moving forward.
Each Institute initiative group and members of the board of directors identified a list of approximately 50 different terms that encompassed surface types, materials and products, existing guidelines, cleaning and disinfection processes, test methods, cleaning and disinfection training and guidelines. A total of 2,023 articles were identified initially and only 358 met inclusion criteria.
The literature search was conducted using One Search, Academic Search Complete, LISTA (EBSCO), PubMed, and Web of Science. A search term list was developed by HSI and the P.I. and refined during the initial search (Table 1).
|Search Terms for the Systematic Literature Review Evaluating Environmental Surface Cleaning and Disinfection, Surface Compatibility, and Selection|
|ACC||Curriculum||Hospital||Rapid field test|
|Bone||Disinfecting||IV pumps||Stainless steel|
|Ceiling||Endoscopes||Medical equipment||Surgical instruments|
Inclusion criteria included experimental and quasi-experimental research designs with quantitative data, published since 1980, available in the English language, and accessible through online research databases. Studies and reports were excluded if not relevant (e.g., commentaries, reviews), provided no statistical reporting, included confounding variables, were not specific to human healthcare environments, and had critical limitations (e.g. sample size, missing data, and lack of available or reliable data). An initial search was conducted, followed by a primary review based on each title and abstract (n=1221). Based on a determination of the title and abstract review, 358 full-text articles were downloaded and reviewed with a focus on inclusion and exclusion criteria. The final review for inclusion was a blind review on the selected studies for data analysis, specifically whether the study included statistic(s), the appropriate selection of statistic(s) was used, the sample size, and the effect size (e.g. the difference in outcomes between two groups) – all factors contributing to statistical power.
Below are a few of the high-level findings:
• Although gaps were expected, what was not anticipated was the significance of the gaps. Inconsistencies in test methods, test organisms, and lack of statistical data to validate products for use was noted.
• Surface materials tested or used for cleaning and disinfection validation were not adequately defined. Stainless steel coupons or various surface materials found within the healthcare setting were common statements rarely was the actual surface material identified.
• The size of the test material (small samples) does not provide adequate evaluation of surface materials ability to withstand the rigorous infection prevention requirement of the healthcare setting.
• There were conflicting definitions for cleaning, disinfection, porous, non-porous, as well as other key terms.
• No guidelines or requirements were identified for testing and evaluating products for surface disinfection compatibility. Or the evaluation of surfaces for degradation and microbial reservoirs.
• Small samples of single surface materials are tested
There are no consistent manufacturer requirements or standards for testing all categories of EPA registered disinfects that support manufacturer’s instructions for use (IFUs). Furthermore, not all manufacturers provide IFUs, leaving healthcare facilities at risk for regulatory noncompliance.
• There are many different guidelines for cleaning, disinfecting and sterilizing with an equal number of infection prevention processes and protocols as each hospital develops its own requirements.
• No requirements for validation that products are clean, disinfected and fit for proposed use.
Surfaces are fomites that contribute to the acquisition and transmission of microbes that cause deadly infections. The findings of the literature review in combination with the numerous requests received by the Institute from healthcare professionals, also, during follow up interviews have identified a critical need for the comprehensive evaluation of surfaces and their ability to be efficiently and effectively cleaned, disinfected and sterilized.
The board of directors has unanimously approved the development of a Healthcare Surfaces Certification program to help manufacturers develop products and healthcare professionals identify products that can be effectively cleaned, disinfected, and sterilized. This program will include the development of surface testing standards, educational programs, and resources as well as a certification process that will provide manufacturers with a certificate of validation from the Healthcare Surfaces Institute.
Goals and objectives for this program include but are not limited to:
• Development of consistent test methods that includes compatibility testing of all categories of EPA registered disinfectants as well as no touch disinfection such a UV and hydrogen peroxide vapor
• The identification of the top four microbes for all testing with option for addition microbial testing. The goal is to have consistent measurable data and information
• Testing of products as assemblies – Many products are made using multiple types of surface materials and or textiles. When combined on one product the ability to efficiently and effectively disinfect all materials can be compromised causing degradation of surface materials.
• Evaluation of surfaces at a micro level. Damage is often unseen, creating microbial reservoirs that support the growth and proliferation of microbes
• Evaluation of IFUs to ensure they provide guidance and recommendations pertinent to active healthcare environments and that support infection prevention processes and protocols.
Product manufacturers can expect support with product development that includes clarity about testing requirements and recommendations, as well as healthcare professional support for the creation of IFUs that support infection prevention process and protocol.
The Healthcare Surfaces Institute continues to grow and evolve. Most importantly, the members are committed to good science and helping standard organizations develop the best requirements for certification that will drive truly value-based purchasing options for healthcare. We are currently working with healthcare professionals and HSI manufacturing partners to begin the development of this certification program if you are interested in becoming a partner and working with us, visit www.healthcaresurfacesinstitute.org .
Linda Lybert is president of Healthcare Surface Consulting and the founder/executive director of the Healthcare Surfaces Institute.
Caroline Etland, PhD, MSN, is currently an associate professor at the University of San Diego Hahn School of Nursing, and a clinical nurse specialist at Sharp HealthCare. She also serves as a board member of the Healthcare Surfaces Institute.
Ellen Turner, a member of the board of the Healthcare Surfaces Institute, reviewed this article.
Applying the Hierarchy of Controls to the Seven Aspects of Surface Selection™
By Linda Lybert and Amber Mitchell, DrPH, MPH, CPH
The Healthcare Surfaces Institute has recently adopted a combination of the Hierarchy of Controls and the Seven Aspects of Surface Selection ™ as a quick guide for patient and healthcare worker safety as it relates to surface selection.
Healthcare surfaces have long been established as fomites -- objects or materials to carry microorganisms that can cause infection and illness. Research has shown that microbes can live on “clean and disinfected” surfaces for days, weeks, and even months. How is this possible when surfaces in healthcare settings are regularly cleaned and disinfected?
Surfaces are complicated. Discussion around the impact surfaces have in infection prevention and control creates confusion and misunderstanding. Some believe environmental or “high-touch” surfaces like sinks, counters, bedrails, door handles, light switches and patient equipment are the main contributing factor for the acquisition and spread of pathogens, but these surfaces only make up about 25 percent of surfaces in patient and procedure rooms.
Limiting focus on these surfaces and/or these thought process leaves about 75 percent of the surfaces that exist in the healthcare environment unaddressed. These include upholstery on furniture, walls, floors, linen, fixtures, and more. They also include surfaces made up of multiple surface materials that interact with patient and personnel, including medical devices, surgical equipment, and instruments. In addition, soft surfaces such as scrubs, hospital gowns, and bedding always move between various areas of the hospital and can serve as fomites.
Seven Aspects of Surface Selection™
To reduce the role that healthcare surfaces play in the acquisition and transmission of pathogens, the Seven Aspects of Surfaces SelectionTM must be evaluated to address this issue proactively.
1. Surface Materials and Textiles: There are many different surface materials and textiles used within healthcare facilities both in the built environment and products used during patient care.
2. Assemblies: Multiple surface materials on any one product must be evaluated individually and as an assembly for use and cleanability. Examples; beds and other medical devices, furniture.
3. Location of the Surfaces: High contamination and high-turnover areas require durable surfaces that can withstand frequent disinfection. Example; OR, ED.
4. Cleaning, Disinfection/Sterilization: Infection prevention protocol, process and products that will be used must be considered and an evaluation completed before products and surfaces are purchased and put into service.
5. Human Behavior: Humans continually interact with surfaces and move throughout the healthcare facility. While hand hygiene is critical, clothing and other products also move throughout the facility. Many questions exist around human behavior and transmission of microbes that cause deadly infections.
6. Microbiology: There are surface materials that support the proliferation of microbes despite routine cleaning. Manufacturers lack standardized testing for microbes that allow purchasers to compare products equitably.
7. Manufacturer Warnings and Instructions for Use (IFUs): Disinfectant compatibility testing for surfaces is rarely, if ever, conducted. It is concerning when manufacturers list all disinfectants as compatible without testing data and validation that they are in fact compatible, creating risk of damage and the potential for a voided warranty for healthcare facilities. It is also important that healthcare professionals request manufacturing warnings. In this document, you will find warnings that include chemicals used in disinfectants and detergents.
Note: Many products have multiple surface materials that cannot all be cleaned, disinfected and sterilized the same way. When they are damage occurs creating reservoirs for microbes to harbor out of the reach of biocides.
By incorporating the Seven Aspects of Surface Selection into the Hierarchy of Controls, an innovative method begins to emerge for addressing surfaces more comprehensively. The process more closely integrates infection prevention and occupational health and allows healthcare institutions, manufacturers, and experts the ability to address controls for surfaces in a more methodical process with the focus first on making the biggest impact.
However, currently, there are no consistent surface testing standards or requirements. This can leave those accountable and responsible for infection prevention and patient care at risk. This is due in part to a general lack of understanding and knowledge about the impact surface materials and composition can have on the ability to successfully clean, disinfect, and/or sterilize them.
Hierarchy of Controls
Controlling exposures to occupational hazards is the fundamental method of protecting workers. While this concept is typically used in occupational health and industrial hygiene disciplines, we can use the hierarchy to apply the same concepts to protect patients and their caregivers from healthcare surface-derived hazards as well. Traditionally, a hierarchy of controls has been used as a means of determining how to implement feasible and effective control solutions in a manner that provides first, the greatest level of protection.
The idea behind this hierarchy is that the control methods at the top of the graphic (below) are more effective and protective than those at the bottom. Following this hierarchy leads to the implementation of inherently safer systems, where the risk of illness is substantially reduced.
The traditional occupational health hierarchy was formally created in the 1960s for use in non-healthcare industries like manufacturing, mining and construction. It is used as the basis of federal and state occupational safety and health regulations, including the Occupational Safety and Health Administration (OSHA). For example, the OSHA Bloodborne Pathogens Standard has resulted in unnecessary needles being eliminated wherever possible (e.g. needleless IV catheter connections), reducing the risk of needlesticks. If a needle cannot be eliminated, can it be substituted for something less hazardous? This might mean using blunt fill needles to draw up medications from multi-dose vials.
If a needle cannot be eliminated or substituted out, can it be engineered to be safer? Disposable hypodermic needles with sharps injury prevention features (e.g., sheathing or retracting needles) are a perfect example of engineering controls.
If a needle cannot be engineered to be safer, are there work practices or administrative controls that can be put into place to reduce sharps injuries? This includes safe disposal practices and careful attention to surgical team safety when using no-hands or neutral zones for surgical instruments.
If, finally, none of these controls can be put into place or there is still an exposure risk after the higher controls have been implemented, does personal protective equipment (PPE) need to be used? Does a single or double pair of gloves need to be worn? Is there risk of a blood splatter, necessitating a gown and/or eye protection be worn to protect someone at the patient bedside or performing a diagnostic test on a patient sample in a clinical lab?
PPE is the lowest and least effective control on the hierarchy for many reasons:
1. It must be available to the healthcare worker when and where it is needed. It must be immediately accessible to them.
2. The worker must make the decision to put it on.
3. The worker must be properly educated about risk, so they are more likely to use it.
4. The worker must be educated about how to properly put it on (don) and take it off (doff) and to safely dispose of PPE so as not to contaminate themselves or inadvertently expose anyone downstream (e.g., environmental services and waste haulers).
5. The PPE must work. It cannot have gaps or tears or an undesirable level or permeability.
6. Multiple pieces of PPE must be compatible. If a procedure can result in a risk of a blood or body fluid splash or splatter (mucocutaneous), can eye protection be worn in an addition to a respirator? Or is the isolation or chemo gown long enough to cover the wrists in addition to glove use?
7. Cost and disposal are concerns. Since most PPE is disposable, providing PPE everywhere it is needed can be costly and if it is not properly disposed of, it can pose a risk to workers downstream. And since PPE is disposable, are there additional occupational or environmental concerns when PPE materials (e.g., latex, nitrile, vinyl) are made or when biohazard or red bag waste is incinerated?
In infection prevention and control as well as in environmental safety and health, professionals have focused heavily on PPE use as required by contact, isolation and/or transmission-based precautions.
Why do we focus on PPE for infection prevention and patient safety, often as a first line defense and not in occupational health and safety?
Why do healthcare institutions focus on work practices like properly cleaning and disinfecting environmental surfaces and cleaning and sterilizing surgical instruments and manufacturers are not held accountable and responsible for ensuring their materials and products meet the demanding requirements and needs of healthcare facilities and professionals.
There is a great deal that the infection prevention and environmental services community can learn from their occupational health and safety partners, including ways to integrate the hierarchy of controls into their processes, policies, and practices. Neither infection prevention nor occupational health have more resources than they need to reduce risks for the patients and providers they work to protect. The most effective programs are those that partner “across the aisle” and share not only resources, but expertise and experience.
The Hierarchy of Controls:
• Elimination: Physically remove the hazard; Institutional Controls: Culture of safety
• Substitution: Replace the hazard
• Engineering Controls: Isolate people from the hazard
• Administrative Controls: Change the way people work and interactive with their environment
• PPE: Protect the worker and patient with barrier controls
Integrating the application of the Hierarchy of Controls to the Seven Aspects of Surface Selection look like this:
It is believed that to reduce the risk of healthcare-associated infections (HAIs) and occupationally associated infections (OAIs) one must clean, disinfect, and sterilize surfaces, devices, instruments, textiles, and patient care items better. This certainly is one aspect of the solution. Unfortunately, it will not adequately address the problem.
When all aspects are included in the Hierarchy of Controls, a proactive strategy becomes clearer and more distinct. Patient and healthcare worker risks are minimized, and sustainable solutions and relationships can be realized.
Linda Lybert is president of Healthcare Surface Consulting and the founder/executive director of the Healthcare Surfaces Institute.
Amber Hogan Mitchell, DrPH, MPH, CPH, is president and executive director of the International Safety Center and a member of the board of the Healthcare Surfaces Institute.
Glenda Schuh, RN, BSN, CIC, and Caroline Etland, PhD, MSN, reviewed this article. Schuh is a consultant in infection prevention and occupational health. Etland is currently an associate professor at the University of San Diego Hahn School of Nursing, and a clinical nurse specialist at Sharp HealthCare. They both serve as board members of the Healthcare Surfaces Institute.