HSI announces the creation of the Healthcare Surfaces Certification Program

Surfaces are fomites that contribute to the acquisition and transmission of microbes that cause deadly infections. There is a critical need for the comprehensive evaluation of surfaces and their ability to be efficiently and effectively cleaned, disinfected and sterilized.

A copy of this article may be found in the October 2019 issue of Healthcare Hygiene Magazine.

The Healthcare Surfaces Institute is a 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 donors 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 2023 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). 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.

Arch terms for the systematic literature review evaluating environmental surface cleaning and disinfection, surface compatibility, and selection: 

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 were 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 material’s 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 IFU’s 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 Institute continues to grow and evolve. Most importantly, the donors are committed to good science and collaboration to bring continuity and the development of the best requirements for certification that will drive true 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.

 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 donor of the Healthcare Surfaces Institute.

Ellen Turner, Global Marketing Director for Eastman Medical Polymer, a sponsor of the Institute, reviewed this article.