Healthcare Hygiene magazine October 2019 | Page 30

HSI Announces Creation of the
Healthcare Surfaces Certification Program
By Linda Lybert and Caroline Etland, PhD, MSN
T
he 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). Inclusion criteria included experimental and
quasi-experimental research designs with quantitative
CLICK HERE FOR data, published since 1980, available in the English
Table 1
language, and accessible through online research
databases. Studies and reports were excluded if not relevant
(e.g., commentaries, reviews), provided no statistical report-
ing, 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,
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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 disin-
fection 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-reg-
istered 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 health-
care 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
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october 2019 • www.healthcarehygienemagazine.com