Healthcare Hygiene magazine September 2020 September 2020 | Page 38
patient safety & quality
By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT,
CADS, FACDONA, FAAPM, FNAP
Vetting Infection Control Technologies: Ensuring Safe
and Efficacious Usage in Healthcare Settings
Anytime there is a pandemic threat or large-scale outbreak
of an infectious disease, there is a predictable entry of
“novel” infection control products and technologies into the
U.S. marketplace. Many of these technologies claim to solve the
specific pandemic or outbreak-related threat yet may not hold the
necessary product registrations from the government nor have
independent efficacy validation to substantiate claims or safety
instructions. Most infection prevention and control products
will be regulated by either the Environmental Protection Agency
(EPA) or the Food and Drug Administration (FDA). In most cases,
products must first be approved by these agencies prior to being
marketed to customers. Healthcare facilities should carefully review
all product information prior to instituting product evaluations/
trials or implementing new products/technologies.
Here are a few best practices to ensure that any products
utilized meet the stringent requirements for safety
and efficacy:
1
Review the product’s registration or approval classification. For
products that are used on humans or given as medications, they
will be regulated by the FDA or the EPA. To determine whether a
product hold these regulatory approvals, healthcare providers can visit
www.fda.gov or www.epa.gov. All product registration information
indicating product approval or registration is available to the public.
2
Review the product’s technical data specific to efficacy, claims,
and safety. It is imperative that healthcare users evaluate products
to ensure that they are safe for the patient, healthcare team, and
environment, and also are efficacious and deliver upon their clinical
claims (e.g., microbe-kill claims, etc.).
3
It is important to note how long an infection control product takes
to work such as an environmental surface disinfectant may take
5 minutes to fully inactive all microorganisms. While, in this example,
that would be appropriate for disinfecting an animate surface, this
timeframe would be far too long for healthcare professionals to
wash their hands. Therefore, products must have reasonable contact
times to achieve efficacy so that compliance with use remains as
high as possible.
4
Ideally,
utilize products that are broad spectrum and demonstrate
validated efficacy against the following key microorganisms:
a. Gram-positive bacteria
b. Gram-negative bacteria
c. Enveloped viruses
d. Nonenveloped viruses
e. Pathogenic fungi
f. Bloodborne pathogens (minimum of hepatitis B virus and
HIV) for environmental surface disinfection especially
g. Bacterial spores as appropriate
5
Speak with colleagues in other healthcare institutions that are
current users of the product to determine their experience
with the product or technologies. This type of personal experience
can be invaluable.
6
Review the product’s safety data sheet to conduct a risk assessment
about potential risks that might be relevant to either the
patient or the healthcare team.
7
Involve your facility infection preventionist (IP) upfront in the
product evaluation checklist. The IP must be an integral partner
in evaluating any new technology to ensure that it meets the current
evidence-based standards and guidelines related to infection
prevention and control.
8
In addition to vetting the safety and efficacy of infection
control-related products, healthcare facilities should ensure the
compatibility of certain products such as environmental disinfection
agents with common surfaces specific to the facility (e.g., overbed
tables, counter tile, stainless steel, etc.).
Emerging infectious disease challenges
and threats create a sense of urgency in the
clinical practice arena, but also can create
risks associated with non-vetted products
that might endanger patients. Following a
standardized process, involving the facility
IP, and thoroughly vetting each product will
significantly mitigate the risks associated
with these new market entrants. IPs bring
unique expertise to the table related to
product evaluation and are an integral
part of the value analysis process in both
inpatient and outpatient settings.
While we cannot stop every outbreak
or pandemic, through a proactive and
comprehensive approach to infection
control, we certainly can be ready and
able to respond to the next infectious
disease threat that might land at our
front doors.
IPs bring
unique
expertise to the
table related
to product
evaluation and
are an integral
part of the
value analysis
process in both
inpatient and
outpatient
settings.
J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC,
PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT,
CADS, FACDONA, FAAPM, FNAP, is the president and CEO of
Community Health Associates, LLC. He also is an adjunct assistant
professor of medicine in the Division of Infectious Diseases at
the University of Louisville School of Medicine. Dr. Garrett is a
frequent lecturer globally on patient safety, infectious diseases,
and medical device reprocessing and safety. He can be reached
at: [email protected]
38 september 2020 • www.healthcarehygienemagazine.com