I rarely use the Talk Clean To Me blog as a means to vent,
but I just can’t keep quiet any longer on this topic. Over the last several months there has been increasing chatter about the need to
find a product that carries an HPV claim as a result of a
published study looking at the
efficacy of some disinfectants against HPV.
I can certainly understand the interest in reading such a study;
however, like any published work we need to understand the limitations of the
study and how that can be applied to your infection prevention practice.
but I just can’t keep quiet any longer on this topic. Over the last several months there has been increasing chatter about the need to
find a product that carries an HPV claim as a result of a
published study looking at the
efficacy of some disinfectants against HPV.
I can certainly understand the interest in reading such a study;
however, like any published work we need to understand the limitations of the
study and how that can be applied to your infection prevention practice.
My intent is not to disparage the study. However, as I have expertise in the
requirements for registering disinfectants with the EPA, the FDA and Health
Canada, I hope I can shed a bit of light on the topic so that you do not waste your
time trying to find a disinfectant with an HPV claim. The following are the questions I ask when
reading a study and determining its relevance:
requirements for registering disinfectants with the EPA, the FDA and Health
Canada, I hope I can shed a bit of light on the topic so that you do not waste your
time trying to find a disinfectant with an HPV claim. The following are the questions I ask when
reading a study and determining its relevance:
1) Question: Were the disinfectants used
representative of commonly used products for disinfection of environmental
surfaces or medical devices?
representative of commonly used products for disinfection of environmental
surfaces or medical devices?
Answer: The study did not include many of the
more commonly used disinfectant actives such as QUATs
or the up and coming Improved
Hydrogen Peroxide products.
more commonly used disinfectant actives such as QUATs
or the up and coming Improved
Hydrogen Peroxide products.
2) Question: Would the testing methodology used in the
study allow for the product(s) to be registered by the appropriate regulatory
body?
study allow for the product(s) to be registered by the appropriate regulatory
body?
Answer: The efficacy
method used in the study was not equivalent to what a disinfectant
manufacturer would have to conduct and submit to EPA, FDA or Health Canada in
order to make a claim of efficacy against HPV.
method used in the study was not equivalent to what a disinfectant
manufacturer would have to conduct and submit to EPA, FDA or Health Canada in
order to make a claim of efficacy against HPV.
3) Question: Are there any labs accredited by the EPA,
the FDA or Health Canada that can conduct testing against HPV to allow for
registration of a claim?
the FDA or Health Canada that can conduct testing against HPV to allow for
registration of a claim?
Answer: No.
An investigation of EPA, FDA and Health Canada accredited labs confirmed
that there are currently no labs that can grow HPV in a lab setting to a
sufficient enough titre that would allow for submission of such a claim.
An investigation of EPA, FDA and Health Canada accredited labs confirmed
that there are currently no labs that can grow HPV in a lab setting to a
sufficient enough titre that would allow for submission of such a claim.
Like HPV,
there are a number of pathogens that cannot be cultured in a lab and therefore
cannot be tested for efficacy. Generally, regulatory bodies recommend that when
testing for efficacy against these kinds of pathogens, surrogate organisms with
similar characteristics are used. For example, Human Norovirus, like HPV,
cannot be cultured in a lab; however, regulatory bodies have instead identified
Feline Calicivirus (FCV) as the surrogate that has similar qualities to Norovirus.
Therefore, if products can prove effectiveness against FCV, a Norovirus
efficacy claim can be made. This same concept cannot be used for HPV however;
regulatory bodies have not yet identified an appropriate surrogate as there is
no Health Canada, EPA or FDA approved test method for HPV. Therefore,
disinfectant companies cannot make an HPV efficacy claim on their product
labels.
there are a number of pathogens that cannot be cultured in a lab and therefore
cannot be tested for efficacy. Generally, regulatory bodies recommend that when
testing for efficacy against these kinds of pathogens, surrogate organisms with
similar characteristics are used. For example, Human Norovirus, like HPV,
cannot be cultured in a lab; however, regulatory bodies have instead identified
Feline Calicivirus (FCV) as the surrogate that has similar qualities to Norovirus.
Therefore, if products can prove effectiveness against FCV, a Norovirus
efficacy claim can be made. This same concept cannot be used for HPV however;
regulatory bodies have not yet identified an appropriate surrogate as there is
no Health Canada, EPA or FDA approved test method for HPV. Therefore,
disinfectant companies cannot make an HPV efficacy claim on their product
labels.
Although this study appears to have compelling evidence, one
must take into consideration the science behind disinfectant claims and what
current guidelines allow. Although there are no approved test methods for HPV
and there are no current disinfectants on the market that have claims for HPV,
it is logical to assume that disinfectants with multiple claims against
non-enveloped viruses could be effective against HPV.
must take into consideration the science behind disinfectant claims and what
current guidelines allow. Although there are no approved test methods for HPV
and there are no current disinfectants on the market that have claims for HPV,
it is logical to assume that disinfectants with multiple claims against
non-enveloped viruses could be effective against HPV.
Climbing down from my soapbox....thanks for reading!
Bugging Off!
Nicole
