REGULATORY FRAMEWORKS
Why should this be of concern to the public and the medical profession?
The thankless task of policing and implementing these incomplete regulations is left to the notified bodies in each country. In the UK, those notified bodies are the MHRA for medical devices and medicines, with the HSE responsible for both biocides and cosmetics. Regulations pushed out by the EU, that the notified bodies may not have been involved in creating, or even consulted on before they were legislated on by the European court, are simply expected to be implemented. As you would expect, the notified bodies are understaffed to deal with the enormity of the task, leaving them with the ability to react to complaints, and very little by way of the active seeking out of non-compliance. The grey areas between the BPD, cosmetic regulations and the Medical Devices Directives (MDD)3
- soon to be the
Medical Devices Regulations (MDR), do not help either the notified bodies, or the companies who are balancing cost of registering, with the appropriate regulatory framework for their products.
An interesting conundrum is that, both the BPR and the MDD frameworks can be used for certain chemicals which are used in the medical/healthcare industry. One of the distinctions used, is the Mode of Action (MOA) which is either chemical of physical. Some groups of chemicals have a “physical action” not a chemical action when killing various species of microbes. In fact, some compounds are so complex, that they can kill different types/species of microbes with different MOAs, at different temperatures, at different concentrations.4-6
The following description is taken directly from the BPR and states that it does not cover “physical or mechanical action”: “Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.”
The MDD describes a medical device as:
“An instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which a) is intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease.”
Many chemicals are described by experts in biochemistry as having a physical action in killing microbes,4-7
but what does this
actually mean? In fact, it could be argued that ‘cleaning’ with a physical action could be undertaken by a person with a cloth and water, wiping over a surface. Does this action clean? Is it a physical action? Yes, it
In China and the USA the regulatory framework’s primary function is to protect the population and, although the regulations can be confusing, there is a clear distinction of what product type comes under which regulatory framework.
must therefore register as a medical device. Or does it? It is easy to see where the arguments can start - does the chemical kill by a physical action, or chemical reaction? In fact, under the strict adherence to the BPR guidance, non-treated water should be registered as a biocide, as it is effective at killing numerous organisms, especially when boiled. So does the temperature kill the microorganism or does the water? In the new MDR, which are due to come into force in the EU from May 2020, regulators have made an attempt to clarify some of these issues and terms. Unfortunately, they have failed to do so well enough, and the potential for argument and varied opinion remains. In the case of the BPR, this flaw in the
regulatory framework is most apparent with new technologies and products needed to deal with the increasing numbers of disinfectant bacteria being identified. The now proven link between disinfectant resistance and antibiotic resistance9-12
is probably one of the most
important causes of concern in the modern age. While billions are being spent across the globe on the development of new antibiotics, almost nothing is being spent on the development of new disinfectants, or in new methods of ensuring disinfectant stewardship.12 As the resistance to either antibiotics or disinfectants has now been proven to cause resistance in the other, we can no longer separate the two. We need a global strategy to advance technology in both areas, otherwise solving a problem in one will be ineffective, as the build-up of resistance in the other area will still occur, causing resistance in both.
While we test patients with resistant bacteria to ensure cocktails of multiple antibiotics are working, almost no testing of chemical efficacy for cleaning is done in our healthcare establishments. We rely on poorly prescribed standard chemical efficacy testing that was developed over 30 years ago. These tests have been proven to be of no value in vivo and are not the correct test methods for many chemical technologies.13
Pigeonholing products
In trying to pigeonhole products into regulatory frameworks that simply are not able to cope with new technologies, and by making those pigeonhole regulations so complex as to be almost unintelligible, European regulators open themselves up to arguments over new technologies and even
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to arguments over older technologies. Instead of asking the simple questions constructed by more reasoned (if no less frustrating) regulatory pathways, such as those in China and the USA, European regulators may be wasting time and effort defending the indefensible. The real concern to us all, at this time of rising antibiotic and disinfectant resistance, should be that regulators may be blocking important advances in disinfecting technologies from becoming available to healthcare establishments throughout Europe. The situation now is that individual country notified bodies are in almost continuous arguments with chemical manufacturers over what is - and what isn’t - registered and approved for use. In addition, which regulatory framework a product or chemical should be registered with, causes further argument and wastes everybody’s time. In most cases, while the European regulators take their time in finalising the register, manufacturers supplying well proven products that are safe and efficacious, simply ignore the regulations, waiting for the notice to “cease and desist” before taking any actions. You might reasonably ask: “Who benefits from this new form of ‘regulatory tax’, and how did it come into force?” Clearly the EU and European Commission have benefited significantly from the “windfall taxes”. In the case of the BPD to BPR change, with more than 7000 products previously registered with the BPD, and with potentially multiple uses and fees with each chemical required to be registered, these financial benefits are easy to see. It is highly likely that regulators have been significantly influenced by large chemical companies lobbying the EU regulators via EU commissioners and politicians, rather than focusing on the safety and efficacy of the products they meant to be regulating. This type of lobbying was proven to change regulatory policy and regulations in the medical implants sector with disastrous results,7
numerous calls to regulate devices in the same way as medicines.8
and there have been Strangely, this
would actually be similar to the way in which the US and China regulate devices. If lobbying is changing the regulations to benefit large companies, then clearly the level of the fees required to register products is also intended to keep small to medium enterprises from registering new products.
OCTOBER 2019
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