Written evidence submitted by Gama Healthcare (CLL0077)

Summary

Gama Healthcare is pleased to make this submission of written evidence for the Health and Social Care and Science and Technology Select Committees’ joint inquiry into lessons learnt from coronavirus.

This submission focuses upon the importance of effective infection control: specifically the need for disinfectant products to be able to demonstrate their efficacy through independent research and testing; and the need for clear guidance for end-users (including NHS staff, the private sector and members of the public) about the efficacy of the products they purchase and how to use them most effectively. It also highlights the importance being able to meet NHS single room capacity targets, which can help reduce transmission risk within hospital and other healthcare settings, and access to effective hand hygiene products.

The importance of infection control has been underlined by the pandemic and the has highlighted key role that prevention has to play in reducing transmission. Proper use of demonstrably effective products plays a crucial role in preventing the transmission of coronavirus – as indeed it can in preventing the spread of other communicable diseases and healthcare associated infections.

The demand for disinfectant products has increased exponentially as a consequence of the pandemic. However, while consumer choice and market competition can be beneficial, it should be a matter of grave concern that there are currently only minimal requirements for suppliers to demonstrate the efficacy of their products. This means there is significant risk of products making false or misleading claims regarding the level of protection they provide. There are already examples of regulators having to act, forcing companies to retract claims that they are unable to substantiate[1].

The seriousness of this situation is enhanced by the increased need for disinfectant products by the NHS at a time when its resources – both financial and personnel – are under unprecedented pressure. There is a considerable risk that procurement of disinfectant products could be driven by cost rather than clinically proven efficacy, with NHS staff and patients then left vulnerable by having to be reliant upon products that do not protect against numerous viruses and other pathogens – including SARS-CoV-2 itself.

At a time when NHS personnel are also at capacity, it is crucial infection control protocols are clear and maximise protection – and that the products provided to the frontline meet high specifications to prevent the transmission of infection and maintain staff and patient safety. We welcome the recently published HSE guidance for potential suppliers of hand hygiene and surface disinfectant products, but the UK must go further in monitoring compliance with the regulations – addressing misleading marketing and packaging claims; thereby providing customers/end users with assurance the products they purchase are fit for purpose.

About Gama Healthcare

Gama Healthcare designs, manufactures and supplies leading infection prevention and control technologies, and is the primary supplier of disinfectant wipes (Clinell Universal) to the NHS. Its team have also pioneered the development of the Rediroom, the world’s first instant isolation room that can be deployed for use to accommodate high-risk patients within five minutes.

Gama Healthcare was founded by two medical doctors, Dr Guy Braverman and Dr Allen Hanouka in 2004 with a mission to prevent infections and save lives. In addition to a team of scientists and technologists, the Gama team includes experienced clinicians and internationally-recognised infection prevention and control experts – including a number seconded to the NHS to advise on infection prevention and control and to work in the front line during the initial peak of the pandemic in the UK between March and July 2020.

Written evidence

• The deployment of non-pharmaceutical interventions like lockdown and social distancing rules to manage the pandemic

The range of non-pharmaceutical interventions to prevent the transmission of the SARS-CoV-2 virus that causes COVID-19 includes the decontamination of surfaces and equipment, since fomites are known to be a mode of transmission of respiratory viruses.[2] This, and enhanced hand hygiene are imperatives not only in the NHS but in other work and office environments, schools and individual households, many of which are new to these forms of control measures.

Government guidance on preventative measures for a range of workplaces has emphasised methods to minimise person-to-person contact, including use of one-way systems and ‘transfer zones’ for shared equipment. Guidance has also underlined the importance of robust hygiene procedures, including hand hygiene and surface decontamination.

There is now also a major focus[3] on preventing healthcare-associated COVID-19 infection, which focuses on key non-pharmaceutical interventions including hand hygiene, environmental hygiene, respiratory hygiene and related personal protective equipment (PPE), and early identification and isolation of patients with COVID-19.

However, if these strategies are to be effective, there must be clear an unequivocal regulation of the marketing and packaging of disinfectant products – specifically the claims they make as to their efficacy. There are currently no statutory requirements or minimum standards for disinfectant products[4], whilst cloth and bucket disinfectants, specifically those with chlorine content, remain highly used despite the greater effectiveness of other chemistries and combined cleaning and disinfectant wipes. This creates a significant risk in the workplace and domestic settings, particularly if the purchasing of disinfectant and cleaning products is driven by price and not by product efficacy. This risk has been heightened by the expansion of the infection protection and control (IPC) product market – with an increasing number of new disinfectants available to consumers, which must be required to demonstrate efficacy claims through research and testing. Any products that cannot substantiate their claims risk providing a reduced level of protection to end-users, potentially including minimal, if any, protection against coronavirus.

The continued risk to the public and need to protect NHS capacity means there is a strong case for i) greater clarity within national guidance for end users on what they should look for in terms of the efficacy of the products they use; and ii) the implementation of robust and enforceable minimum standards on disinfectant products to avoid misleading or inaccurate claims; and iii) guidance for end users on the safe and effective use of disinfectant products. This should include a requirement for products to have been subject to rigorous independent testing.

Introducing an assurance scheme similar to those administered by the Environmental Protection Agency (EPA) in the USA and the Therapeutic Goods Administration (TGA) in Australia which provides a list or register of disinfectants that have met agreed standards; have been tested to the right test methodologies and can substantiate any efficacy claims is one way forward. Such an approach would give end users greater assurance that the products they are purchasing and using are fit for purpose and simplify procurement processes.

It remains paramount that NHS services and staff use and can continue to access disinfectant products that are proven to protect staff and patients from the risk of transmission of pathogenic microorganisms, including coronavirus. We have also to remember that although the current issues with COVID-19 have brought infection prevention and control to the forefront, the NHS has for some time also been struggling with healthcare associated infections and the increasing number of cases of infection with multi-drug resistant organisms (MDROs), Clostridioides difficile and other viruses such as influenza and norovirus, many of which like the emerging threat of Candida auris[5], are resistant to a number of low-level disinfectant products. The threat from other pathogens that cause healthcare-associated infection (HCAI) will not have disappeared during the current crisis, it is just that they have temporarily fallen from the spotlight.

The 2016 Carter Report on NHS procurement recommended fundamental changes in practice, recognising the wide array of products, often with similar if not identical uses, purchased by the NHS; along with the need for increased transparency in procurement practices with the goal of saving the NHS c.£5 billion by the 2019/20 financial year.

We support the principles of the Carter Review in terms of the NHS demanding value from its supplier base. However, in the case of disinfectant products we would caution very strongly about future procurement being purely cost driven. This risks a ‘race to the bottom’, where products procured in future do not provide adequate protection for staff or patients. This would represent a false economy: it would increase the risk of pathogen transmission, thereby potentially putting increased pressure on health service resources. There is also an issue around product compatibility with medical devices and equipment, with the potential for some products (that are often cheaper in cost) having a corrosive effect on vital and extremely costly NHS equipment. A small saving in the choice of a disinfectant could lead to greater costs due to damaged clinical equipment, which if malfunctioning or out of service are then not available for patient care. Similarly, damage to other surfaces such as fixtures and fittings is often imperceptible to the eye but the damage caused can create a surface where microorganisms can attach more readily and become more difficult to effectively clean and disinfect over time.

Damage caused by such products would swiftly overturn any short-term savings made through procurement and put additional pressure on resources if vital equipment has to be taken out of service and replaced.

The pandemic has also demonstrated the importance of increasing NHS isolation capacity. The NHS in England currently has a target of 50 percent single room capacity but is short of meeting this target. The availability of single rooms to isolate patients reduces risks associated with admittance onto a ward setting. The NHS must consider innovative solutions including de-facto ‘pop-up’ isolation facilities that can be deployed at short notice. This would provide the health service with rapid response capacity in the event of highly contagious pathogens, of which coronavirus is one. 

• The impact on the social care sector

It is also critical that other health and social care providers, not just the NHS, have access to similarly effective disinfectant products – whose efficacy can be proven through rigorous clinical and scientific testing – and to be provided with advice and training on effective usage.

Government data has demonstrated that social care settings have been at high risk of coronavirus transmission, with many outbreaks reported. Effective infection control practices, including correct and effective use of disinfectant products with demonstrable efficacy, is critical to reducing the risk of transmission.

This is particularly relevant when the demands on staff capacity are high, it remains essential that best practice in infection prevention and control is maintained. Making the process of cleaning and disinfection as time efficient as possible will support greater compliance with cleaning protocols. A number of infection control products (including Clinell Universal) covers both the requirement to clean and disinfect in one step, demonstrably saving time and resource[6]. Changing to a single system not only saves time and effort, it has also been shown to reduce transmission of MDROs[7].

The impact on BAME communities

• Testing and contract tracing
• Modelling and use of statistics
• Government communications and public health messaging

The publication of guidance across sectors, in addition to health settings, is welcome given the importance of effective cleaning and disinfecting process to reducing the transmission of coronavirus.

However, whilst measures such as one-way systems and transfer zones for shared materials are welcome, guidance should go further by outlining best practice in terms of what cleaning/disinfectant protocols should look like; also what specifications business and the public should look for in the disinfectant products they are purchasing.

The government should also consider the introduction of minimum standards and regulations for disinfectant products, which should include a requirement for demonstrable clinical and scientific testing to prove efficacy against pathogens, including coronavirus.

As outlined above, the demand for disinfectant products has seen the market expand rapidly. There is significant risk that products can make misleading, inaccurate or unsubstantiated claims about their efficacy. Introducing minimum standards, which would apply to product descriptions and marketing, would reduce this risk to the public.

• The UK’s preparedness for a pandemic

It is clear the UK has learned considerable amounts about SARS-CoV-2 specifically, both in terms of its treatment and its suppression. Many of these lessons, particularly in terms of reducing the risk of transmission can also be applied to other viruses; MDROs and other new or emerging infections that could be the cause of future epidemics or pandemics.

A salutary comment in a paper published in 2005 after the first SARS pandemic commented “the agent’s tenacity is considerably higher than that of HCoV-229E, and should SARS re-emerge, increased efforts need to be devoted to questions of environmental hygiene”[8]. The re-emergence of a globally active pandemic coronavirus should remind governments that it is not a question of if, but when this will occur again.

In the future, the UK’s preparedness will be conditional on access to appropriate products that protect the public in all environments, including disinfectants as part of robust infection control strategies – also PPE and hand hygiene products. As outlined above, there is a risk that with market expansion, some disinfectant products may make misleading and inaccurate claims about their efficacy. This should be addressed by the introduction of regulations on the claims and marketing of products; a robust system of monitoring compliance with such regulations and minimum standards that include rigorous product testing. PPE and hand hygiene products must of course also be able to demonstrate quality/efficacy.

Unless and until such frameworks are in place, purchasing driven by cost rather than value– particularly if product efficacy cannot be substantiated through testing and research - puts the public at risk, but also creates unnecessary risk and can result in additional costs for NHS and social care settings (e.g. if disinfectant products are incompatible with and cause damage to high value devices and equipment).

Whilst the 2016 Carter Review correctly identified a need for transparency and greater efficiency in NHS procurement, we would strongly caution against cost being the driver on health service procurement, particularly in the case of infection control. This risks creating a false economy if ineffective products result in increased transmission risk that in turn places additional demands on NHS capacity; whilst incompatible products may cause damage (i.e. corrosion) to high-value medical devices and equipment.

Further information

For further information, please contact Dr Guy Braverman, Managing Director and Founder of Gama Healthcare

Nov 2020