Dec 10, 2020

The role of air sterilisation in the fight against Covid-19

air sterilisation
infection control
covid-19
Katie Houghton
4 min
The role of air sterilisation in the fight against Covid-19
Katie Houghton, managing director of CorrMed, explains how air sterilisation could be the superhero in the fight against Covid-19 this winter...

When trying to figure out what ‘best’ to do for the UK and globally in these unprecedented times, it is easy to become paralysed with indecision at the options. Do we prioritise the NHS while keeping the economy closed and people at home, or is it ‘best’ to open the economy and try to save jobs, knowingly increasing pressure on healthcare workers? 

Add to this the threat of a ‘twindemic’ with seasonal flu and that indecision deepens. The biggest challenge is people. People spread the pandemic, the pathogens, and the possibility of more problems, and no amount of cleaning, face masks, or hand sanitising can fully eliminate risk as long as people keep interacting. So, what should we do? 

Air sterilisation might just be the unsung hero for this problem, both within and beyond the healthcare setting, and both as a short-and long-term solution to support the economy reopening without deepening the risk. 

How long will people be prepared to wear masks in public or stick with the rule of six? Shouldn’t we be looking ahead to see how we create long-term pathogen controls in public places and offices, not only to reduce the immediate risk and deliver infection control, but also to generally decrease infection risk and absenteeism within the economy? 

This can then go hand in hand with the longer-term proactive measures like vaccine and medicine developments which will no doubt help to reduce and treat cases, minimising deaths in the coming years. 

What is air sterilisation and how does it help? 

Aside from the emergence of new, unseen pathogens like Covid-19, the biggest challenge in infection control stakes is the movement of people. An area is only ‘clean’ in the moments after it has been cleaned, before people make their way through it; coughing, spluttering, and touching, when aerosolised spores and pathogens start to resettle on surfaces. 

Add to this the long-tail incubation period of Covid-19 and a single infected individual is unknowingly spreading the virus for days before they show any symptoms. 

Current guidance for managing infection risk has three core focuses: cleaning, accurate record-keeping, and space adaptations such as Perspex screens. The question is whether these steps are enough, or whether they just create the perception of safety within an environment. 

According to research by King’s College London, who ran an antibody testing study, at least one in five people from the group didn’t show any symptoms at all of Covid-19 despite having, or having had the virus. Meanwhile more than 25 per cent who did fall ill, did so without having any of the three core symptoms that commonly identify those with Covid-19. The average business cannot claim to be infection control experts, so how can we manage the real risk of infection effectively? 

Air sterilisation is not actually a new solution, but it is in my opinion a severely underutilised one. It involves the installation of a discrete, standalone unit which works by using a series of air and surface purification technologies to help manage infection risk in a room. 

Each brand varies slightly in terms of what techniques are used and how effective they are, but they will have a set purpose to neutralise microbes, bacteria, dust or even odours. We are the UK distributors for a brand called AIRsteril for example, which works both for air sterilisation and surface sterilisation by producing plasma quatro.

The AIRsteril technology specifically combines sterilising, cleaning, and purifying technologies, including germicidal UV light, dual UV operation, Photocatalytic Oxidation (PCO) and a purifying plasma of superoxide ions and optimal ozone. These techniques together kill up to 99.9 per cent of germs and viruses, before releasing the purified air back into the room as a plasma. 

The plasma then kills airborne pathogens, viruses, bacteria, fungi, mould spores and allergens, and decomposes odours and harmful gases. Its effectiveness was tested by Leeds University and shows that airborne microorganisms were undetectable after just 60 minutes.

This is where things get really cool, as the process not only manages airborne infection risk, but also sanitises surfaces and the wider environment. The purified plasma breaks down microorganism cell walls, destroying the cells and preventing them from reproducing. As the plasma moves over surfaces – any surfaces including hard and soft materials – it also kills the germs which are left behind by touching, breathing and coughing or which have settled in the environment.

The core advantage is that it works constantly, so even if people move around and leave pathogens behind in between cleaning schedules, viruses and bacteria will likely be eliminated in a matter of minutes if not hours. To put this into context, AIRsteril was tested in a quantified NHS call centre environment, prior to the pandemic; constant air sterilisation resulted in a 42 per cent reduction in absenteeism, particularly for asthma, cold, cough, influenza, chest, and respiratory problems.

While the priority here was managing absenteeism, this model translates to significantly reduced infection transfer, and significantly reduced disruption through suspected Covid-19 cases.

For me, the solution isn’t simple, but I genuinely believe that we can successfully minimise infection risk through a combined effort of public and private measures, medicine and vaccines, and with the addition of active technologies like air sterilisation to manage the overall risk.

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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