John Curtin, managing director of Decontamination Limited, considers the products and services currently available to healthcare.

John Curtin, managing director of Decontamination Limited, with AFNOR standard NF T 72 281-compliant Phileas airborne disinfection products

With a wide range of environmental decontamination (ED) equipment and services to choose from, some healthcare facilities find it difficult to understand what they need to know to make an accurate assessment of available products and services. The aim here is to differentiate the fact from the fiction.

ED equipment and services can assist in:
• reducing infection rates by up to 80 per cent
• reducing the morbidity/mortality associated with these infections
• increasing patient safety and bed availability
• reducing costs associated with outbreaks.

With the proliferation of ED products and service what do you need to know to make a realistic assessment?

ED products/services available include chemical disinfection such as hydrogen peroxide, ozone, hydrogen peroxide mixed with a secondary disinfectant, chlorine dioxide, and ultra violet light. Some are sold for use by healthcare staff or provided as a service by manufacturers or their distributors.

A report is available which analyses the various products and their efficacy in comparison to the current guidelines and standards. What follows is an edited version of the report.

The products shown in the table below represent those widely used in healthcare across the UK, EU, and U.S.

Comparison of available Products and Services

What are the important points on which ED products should be evaluated?

1) Efficacy
2) Health & Safety
3) Suppliers with a Track record of Proven Deployment capability

1. Efficacy

a. Approved Disinfectant
For disinfectants to be deployed for ED, they must be approved in accordance with the EU Biocide Product Regulations (BPR) for the relevant product category, in this case PT2 – public and human healthcare. Approval must cover all active ingredients in the formula, and be able to show that ingredients not shown to be active are proven to be so. Suppliers will be able to provide Product Dossier Numbers to support compliance with BPR.

b. Efficacy standards
The only standard for spraying of disinfectant as a decontaminant in healthcare facilities within the EU, is the French standards agency AFNOR standard NF T 72 281. This requires both equipment and associated disinfectant to achieve a level of pathogenic kill, from a known quantity of pathogen, expressed as a log reduction. The current version was released in 2014.

The standard covers pathogens representative of the types found in healthcare facilities. To be compliant it must be conducted by an approved, independent, French laboratory. Certification is only granted to products which satisfy the criteria for all the required pathogens. Products which fail to meet the standard cannot be deployed in French healthcare facilities.

Since 2012 the EU has recognised that ED has become an essential part of the fight against infections. A working party was established to devise a standard for products (equipment and disinfectant) so healthcare facilities can have a reliable comparison for all those claiming to be able to deliver the results they need. The standard, which will soon be implemented, will be based on the French AFNOR standard NF T 72 281.
All EU providers of equipment and services will be expected to meet the new standard.

Of the products in the table only two appear to be compliant with NFT 72 281 (2014). Others appear to have only been tested in accordance with the standard.

c. The importance of understanding efficacy standards

• Allows users to compare marketing claims to independent data
• Standards have been met and disinfectants are approved for deployment

CLAIM
Taken from a UK website, for an ED product currently in use in UK hospitals:

“Low chemical consumption – 1m/m³”
“For example, an area of 50m³ can receive preventative treatment in just 33 minutes (3 minutes spraying, 30 minutes contact time)”

FACT
Laboratory test data provided by the manufacturer, to reach the NF T 72 281 (2104) standard, showed the following:
• Disinfectant required to meet the pathogenic kill requirements – 5ml to 7ml/m³, with 2 hours contact time.
• Cycle time – 3.5 to 5.5 hours. For some pathogens this meant a second cycle and 2-hour contact time.
• To reach the required standard for C.diff spores – a double concentration disinfectant was required, resulting in the need for secure storage and transportation.

d. Independent, published data on efficacy

Having your ED system independently assessed by recognised experts in the field of infection control, working for an eminent healthcare institution, in a healthcare environment and having effective results published in an eminent journal, can lead to user acceptance, and provide a significant advantage to the supplier for sales.

Additionally, a comparative study of ED technologies undertaken in the same manner, where one product is significantly more effective than one or, several others, can have the same advantageous effect.

However, can the data being presented in the published article be completely relied upon?

CLAIM
Article published in the Journal of Hospital Infection in 2013 claimed that an ED system currently deployed in UK healthcare had been used in 2008, to assist in infection rate reductions at a large NHS trust.

FACT
• The article’s named product did not exist in the UK in 2008.
• One of the authors of the article had presented at an international hospital infection conference in Liverpool, in late 2010, and attributed the ED assistance to an alternative supplier’s product
• On the basis of the above, the article was challenged by the alternative supplier

There is no implication that the authors of the article have deliberately misled either the journal or, its readers. However, the manufacturers of the ED system have used and continue to use this article as evidence of their product’s ability to assist in infection rate reductions.

This type of published data can assist in sales efforts.

Claims like this, and others, confirm the need for healthcare facilities to:

• Understand the information required for assessing ED products
• Be in receipt of independent efficacy data verified to a known standard
• Ensure products are independently proven to meet required standards not simply based on the fact they are ‘similar’ to validated technologies.

2. The importance of Health & Safety

The use of ED can come with risks. It requires proven health and safety protocols and appropriate equipment to protect deployment staff, patients, healthcare staff and visitors.

Healthcare facilities that intend to deploy either ED services or products must be able to rely upon the manufacturers’ and distributors’ recommendations for deployment and health and safety protocols.

Protocols should include:
• Proven Method Statement for deployment
• Risk Assessments in accordance with national/international standards or equipment, disinfectants, manual handling of the equipment and use of any ancillary equipment
• Materials Safety Data sheets for any disinfectant
• Confirmation that the disinfectant does not contain any substances or residues damaging to human health and are approved for purpose
• Certified training for operators, supervisors, and management
• Remote management/operation of equipment for maximum safety or, where not possible robust protocols for manual deployment
• Understanding deployment requirements for: ventilation systems, medical equipment, electrical equipment, and smoke detection
• Insurance to meet public, employer, and product liabilities

Providers should also be able to show:

• An understanding of the health and safety regulations that apply to the use of:
o Electrical equipment
o Disinfectants and their workplace exposure limits
o Suitable testing methods to ensure safety
o Recommended Personal Protective Equipment

What are some of the health and safety risks?
a. Disinfectant composition

The composition of disinfectants need to be assessed to ensure there is no risk of toxic residual precipitate or, airborne levels that may exceed approved exposure levels for toxicity or, require to be removed post decontamination. An area currently under scrutiny is the silver content of disinfectants used for ED.

The Biocide Product Regulations have no disinfectant containing active silver or silver compounds approved for the review participant process, for airborne disinfection. In addition, no disinfectant containing silver nitrate as an active biocide can be used for ED. This was recently reinforced by the Health & Safety Executive. Its statement read:

“Silver Nitrate containing biocides – is your infection control system legal?
UK Health and Safety Executive (HSE) statement:

“It would currently be illegal to make available and use a PT2 biocidal product, containing silver nitrate as the active substance, as silver nitrate has not yet been approved as a PT2 active substance and is being assessed as a new active substance.”

Hospital infection control managers, facility managers and purchasing teams are urged to review the biocidal products they use, particularly those associated with automated airborne disinfection or HPV systems and confirm that they do not contain silver nitrate. To reiterate, as per the UK HSE statement, it is illegal to market or use a biocidal product containing sliver nitrate as an active substance for a PT2 use.

In addition, if a product contains silver or silver nitrate as a non-active stabilising medium it must be able to prove that by providing the following:
o Product Dossier Number
All products that are part of the BPR review programme can provide this information.

CLAIM
Letter sent by manufacturer of ED products and disinfectants, to its users, currently in use in UK hospitals and the agent for providing the disinfectant for a competitor product also used widely in the UK stated the following:

“We ………… confirm our acknowledgement of the new European regulations, and that accordingly all our products,……, are in compliance with them.”

FACT
Both products had, previously, highlighted the fact that their disinfectants had active silver/silver compounds that potentiated the disinfectant process, meaning they required a lesser concentration of the other active biocide. Should this no longer be the case and the other active biocide has not been changed they will be able to provide a Product Dossier Number for the review programme to confirm this.

More importantly they, nor any healthcare provider, can rely on any validation/efficacy data that was produced, based on the original active substances. That data is no longer relevant to the new mixture. The manufacturer must be able to prove the efficacy of the new mixture.

b. Safe deployment
Of prime importance in the deployment of ED is that the provider can prove it is possible to deploy their products and services safely without risk to:
o Staff
o Patients
o Visitors
and that their methods are robust.

They must be able to show the following:

    o No risk of exposure to chemical beyond safe workplace exposure limits
o Suitable Personal Protective Equipment to be used by deployment staff, where appropriate
o Re-entry procedures are guaranteed to protect staff, patients, and visitors from exposure to higher than approved levels of airborne chemicals
o The chemical being used will have no detrimental effect to materials, electrical or, medical equipment
o Method statements clearly state what must be removed from and can stay in the area to be decontaminated

CLAIM 1.
A manufacturer of chemical-spray based ED systems uses relative humidity to assess the required levels of decontaminant to achieve disinfection and the safe levels of decontaminant remaining in the area at the completion of the process. Once the relative humidity has returned to the original level they claim it is now safe for re-entry and no further assessment is required.

They have considered this method is an acceptable alternative to the use of a gas monitor to assess the residual levels of airborne decontaminant.

FACT
Measurements, by users of this equipment and a recent independent, comparative study in a leading healthcare journal, using approved gas monitors have shown that the airborne levels of decontaminant still exceeded those approved for either short or long-term workplace exposure, at the point at which relative humidity returned to the level prior to the start of the cycle. Re-entry based on the manufacturers measuring system would be considered to be in breach of health & safety regulations.

CLAIM 2.
The use of extraction will guarantee that the levels will return to the safe exposure levels throughout the area being decontaminated. Extraction is used by some suppliers of ED with varying levels of success.

FACT
Extraction is used by some suppliers of ED to varying levels of success. If this is not a simple four-walled space but contains multiple rooms e.g. en-suite facilities this can impact on the ability to extract all the remaining decontaminant.

Extraction can only be used once the decontaminant has had sufficient contact time to meet its pathogenic kill levels. At this point the airborne levels are likely to still be more than the safe exposure limits. Because of this the extraction unit must be already in place in the area being decontaminated.

Additionally, the monitoring of the airborne decontaminant is being undertaken at a single point in the area and can only be representative of the levels at that point and not an average of the whole area. It will always be necessary to have a safe, protected method for assessing whether the whole area is safe for re-entry.

Extraction and on-board monitoring should only be seen as a guide to safe levels in the area.

3. Suppliers with a track record of proven deployment capability

Since 2010 several new providers of ED have entered the healthcare market. Most recently, some companies are now starting to offer franchises for ED businesses in healthcare to anybody who has the funding to buy one.

New ED products are being developed and some manufacturers are looking for distributors in countries outside their own territory to increase sales. Healthcare is considered a target market.

Healthcare facilities using providers without the necessary knowledge risk:

• Exposure of operators, patients, staff, and visitors to chemicals exceeding approved limits, leading to illness, impaired mobility and senses, hospitalisation, and potentially more serious outcomes
• Damage to expensive medical and electrical equipment due to inappropriate and/or excessive levels of chemical
• Increases in infection rates, rather than a decrease
• None of the patient and financial benefits of a professional and expert deployment.
• Healthcare staff needing to remove residual levels of chemical precipitate, necessitating PPE, adding to cycle times, with no assessment capability as to any residual health and safety risk.

Healthcare facilities need the following for an objective evaluation of ED products:

• Proof that products are effective in a healthcare environment
• Appropriate independent, verifiable efficacy data
• Proven expertise in the deployment of ED products and services in healthcare facilities
• Verifiable deployment references
• Be provided with proven protocols for the safe delivery of ED in healthcare facilities.

Manufacturers/distributors of ED products and providers of ED services

Healthcare is a prime target for manufacturers of ED and their distributors. However, distributors can be underprepared, have little or no background of the issues surrounding healthcare facilities and HCAIs.

Training for distributors is limited. Few manufacturers have expertise of healthcare deployment. Product support is often based in a different country or continent. This can create health and safety risks for all, as well as a risk to patient safety.

To ensure the most suitable provider is identified, manufacturers must be able to supply:

• Products proven to be effective in a healthcare environment
• Appropriate independent, verifiable efficacy data
• Proven expertise in the deployment of ED products and services in healthcare facilities
• Verifiable deployment references
• Provide proven protocols for the safe delivery of ED in healthcare facilities.

Failure to satisfy these criteria could result in, at best, additional costs, and no return for the healthcare facility. At worst, it could result in the healthcare facility relying on an ineffective process that results in increasing infection rates and patient deaths.

This is an edited version of a report entitled Environmental Decontamination in UK Healthcare. To request a copy, e-mail john@decontaminationuk.co.uk

John Curtin has been involved in the sale and deployment of ED products and services in the UK and internationally for more than 12 years.

Decontamination Limited is the UK Healthcare distributor for the AFNOR standard NF T 72 281 compliant Phileas range of airborne disinfection products.