Evidenced effectiveness

08 June 2012
Volume 28 · Issue 6

Bob Newsome explains the importance of proven science in product development.

Supply and demand is a theory that has driven economic thinkers for many a decade and from Keynes to Milton the concept of which element takes precedence has determined the economic direction of many countries and many businesses. In the main, products are supplied in answer to a market demand – whether real or perceived, but there are instances where demand is created by the supply of a product. The success of Apple is one such example; Apple has driven market demand for their products by creating 'desire', rather than meeting an implicit market need.

In terms of our own industry and infection control in particular, the need for products in this sector has been driven to a large extent not necessarily by customer demand but in response to the publication of HTM01-05 guidelines in 2009. Amidst the scramble to take advantage of the opportunity presented by this document it is important that companies do not lose sight of their responsibility to provide the market with credible, effective products, designed and developed with the support of robust scientific documentation.

My belief in the viability of evidence-based products comes from the heritage established by Dentisan's parent company Quadralene and is underpinned by the employment of our dedicated research and development team which includes several research chemists. Led by our technical director Peter Bacon, this team develops new formulations and technologies to meet many of the market's most demanding scenarios.

I believe that scientific credibility is important for a scientific profession such as dentistry and products which are backed by academic support have such credibility. In 2009 we established a Knowledge Transfer Partnership with Nottingham University School of Biosciences in order to add integrity and evidence to our manufacturing processes. Having worked alongside the University on the development of Bioclear we were presented with the Lord Stafford Award in 2010 in recognition of our role in this successful collaboration between academia and industry.

During the project, bioluminescence evidence collated by Prof Phil Hill together with extensive laboratory testing proved the product's efficacy against the bacteria that make up biofilm and its ability to inhibit re-growth. Proof that means as a company we are able to substantiate the claim that the use of Bioclear effectively removes Dental Unit Water Line (DUWL) biofilm and with regular use maintains water quality <200 cfu/ml="" achieving="" total="" compliance="" with="" htm="">

Such external validation of research processes should be the cornerstone of any manufacturing business and provides evidence that any product brought to market is designed to meet a specific need and is backed by scientific research rather than being the result of a marketing fantasy.

Science is founded on the search for evidence and the reproducibility of results. Success is measured in terms of the methods employed under controlled conditions in the lab, being able to be repeated in commercial practice with results that are consistent and achievable under the variable conditions found in a practical environment. The very nature of research and development requires the employment of strict processes that ultimately create a product that fulfils predefined conditions. For example in the case of surface cleaners it is difficult to reconcile compatibility with a broad range of materials and effective cleaning from a pH neutral product. The challenge in developing a product such as Biocleanse Ultra was to create a pH neutral formulation that could both remove soiling and disinfect in a single process and had broad material compatibility.

Our desire to develop an alcohol free surface cleaner was born from our understanding that the market was gradually migrating away from the use of alcohol based products. This market shift has itself been instigated by advances in bioscientific research which have highlighted the shortcomings of traditional alcohol and chlorine based disinfectants as effective cleaners.

In the past, alcohol was widely adopted as a disinfectant where its rapid drying properties were perceived as a benefit in achieving a short rapid turn-round time between patients, however various studies show that alcohol is not effective as a cleaner, particularly where protein based soils are present as is likely to be the case in medical and dental environments. So although alcohol will disinfect clean surfaces it does not clean effectively therefore necessitating a two-stage process to adequately comply with guidelines.

For practitioners and practice managers to make informed decisions about the products they use they must have knowledge and awareness of the science behind the need for infection control procedures, but should also seek the reassurance that comes from external validation.

Part of this prescribed external validation process is that products suitable for use within a healthcare environment must have CE marking. 'CE' is an abbreviation of the French phrase 'Conformité Européene' which literally means 'European Conformity'.

CE marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. Furthermore, CE marking indicates to governmental officials that the product may be legally placed on the market in their country and ensures the free movement of the product within the European Union.

Conforming to CE regulations requires stringent adherence to protocols and provision of evidence of research and conformity. Manufacturers must provide and maintain technical documentation and carry out conformity assessment procedures and when appropriate must protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints of non-conformance and product recalls. So in effect CE marking is evidence that procedures have been carried out to a sufficient standard to satisfy the regulatory bodies and in so doing offers consumers protection and reassurance that the products being used are fit for purpose.

The collation of data and statistical evidence to support efficacy of products is particularly important in the realms of infection control where practices must document use of compliant products in order to satisfy HTM01-05 regulations and pass CQC inspections. In these areas it is incumbent on practice personnel to select appropriate products that are fit for purpose and which can play a positive role in securing patient outcomes. To do so with confidence requires trust in the integrity of the manufacturing brand supported by evidence of the value of their research heritage and manufacturing strength.