A trusted source

Infection control is one of the most important aspects of running a dental practice and failure to meet regulations can result in severe penalties or even closure. So ensuring that all decontamination and cleaning products are effective and conform to regulations is essential. But how can practices be assured that their choice of infection control products will enable them to meet guidelines with confidence, without relying on internet hearsay?

A Wikipedia entry is likely to appear in the internet search results on any subject. This online encyclopaediahas 30m articles in 285 languages that can be edited by any individual, at any time. But anyone using the internet should be careful to only use trusted sources such as official company websites and should steer clear of unknown sites and unreliable recommendations. Even forums, where the exchange of professional opinion is becoming more commonplace, should be treated for what it is – private opinion made public, often by a small group of individuals who may or may not be in possession of all the facts about a particular product or service.

So if the internet cannot always be trusted to provide reliable information, where should dental professionals look to ensure the products they are buying are thoroughly researched and comply with the necessary regulations?

 

 

Companies working within the dental industry understand that ensuring that their products are thoroughly researched and developed helps to build a positive brand image and ensures professional trust in that brand. One way of assuring the quality of a product is for dentists to choose only products that are appropriately CE marked. CE marking is a legal requirement within Europe to show conformity with specific regulations for certain types of product including medical devices. For medical devices, the key criteria are based on:

? the ability of the manufacturer to substantiate the claims it makes for the product, and

? the safety of the product in either use or potential misuse. Medical devices in the area of infection control fall into two categories. The first is cleaners for medical devices, which are classified as class I medical devices and are CE marked by self-certification. For example at Dentisan, we are able to self certify based on our ISO 13485 quality system which demonstrates that the management of all our processes is robust and we are also registered with the MHRA as a manufacturer. The MHRA is the UK Competent Authority for medical devices and has responsibility for ensuring that the requirements of the Medical devices legislation are followed.

The second type of medical device refers to disinfectants for use on medical devices, which are classified as class II medical devices and are CE marked on the basis of an external audit of a technical file (TF). The TF is prepared by the manufacturer and must be able to demonstrate that the product meets all the essential requirements laid down in the legislation and that all the necessary evidence has been assembled to show safety in use and to support the claims made for the product’s performance.

In order to verify an application, the TF is assessed by a notified body acting on behalf of the MHRA. Once the notified body is satisfied with the information provided, the product can be added to the CE marking certificate making it possible for the manufacturer to place it on the market with the CE mark.

In addition to CE marking, third party product testing gives independent results, which logically have greater credibility than internal tests. The choice of tests carried out depends on the claims being made and BS EN 14885 determines which test methods are to be used for different types of microbiocidal claims and applications. Scientifically speaking it is also important to make sure that cleaners and disinfectants are tested for efficacy across the range as in some circumstances, for example in surface wipes, the wipe substrate can affect the efficacy of the disinfectant liquid with which they are impregnated. This can be the result of interaction between formulation components and the fibre materials or with chemicals that are used in the manufacture of the cloth. For a CE marked disinfectant product this test should ideally be performed after a period of storage correspondingto the shelf life of the product, thereby demonstrating that the formulation retains efficacy when in contact with the wipe material for the full period of the product’s shelf life.

Working with reputable external organisations is another way of demonstrating credibility and gives confidence to dentists and practice managers.

With ever-growing competition in the dental infection control marketplace it is easy for practices to think that one cleaner or surface wipe is pretty much the same as another. But in order to comply with guidelines practices need to use effective products that can be relied upon to perform to expectations – a practice simply cannot afford for its procedures to fall below this level. Purchasing products sourced from trusted and reliable suppliers, who have invested in the necessary external testing and accreditation processes, gives not only peace of mind but also keeps you ahead of the competition and on the right side of the regulatory bodies.

References available on request.