Testing requirements of dental decontamination equipment

The performance of dental decontamination equipment has been brought into focus over the previous 10 years with the publication of European standards, Health Technical Memoranda and the myriad of publicity regarding variant Creutzfeldt-Jakob disease. We have seen instruments become single-use and then single-patient use due to perceived shortfalls in decontamination processes (Department of Health (DH), 2010) and adverse publicity surrounding dental decontamination (Daily Telegraph, 2012).

This article discusses the particular requirements surrounding testing (or validation as its correctly called) of this equipment.

Let's start at the basics. What equipment do we actually mean? Fundamentally, this article is going to talk about steam sterilizers (or often called autoclaves) and washers. These are often referred to as benchtops, although they don't necessarily fit on a bench. In European standards parlance, this may be defined as ‘small’ (British Standards Institute, 2010) (in the case of sterilizers) and maybe complex or relatively simple. The European Standard, BS EN 13060 (British Standards Institute, 2010), defines a small steam sterilizer as one having a chamber capacity of less than 60 litres and therefore most of the sterilizers used in dental surgeries will be within that category. However, the European Standard for validation of steam processes, BS EN ISO 17665 (British Standards Institute, 2006), makes no such differentiation. Neither does the European Standard for washers (BS EN ISO 15883 [British Standards Institute, 2009]). This leads to a fundamental question that we should all ask ourselves. If: