University of Chicago
Type of paper: Thesis/Dissertation Chapter
European EN and International ISO standards
The abbreviations “EN” refers to European Norm while “ISO” refer to International Standards Organization. Endoscopy literally means “looking inside” and it is usually refers to look inside the body usually in relation to medical reasons using an instrument called an endoscope. It is used to examine the interior parts of a hollow organ or cavity of the body, and they are inserted directly into the organ.
The endoscopes, especially flexible endoscopes are usually complex but can be reused but require very unique conditions for reuse in respect to their decontamination. It is not only their outer surfaces that are exposed, but also their air channels, water channels and even their accessories that enable them to function in the right manner. Their exposure to body fluids and other contaminants means that their reuse has to be very carefully looked into so as to avoid spread of diseases. It is also important to realize that most endoscopes are heat labile and cannot be autoclaved meaning they change under different heat conditions.
European (EN) and International (ISO) standards that would be applicable to an endoscope decontamination unit (EDU) in the UK
As abstracted from EN ISO 15883, information from the manufacturers should be given prior to purchasing the endoscope. This implies that the manufacturer provides information such the best disinfectants to use with that particular endoscope and what is expected when cleaning, for example the bacteria expected to be found there and also if the disinfectant in question is compatible with the automatic reprocessor in which it is being used. (Gurusamy Manivannan, 2008)
As per BS EN ISO 15883-1, a temperature recorder having no fewer than ten sensors should be used, and the specifications are well indicated in the ISO standard. This is because the endoscopes are heat labile, and temperature may affect the chemical compositions of the accessories or other chemicals involved.
The manufacturer should also establish the worst conditions under of the devices configuration. Such conditions encompass temperature, detergent concentration and surrogate device configuration. This also includes water flow pressure for use during testing. This may also be categorized in a similar manner as biocompatibility testing where limits such as residual limits are stipulated as per ISO 10993. (Denise Sheard, 20120
The calibrations should be checked in accordance with ISO 10012-1 for uniformity purposes. These are usually dictated by manufacturers using a validated method of applying a sensible reference. Each instrument should also be labeled with a unique reference number. This is important when measuring passage of fluids or drugs so as to get accurate and true results.
The standard prEN ISO 15883-1-2004 has a clause that indicates that the manufacture shall all addition information associated with the use and decontamination of the particular endoscope. Information such as maximum flow and pressure of fluids within each channel in the device and the maximum possible permissible restriction of flow within each channel is deemed important and must be provided. (James Walker, 2014)
There is also a standard similar to both that the manufacturers may be requested to give information concerning the device at any stage, and act as consultants. This is stipulated in prEN ISO 15883-1-2004. This is important when complications arise that personnel involved were not expecting
Gurusamy Manivannan, Disinfection and decontamination: principles, applications and related issues. Boca Raton : CRC Press/Taylor & Francis Group, 2008
Denise Sheard , A practical guide to decontamination in healthcare . Hoboken: John Wiley & Sons, 2012.
James Walker, Decontamination in hospitals and healthcare. Oxford: Woodhead Publishing, 2014