STERILE SERVICES
Key regulations: Disinfectionbytherules
When examining the regulations and directives governing the manufacture and sale of disinfectants and cleaners, Clare Clark - BSc (Hons) Microbiology, ACIST, MRB, technical support manager, schülke UK, explains why it is necessary to consider what constitutes a medical device (MD), and why this is significant.
Regulations and directives surrounding the production and sale of disinfectants into the healthcare sector are complex. These regulations are of significance to NHS Trusts and some understanding is required to ensure that chosen cleaning and disinfection products meet legal requirements for use in the hospital environment. Also, as various EU directives come into force, a number of products which have not undergone the necessary processes and approvals will cease to be available.
This has already been experienced in the
Republic of Ireland where a leading brand of alcohol based wipes has been discontinued as a direct result of not being supported through the essential directives. Whatever the outcome of Brexit, it is highly likely that the UK will continue to work with EU directives and regulations when it comes to classifying disinfectants and cleaners. This article gives an outline of the key influencing regulations, what they mean in practice and an indication of the timescale over which they are being implemented.
The Medical Devices Regulation (MDR)
On 5 April 2017, two new regulations for medical devices were adopted, replacing the existing three directives. These new regulations will apply following a transitional period of three years for medical devices and five years for in vitro diagnostic medical devices.
Although the core legal framework consists of two regulations, the one which is applicable to disinfectants and cleaners used in the hospital environment is Regulation (EU) 2017/745 regarding medical devices. This part of the regulation covers products and equipment which will come into direct contact with the patient. A product such as a flexible endoscope is
AUGUST 2019
In general, for a disinfectant to be classified as a medical device, it must be specifically indicated for the disinfection of medical devices.
classified as a medical device and, according to the regulation, any product which is used to clean or disinfect a medical device must carry a CE mark.
The MDR provides guidance on defining a medical device (MD) and is based on the stated intended purpose of the product. According to this EU Regulation, a medical device is defined as: “any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used alone or in
Clare Clark,technical support manager, schülke UK
combination, for human beings for one or more of the specific purpose(s)’ which includes ‘products specifically intended for the cleaning, disinfection and sterilisation of medical devices.”
In general, for a disinfectant to be classified as a medical device, it must be specifically indicated for the disinfection of medical devices. For example, when reprocessing a flexible endoscope, which is categorised as a medical device (as it is used specifically for diagnostic and / or therapeutic purposes) a disinfectant with an MD certification must be used during the process. The Medical Devices Regulation relates to the safety and performance of a product. For a manufacturer to legally place a device on the European market, the essential requirements of the directive must be met and a CE mark applied. These requirements ensure that a product is safe for its intended use and is fit for purpose. It must also carry appropriate labelling and relevant testing must have been carried out to a specified standard.
A CE mark is similar to the previously used UK Kite mark, but the CE marking is in line with EU regulations and directives. The letters “CE” are the abbreviation of the French phrase “Conformité Européene” which literally means “European Conformity”. The term initially used was “EC Mark” and it was officially replaced by “CE Marking” in the Directive 93/68/EEC in 1993. “CE Marking” is now used in all EU official documents. 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.
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