STERILE SERVICES
well as the disinfection of medical devices. The process of authorising active substances for registration is currently underway. It is likely to take a number of years with 2024 being the estimated completion date. The first stage is the authorisation of active substances which need to be registered with a competent authority and 22 different product types are listed under BPR. Any substance not falling into one of these 22 categories or not being registered cannot be sold within the EU. A new active substance will need to be evaluated to ensure that it poses no unacceptable risks before products containing it can be authorised and made available on the market.
Once the active substance has been approved by the Biocidal Products Committee, there is a two year period in which to register the finished biocidal product. Some active substances have already been approved such as alcohol and are therefore currently going through the product approval stage. Once a product has gone through this process, an approval number is supplied which will be added to the label of the product. This means that some disinfectants may eventually carry both a CE and a BPR number.
As more active ingredients are approved, disinfectants in the UK will start to include a BPR number on their labels, until this time, Trusts can ask manufacturers if the product has or is in the process of applying for BPR
registration. The process has already taken place in the Republic of Ireland where disinfectants now carry a BPR registration number on the label. Products not undertaking this process may not be available to purchase in the not too distant future. If a manufacturer does not wish to
undertake the lengthy and costly BPR registration process, they are obliged to remove the product from the market, as has already been seen with a particular brand of alcohol wipes. More disinfectants are likely to be withdrawn from sale as manufacturers fail to conform to BPR or decide to withdraw from sale within the EU. The UK’s likely withdrawal from the EU is not likely to change the way that MDR and BPR affect the classification and regulation of cleaners and disinfectants in healthcare settings in the UK. Manufacturers are intrinsically linked to Europe and this is unlikely to alter. In the meantime, Trusts should consider that not all cleaners and disinfectants will continue to be available, and not all will necessarily comply with the standards set out by the MDR and BPR. To protect both patients and staff, it is essential to check that all disinfectants and cleaners are compliant with the necessary regulations.
Reference
1 Medicines & Healthcare products Regulatory Agency (MHRA). (2016) Guidance on legislation Borderlines with medical devices
CSJ
To learn more about ‘Regulations, Norms and Guidelines’ type the link below for 45 minutes’ verifiable CPD based on a presentation to the Institute of Decontamination Sciences (IDSc) annual conference 2018, by Mr Wolfgang Merkens (Schulke & Mayr GmbH). The course has been designed in conjunction with the IDSc and includes the role of disinfectants in the decontamination process together with a review of criteria commonly used for the selection of disinfectants.
www.schuelke-learning.com/course/ disinfection-selection-for-reprocessing- flexible-endoscopes
AUGUST 2019
WWW.CLINICALSERVICESJOURNAL.COM I
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