Abstract :
An Overview of the European Scene and Progress in Working Group 1
(Human Medicine)
R. A. Simpson
Healthcare Science Ltd, Unit 5 Northend Industrial Estate, Burymead Road,
Hitchin, Herts SG5 IRT, UK
Methods of testing the antimicrobial efficacy of disinfectant products differ from
country to country according to national standards and regulatory requirements.
Within Europe, work is underway to harmonize disinfectant test methods for
medical, veterinary, food and institutional applications within the European
Standards Committee, CEN/TC216. In replacing existing British Standards, the
new European Standards will also provide the technical basis for implementing
European Directives concerned with the essential requirements for safety and
efficacy of disinfectants, as in the draft Directive on Biocidal Products and the
recently published Directive on Medical Devices.
The scope of CEN/TC216 includes terminology, requirements, test methods
including potential efficacy under in use conditions, recommendations for use
and labelling. The work programme began with ʹPhase Iʹ quantitative suspension
tests used as a basic screen to establish whether a product does or does not have
bactericidal, fungicidal or sporicidal activity. Tests appropriate for the product in
use are developed in working groups for each field of application, as ʹPhase 2ʹ
tests covering an extended range of organisms (surface-dried and in suspension)
and specified test conditions such as organic soiling, water hardness and
temperature. The Medical Working Group is also producing tests for virucidal
and mycobactericidal activity, biocides against Legionella, hand disinfection,
surgical skin disinfection and antiseptics.
The technical issues raised in discussing tests for hygienic hand disinfection,
surgical hand disinfection and medical instrument disinfection have highlighted
differences in user, infection control and test laboratory practices across Europe.
Other issues for debate include health and safety and ethical considerations arising
from established methodology in Austria, Germany and the UK, whereby test
organisms are applied directly to the hands of volunteers.