EN 17430 - Interview on the introduction of the new standard for the efficacy evaluation of hand disinfectants

Dr. Brill Institutes offers important new support for hand disinfectant manufacturers

The Europe-wide introduction of the EN 17430 standard will revolutionize the efficacy evaluation of hand disinfectants in the medical sector.

Dr. Brill, what makes the new EN 17430 standard so important?

Dr. Florian Brill: "The standard represents a milestone in infection prevention with regard to evaluating the effectiveness of hand disinfectants. Until now, the effectiveness of these products against bacteria was tested in practice in accordance with EN 1500. Now, for the first time, the products can also be tested on test subjects against viruses. The standard therefore brings with it completely new requirements for hand disinfectants. Many products on the market now have to be tested in accordance with the standard. For us, this test procedure further rounds off our product range."

Dr. Paulmann, your laboratory team in Bremen was involved in the development of the standard for Dr. Brill Institutes and will continue to test products for customers in the future. What is so special about the new test procedure?

Dr. Dajana Paulmann: "It's a next-level test. We are testing whether the disinfectant virucides are effective on the surface of the hands. To this end, they are now being tested on at least 18 test subjects whose hands have been contaminated with the murine norovirus, which can only infect mice. Until now, the virucidal effect according to EN 14476 has only been tested in test tubes, which is not very practical because hands have a complex surface structure. Everyone on the market is familiar with the EN 1500 standard, which is used to test against bacteria. EN 17430 is the further development for testing against viruses."

For how many companies is the new standard relevant?

Dr. Florian Brill: "We can assume that between 50 and 100 manufacturers across Europe with up to 1,000 products will have to tackle the new tests. If you don't test, you risk a downgrade in the efficacy level. Products may then no longer be used in hospitals because their virucidal efficacy is no longer proven. The development of this standard began around ten years ago. We were involved the whole time - both in the experimental development of the test procedure and in drafting the text. There is no fee for this development work. But customers know that we are very familiar with the topic because we have been working on it for a long time."

How long do customers generally have to prepare for the test procedures?

Dr. Dajana Paulmann: "Companies now have 18 months to have their products tested in accordance with the new standard. The test is time-consuming and therefore takes around six to eight weeks. However, we have been offering a screening procedure for some time now, which has already been taken up. This works with five test subjects, only takes up to four weeks and provides customers with an initial impression of whether the product meets the requirements of the new test procedure. Anyone who then orders the entire test in the second step will, of course, be reimbursed for the screening procedure."

Is your development work in this area complete with the publication of the standard?

Dr. Florian Brill: "No, we will continue to work on the topic in order to ensure patient safety in the best possible way. As the new standard has so far only been tested with the murine norovirus, we are already researching other viruses for this practical test. There is definitely further research interest in this area."