At a time when the NHS is facing a changing future, we look at the increase of single-use wipes and the development of new test methods that enable simpler and more accurate purchasing decisions
Wipes have been used to remove dirt from soiled skin and surfaces for many years. The concept of the single-use wipe is not new, however, in recent years, there has been a significant increase in the development, education and acceptance of single-use wet wipes in the healthcare market. Wipes are now the accepted and ‘normal’ method of cleaning and disinfecting high touch areas, non-invasive medical devices and surfaces in the near patient environment within healthcare settings. As a result of this market trend, the NHS is now one of the major consumers of cleaning and disinfectant wipes in the UK. Since 2011, when the Royal College of Nursing wrote ‘Wipe It Out’, their guidance paper on the selection and use of disinfectant wipes, the development in wipes technology and availability through NHS supply routes has enabled all parts of the NHS to benefit from the practicality, time saving and lower risk of contamination that wipes can offer.
Infection control and prevention is one of the major challenges within the healthcare environment. An estimated £1 billion per year is spent by the NHS in combatting healthcare acquired infections (HCAIs). If selected and used correctly, wipes for cleaning and disinfection can be an effective means of supporting the fight against infections.
Wipes guidance
Six years ago, the Royal College of Nursing made recommendations following a review of the use and selection of wipes in health care. They put forward the recommendations having noted that at the time, there was little or no guidance available to support the decision maker when choosing wipes as an effective infection prevention intervention. “The selection of an appropriate product can be a complex process that includes the consideration of scientific information and the interpretation of laboratory test data. The need for rigour in purchasing any item for use in a health care setting is also important to ensure financial resources are used appropriately.” (Wipe It Out: 2011)
Their recommendations included a collaboration between scientific and professional organisations, users, manufacturers and standards organisations in order to investigate the development of realistic standard test methods. A further recommendation was for manufacturers to
provide test data on the efficacy of active ingredients with shorter contact times. This furthers a report by Gareth Williams of Cardiff University, Wales, which was presented at the American Society for Microbiology General Meeting in Boston in 2008. It reported that bacteria were removed from surfaces when wiped, but were not necessarily killed, thus creating a potential source for recontamination. Many leading wipes providers rely on brand names for credibility. As such, efficacy claims made by such brands are used for headline sales purposes and often not referenced back to detailed reports. Wipes that are only tested in laboratory conditions with a solution test may not be advanced enough or reproducible in a healthcare working environment. Long contact times are not realistic in a hospital environment. Time constraints on staff as well as the warm conditions mean surfaces will not be wiped and remain wet for the whole contact time duration.
The microbial efficacy of disinfectant wipes has traditionally been tested by extracting the impregnated disinfectant solution from the wipes and adopting the EN standard designed to test liquid disinfectants, not wipes. Using a solution test to measure the efficacy of wipes means that there is no consideration for the amount of active solution a wipe will release to a surface when used, or the impact of the pressure, the wiping action and any cross contamination. The material used to make a wipe can make a significant difference to the efficacy. Some materials will absorb and not release certain parts of a solution meaning that a solution might have efficacy against certain organisms but when it is released from a wipe, it can no longer provide that efficacy.
Testing the efficacy of wipes
In 2015, Dr Jürgen Gebel of the University Hospital in Bonn, Germany, and his team published the EN16615:2015, which is now the only accepted and referenced EN standard for testing the efficacy of disinfectant wipes. The objective of the EN 16615 is to test the actual wipes efficacy rather than the extracted solution used in the wipe as per previous test methods. This gives a better representation of the wipes in use by using a mechanical wiping motion with a constant measured pressure on the surface. It ensures there is no cross contamination caused by the wipes and confirms the compatibility between the active ingredients in the solution and the wipe material.
The steps below (also illustrated) describe Dr Jürgen Gebel’s method for EN16615 tests.
- A vinyl test area is prepared, replicating the surface to be disinfected. This area is marked with four 5x5cm squares (25cm2). EN16615 is known as the ‘4 field’ test because of the four test fields.
- The first field is inoculated with a measured amount of the microorganism to be tested. EN16615 has been developed to test for efficacy against bacteria and yeasts.
- The microorganisms are dispersed evenly over the first test field and the surface is left to dry. The remaining three test fields are left ‘clean’.
- To simulate the physical downward force of a person wiping a surface, a block weighing 2.5kg is placed on top of the test wipe.
- The block is pushed from the side in a smooth, two second, motion across the whole test area. The wipe is carried first over the inoculated field, then over the clean fields two to four.
- This wiping motion is then reversed, with the block and wipe pushed back over all four fields in another smooth two second motion. By passing the wipe back over clean fields, the test shows if cross contamination is occurring.
- After the requested contact time, all four fields are swab tested to measure the presence and level of the test microorganism.
Passing the test requires a five log reduction in bacteria or four log for yeast in test field one and less than 50 colony forming units (cfu) of organisms in fields two to four.
Pal International, the Midlands-based innovator of infection prevention products and owner of the Medipal brand, has been actively campaigning to raise awareness of the first real-world, European test for chemical disinfectant wipes. Manufacturing and operating under strict quality management systems such as BSI ISO9001:2008, ISO13485 (CE Marking for Medical Devices), ISO14001 (Environment), BRC and GMP and Halal, Pal International works with active substance suppliers from the Article 95 list of approved suppliers, accredited testing laboratories and established non-woven materials manufacturers to produce disinfectant wipes that are truly compliant at all levels.
Responding to healthcare market demand for a robust single-use product, the company has applied its technical expertise, as well as an understanding of the strict regulations surrounding the use of disinfectant chemicals in their wipes to create the new Medipal 3in1 Disinfectant Wipes. This product range can be used for cleaning and disinfecting as well as offering sporicidal efficacy whilst remaining alcohol and PHMB free.
Medipal 3in1 disinfectant wipes continue to be compliant with the latest regulatory requirements governing harmonised product safety, efficacy and consumer communication across Europe. Medipal is at the forefront of regulatory developments such as EU exit matters concerning the Biocidal Products Regulation, implementation of the Medical Device Regulation in 2017 and new efficacy test standards. Whilst efficacy tests are constantly being reviewed and developed such as the new prEN 16777 in draft form for chemical disinfectants, it is likely in the future, that more bespoke tests incorporating mechanical action (wiping), and those incorporating any emerging resistant microorganisms will prevail.
Contact Medipal on:
uksales@palinternational.com
Tel: +44 (0) 1455 555 700
Pal International Ltd. Bilton Way, Lutterworth Leicestershire LE17 4JA United Kingdom
