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Table 4 Six proposals to improve the validity of products claims and efficacy claims that are published in positive lists by infection control societies

From: Efficacy of hand rubs with a low alcohol concentration listed as effective by a national hospital hygiene society in Europe

Parameter Proposal
Type of test method The minimum requirement should be fulfilling the European norms if they exist.
Number of test reports At least two independent test reports should be available for every type of claim.
Traceability of test product In case of blinded formulations being tested, a test facility should store a sample that may be used by the society as a control in case of conflicting results and to ensure the identity of a formulation that is listed by name.
Restrictions of using a Sephadex column to avoid false positive efficacy data In virucidal testing, use of a Sephadex column to reduce cytotoxicity should only be allowed when the initial virus titer is not high enough (according to EN 14476) and data according to the same method (e.g. EN 14476) are provided showing that there is no virus detectable after the recommended concentration and exposure time without using a Sephadex column. Virus controls with and without columns are not sufficient because a possible loss of virus in the column is mainly influenced by the ingredients of the test product.
Traceability of test product A product sample should be submitted with the application for listing to allow verification of specific details mentioned in the application forms and the test reports (e.g. appearance of the product, smell, pH value, density or refraction index).
Procedure in case of conflicting results If it is suspected that listed data are not reproducible elsewhere the society should get a product sample from the market and initiate its own efficacy test in an independent laboratory. In case of a major deviation of the results compared to submitted data, a careful analysis should be done to find the reason (identity of formulation, experimental details etc.) which may finally result in a change of the listed parameter.