First Italian guidelines to ensure the microbiological safety of water used in the medical device industry - An operational tool

Abstract The microbiological quality of the water used in the production of Medical Devices (MDs) plays a crucial role in the prevention of risks associated with the use of MD products. Water must comply with specific microbiological requirements to guarantee that the MD or its use do not pose a risk to human health. The assessment of water quality in MD manufacturing facilities is currently based on the microbiological parameters required of the pharmaceutical industry. A project aimed at the development of microbiological water quality guidelines for the Italian MD industry was therefore initiated, funded by the Italian Ministry of Health and carried out by the National Institute of Health (ISS). The proposed set of guidelines draws on experimental evidence from two preliminary studies: an analysis of questionnaire-based interviews and a microbiological analysis of water samples from 16 Italian MD production facilities. The resulting document - first of its kind in Italy - is an operational tool addressing critical issues in water quality management, having the potential to contribute to the reduction of the risk of water contamination in MD manufacturing. The guidelines, comprising twelve recommendations, were put together following the National Guidelines System's Methodological Handbook: How to Produce, Disseminate and Update Public Health Guidelines (2011). The full text of the proposed guidelines can be downloaded from the website of the Italian Ministry of Health.