Microbiological water quality in the medical device industry in Italy

Water used in industrial processes may originate from different sources and must therefore be treated before entering the water supply network, so as to comply with quality requirements in terms of purity, salinity, chemical, physical and microbiological parameters. Notably, in the production of medical devices (MDs), water often comes into direct contact with the product, making microbiological quality control imperative. The objective of this study was to evaluate the microbiological quality of water used in the manufacturing of MDs in Italy in the framework of a project aimed at the drafting of guidelines to ensure the microbiological safety of industrial water for MD production. The test phase was preceded by an inspection carried out at the sites of the 16 participating MD manufacturers. Samples were taken once a month for three consecutive months and cultured. The results showed a constant presence of Pseudomonas spp. and Staphylococcus spp., and an occasional presence of intestinal Enterococci and fecal E. coli. Salmonella spp. were not found. The inclusion of Pseudomonas spp. and Staphylococcus spp. in routine monitoring programs of process water sanitation would be advisable in order to avoid the risks associated with the use of microbiologically contaminated water and prevent the formation of biofilms in water systems.