[Microbiological testing of flexible endoscopes: contribution of the approach of accreditation in the implementation of regulation]

Abstract

The microbiological surveillance of flexible endoscopes reprocessing involves counts of the mesophilic total aerobic revivable flora and the detection of indicator microorganisms of dysfunction. We presented the assay at the COFRAC certification, to ensure a maximal level of confidence in the quality of our results. The existing quality system management was used by the type B widened flexible scope for data from previous accreditations for the identification of Staphylococcus aureus, Enterococci and Enterobacteriaceae. The quality insurance of the results and the technical authorization were guaranteed by the participation at a program of interlaboratory comparisons and the elaboration of internal quality controls. Risks analyses and conventions were wrote with endoscopy sectors. The visit led the opening of a single and not critical deviation sheet on the control of consumables and the accreditation for the analysis was pronounced.

Keywords: accreditation; endoscopy; microbiological control; regulation; safety; standard NF EN ISO 17025.