Infusion devices postmarketing survey: analysis of the reports made in 1998 to the French agency for medical devices.

Objectives: To analyze retrospectively the data base of the French national vigilance reporting system concerning infusion devices during the year 199 8. Methods: Each report has been reviewed and classified, except implantable c atheter ports. Results: The study included 309 reports. Among them, 28% concerned infusion pumps and 72% single use devices, i.e. catheters, infusion lines, taps, co nnectors, etc. We observed six deaths and 23 severe incidents. Only 25% of devices could be formally investigated by manufacturers. The origins of inc idents were very different between infusion pumps and single use devices. T he first showed simple failures, software errors, maintenance omissions or errors, and problems related to obsolescence of the device. The second reve aled manufacturer quality insurance failures, design and utilization errors , and problems related to the technique itself rather than device. Discussion: Our findings are similar to the few data available in internati onal literature,. They address the need to obtain an adequacy between the p erformances of devices which vary with generations of devices and the clini cal risks: newest and safest devices should be preferred for the infusion o f the most critical drugs. (C) 2000 Editions scientifiques et medicates Els evier SAS.