Designing safer medical devices requires financial and political support

See pp 501, 517, 562, 563

EDITOR—Berwick emphasises the need to redesign medical devices to help avoid errors.1 In the European Union a task group from the European Standards Organisation (CEN) reported on ways to reduce the incidents of accidental misconnection of lines to patients.2 It identified a need to differentiate between connectors used in lines and syringes for enteral feeding, vascular access, and administering and sampling gases in the respiratory system, including a risk analysis of the results of misconnection.

The report was not welcomed by EUCOMED, which represents several European medical device manufacturers, because its proposals create more hazards for users and increase costs in a highly competitive sector of the medical device industry with high volume, low cost products. The Japanese government changed the design of connectors on syringes and enteral feed systems in less than a year because of an associated death, but none of the standards bodies in the European Union has so far volunteered to develop new standards for connector systems, as recommended by the task group. Central funding from the European Commission has been sought, but the work is effectively now on hold.

Many non-interchangeable keyed connectors are manufactured, mostly for specialised applications. Those that are not patented are freely available and could be fitted on to hypodermic syringes and lines, allowing differentiation of line or syringe by function—for example, respiratory, vascular, enteral, or neuraxial. A separate key for intrathecal needle and syringes is possible and would require the drugs to be supplied by the pharmacist in a specialised syringe. At least one connector system incorporates an anti-tamper lock, preventing unintended disconnection. Differentiation of connector is one prompt to increase safety, differentiation by size and shape of the drug container is another. Thus intravenous drug infusions should always …