MedTechbloggen

FDA har konstaterat att det inte är ovanligt att mikrorganismer överförs mellan patienter vid användning av endoskop med tillbehör. Problemet ligger ofta i rengöringsprocessen. Ett annat bekymmer är att kliniker använder tillbehör avsedda som engångsprodukter, flera gånger. Sammanfattningen av åtgärdsförslagen från FDA lyder:

“• Establish an institutional program with written procedures for endoscope processing, and ensure that those responsible for processing understand the importance of this job.

• Train and re-train employees to process endoscopy equipment properly, periodically assess their competence, and be sure they follow the endoscope manufacturer’s processing instructions.

• Be sure staff members understand that endoscopes cannot be properly disinfected or sterilized without first cleaning them thoroughly in order to remove gross contamination and debris.

• Be sure your automatic endoscope reprocessor or sterilizer is compatible with the endoscope, and that the connecting parts of these devices fit properly.

• Finally, be sure that endoscopes or accessories that will come in contact with sterile tissue are sterilized before each use, and that endoscopes that will come in contact with intact mucous membranes — in the respiratory and GI tracts, for example — undergo at least high level disinfection before each use.

The safety communication also lists the responsibilities of manufacturers in helping to assure that endoscopes and their accessories are properly processed.”

Här borde finnas möjligheter för tillverkarna av de medicintekniska produkterna att designa sina produkter för lättare hygienhantering. MedTechbloggen bjuder på tipset!