Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.
Mark Goodman and Barry Thompson, Baker & McKenzie LLP03.04.20
FDA recommends moving away from using duodenoscopes with fixed endcaps due to challenges cleaning them for reuse and persistent high contamination levels.
FDA has determined the manufacturers, Boston Scientific and Coloplast, haven't demonstrated reasonable assurance of safety and effectiveness for these devices.