New medical technology offers the promise of improving patient care, as well as the potential for harm if caregivers are not sufficiently educated about its operation and use. Without a comprehensive approach, caregivers may learn how to use complex technology at the patient’s bedside, through trial and error, instruction manuals or informally from their colleagues. An article in AACN Advanced Critical Care describes how Memorial Hermann Health System in Houston developed an interdisciplinary fail-safe process to analyze and scale training for use of medical devices, with a risk assessment tool to predict the severity and frequency of potential harm to patients.

Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval. The firm has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, the inferior vena cava, and/or the femoral and iliac veins; additional procedures to retrieve the fragments; permanent patient disability; pulmonary embolism; stroke; damage to other organs; or death. One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon. There were no deaths reported.