Venous needle dislodgement during hemodialysis: An unresolved risk of catastrophic hemorrhage

Venous line disconnection or needle dislodgement during hemodialysis with resultant hemorrhage is a potentially lethal event. The risk is compounded by the frequent failure of standard dialysis machines to detect the event, as blood flow through the venous needle typically creates enough back pressure to prevent venous pressure alarms even if the needle is completely out of the patient's AV access. Manufacturers are well aware of the risk and device literature contains specific warnings about it. The FDA publishes reports on its website about these events; so far this year there have been seven reported events with five deaths. Informal sources indicate that the actual (unreported) occurrence is much more frequent; we are aware of four additional events within our region alone. Efforts to reduce the risk include protocols requiring the access needles to always be visible, and use of enuresis detection devices. Anecdotal experience with these efforts suggests they are not highly effective. Protocols requiring documentation of more frequent needle site checks or alternate methods of securing the needles have not been formally evaluated. However, such efforts do not address the primary problem: there is a need for an engineered solution to this problem. Requirements for such a solution include: reliable detection of needle position and blood flow discrepancies, a useful alarm, and feedback to stop the blood pump. Persistence of this problem raises issues of regulatory oversight.