Regulatory failure contributing to deaths of live kidney donors.

ABSTRACT

Hemorrhagic deaths of living kidney donors from failure of vascular clips used on the renal artery, first documented in 2006, have continued due to postoperative Hem-o-lok clip failure with sudden, massive bleeding. While the FDA issued a Class II recall of the Hem-o-lok clip for laparoscopic donor nephrectomies in 2006, two live kidney donors in the United States and one in India have since died. Compliance in timely reporting of deaths by the manufacturer and donor hospitals has not been enforced. Oversight agencies did not inform practitioners that donors died due to clip failures. A February 2011 survey disclosed that Hem-o-lok or other clips are still used by some surgeons as a sole means of arterial control in laparoscopic donor nephrectomy; thus, a practice with documented fatal outcomes persists. We conclude that systems failures by oversight-regulatory agencies in communication to active clinicians led, at least in part, to preventable deaths. Information which was disseminated was neither complete nor timely. A corrective plan, funded by oversight agencies and the Hem-o-lok manufacturer, is proposed. All surgeons operating on a living organ donor must select vascular control techniques that entail tissue transfixion and assure a safe operative recovery. The Hem-o-lok and other surgical clips must not be used to control the donor renal artery.