Regulatory Failure and Deaths of Live Kidney Donors

Abstract and Introduction

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.

Introduction

"An extra professional burden falls on the surgeon performing the donor nephrectomy
Joseph Murray, M.D., Nobel Laureate, 1990.
Deaths of two living kidney donors from vascular clip failure were first documented in January 2006 in our report of preventable hemorrhage after donor nephrectomy. That study stressed the mortal danger of major vessel control with hemostatic clips, and emphasized the necessity of transfixion control (suture or staple anchored within the vessel wall) of the donor renal artery. A nationwide survey of transplant surgeons further affirmed a clear professional opinion that renal arterial control with clips (nontransfixion) is unsafe. By June of 2006, the US Food and Drug Administration (FDA) and Teleflex, the manufacturer of the Hem-o-lok locking clip, issued a Class II recall indicating that its use on the renal artery in laparoscopic donor nephrectomy was contraindicated.

Since the Class II recall, to our knowledge, two live kidney donors in the United States (2008 and 2011) and one in India (2008) have died, and an additional three donors have suffered severe hemorrhagic events from failure of the Hem-o-lok clip. Each of these catastrophes occurred following closure of the surgical incisions, and each surgeon apparently believed that all major vascular structures were secure as the operation ended. The donor surgeons were either unaware of, or ignored, the FDA recall or device contraindication.

To better understand how system failures contributed to this pattern of preventable death from massive hemorrhage due to clip failure, we sought information from both regulatory and professional communities. There were clearly missed opportunities for effectively communicating critical information to active clinicians; thus, at least in part, regulatory failure led to donor deaths.