Regulatory Failure and Deaths of Live Kidney Donors
Regulatory Failure and Deaths of Live Kidney Donors
It is apparent that system failures occurred in oversight agencies and organizations since timely and clearly stated warnings about fatal outcomes involving donor renal artery control with clip devices were not fully effective ( Table 2 ). We believe that the manufacturer, the FDA and UNOS did not act in a fashion which facilitated corrective action at the point of care. It appears that lack of information regarding individual deaths and a pattern of adverse events contributed to ongoing fatalities. Additionally, while these events were catastrophic in nature, their low frequency increased the challenge of pattern recognition for similar events occurring at different live donor programs. Detection would have required regular, centralized analysis of pooled data over time, an activity not feasible through all of the events recorded in this report. Current UNOS surveillance of live donor programs would seem to be a positive step, at least in so far as center awareness may be concerned.
Patient confidentiality, peer review, liability issues and defensive medicine are legitimate considerations in limiting disclosure of facts concerning adverse events. The FDA's apparent acceptance of the manufacturer's assessment that bleeding was caused by "misapplication of the clips", omitted an opportunity to require an independent analysis of Hem-o-lok clips, to overcome proprietary conflict of interest, and to improve patient safety. Potentially life-saving safety information must be timely disseminated to transplant teams, donor hospitals and all concerned with the safety and outcomes of living kidney donors.
The vast majority of our donor–surgeon colleagues want—and need—timely, clearly stated patient safety information. Thus, we believe that a corrective action plan, funded by oversight agencies and Teleflex, should now include:
Finally, we understand that some surgeons continue to have confidence that clips, including the Hem-o-lok device, provide secure renal artery closure. As "implantable clips", they are categorized as Class II medical devices by the FDA. Similar to many other Class II devices, they were and have all been initially cleared for human use through the 510(k) clearance process without any review by the FDA of safety and effectiveness, on the basis of being substantially equivalent to other devices already in use. At the FDA's own request, the Institute of Medicine (IOM) has just reviewed this approach and concluded that conclusions include that (1) the process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is not objective review of the device itself; and (2) postmarket surveillance is inadequate. These findings by the IOM validate our observations about Hem-o-lok clips, for which basic data demonstrating safety and effectiveness have never been published or reviewed by the FDA. We also note that failure of the manufacturer and donor facilities to comply with MAUDE reporting requirements might be the source of financial penalties that would represent potential funds for enhanced analysis of MAUDE reports by the FDA. Of greatest concern is the finding that even in February 2011, 16/180 US based ASTS members responding to a new survey indicated that Hem-o-lok or other clips are always or sometimes used as a sole means of arterial control in laparoscopic donor nephrectomy at their institutions.
It appears to us unclear why the 2006 recall applied only to the use of Hem-o-lok clips in laparoscopic donor nephrectomies. From a surgical perspective, there is no logical rationale for expecting that clip use on a renal artery stump will be safer simply because the incision is larger (in an open approach), or smaller (in a robotic approach), or traverses an internal organ (natural orifice approach). In fact, we wonder whether the Hem-o-lok clip is safe for use on any artery of similar caliber to the renal artery, e.g. the splenic artery.
In light of the data we have assembled, and the technical nuances that distinguish a donor nephrectomy (complete skeletonization of the vessel, short stump), continued use of clips are both legally indefensible and morally intolerable. All surgeons who accept the privilege of operating on a living organ donor must honor that person by selection of a vascular control technique that entails transfixion of tissue, and that assures, to the highest degree, a safe operative recovery followed by a long and healthy life.
Failures and Proposed Remedies
It is apparent that system failures occurred in oversight agencies and organizations since timely and clearly stated warnings about fatal outcomes involving donor renal artery control with clip devices were not fully effective ( Table 2 ). We believe that the manufacturer, the FDA and UNOS did not act in a fashion which facilitated corrective action at the point of care. It appears that lack of information regarding individual deaths and a pattern of adverse events contributed to ongoing fatalities. Additionally, while these events were catastrophic in nature, their low frequency increased the challenge of pattern recognition for similar events occurring at different live donor programs. Detection would have required regular, centralized analysis of pooled data over time, an activity not feasible through all of the events recorded in this report. Current UNOS surveillance of live donor programs would seem to be a positive step, at least in so far as center awareness may be concerned.
Patient confidentiality, peer review, liability issues and defensive medicine are legitimate considerations in limiting disclosure of facts concerning adverse events. The FDA's apparent acceptance of the manufacturer's assessment that bleeding was caused by "misapplication of the clips", omitted an opportunity to require an independent analysis of Hem-o-lok clips, to overcome proprietary conflict of interest, and to improve patient safety. Potentially life-saving safety information must be timely disseminated to transplant teams, donor hospitals and all concerned with the safety and outcomes of living kidney donors.
The vast majority of our donor–surgeon colleagues want—and need—timely, clearly stated patient safety information. Thus, we believe that a corrective action plan, funded by oversight agencies and Teleflex, should now include:
Reclassification of the Hem-o-lok recall to Class I: contraindicated for use in any donor nephrectomy.
Collaboration with the ASTS, UNOS, The American Urological Association, The American Association of Kidney Patients, the National Kidney Foundation and other professional and patient organizations to disseminate data driven information about the risk of nontransfixion methods of renal artery control in donor nephrectomy.
Establishment of a National Quality Assurance and Performance Improvement Program for living donors, using monthly and long-term reviews of data, within the UNOS committee structure, and supplied by data provided by individual live donor programs, in order to promptly identify dangers to living donors.
Requirement that a donor life and medical insurance program, such as the Living Organ Donor Network (LODN), be implemented in all transplant centers performing live donor procedures.
Investigation of Hem-o-lok safety, use and outcomes in all types of nephrectomy. Objective analysis by a multidisciplinary team, including members of the urology community, should be required by the FDA for assessment of the Hem-o-lok clip for use in nondonor nephrectomies.
Finally, we understand that some surgeons continue to have confidence that clips, including the Hem-o-lok device, provide secure renal artery closure. As "implantable clips", they are categorized as Class II medical devices by the FDA. Similar to many other Class II devices, they were and have all been initially cleared for human use through the 510(k) clearance process without any review by the FDA of safety and effectiveness, on the basis of being substantially equivalent to other devices already in use. At the FDA's own request, the Institute of Medicine (IOM) has just reviewed this approach and concluded that conclusions include that (1) the process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is not objective review of the device itself; and (2) postmarket surveillance is inadequate. These findings by the IOM validate our observations about Hem-o-lok clips, for which basic data demonstrating safety and effectiveness have never been published or reviewed by the FDA. We also note that failure of the manufacturer and donor facilities to comply with MAUDE reporting requirements might be the source of financial penalties that would represent potential funds for enhanced analysis of MAUDE reports by the FDA. Of greatest concern is the finding that even in February 2011, 16/180 US based ASTS members responding to a new survey indicated that Hem-o-lok or other clips are always or sometimes used as a sole means of arterial control in laparoscopic donor nephrectomy at their institutions.
It appears to us unclear why the 2006 recall applied only to the use of Hem-o-lok clips in laparoscopic donor nephrectomies. From a surgical perspective, there is no logical rationale for expecting that clip use on a renal artery stump will be safer simply because the incision is larger (in an open approach), or smaller (in a robotic approach), or traverses an internal organ (natural orifice approach). In fact, we wonder whether the Hem-o-lok clip is safe for use on any artery of similar caliber to the renal artery, e.g. the splenic artery.
In light of the data we have assembled, and the technical nuances that distinguish a donor nephrectomy (complete skeletonization of the vessel, short stump), continued use of clips are both legally indefensible and morally intolerable. All surgeons who accept the privilege of operating on a living organ donor must honor that person by selection of a vascular control technique that entails transfixion of tissue, and that assures, to the highest degree, a safe operative recovery followed by a long and healthy life.
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