It is important to note that in the early days of transplantation, DCDD protocols were frequently used, and in some organ procurement organizations OPOs , it remained a common practice into the s. In recent years, organ recovery from DCDD has again become more commonplace. Therefore, it is important to clarify the practical aspects of this process. Although it is uncomfortable to discuss the issues around death and, particularly, those that deal with the body after death, openness and clarity about the events that occur in the process of DCDD are very important.
Furthermore, healthcare and transplantation professionals must ensure that all aspects of the planning and development of DCDD protocols are transparent and open to a wide range of patient and stakeholder inputs. Successful transplantation of an organ from a deceased donor requires that the organ be viable, a goal that can be met by minimizing the ischemic injury caused by a lack of bloodflow carrying oxygen and other nutrients to the organ s.
The length of time in which the organ can be deprived of oxygen ischemic and still be successfully transplanted varies among types of organs. In cases of neurologic determination of death, after death is declared—and when there is consent for organ donation—continuous cardiopulmonary function is achieved with artificial assistance until the organs are removed, permitting high-quality circulation of oxygenated blood to maintain organ viability.
For individuals who have had cardiac arrest, advanced cardiac life support protocols are followed Box and may be continued as the patient is transported to the hospital. In some cases, all resuscitation measures are administered in the home or other field setting; and if they are found to be nonproductive in regaining heart function, death can be declared in the field by emergency medical personnel, in consultation with a physician.
In cases of circulatory determination of death, individuals are generally not on ventilatory support at the time of death, so there is an immediate need to proceed with organ-preserving measures to limit the damage from warm ischemia and improve the viability of the organs for transplantation Bos, Termination of advanced cardiac life-support efforts occurs if there is no response after the following interventions have been performed:.
The operation of the airway device has been confirmed and the device has been secured. Oxygen and end-tidal carbon dioxide levels have been monitored to ensure that proper oxygenation and ventilation have been achieved. For cases of controlled DCDD, measures for preservation and recovery may include the administration of medications to improve organ viability, including heparin, or the use of intravenous cannulation or cardiopulmonary assist devices bypass procedures.
For cases of cardiac arrest in uncontrolled circumstances, there is not time to plan in advance to maintain organ viability, but certain organ preservation measures can be implemented after death is declared. Researchers have found that the liver is more susceptible to warm ischemic injury Abt et al. Department of Health and Human Services and published in , noted that organ donations from living donors and DNDD donors would not bridge the widening gap between organ supply and demand in the United States IOM, Despite the clear need to increase the rates of organ donation, the report found that the majority of transplantation programs in the United States did not have a mechanism or protocol for organ recovery after DCDD.
Although implementation of uncontrolled DCDD protocols and programs is recognized as an opportunity to greatly increase the number of potential organ donors especially kidney donors , the need to limit the warm ischemia time by means of early postmortem cannulation and cooling has raised the fundamental ethical issue of initiating organ preservation before informed consent is obtained from family members.
At the time that the IOM report was published, enabling legislation existed in several other Western democratic countries and in three jurisdictions in the United States Washington, D. Following publication of the IOM report, the U. Subsequently, the addition of DCDD donors to the potential donor pool naturally evolved in a parallel direction that favored an emphasis on controlled DCDD.
Many of the same challenges discussed in these two reports still confront the widespread adoption and implementation of DCDD. The present report further expands on those recommendations and emphasizes the need for ongoing efforts to ensure that DCDD is a priority for hospitals and OPOs.
A national conference in examined the essential actions needed to expand the practice of DCDD in the continuum of quality end-of-life care. Conflict-of-interest safeguards—separate times and personnel for important decisions;. Determination of death in controlled non-heart-beating donations by cessation of cardiopulmonary function for at least 5 minutes by electrocardiographic and arterial pressure monitoring; and.
Family options e. Recommendation 1: All OPOs should explore the option of non-heart-beating organ transplantation, in cooperation with local hospitals, healthcare professionals, and communities. A protocol must be in place in order for non-heart-beating organ and tissue donation to proceed.
Recommendation 2: The decision to withdraw life-sustaining treatment should be made independently of and prior to any staff-initiated discussion of organ and tissue donation. Recommendation 3: As recommended in the IOM report, statistically valid observational studies of patients after the cessation of cardiopulmonary function need to be undertaken by appropriate experts.
Recommendation 4: Like all care at the end of life, non-heart-beating organ and tissue donation should focus on the patient and the family. Recommendation 5: Efforts to develop voluntary consensus on non-heart-beating donation practices and protocols should be continued. Recommendation 6: Adequate resources must be provided to sustain non-heart-beating organ and tissue donation. Adequate resources are required to cover 1 the costs of outreach, education and support for OPOs, providers, and the public, and 2 any increased costs associated with non-heart-beating organ and tissue recovery.
Recommendation 7: Data collection and research should be undertaken to evaluate the impact of non-heart-beating donation on families, care providers, and the public. As discussed at that conference, there is an ongoing need to ensure that all OPOs and hospitals have policies, organizational structures, and institutional support for DCDD and that there is adequate professional education on organ donation under these circumstances.
Furthermore, all DCDD-related efforts must have a strong component of public education, and include measures to strengthen and sustain trust in the medical system.
Clear messages and transparent actions are essential for promoting DCDD as an organ donation option. Any episode of inadequate or inappropriate information being conveyed to the public can negatively.
Support studies assessing the frequency of autoresuscitation of patients eligible for DCD and other patients who have died after the withdrawal of life-sustaining therapy. Recommend that the Organ Procurement and Transplantation Network OPTN modify data submission standards to capture data from Phase I and Phase II clinical trials with the minute-by-minute collection of data to measure systolic and diastolic blood pressure, the level of oxygen saturation, and urine output.
Establish organ-specific subcommittees on DCD to address organ-specific suitability criteria and allocation policies. The committee concurs with the actions recommended in earlier IOM reports Boxes and and at the National Conference on Donation after Cardiac Death Box and encourages further efforts to overcome the general inertia regarding the full implementation of the policies and practices that will facilitate and expand DCDD.
It will be important to focus on the systems changes at the hospital and the OPO levels and will also require that the public and healthcare professionals be engaged in discussions about the complexities of DCDD.
Several European countries have developed and have used the infrastructures of both the emergency medical services and the transplantation services to provide optimal emergency care and to be available as needed to. Conduct financial analysis of the long-term impact of DCD organ use on transplant centers.
Joint Commission on Accreditation of Healthcare Organizations. Provide an annual DCD report that includes regional profiles, new developments, and trends and outcomes. Revise regulations governing donation, utilization, and reimbursement to reflect the unique characteristics of DCD procurement and transplantation. Furthermore, in the early s efforts were made in Washington, D. Furthermore, the Office of Decedent. The office was staffed by family advocates with experience in counseling and crisis management and trained in organ and tissue donation.
The medical criteria established for donors for this program were as follows: the donor had to be 18 to 55 years of age, the time of asystole had to be known, asystole had to be for less than 30 minutes, the donor could have no infection or cancer, the donor had to have negative test results for human immunodeficiency virus and hepatitis B virus, and the donor had to have a low-risk medical history Kowalski et al.
The program used two procedures to preserve the organs: cannulation of the femoral arterial-venous system to perfuse the kidneys with preservative solution combined with iced peritoneal lavage for cooling Kowalski et al.
Forty-five minutes was the maximum length of time allowed between cardiac arrest and the beginning of in situ organ preservation. The number of solid-organ donors in the hospital increased from 9 in — to 15 in —, with 60 percent of the donors in coming from the rapid recovery program.
Ninety-one deaths met the criteria for the program but the family could not be reached within the minute window needed to begin solid organ preservation. Families of 29 of the 91 decedents were located within 4 hours and 10 of those families consented to tissue donation. The District of Columbia government amended its Anatomical Gift Act to permit the initiation of organ preservation methods after death and pending consent for donation.
If the family could not be reached, the preservation methods were discontinued. The program illustrates the potential for communities to come together to support organ donation efforts; the challenges in financing this program, however, led to its discontinuation and point out the necessity of sustained funding sources for such efforts to be fully developed and implemented.
Furthermore, there needs to be a broader appreciation of the impact that DCDD could have in terms of the numbers of lives that could be saved as well as the healthcare cost savings that could be achieved by reducing the numbers of people receiving dialysis. Several European countries have explored and implemented DCDD programs focusing on patients with unanticipated cardiac arrests. The Hos-. Cardiac arrest is considered irreversible after a minimum minute resuscitation period without a return of the circulation Sanchez-Fructuoso et al.
The criteria used to identify potential organ donors include no evidence of drug dependency or death by physical violence, and the onset of external cardiac massage and mechanical ventilation within 15 minutes of cardiac arrest.
This onset of care within 15 minutes means that acceptable potential do-. Criteria used to assess eligibility for kidney and other organ preservation among individuals suffering out-of-hospital sudden cardiac-related death:.
No evidence of serious injury to chest or abdomen head trauma is not an exclusion criterion if there is no evidence of violence or foul play. Pronounced dead after at least 30 minutes unsuccessful CPR by physician not associated in any way with the transplant team.
Transplantation team begins cannulation and cooling, obtains requisite blood samples, and, in the absence of a donor card, takes over care under previously agreed conditions of. The total warm ischemia time, i. The family is contacted and notified of the death according to the institutional protocol. The medical examiner is contacted depending on local customs and legal requirements.
Donation is requested from family within 4 hours by a trained individual from the transplantation team. Deceased potential donors are transported by the emergency medical services personnel to the hospital.
The transplantation laws in Spain allow perfusion of the organs through cardiopulmonary bypass while the family is being located and a determination regarding donation is being made Alvarez et al. Unique features that facilitate uncontrolled DCDD in Madrid include the use of intensive care ambulances that are staffed by a prehospital physician and nurse who deliver patient care in the field Alvarez et al.
Examination of the — data from the Hospital Clinico San Carlos reveals that among potential uncontrolled DCDD donors, 62 patients met the criteria for donation and 53 became actual donors 9 were lost because of an inability to obtain either family or judicial consent for donation after cold perfusion had been instituted Alvarez et al.
From these 53 consenting donors, 72 kidneys were transplanted, 80 percent of which had the expected delayed function characteristic of DCDD grafts but had long-term graft survival rates comparable to those of kidneys from DNDD donors Alvarez et al.
It is important to note that about 40 percent of the 53 donors died of trauma. When the month cumulative probability of graft survival was evaluated as a subset analysis of the same patients in a separate paper, not only were the DCDDs comparable to the DNDDs, but also both within and across these two donor groups, long-term graft functioning was similar whether death was a primary cardiac event or secondary to trauma Sanchez-Fructuoso et al.
DCDD efforts in multiple countries Table show the potential for increasing the number of organ transplants, particularly kidney transplants. Data from more than a decade of assessments are now available to evaluate the effectiveness of augmenting the donor pool by increasing the number of controlled DCDD donors. However, when viewed in absolute terms, which are the numbers that matter to patients awaiting organs, there were just fewer than DCDD donors in , up from about 60 in Because of the large and growing gap between the number of organs available for transplantation and the number of individuals on the transplant waiting list in the United States Chapter 2 , it is important to explore any scientifically credible and ethically acceptable proposal that might increase the organ supply.
This may, of necessity, require a reexamination of the sources of organs and strategies for their acquisition that were rejected in the past at a time when the crisis was less acute. Currently, the donation rate also termed the conversion rate is calculated as the number of actual donors i.
DCDD as percentageof total a. The present IOM committee concurs with the general ethical principles established in the IOM report, and these have subsequently been embraced by both U. The present IOM committee also endorses many of the specific ethical recommendations that these bodies have made:. Informed consent for all premortem interventions such as cannulation or heparinization must be undertaken for the purposes of organ donation.
Safeguards against conflicts of interest must be taken, including the use of separate times and separate personnel for important decisions. Determination of death may be made only after circulation has permanently been lost.
Family wishes to be present at the time mechanical supports are withdrawn should be honored, and families should not incur expenses related to donation. Nevertheless, despite the identification of general ethical principles and some specific ethical rules to guide the practice, DCDD has remained controversial in many circles and has not achieved its full potential, in part because of the controversy surrounding the subject Bernat et al. Although the present IOM committee acknowledges that society will never enjoy complete consensus on ethical matters and that some individuals and families will choose not to donate, it is also convinced that some obstacles to DCDD are primarily due to the inadequate education of families, communities, and healthcare professionals.
Therefore, although a complete analysis of the ethical issues surrounding DCDD is beyond the scope of this report, this committee believes that it is worth examining why three IOM committees and at least two international consensus conferences have all concluded that both controlled and uncontrolled DCDD can proceed in an ethical manner yet so little has changed in clinical practice.
Although U. The U. This section seeks to develop two main theses regarding controlled DCDD:. Although DCDD has been controversial in some circles, a consensus is emerging that controlled DCDD can proceed in accordance with widely shared ethical commitments. Anecdotally, DCDD is frequently more controversial among healthcare workers than it is among the general public, a situation quite the reverse of that for the recovery of organs from DNDD donors.
This section explores points of controversy surrounding DCDD and presents the standards of practice and ethical resolutions that are emerging in the United States. Whether death is pronounced by the use of circulatory or neurologic criteria, irreversibility is part of the legal definition of death.
At the same time, under normal circumstances, organs quickly deteriorate when circulatory or neurologic functions are lost. Therefore, to enable the transplantation of organs, it is necessary to declare death as soon as possible. In , an IOM committee recommended that death be pronounced at least 5 minutes after the cessation of cardiopulmonary function.
Some considered this waiting time inadequate because they believe that circulatory functions are not yet irreversibly lost and that with aggressive resuscitative efforts, some level of functioning might be restored Cole, ; Menikoff, Both in and in , IOM committees presented a response to this concern that has subsequently been embraced by multistakeholder consensus conferences and several ethicists DeVita, ; DuBois, ; Canadian Council, ; Bernat et al.
This response comprises two key points. First, the best available data and expert judgment indicate that. The committee urges that further observational studies be conducted on spontaneous resumption of circulation. Although the concept of neurologic determination of death is foreign to many laypeople, medical and nursing students are taught that the brain supports consciousness, the respiratory effort, and the integrated functioning of the organism and that when the brain ceases to function the organism is dead.
Therefore, it is not surprising that some medical personnel have objected to the use of circulatory criteria to pronounce death when the permanent loss of neurologic function is in question Lynn, ; Menikoff, However, here, too, a consensus on what is legally and ethically permissible is emerging. First, UDDA clearly allows the use of circulatory-respiratory criteria to determine death. Second, by requiring a 2- to 5-minute waiting period, DCDD actually exceeds requirements of ordinary medical practice, in which there is no fixed observation period from the time that circulation arrests DeVita, Third, once circulation is permanently lost, so, too, is neurologic function permanently lost.
Consciousness is lost and brain function ceases approximately 15 seconds after circulation to the brain ceases. If the circulation does not resume, neither will neurologic functions resume.
As noted above, heparin is an anticoagulant that is frequently administered to potential donors shortly before mechanical support is removed. The purpose is to prevent blood from clotting in the organs that will be transplanted; the omission of heparin could negatively affect organ recov-. The use of heparin has been controversial on the basis of theoretical concerns that it could contribute to active cerebral bleeding and thereby hasten death. However, there is no evidence that heparin in fact has such an effect.
Although it can successfully prevent clots from occurring, it is unlikely to dissolve clots or exacerbate active bleeding, particularly in a patient expected to die within minutes of the withdrawal of mechanical supports. Moreover, the effects of heparin can be reversed in the rare patient who might recover cardiac function within the permitted window of time allowed by DCDD protocols.
Some have further objected that medications that are not meant to benefit the donors themselves should not be administered. However, it is important to note that consent is obtained for the use of premortem medications to facilitate donation and that the entire procedure of organ donation is meant to benefit someone other than the donor.
Careful attention to ensuring quality end-of-life care is paramount see Chapter 4. The option to donate organs by using DCDD is a specialized form of end-of-life care. Professional education of nurses, physicians, and other healthcare providers should emphasize the central role of providing quality end-of-life care, regardless of a decision to donate organs. The medical and ethical literature on controlled DCDD rarely discusses the fact that donation follows the withdrawal of mechanical ventilatory support.
Yet, surveys indicate that among the general public the acceptability of DCDD is directly tied to the acceptability of withdrawing artificial ventilation Keenan et al. Supreme Court has embraced widely accepted distinctions between foreseeing and intending death and between causing and permitting death Vacco v.
It is common practice to withhold or withdraw treatments that are considered unwanted, medically ineffective, or overly burdensome. Confusion over the boundaries of ethically permissible withdrawal of life-supporting treatment in conjunction with DCDD is evident in the literature about DCDD. Moreover, anecdotal data indicate that the connection between DCDD and the withdrawal of ventilatory support causes psychological distress for some healthcare workers involved in the transplantation process Spike, This suggests that such confusion can have a detrimental effect on the implementation of DCDD protocols and on the healthcare professionals themselves.
Clearly, to the extent that controlled DCDD depends upon a decision to withdraw life-sustaining treatments, it is important that the legal and ethical justifications for withdrawing treatments are made explicit through education, practice, protocols, and professional standards. All individuals involved in the process must understand that the decision to withdraw life-sustaining treatment is independent of the decision to donate and that the withdrawal of life-sustaining treatment will proceed even if the patient is ineligible to donate.
Finally, whenever life-sustaining treatments are discontinued, it is important to distinguish withdrawing unwanted or ineffective medical interventions from withdrawing care for the patient or family. Of all the ethical issues that DCDD presents, the topic of conflicts of interest has generated the least controversy.
These decisions and discussions frequently require separate staff which is always the case in the determination of death and separation in time. Although the present IOM committee has recommended against offering financial incentives for organ donation Chapter 8 , it bears stating that under no circumstances should financial incentives for organ donation be offered to families who need to make decisions regarding the continuation or discontinuation of life-sustaining treatments.
Families of dying patients often want to be present when death is determined. Increasingly, protocols permit families to be present in the operating room until death is pronounced; some protocols even permit death to be declared outside of the operating room when it is feasible to subsequently quickly transport the donor to the operating room.
The committee encourages the use of such practices and the allocation of sufficient institutional and human resources and support systems to implement them.
This committee has supported the trend within the transplantation community to honor documented donor wishes. However, when donation is coupled with a decision to withdraw life-sustaining treatments—a deci-. This is primarily because DCDD directly affects the timing and environment for the withdrawal of treatment. Moreover, when families oppose donation, DCDD could introduce a conflict of interest for families as they decide whether or when to withdraw mechanical ventilation.
The National Conference focused exclusively on controlled situations Bernat et al. This is also a complex and often misunderstood area Box However, given the significant potential of uncontrolled DCDD to increase the number of organs available for transplantation, this committee believes that it is imperative to further explore the essential issues and opportunities.
This section briefly examines some of the ethical issues that surround uncontrolled DCDD. The discussion explores the potential impact that uncontrolled DCDD could have on the number of organs recovered and offers specific recommendations. Because DCDD has primarily occurred in controlled settings in the United States, the unique ethical issues that arise regarding uncontrolled DCDD have not been as thoroughly examined by ethicists and policy makers.
These ethical issues fall into two broad categories: concerns about resuscitation efforts and concerns about informed consent. Fund research on innovative approaches to increasing rates of organ donation and enhancing organ viability. Although the committee recognizes the challenges in developing and implementing DCDD programs, the opportunity to save lives necessitates a careful effort to fully explore the recovery of organs after the circulatory determination of death.
In addition, the committee hopes that these efforts, along with concurrent actions focused on the prevention of health conditions that lead to the need for transplantation and research to explore alternatives to transplantation, will significantly reduce the size of the organ transplant waiting list in the near future. Rates of organ donation lag far behind the increasing need. At the start of , more than 90, people were waiting to receive a solid organ kidney, liver, lung, pancreas, heart, or intestine.
Organ Donation examines a wide range of proposals to increase organ donation, including policies that presume consent for donation as well as the use of financial incentives such as direct payments, coverage of funeral expenses, and charitable contributions.
This book urges federal agencies, nonprofit groups, and others to boost opportunities for people to record their decisions to donate, strengthen efforts to educate the public about the benefits of organ donation, and continue to improve donation systems. Organ Donation also supports initiatives to increase donations from people whose deaths are the result of irreversible cardiac failure.
This book emphasizes that all members of society have a stake in an adequate supply of organs for patients in need, because each individual is a potential recipient as well as a potential donor. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.
Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book. In multi-arm trials, data were pooled to create single pair-wise comparisons.
Analyses were stratified by specific intervention setting where available. Interventions were highly varied in terms of their content and included strategies such as educational sessions and videos, leveraging peer leaders, staff training, message framing, and priming. Most studies were rated as having high or unclear risk of bias for random sequence generation and allocation concealment and low risk for the remainder of the domains.
Low certainty evidence showed organ donation registration interventions had a small overall effect on improving registration behaviour 16 studies, 1,, participants: RR 1. In particular, interventions delivered in the community by trained peer-leaders appear to be effective 3 studies, participant: RR 2.
There was some evidence that framing messages e. Overall, the studies varied significantly in terms of design, setting, content and delivery. Selection bias was evident and a quarter of the studies could not be included in the meta-analysis due to incomplete outcome data reporting. No adverse events were reported. Low registration rates are especially common in countries with explicit consent registration policies—that is, individuals must opt in to become organ donors—compared to countries with presumed consent policies—where individuals are organ donors by default but can opt out.
Furthermore, changing registration policies involves implementation challenges and ethical considerations surrounding informed consent.
To date, most jurisdictions have maintained their existing policies, thus prompting the question, what can be done within explicit consent systems to improve organ donor registration rates? Prior research provides us with a good understanding of predictors of organ donation attitudes and intentions, yet little is known about how to increase actual registrations. To address these limitations, our research team conducted a field experiment in the Province of Ontario to test behavioral marketing interventions targeting information and altruistic motives in an effort to increase new organ donor registrations in a prompted choice context.
We supported our interventions with improvements to streamline the registration process i. Our paper contributes to the limited evidence for low-cost and scalable solutions to increase organ donor registrations within the current explicit consent systems. Our field experiment demonstrates how intercepting customers with promotional materials at the right time an information brochure and perspective-taking prompts , along with other process improvements, can increase new organ donor registrations.
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