On the List: Fixing Americas Failing Organ Transplant System

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For example, there is variability in the rates at which consent is obtained for deceased organ donation in various transplant centers and OPOs Chapter 4.

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A study examining the variability among transplant centers found that 30 centers 16 percent had consent rates of 70 percent or higher, whereas 18 centers had consent rates below 30 percent DHHS, This is similar to the variation of donation rates reported by OPOs, which ranged from As discussed throughout this report, efforts by OPOs and participating hospitals to increase the availability of organs for transplantation are focusing on increasing the consent rate for donation as well as on increasing the population of potential donors.

Although this report focuses on solid organ donation, many of the matters it discusses are closely tied with tissue donation. However, the tissue recovery and distribution system is quite different, particularly in the extent of private-sector commercial involvement. The resulting issues and challenges impact both the solid organ and tissue donation and recovery systems Youngner et al. In the United States, deceased organ donation is an opt-in system in which the donation decision is made by the individual or by his or her family.

Most current U. The donor-eligible deaths determined by neurologic criteria—estimated to number between 10, and 16, per year—represent only a small fraction of the more than 2 million annual deaths in the United States Guadagnoli et al. For deaths determined by neurologic criteria, organ viability can be maintained through ventilatory support and thereby improve opportunities for successful transplantation. Death determined by circulatory criteria is much more common in the population at large, but, because it often occurs outside of the hospital setting, maintaining the viability of the organs presents distinct challenges Chapter 5.

In practice, however, organ donation and recovery involve a complex set of circumstances and decisions. Despite such positive reasons to consider organ donation, historically only 50 percent of families asked to consent to organ donation do so JCAHO, However, progress has been made both in identifying dying patients who would be potentially suitable donors and in obtaining family consent for donation. Gortmaker and colleagues , examining data, found that 27 percent of eligible patients had not been identified as potential donors or the family had not been contacted.

This contrasts with data collected between and by Sheehy and colleagues , who found that only 16 percent of eligible patients were not identified as potential donors. Results from the latter study showed that 54 percent of the families who were asked to donate consented and that 42 percent of the potential donors became actual donors. These results suggest substantial improvements over the course of the decade, and consent rates have continued to improve in recent years. The process of organ donation is outlined in Figure It is difficult to determine the uppermost potential for the number of deceased organ donors.

Efforts to date have focused on estimating the number of potential deceased organ donors with neurologic determination of death. However, the potential pool also includes a large number of individuals whose deaths are determined by circulatory criteria, although estimating the number of such potential donors is a complex task see Chapter 5.

Kidney Failure (ESRD) Causes, Symptoms, & Treatments - American Kidney Fund (AKF)

Guadagnoli and colleagues estimated the number of potential deceased organ donors neurologic determination of death in the United States in to be 16,; the actual number of deceased donors in was 5, This analysis used hospital case-mix data, hospital bed size, medical school affiliation, and status as a trauma center to estimate the. Reprinted with permission from Blackwell Publishing. Because of variations in demographics, the number of eligible hospitals, and other factors, there is wide variation in the number of donations that a single OPO works with each year in ranging from 13 to donors HRSA and SRTR, Sheehy and colleagues reviewed hospital medical records of deaths submitted by 36 OPOs from through Forms were completed for deaths occurring in hospital intensive care units for all individuals who met the neurologic criteria for death and who were 70 years of age or younger.

That study estimated that each year in the United States there is a national pool of 10, to 13, potential donors for whom death is determined by neurologic criteria. As seen in data from and Table , the annual pool of eligible donors with neurologic determination of death has numbered approximately 12, In , there were approximately 2. Despite a number of coexisting conditions that would preclude organ donation, a comparison of the number of potential eligible donors with the number of actual donors Table shows that there could well be a large number of additional donors if technologies and systems are developed in the future to keep organs viable.

This would include an increased focus on donation after circulatory determination of death Chapter 5. Furthermore, issues regarding organs that are recovered but that are not used have yet to be fully explored Chapter 2 ; Delmonico et al.

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Eligible deaths a. Actual deceased donors b. Additional deceased donors d. Actual Number of Donors, a. Transplant recipients probably know best the real value of increasing the numbers of donated organs: an extended lifetime, improved quality of life, and a chance to resume activities that would have been precluded without a transplant. A year overall increase in life expectancy is reported for kidney transplant recipients compared with the life expectancy.

Transplant recipients not only experience gains in life expectancy but also enjoy improvements in the quality of their lives. A literature review of independent studies involving approximately 14, transplant recipients demonstrated statistically significant improvements in physical functioning, mental health, social functioning, and overall perceptions of quality of life following transplantation Dew et al.

These improvements are particularly striking when they are contrasted with the pretransplant conditions of patients requiring a transplant, such as the health complications and difficulties associated with long-term dialysis and other medical interventions. Moreover, many individuals face imminent death without a transplant.

The lack or inferiority of alternative therapies should be considered when post-transplant quality-of-life data are evaluated Whiting, The financial burden of immunosuppression therapy is thought to play a significant role in patient noncompliance with treatment regimens Chisholm et al. Improved immunosuppression protocols and the provision of patient education and support services have been recommended as ways to promote positive outcomes and enhance the quality of life for transplant recipients Galbraith and Hathaway, Most countries around the globe also face such problems as long waiting lists for organ transplantation and challenges with the allocation of scarce organs.

In the last decade, organ donation systems, transplantation programs, and organ exchange organizations have received increasing resources and attention from governmental agencies. In some countries, such as Spain and France, the government itself operates those organizations. Most countries e. Most organ exchange organizations operate on a na-. Retransplantation may be needed for a number of reasons. In , Bolstering the infrastructure for organ donation and transplantation has been a major focus in a number of countries.

In recent years Spain has been successful in significantly increasing its donor rates. Among the major changes instituted in Spain are an active donor detection program conducted by well-trained transplantation coordinators; an extensive transplant coordination network linking national, regional, and hospital efforts; hospital-level coordinators; increased economic reimbursement for hospitals; professional and public education efforts; systematic death audits conducted in hospitals; and a focus on expanded-criteria donors and on donation after circulatory determination of death Matesanz, , , Cross-country comparisons of donation rates are generally based on the number of donors per million population, a measure that has been criticized because of inconsistent definitions Box According to a report by the Council of Europe, Spain had the highest number of deceased donors per million population However, it is difficult to draw accurate or meaningful international comparisons, even for those countries closely aligned geographically, politically, and socioeconomically.

A combination of factors influences the effective-. The methods used to calculate the rates of donation remain a subject of debate. Thus, the methods used to calculate donation rates can alter international comparisons. In addition, the validity and the reliability of the data must be considered.

However, even when different methods are used to calculate donation rates, several countries consistently have high rates of donation: Spain, Austria, Belgium, Norway, France, Switzerland, Portugal, Italy, and the United States. Measures of the efficiency of a given national system, that is, its adequacy in converting the potential for donation into a realized donation Roels, , can provide important insights into the potential for additional organ donations.

In many countries, explicit consent is needed for organ donation. An alternative approach used by a number of countries is a presumed-consent or an opt-out approach, in which the default policy is that citizens are presumed to be organ donors unless they have expressly opted out of the system Chapter 7. This is applied with various degrees of strictness. Some countries follow a strict or strong presumed-consent model with little to no role for the family in the organ donation decision-making process.

On the List: Fixing America's Failing Organ Transplant System

Other countries have a presumed-consent law, but in practice the donor family is involved in the consent process. The ethical issues surrounding transplantation have come under close scrutiny in most countries, and legislation has gradually been introduced to. For example, the relatively low rate of donation in Brazil has been attributed, in part, to distrust of the medical community. Brazil has a large underclass with poor access to health care, and the quality of health care varies greatly. When a new policy of presumed consent was established, Brazilians reported difficulties, even obstacles, in registering as nondonors, further fueling fears that the healthcare system authorities were not to be trusted McDaniels, The presumed-consent statute was subsequently repealed.

There are wide differences in the policies and statutes regarding living donation among various countries. For example, Iran has a government-regulated program that compensates and monitors living unrelated kidney donors Ghods, , whereas many other countries prohibit the exchange of money for transplantable organs.

Cultures vary in the extent to which people are willing to donate their own organs and the organs of their deceased relatives Sanner et al. A common problem across cultures, however, is that few individuals have informed their families of their wishes, and where donor cards are available, even fewer have signed them Sanner et al.

Cultures have different views and traditions about death, and there have been significant debates about the determination of death by neurologic criteria. In Denmark in the s and Germany in the s, many believed that prolonged public debates over the determination of death by neurologic criteria led to declines in organ donation rates Matesanz, In Japan, cultural and religious beliefs, particularly those associated with the wholeness of nature and of the human body, have played a role in resistance to the determination of death by neurologic criteria.

Under a law adopted in in Japan, death is pronounced by neurologic criteria only in cases of organ donation and only for those who consented, while they were alive, to organ donation and to the use of brain-based criteria Veatch, The next of kin must also give their consent to organ procurement and agree to the pronouncement of death Fitzgibbons, Cultural and religious traditions and beliefs about the treatment of the dead body, beliefs about life after death, and fears of mutilation can also influence decisions about organ donation.

The major tenets of nearly all religious traditions, however, are compatible with the practice of organ donation Chapter 2. Yet, religious beliefs are often invoked in expressing resistance to organ donation, perhaps in part reflecting differences between official religious policies and folk beliefs and practices. Because the concepts and processes of organ donation are so closely intertwined with emotional issues of death and dying, it is of utmost importance to the committee, as it is to the transplantation community, that the terminology used to describe and discuss all aspects of organ transplantation be both as accurate and as sensitive as possible.

Terminology in this field has had both positive and negative connotations. On the one hand, some terms have played a role in creating or propelling myths, have led to increased misconceptions and fears about organ and tissue donation, or have bred mistrust of the system in general. Other terms have a more positive role in the healing process of a hurting family and in motivating the public to agree to donation. The National Donor Family Council and numerous recipient and donor family organizations have been active in addressing terminology.

Some terms that have seemed descriptive or useful in the past are now being reconsidered in favor of terms that are sensitive to the donor family and that affirm the value of individual human life see Table S-1 in the Summary. In the past, the term donor did not require any specificity. Today, as more people choose to become living donors, there is a need to distinguish between living and deceased donors.


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The term cadaveric has been used in the past but has an impersonal connotation a dead body intended for dissection. The term deceased donor is preferred because it conveys a more positive message and also denotes that it is a donation by an individual human being. Although the medical community has used the term harvest , it has agricultural and impersonal connotations for the general public. Similarly, the word retrieval suggests the reclamation of an object and can be quite unpalatable, especially to donor families. The word receive might even be more appropriate because it highlights the gift relationship.

Even though the term procure is widely used, it is also receiving close scrutiny. This term, similar to retrieve , has an impersonal connotation that does not fit with the intensely personal and emotional decisions regarding the end of a human life. The term life support can be a confusing term for a family who has been notified that their loved one is dead. When death occurs, there is no support that can make the individual alive again. After the declaration of death by neurologic criteria, if there is consent for organ donation, the organs may be perfused with oxygen for several hours through mechanical support.

Further confusing to families in times of crisis are the terms brain death and cardiac death. To some, these terms imply that certain organs have died but do not convey that this is a final determination of death. In order to avoid such confusions, the committee recommends use of the word death , adding either circulatory determination of death or neurologic determination of death where it is important to have greater specificity. Instead of donation after cardiac death and donation after brain death , the committee believes it would be clearer to use the phrases donation after circulatory determination of death DCDD and donation after neurologic determination of death DNDD.

Even though these phrases are more cumbersome, they better convey the finality of death and provide additional information on how that death was declared. As terms continue to evolve, the committee urges all who are involved in organ transplantation to use words and phrases that clarify rather than mystify the process of organ transplantation and that affirm the value of each individual human life.

It is also important at the outset of this report to clarify the measures of deceased donation that the committee used. The donation rate also termed the conversion rate is the number of actual donors i.


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The consent rate can be slightly higher than the donation or conversion rate, since after consent is obtained it might be determined that the organs are not suitable for recovery. Both of these measures have focused on donation after neurologic determination of death. As the measures are currently defined, the denominator for each excludes patients who are eligible for donation after circulatory determination of death.

The implications of this approach are further discussed in Chapter 5. Current efforts in the United States to increase rates of organ donation involve the collective work of numerous governmental and private-sector organizations. This section provides a brief overview of ongoing efforts. The chapters that follow provide further insights into the many parties that enable, facilitate, and promote organ donation. HRSA is a major federal funder of research and initiatives to increase organ donation rates in the United States.

The potential impact of these budget reductions on organ donation efforts is of concern. The National Institutes of Health NIH funds grants for organ transplantation research that primarily focus on biomedical studies of improvements in surgical techniques for transplantation, understanding immune-related processes, and improving graft survival.

Additionally, and to a more limited extent, NIH funds have been applied to behavioral research on organ donation. States play an important role in promoting organ donation through legislative action e. OPOs work closely with donor families, transplant recipients, and others in a range of donation efforts.

In addition, numerous voluntary health organizations focus on public education about organ donation and the provision of support for donor families, living donors, and transplant recipients. For example, the Coalition on Donation is a not-for-profit alliance of national organizations and local coalitions across the United States that have joined forces to educate the public about organ, eye, and tissue donation Coalition on Donation, The National Kidney Foundation and similar organizations that focus on relevant diseases and organ systems also support research and efforts for public and professional education.

Other organizations, such as the National Donor Family Council, support the needs of donor families, assist the healthcare professionals who work most closely with these families, and raise public awareness. The Joint Commission on Accreditation of Healthcare Organizations has promoted organ donation efforts by incorporating policies and procedures on the identification and referral of potential donors into hospital accreditation standards. Professional organizations, including the Association of Organ Procurement Organizations, the American Society of Transplantation, the American Society of Transplant Surgeons, and the Organization for Transplant Professionals, are active in professional education and also work to promote organ donation through advocacy and public education efforts.

Numerous clinical studies have documented the benefit to patients of organ transplantation in terms of life expectancy and quality of life. Increasing the rates of organ donation would provide these benefits to more patients and would reduce the waiting time for many transplant recipient candidates. Policies that increase the organ supply also entail monetary and.

The literature on the cost-effectiveness of transplantation provides indirect evidence of the economic value of increasing the organ supply. Kidney transplantation has been estimated to be highly cost-effective compared with the cost of dialysis Winkelmayer et al. Estimates of the cost-effectiveness of nonrenal transplantation are more variable Ramsey et al. Most of these studies find that the cost per life year gained is less than commonly cited estimates of the value of a life year Richardson, , although cost data are often incomplete and, for studies based on transplants occurring in European countries, may not be generalizable to the United States.

Several studies have directly addressed the economic value of increasing organ donation.


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Mendeloff and colleagues used published estimates of the costs of and quality-adjusted life years gained from kidney, liver, and heart transplants to calculate the monetary value to society of a deceased organ donor, assuming that each donation results in 1. Interpretation of the findings of these studies requires one note of caution, however, in that they are based on historical outcomes data, and the patients who would gain access to transplantation as a result of an increased organ supply may differ systematically from patients who currently receive a transplant.

Because the cost-effectiveness of transplantation varies widely by age group Jassal et al. Schnitzler and colleagues b have made progress on this front by measuring the life years gained from transplantation on the basis of the pretransplantation death rates of patients near the top of each organ-specific waiting list.

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They have found that an additional deceased organ donor yields a gain of For the case of livers, an analysis by Gibbons and colleagues suggests that urgent patients status 1, under the old classification system derive a greater benefit from transplantation than nonurgent patients.

An increase in the organ supply will increase the number of patients who receive transplants, but even when the number of transplantations is held fixed, an increase in the supply will reduce the waiting times for patients who would eventually receive a transplant anyway. A number of studies indicate that longer waiting times are associated with worse outcomes Everhart et al. It may be possible, however, to provide transplants to patients too early in the course of their disease, in the sense that the benefit of the reduced waiting time is outweighed by the immediate risk of postoperative mortality Kim and Dickson, ; Alagoz et al.

A number of secondary effects of increasing the organ supply should be considered when the value of increasing donation rates is assessed, although these have not been well documented. If the organ supply increases, providers may place more patients on the waiting list, particularly those who are less likely to benefit from transplantation.

Physicians may also become reluctant to use low-quality organs Howard, In evaluating the payoffs from increasing the organ supply, it is important to remember that cost-effectiveness studies are approximations and that some nonmonetary costs and benefits are not easily quantified. Moreover, policies that are implemented to increase the supply of organs must be compared with other opportunities to improve the length and quality of life through public policy. In a country in which so many people have limited access to effective health care, many unexploited opportunities to obtain quality-adjusted life years at a low cost probably exist.

Nevertheless, with these caveats in mind, the committee concludes that the available data suggest that well-designed policies to increase deceased and living organ donation are potentially cost-effective and even cost saving. In considering the total picture of organ transplantation, it is helpful to step back and examine each of the points at which interventions and initiatives could make a difference in equalizing the supply and the demand for organs for transplantation. However, reducing the demand for organ transplantation would be even more effective, because it would mean that greater numbers of healthier individuals have not reached the point of needing an organ transplant.

In general, transplantation should be seen as a rescue technology; it is an invaluable resource and option when it is needed, but prevention measures leading to improved health status are the first line of defense to avoid, where possible, the need for transplantation. The committee recognizes that not all causes of organ deterioration and failure can be prevented; however, for those cases in which prevention could make a difference, it is important to begin to implement preventive interventions at the earliest time possible and to minimize the rejection of the transplanted organ s.

Transplantation occurs at the end of a continuum of symptoms, diagnoses, treatments, and interventions. The prevention framework of public health, with insights from the Haddon matrix a model originally developed to address injury prevention , provides a context for considering the numerous points at which interventions could improve health status and reduce the demand for transplantation Table If transplantation is considered the event, then pre-event measures and interventions could focus on efforts to prevent the onset of disease or minimize its outcomes so that it will not reach the point of requiring transplantation.

Examples of pre-event interventions include education on healthy lifestyles and screenings for stroke, diabetes, and high blood pressure. Event interventions focus on high-quality care for the patient during transplantation and the provision of support to the patient and family so that they understand the transplantation procedures and the necessity for follow-up. In the third phase—the post-event phase—the focus is on restoring lost function and former quality of life, with particular attention to access to immunosuppressive therapies and ensuring that the donated and transplanted organ is fully maintained so that retransplantation is not necessary.

The goal, of course, is to minimize the need for organ transplantation by preventing the underlying disease risk factors that lead to organ deterioration and failure. Although not all the medical conditions necessitating organ transplantation can be prevented, preventive interventions and the treatment of contributory diseases as early as possible have the potential to reduce significantly the demand for organ transplantation.

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Environmental changes relevant to addressing precursor conditions e. Coverage for immunosuppressive drugs and posttransplantation-related health care. A variety of technological advances in development might improve organ viability or diminish the need for living or deceased organ donation. Ongoing research on organ preservation and organ culture is examining methods to improve organ function and viability. Nanotechnology offers the potential for the insertion of implantable devices that would restore organ function or serve as an organ replacement.

For example, mechanical devices such as the left ventricular assist device currently serve as a bridge for those waiting for a heart transplant, but refinements or reengineering. Xenotransplantation transplantation of an organ between two different species has been an ongoing area of research and has some current clinical applications e. However, the use of organs or tissues from other species continues to encounter biological barriers regarding immunosuppression, organ rejection, and disease transmission as well as the psychosocial concerns of some individuals regarding the use of organs from animals.

Stem cell research offers the promise of repairing or restoring organ function in the near future. Other technologic developments are raising new ethical questions. Organs such as the face and the ovary have been transplanted with some success and raise ethical concerns about identity and reproductive lineage. It is too early to determine if and how public attitudes regarding these developments will impact rates of organ donation.

Until the time that preventive measures diminish the need for transplantation or alternative approaches offer an effective option, numerous families, healthcare and transplantation professionals, and many others continue to make extraordinary efforts each day to ensure that organs are donated and are successfully transplanted with the goal of improving the quality of life and the length of life for transplant recipients.

The large gap between the supply and the demand for solid organs has prompted the need to carefully examine a variety of policy, organizational, and institutional changes that might be made to increase rates of organ donation. This report examines a range of proposals for increasing deceased organ donation Table and briefly discusses some ethical concerns raised by living donation. The subsequent chapters examine changes in the organization, processes, and interactions of hospitals and OPOs Chapter 4 ; expanding the pool of potential organ donors through donation after circulatory determination of death Chapter 5 ; and individual decision making, public education, and research Chapter 6.

Opt-out policies, particularly presumed consent, are discussed in Chapter 7 , and Chapter 8 focuses on financial and nonfinancial incentives. Living donation is discussed in Chapter 9 , and the report concludes in Chapter 10 with a synopsis of the opportunities for action to increase organ donation.

Abadie A, Gay S. The optimal timing of living-donor liver transplantation. Management Science 50 10 — Bernat JS. The concept and practice of brain death. Progress in Brain Research — Renal transplant patient compliance with free immunosuppressive medications. Transplantation 70 8 — Coalition on Donation. Who We Are. A cost comparison of heart transplantation versus alternative operations for cardiomyopathy. Annals of Thoracic Surgery 72 4 — Council of Europe. International figures on organ donation and transplantation.

Transplant Newsletter 10 1. Organ donation and utilization in the United States, American Journal of Transplantation 5 4 Pt 2 — History of organ donation by patients with cardiac death. Kennedy Institute of Ethics Journal 3 2 — Does transplantation produce quality of life benefits? A quantitative analysis of the literature. Transplantation 64 9 — DHHS U.

Prepared by The Lewin Group, Inc. Eggers PW. Health Care Financing Review 22 1 — Increased waiting time for liver transplantation results in higher mortality. Fitzgibbons SR. Galbraith CA, Hathaway D. Long-term effects of transplantation on quality of life. Transplantation 77 9 :S84—S Ghods AJ. Changing ethics in renal transplantation: Presentation of Iran model. Transplantation Proceedings 36 1 — Waiting for organ transplantation: Results of an analysis by an Institute of Medicine committee.

Biostatistics — Improving the request process to increase family consent for organ donation. Journal of Transplant Coordination 8 4 : — Cost-effectiveness of lung transplantation in relation to type of end-stage pulmonary disease. American Journal of Transplantation 4 7 — Potential organ-donor supply and efficiency of organ procurement organizations. Health Care Financing Review 24 4 : — Guidelines for the determination of death. Journal of the American Medical Association 19 — Halloran PF, Gourishankar S.

Historical overview of pharmacology and immunosuppression. Primer on Transplantation , 2nd ed. Howard DH. The impact of waiting time on liver transplant outcomes. In , France introduced a law that requires doctors to only inform the relatives about which organs are to be procured, and not ask their permission to procure. We believe the consent of the family members next of kin should always be sought if a person has not registered their consent before death for their organ to be procured. Historically, Australian governments have been wary of adopting an opt-out system of organ donation.

Despite several states considering reforming the current organ donation system and a independent review looking at options to boost donation rates, an opt-out system was not considered preferable. We suspect this was because people tend to react negatively when their choice is taken away. There is no conclusive evidence opt-out systems of organ donation increase the number of donors available. An opt-out system is unlikely to increase donation rates without the consent of the family. In our society, the family have always been responsible for decisions about a burial or cremation of the body of their relative.

Arbitrarily violating this right would cause psychological harm and no direct benefit. It shows how devastating un-consented procurement of organs of a deceased relative would be. There are other reasons why non-consensual organ procurement would cut across social expectations. Autopsies are now not performed routinely and if conducted are not without the consent of relatives.

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This further adds to the notion relatives have decision-making rights. Are we to have an opt-out system which includes all citizens? Who would ignore the practices of certain religions which expect the deceased body to be buried intact? These are all insurmountable obstructions to hard opt-out systems. There is significant variability in how opt-out systems work.

Take Spain, for example. It introduced an opt-out system , often referred to as a presumed consent model, in and it took almost a decade before donation rates increased. Brazil also introduced a presumed consent system of organ donation but abolished it after a year and a half, in late This was due to uncertainty, fear and mistrust of the medical profession prematurely declaring people dead to remove organs.

And even under the presumed consent system, the majority of doctors would only remove organs from the deceased after receiving consent from family members. Opt-out systems of organ donation go against the very concept of gifting or donating. It presumes consent by the deceased when none exists. As a society, we need to normalise organ donation and dispel the fears, myths and perhaps sheer ambivalence that surrounds it.

We need to encourage innovative education programs and engagement with individuals and families to promote robust, honest and meaningful conversations about organ donation. Read more: Organ donation campaigns could be more effective if they focused on feelings rather than facts. It may be difficult to have conversations about organ donation with families after a tragic accident or a sudden death. But, where possible, doctors should engage families in discussions about organ donation early on. Family members should be encouraged to respect the wishes of the deceased, whether that was via the organ donation register, a prior conversation, or by any other means.



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