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Deceased organ donation and transplantation in India: Promises and challenges
Correspondence Address: Source of Support: None, Conflict of Interest: None DOI: 10.4103/0028-3886.227259
Organ transplantation has improved the lives of hundreds of thousands of patients all the world. The total organ donation shortage of the country can be met with if even 5 to 10% of the victims involved in fatal accidents serve as organ donors. The challenges include an interplay of sociocultural factors, beliefs and superstitions, lack of communication and organizational support, and negative views by the media. Several initiatives to encourage deceased organ donation include the Indian Network for Organ Sharing, a subdivision of the National Organ and Tissue Transplant Organization, the Transplantation of Human Organ Act (THOA), as well as the Transplantation of Human Organs and Tissue Rules. There are stringent criteria instituted for the retrieval, preservation and transportation of donor organs. This article reviews the ongoing efforts being implemented to encourage organ transplantation. Keywords: Brain death, deceased organ donation, legislation, organ preservation, organ retrieval, organ transplantation, organ transportation
Organ transplantation is one of the greatest medical marvels of the twentieth century, which has prolonged and improved the lives of hundreds of thousands of patients, worldwide. Countless acts of generosity by organ donors and their families have made transplantation not only a life-saving treatment but also a shining symbol of human solidarity. The disparity between the huge demand for organs and their poor supply is the main issue of concern. Organ shortage is a global issue and deceased organ donation is the major sustainable solution. The total number of road accident fatalities reported in 2013 in India was 1,37,572, contributing to almost 1.1% of the world's total deaths.[1] In nearly 40 to 50% of road accident fatalities, the cause of death has been head injury. These victims of head injury from road traffic accidents alone, are in enough numbers to meet the demand of potential donors of organs in the country. The total organ donation shortage of the country can be met with if even 5 to 10% of these persons involved in fatal accidents serve as organ donors. This is, however, an utopian situation and there are a number of barriers and challenges that are at play in achieving this goal of completely meeting the demands for organ donation. This article attempts to look at the existing challenges and the ongoing efforts being implemented to circumvent the problems that interfere with the successful running of the organ donation program. The evolution of the rules regulating the contemporary issues related to organ donation have also been highlighted. Suggestions to improvise upon the current practices have also been incorporated.
The deceased donor donation rate in India stands at around 0.34 per million, which is abysmally low when compared to the organ donation rate prevalent in other developed countries.[2] In the Indian scenario, many cultural and religious beliefs influence the decision making regarding deceased organ donation. Lack of awareness (80.1%), religious beliefs and superstitions (63.4%), and lack of faith in the healthcare system (40.3%) have been believed to be the most important reasons for the family members refusing for giving their consent for organ donation of their close relatives.[3] Sociocultural factors In Asian countries, such as in India, China and Japan, the concept of life after death is cross linked with the concepts of ethics, religion and spirituality. It is very difficult to even start a conservation regarding organ donation in these regions of the world, especially in the case of a brain-dead donor. Religious concerns may also have an impact. Beliefs and superstitions Public awareness regarding organ donation is very low in our country and this negatively impacts the whole concept. Many superstitions that are prevalent even now create a negative attitude towards organ donation. Superstitions such as being born with a missing organ (that has been donated); and, that tampering with the body will not free their dead relatives from the cycle of life-death-rebirth, are some of the prevalent superstitions.[4] The concept of 'brain death' and its legal implications are not familiar to the majority of the population in India. There is a lack of awareness about these issues even among the medical professionals. Lack of effective communication An educated donor who is willing to donate his organs usually has a good knowledge about the concept of 'brain death' and the procedures related to organ donation. He is more likely to effectively communicate with the family members regarding his willingness to donate his organs. Many a times, people sign the donor card due to peer pressure and other factors without having a complete knowledge about the issues involved. These people are less likely to stick to their decision in the future and usually back out from their commitment prior to their death. Lack of organizational support The lack of an adequate number of transplant centers with staff, as well as transplant coordinators who are adequately educated and well-versed with the procedures required to conduct an organ donation program is acting as a significant roadblock to the deceased donation program. Lack of good dialysis programs, research, and effective national health insurance plans, also pose a challenge. Many hospitals do not have a clear protocol for declaring brain death. Some of them also do not have effective transplant coordinators who could sympathetically approach the family members of the brain-dead, potential donor patients, and take consent from them regarding organ donation. Even the medical community has very little knowledge, and therefore, any efforts made in this direction are thwarted by them to a great extent. Negative propaganda by the media The entire concept of deceased organ donation is built upon mutual trust and a feeling of altruism. Any negative ideas, which breaks this trust, acts as an impediment to the whole process.
Public-private partnerships with the help of transplant coordinators have immensely contributed to improving organ-procuring rates in India over the recent years. This holds true in the case of southern states of India (Tamil Nadu, Kerala, Andhra Pradesh and Pondicherry), where deceased organ donation and transplantation is much better established than in other parts of the country. MOHAN (Multi-Organ Harvesting and Networking) foundation is a philanthropic non- governmental organisation based in south India, which works to improve organ donation and transplantation rate. It is the first organisation to promote deceased organ donation and has been in existence since 1997. It is also the first organisation in India to promulgate the system of organ sharing system in India in 2000 by establishing the Indian Network for Organ Sharing (INOS).[5] Transplant coordinators Appointment of a transplant coordinator has been made mandatory for all transplant centers. They help in counseling of families for taking consent for organ donation and coordinate the process of donation and transplantation. They should be employees of the registered hospital and possess qualifications related to medicine, social work or public health.[6] NOTTO – National Organ and Tissue Transplant Organization This is a national level organization set up under the Directorate General of Health Services, Ministry of Health and Family Welfare. The National Human Organ and Tissue Removal and Storage Network is a subdivision of this organization, which was formed as mandated by the Transplantation of Human Organ Act (THOA) amendment in 2011. This is established in Delhi and will gradually expand to involve other states and regions of the country. It functions as an apex center for conducting all India activities related to coordination and networking, for the procurement and distribution of organs and tissues, for maintaining the registry of organs, and for facilitating tissue donation and the transplantation of the harvested organs across the country. Green corridors Green corridor refers to a special road route that facilitates the transportation of harvested organs meant for transplantation to the desired hospitals. The street signals are manually operated to avoid stoppage at red lights and to divert the traffic to ensure a rapid transportation of the desired organ. There are many recent instances in India where organs were transported in time using this facility. Tissue banks Tissue banking is the process in which biomedical tissue is stored under cryogenic conditions to be used later when the need arises. A number of tissue banks have been established in India in the recent times, which help in storing tissues such as the cornea, skin, heart valves, bones and tendons for later use. These centers help in preventing tissue wastage to a great extent.
Legislation Transplantation of Human Organ Bill was introduced in the Lok Sabha on 20th August 1992. Transplantation of Human Organ Act (THOA) was passed in 1994. This is the primary legislation related to organ donation and transplantation in India. Before the introduction of this Act, the regulations for organ donation and transplantation in India were nonexistent and malpractices were rampant. The amendment to the Act was passed by the parliament in 2011, and the rules were notified in 2014 as the Transplantation of Human Organs and Tissue Rules – 2014.[6] The relevant statements related to the deceased donor transplantation from the Transplantation of Human Organs and Tissue Rules – 2014 are discussed in brief.[7] Section 3 - Authority for removal of human organs or tissues A living person may authorize the removal of any organ or tissue of his or her body during his or her lifetime according to the prevalent medical practices. Section 4 - Panel of experts for brain-stem death certification The appropriate authority shall maintain a panel of experts to ensure an efficient functioning of the Board of Medical Experts and it shall remain fully operational at all times. Section 5 - Duties of the registered medical practitioner The registered medical practitioner of the hospital in consultation with the transplant coordinator, if available, shall ascertain, after certification of brain death of a patient in the intensive care unit, from his/her near relative or, if near relative is not available, then, any other person related by blood or marriage, and in case of an unclaimed body, from the person in lawful possession of the body, namely: 5.1(a) - that the person in the presence of two or more witnesses (at least one of whom is a near relative of such a person) had authorized before his/her death, as specified in form no. 7 or other documents like driving license, etc., the removal of his/her organs after death and he/she has not revoked the above said authorization. 5.1(b) - if authorization was not made by the person to donate the organs after death, then the registered medical practitioner in consultation with the transplant coordinator, shall make the near relative or person in lawful possession of the body, aware of the option to authorize or decline the donation and an authorization to this effect shall be ascertained as per Form 8 to record the status of consent, and in case of an unclaimed body, the same shall be made in Form 9 by the authorized official. 5.1(c) - after authorization and consent is given, the registered medical practitioner through the transplant coordinator informs the authorized registered Human Organ Retrieval Centre through an authorized coordinating organization by available documentable mode of communication. 5.2. The above-mentioned duties also apply to the registered medical practitioner working in an Intensive Care Unit in a hospital not registered under this Act. 5.4 – A registered medical practitioner, before removing any organs/tissues from the body of a person after death, should in consultation with the transplant coordinator ensure the following, namely, that the authorization has been given as specified and the same has not been revoked, and the consent of the near relative or person in lawful possession of the body shall also be required notwithstanding the authorization been made by deceased donor. Provided that if the deceased person who had earlier given authorization but had revoked it subsequently, and if the person had given in writing that his organ should not be removed after his death, then, no organ or tissue will be removed even if consent is given by the near relative or person in lawful possession of the body. 5.5(b) - that the near relative of the deceased person or the person lawfully in possession of the body of the deceased donor has signed the declaration, as specified in Form 8. 5.5(c) – In the case of brain-stem death of the potential donor, Form 10 has been signed by all the members of the Board of Medical Experts. Provided that where a neurologist or a neurosurgeon is not available, an anesthetist or intensivist who is not a part of the transplant team nominated by the head of the hospital duly empanelled by Appropriate Authority may certify the brain stem death as a member of the said Board. 5.5(d) In the case of brain-stem death of a person of less than eighteen years of age, Form 10 has been signed by all the members of the Board of Medical Experts and an authority as specified in Form 8 has been signed by either of the parents of such a person or any near relative authorized by the parent. Section 6 - Procedure for donation of organ or tissue in medico-legal cases 6.1 - After the authorization and consent are obtained, the registered medical practitioner of the hospital should make a request to the Station House Officer or Superintendent of Police or Deputy Inspector General of the area either directly or through the police post located in the hospital to facilitate timely retrieval of organs or tissue from the donor and a copy of such a request should also be sent to the designated post mortem doctor of the area simultaneously. 6.2 - It should be ensured that by retrieving organs, the determination of the cause of death is not jeopardized. 6.3 - The medical report in respect of the organs/tissues being retrieved should be prepared at the time of retrieval by the retrieving doctor and should be taken on record in postmortem notes. 6.4 - Wherever it is possible, attempt should be made to request the designated postmortem registered medical practitioner, even beyond office timing, to be present at the time of organ or tissue retrieval. 6.5 - In case a private retrieval hospital is not doing post mortem, they should arrange transportation of body along with medical records, after organ or tissue retrieval, to the designated postmortem center and the post mortem center should undertake the postmortem of such cases on priority, even beyond office timing, so that the body is handed over to the relatives with least inconvenience. Section 8 - Removal and preservation of organs or tissues The removal of the organs/tissues should be permissible in any registered retrieval or transplant hospital or center and preservation of such organs/tissues should be ensured in registered retrieval or transplant center or tissue bank according to current and accepted scientific methods in order to ensure viability for the purpose of transplantation. Section 9 - Cost for maintenance of cadaver or retrieval or transportation or preservation of organs or tissues The cost for maintenance of the cadaver, retrieval of organs, their transportation and preservation, should not be borne by the donor family and may be borne by the recipient or institution or Government or non-Government organization or society, as decided by the respective State Government or Union territory Administration. Section 32.8 - Pledge for organ or tissue donation after death Those persons, who, during their lifetime have pledged to donate their organs/tissues after their death, shall in Form 7 deposit it in the paper or electronic mode to the respective networking organization/institution where the pledge is made, who shall forward the same with the respective networking organization and the pledger has the option to withdraw the pledge through intimation.
Deceased donors can be divided into two subgroups - donation after brain death (DBD) and donation after cardiac death (DCD). DCD is not done regularly in India due to multiple issues at legal and practical levels. Certification of brain death Three prerequisites should be met with while certifying brain death, such as (1) coma or unresponsiveness, (2) absence of brainstem reflexes, and (3) apnea. As there is no global consensus on the criteria for establishing brain death, different tests are used in different parts of the world. In India, apnea testing is used for documenting brain death, which checks the integrity of the brain stem respiratory center at high levels of carbon dioxide. Candidates should be normothermic (core temperature ≥36°C), stable hemodynamically (systolic pressure ≥90 mm Hg), free from sedative and paralytic drugs with normal oxygenation and near normal PaCO2. If respiratory movements are not present and the PaCO2 is >60 mm Hg or elevated >20 mm Hg from baseline value, the test is considered positive.[8] A second apnea testing is required for certifying brain death in many countries. The time interval between the first and second testing is also country specific. The second test is done at an interval of 6 hours in India and it has to be certified by four physicians from a recommended panel; two of these have to be doctors nominated by the appropriate authority of the government with one of them being a neurologist. If a neurologist or neurosurgeon is not available, an intensivist or anesthetist nominated by the head of the hospital may certify brain death. Form 10 is used for certifying brain death.[6] Additional tests are not required to confirm brain death as per the American Association of Neurology (AAN) guidelines. In patients in whom a complete clinical examination cannot be done, however, ancillary testing can be used to confirm brain death such as cerebral angiography, cerebral scintigraphy, isotope angiography, transcranial Doppler ultrasound and electroencephalogram. The AAN also recommends that the physicians should be wary about the false positive results and may choose not to proceed with declaration of brain death rather than ordering these ancillary tests in case of unreliable clinical findings.[9],[10] Standard and extended criteria donors The donors are further differentiated into standard criteria donors (SCD) or extended criteria donors (ECD), depending on whether the age of the donor is 60 years or more, or the age is 50 – 59, with the presence of at least two of the following: hypertension, death from cerebrovascular accident and terminal creatinine >1.5 mg/dL Scoring systems - Kidney donor profile index and deceased donor score “Kidney donor profile index” (KDPI) was approved by the Organ Procurement and Transplantation Network Kidney Transplantation Committee in 2013, to estimate the risk of post- transplant kidney graft failure from a particular deceased donor kidney relative to other kidneys. The KDPI score includes the donor's age, height, weight, ethnicity, serum creatinine level, history of diabetes, history of hypertension, hepatitis C status, cause of death, and whether the donation would occur after cardiac death. Each kidney is scored in a KDPI spectrum from 0% to 100%. Lower scores are accepted to have a longer potential function of the donor organ than those with higher scores.[11] The deceased donor score was determined from five donor variables obtained at the time of procurement. The variables were donor age (0-25 points), history of hypertension (0-4 points), creatinine clearance (0-4 points), human leukocytic antigen (HLA) mismatch (0-3 points), and cause of death (0-3 points), with the total number of points ranging from 0-39. A grade (A to D) was then assigned to the specific deceased donor based on his cumulative score. Greater than 20 points or grades C and D were defined as marginal donors with a much shorter potential function of the donor organ.[12] Organ retrieval The surgery for organ retrieval is performed in controlled settings with careful physiological monitoring to ensure optimal organ perfusion and oxygenation until complete perfusion and cooling of donor organs has taken place. Kidneys from deceased organs are retrieved in conjunction with other thoracic and abdominal organs and, therefore, will require coordination of the surgical teams performing different roles. Kidneys can be retrieved along with other thoracic and abdominal organs (A) or can be retrieved alone (B). (A) Retrieval procedure – multiple organs The abdomen is opened and control of the infra-abdominal aorta is obtained. Aorta is cannulated just superior to the level of common iliac bifurcation after administering heparin. Aorta in clamped in the supraceliac location and either the inferior vena cava or the right atrium is opened and suction devices are placed to facilitate perfusion. The abdomen is packed with ice for cooling while flushing and recovery of other organs are performed. The heart and lungs are retrieved first, followed by the liver. Retrieval of the pancreas along with the intestine is then performed. The kidneys are retrieved at the end of the procedure. Retrieval of the kidneys can be done individually or en bloc. Individual recovery of kidneys is performed by transecting at the left renal vein. The aorta and vena cava are transected just superior to their bifurcation, and at a superior level to the emergence of the superior mesenteric artery and the right renal vein. The right renal vein is identified prior to the transection of the vena cava to preserve a superior cuff that can be used later for venous reconstruction. The retrieval of the individual kidneys is started by isolating the ureter and gonadal vein and transecting the renal vein distal to the point of emergence of the gonadal vein. The anterior wall of aorta is sharply transected followed by division of the posterior wall. Gerota's fascia is removed with the kidneys and separated at a later time. En bloc removal of kidneys is performed without longitudinal transection of the aorta or division of the renal vein. (B) Retrieval procedure – kidney alone Utilizing a midline abdominal incision, the peritoneal cavity is widely opened. Retraction of the small bowel exposes the posterior parietal peritoneum, which is then incised. This permits the superior and left-sided retraction of the bowel. The duodenum as well as pancreas are also retracted superiorly to obtain exposure of the proximal aorta and vena cava. The superior mesenteric and celiac trunks are ligated and divided several centimeters above the level of the left renal vein that is crossing the aorta. The proximal and distal aorta and distal vena cava are the ligated. Perfusion of the kidneys is begun through the intravenous tubing that has been introduced into the distal aorta. The perfusate then returns back through a suction catheter placed in the suprarenal vena cava. Isolation of the kidneys and the ureters are then performed. The distal aorta and vena cava are transected. The lumbar vessels are then divided, allowing the en block removal of the tissue while the cold perfusion continues. The viability of the organs should be maintained during transportation from the donor hospital to the transplant center and during organ preparation on the back table. The main strategy of preservation is cold storage, which is based on the principle of reducing metabolism while perfusion is absent. This can be achieved by static cold storage techniques and continuous machine perfusion (dynamic perfusion). In the static cold storage technique, the organs are perfused with cold solution via their arterial supply and suspended in a bath of the storage media on ice. Static cold storage is being currently practiced in our country. The continuous machine perfusion, which is a form of dynamic preservation, uses a machine to achieve a pulsatile perfusate flow. This requires more equipment and a higher level of technical training. This technique is specifically important in the expanded criteria donors and 'donation after circulatory death' group of kidney or liver donors, to reduce the duration of warm ischemia so as to improve the graft outcome. Various preservation solutions are used for this purpose. The most commonly used preservation solutions are the University of Wisconsin and the histidine-tryptophan-ketoglutarate solutions, which vary in the composition of electrolytes, buffers, antioxidants and energy precursors they contain, but share similar goals of reducing graft edema, intracellular acidosis and production of reactive oxygen species and in providing energy substrates for metabolism.[13] Cold ischemia time refers to the amount of time that an organ is not receiving blood supply and is maintained on a cold preservation fluid. Cold ischemia time varies widely from organ to organ, but in general, the sooner an organ can be transplanted, the better it is for ensuring its viability. The commonly accepted cold ischemia times for various organs are as listed below: Heart: 4 hours Lungs: 4 to 6 hours Liver: 6 to 10 hours Pancreas: 12 to 18 hours Intestines: 6 to 12 hours. Kidneys: 24 hours (may be extended up to 72 hours if placed on mechanical perfusion) Various new developments are being attempted on this front such as isolated perfusion at elevated temperatures, ischemic preconditioning and gene therapy. Tissues such as cornea, skin, heart valves and bones may also be harvested and terminally sterilized and stored in tissue banks. These tissues can be used later for future transplant and reconstructive surgeries. Thus one organ donor can save up to eight lives by donating heart, 2 lungs, pancreas, two kidneys and intestine. The same donor can also save or improve the lives of up to 50 people by donating tissues and eyes. Organ transport Organs are transported from the donor hospital to the transplant center in cases [Figure 1]. This is in situ ations where the recipient is located at a different center or when there is no expertise/facility available at the retrieval center. In India, still the conventional method of road transport is being used for transport. Green corridors have been particularly helpful in this regard. When the distance is more, the organs are transported via commercial airlines. There have been many instances where valuable organs have been wasted due to delay in the transportation process. Private ambulances are too prohibitively expensive at this point of time.
Disposal of the body Burial/disposal of the body is done as quickly as possible. This is particularly important as the issues around the time frame within which death ceremony should be done is particularly important to certain families based on their faiths and beliefs.[14] The delay in funeral is a major factor for many families in refusing donation of organs, and therefore, every effort should be made to ensure a quick release of the body for disposal.
The potential for deceased organ donation is huge in India, where the program is still in its infancy. If properly organized, the deceased organ donation process has the potential to fully cover the organ shortage gap making it a possible alternative to living transplant program. Recently, there has been a spurt in the deceased donation program throughout the country, more so in the southern states. Donation after cardiac death (DCD) With new evidence that organs can tolerate short periods of warm ischemia with successful outcomes, the concept of DCD is gaining much interest. DCD is further categorized based on the modified Maastricht classification.
While retrieval from an uncontrolled DCD is still possible, this has to be conducted in a very organized setup where there is provision for quick mobilization of the necessary support at a very short notice. For the same reason, this is practiced only in very few centers around the world. It also may raise many legal and ethical concerns. DCD has not been implemented systematically in India because of the lack of clarity about it in the THOA and its modifications. But the point worth mentioning is that there is nothing mentioned against performing such donations. In India, the main donation occurs among the IV and V categories. Category III is complicated because it involves withdrawal of life support in end-of-life situations and there are no clear guidelines for this practice at present in our nation.[15] Circulatory death is declared after a period of 5 minutes of continuous asystole after resuscitation or withdrawal of life support. The transplant team can proceed with organ retrieval at this point. DCD is an easier concept to be accepted by family members. This practice has the potential to become a major source of organs, if implemented correctly. The laws have to be modified to include this provision to strengthen the deceased donation program. The medical fraternity and policy makers should come together to formulate clear guidelines to be followed in such scenarios, as is practiced in other parts of the world. Future directions Awareness and communication:
Infrastructure and organizational support:
Laws and guidelines
Financial aids
Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
[Figure 1]
[Table 1]
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