Policy framework for advancing eye banking and cornea transplantation

The eye donation fortnight 2021 is an occasion to look forward to as the eye donation program and corneal transplantations recover from the tremendous jolt suffered in the wake of the SARS-COVID-19 pandemic. Through concerted efforts of eye banks, Eye Bank Association of India (EBAI) and National Program for Control of Blindness (NPCB) collections and transplants have now gathered pace. However, we still cannot avert the question of whether we will have sufficient corneas in non-COVID years to meet the demand for cornea transplantations in India. Despite years of progress, the answer to this question remains elusive. The reality of the situation is not lost on the eye bankers and cornea surgeons working toward improving the situation. We have capable eye banks in most regions of the country, successful Hospital Cornea Recovery Programs at many major hospitals and mortuaries, and an active network of volunteers and families voluntarily coming forward to donate the eyes of the deceased. The imperative is now to seek a policy and regulatory framework that can accelerate the pace of this movement. Let us first consider the question of the supply of corneas. There is a shortage of tissues in general and a specific shortage of optical-grade corneas. The solution to the two problems is intermingled. Consider this: millions have pledged for eye donation in India. However, unless the person who has pledged had actively talked to their family and the family has high motivation for eye donation, there is no way to act upon the deceased’s wishes at the time of death. This implies that there should be some mechanism to fulfill the donor’s wish after the death. However, left at the discretion of the relatives, the pledge may not convert into transplants. In the immediate aftermath of a death, the family has many logistical matters to handle, on top of coping with the grief of losing a dear one. Under these circumstances, it may be a remote possibility that someone in the family will identify an eye bank and communicate regarding the eye donation. This can be contrasted with the HRCP wherein a well-trained eye donation counselor routinely motivates more than 50% of the families of the deceased for a donation. This is despite the fact that these families are otherwise unaware about eye donation. The crucial factor here is to request for an eye donation during the time of bereavement, especially if the request is made by a professional eye banker trained in grief counseling. Thus, the policy framework needs to change and we need to facilitate a request for eye donation during the time of death. Two solutions are envisaged in this regard. First, a “required request” mandating that during the declaration of the death by the medical personnel, it should be mandatory to request the family to donate eyes. Second, a “required referral” mandating that the person who declares the death must also inform the registered eye bank about the death, provide relevant medical information for screening of the patient, and allow the eye bank personnel to request the family of the deceased for a donation. Both are necessary, but the latter, in our view, is vastly more productive. This is because the person who will deal with the death of the donor is most probably a clinical staff, for example, in a hospital. If they were to implement a “required request,” it may unnecessarily burden them with an unrelated task. Moreover, they may not have staff who are trained to screen for eye donation suitability and counsel the family. In addition, if the medical history of the deceased has contraindications, then no “request” should be made as the cornea cannot be used. Therefore, we think that “required referral” to a competent eye bank that has the eye donation-specific subject matter expertise is a more practicable solution. It solves the problem of information transmission at the time of death and lets the eye bankers and the hospitals play a complementary role. A personnel who institutes the “required request” can do so by delegating the duty to a registered eye bank. In that case, the implementation is the same as a “required referral.” The central benefit of a law mandating “required request” or “required referral” is that it will enforce all hospitals, trauma care centers, and mortuaries to be a source for eye donation. Even in the absence of any such law, if notification of all death from these places within the specified time to a designated eye bank is made mandatory and the eye bank personnel are allowed to screen and counsel the families, it will be a giant step forward. Now coming back to the issue of tapping into the opportunity provided by a pledged organ donor. How will authorities dealing with life and death ever get this information? The amendment to Central Motor Vehicle Rules in 2018 has taken a laudable step in this direction by mandating the capture of this information and indicating it on the driving license. To the best of our knowledge, Rajasthan, Gujarat, and Chandigarh have implemented the same. This looks promising as most optical-grade tissues come from donations secured from trauma care centers and mortuaries. In general, the Aadhar card is the most frequently used document for identification for various purposes. Thus, this information may also be incorporated in the Aadhar card. Additionally, all Aadhar cards are issued by the same body, that is, Unique Identification Authority of India (UIDAI), which means that this de-facto becomes a National Donor Registry. Patient care entities can get this information when enrolling patients and have this information readily available. Thus, the information about the intent of a donor will flow to the point where the knowledge is actually useful. The next step can be that a “First-person consent” law is promulgated, which means that eye banks do not require the consent of the family to collect the corneas if the deceased had already pledged to donate. However, given that eye donation helps the family to alleviate their grief by consenting to the donation and gives their act a social recognition, a donation through family consent has a superior value in propagating the cause and is less prone to misinterpretation by the community. Up to now, we have dwelled on the issue of policies that can significantly increase cornea supply. However, corneas are also highly perishable. As far as sight-restoring transplants are concerned, a cornea remains viable for 4–14 days depending on the preservative media used. Unfortunately, demand for a specific cornea within a certain time limit may not exist among the surgeons or area catered to by an eye bank. In that case, it is beneficial to make that cornea available to other recipients. This requires a framework for exchange of information on patients who are waiting for corneas. Rules such as precedence based on the location of the cornea, condition of the waiting patients, and feasibility of transportation from source to destination within a specified time can be defined on top. This can be conceptualized as a “National Waitlist Registry,” which can ensure the best use of every available cornea, reduce wastage, and smoothen geographic disparity of cornea availability and cornea demand. EBAI, in collaboration with NOTTO and NPCB, can be a nodal agency to maintain such a registry. In conclusion, required referral law and required request law, opening every trauma care center and mortuary to eye donation program, a national donor registry and national cornea waitlist can provide an encompassing policy and regulatory framework to make India a leader in cornea transplantation. While initiative by the federal government can be the prime mover in realizing this policy environment, it is by no means the only way forward. As health is in the state list in the Constitution of India, many of these policies can proceed from state-level endeavors. In fact, a state-level initiative can demonstrate the use-cases and achieve stable implementation which can then be replicated by other states or scaled up at national level. Whatever the case, the onus is on us, as eye bankers, to do advocacy with the state governments and central government to see that our dreams come to fruition. About the author Prof. Namrata Sharma Prof. Namrata Sharma did her post-graduation from Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi. She did her fellowship from Moorfields Eye Hospital in London, UK. She is the Regional Secretary, Asia Pacific Academy of Ophthalmology and Honorary General Secretary of All India Ophthalmological Society. She has two patents to her credit and more than 450 publications in international peer reviewed journals. Her international awards include Senior Achievement Award, International Ophthalmologist Education Award and “Best of Show” awards (6 times) by the American Academy of Ophthalmology. She has 118 book chapters and has authored 11 books. She has been conducting numerous instruction courses at various international conferences. She has contributed to path- breaking research and is the principal investigator in many multicentric international clinical trials.