Tissue donation

The tissue donation means the providing of tissues of a living or dead person for transplantation . The donation and transplantation of human tissue has been regulated in Germany since 2007 by the Tissue Act , and for blood products since 1998 by the Transfusion Act .

Differentiation from organ donation

In contrast to organ donation , the recipient of a tissue donation usually does not require immunosuppressive therapy afterwards . In contrast to organ removal as part of an organ donation, tissue removal can also be carried out after the final death of a person, so that a diagnosis of brain death is not necessary. Organizationally, other organizations are responsible: While in Germany, in accordance with Section 11 of the TPG Transplantation Act, only a central coordinating body is responsible for organ donation ( German Organ Transplantation Foundation ), the legislature does not provide for a comparable individual mandate for tissue donation (Tissue Act). In contrast to organ donation, there are various non-profit and commercial institutions that are active in the field of tissue donation, the preparation of the donated tissue and its distribution to clinical users. These facilities differ greatly in terms of their focus on local, regional or even supraregional supply, in terms of the types of tissue involved (e.g. corneas , bones , heart valves ) and the legal basis on which this work is carried out (e.g. § 21a AMG ( Approval) vs. § 21 AMG (approval)).

There are clear differences between tissue and organ donations on the recipient and donor side as well as on the medically supervising side. Approval for these procedures must also be given independently of one another after death, be it in the context of a separate declaration or by inferring the presumed will of the patient with the help of relatives.

requirements

Transplantable Tissues

To secure patient care are currently u. a. Corneas , amnion (outer egg shell of the maternal placenta ), skin , bones , connective tissue and tendons as well as heart valves and blood vessels are donated. These tissues are only removed by specially trained, experienced employees. To protect the potential transplant recipient, each donor undergoes a risk assessment that assesses potential transmission with infections or malignancies.

Cornea

During the corneal donation, the eyeballs or sclera are removed. A collection is possible up to 72 hours after death. A prosthesis is then inserted. The removal cannot be seen from the outside. A farewell to the deceased is possible without restrictions.

Amnion

The amnion is obtained from the maternal placenta. It's part of the amniotic sac . The placenta donation is a living donation. To reduce the risk of contamination, an amnion donation is only possible as part of a planned caesarean section if the tissues are not subjected to a validated sterilization process . If a validated sterilization procedure is used by the processing tissue bank, the amnion donation can also be obtained as part of a classic birth process. The amniotic membrane is u. a. Used in ophthalmology for the treatment of surface defects on the conjunctiva and cornea of ​​the eye and for the temporary covering of burn wounds in children and adolescents, in wound healing disorders, in oral and maxillofacial surgery and gynecological surgery.

blood

Individual blood components can be transferred in a blood transfusion ; whole blood donations are rarely made. The collection is made from living donors.

Heart valves and blood vessels

Heart valves are mainly donated as part of organ donations or heart transplants (living heart donation). Only hearts that can not be used for a whole organ transplant due to previous illnesses or are replaced as part of a heart transplant are eligible for a heart valve donation . Both pulmonary and aortic valves are required in tissue medicine .

Vascular donations that are not required for organ transplantation are of increasing relevance in tissue medicine. Human artery or vein grafts are often used in emergency surgery.

Bones and skin

Bone and soft tissue can be donated both from living donors (e.g. femoral heads as part of joint replacement surgery) and from deceased persons. The bones of the extremities , the iliac crest , costal cartilage as well as tendons, ligaments and skin are removed.

Age limits

According to Section 2, Paragraph 2, Clause 3 of the Transplantation Act , persons over the age of 16 can independently consent to an organ and tissue donation or declare the transfer of the decision to a third party and object to an organ and tissue donation from the age of 14. There is no maximum age limit for tissue donation. Corneal donations are possible up to old age, heart valve donations usually up to the age of 65. Bones can be donated well into old age, skin up to the age of 75 and soft tissue (tendons, connective tissue) up to the age of 65. The condition of the tissue is decisive. Your suitability for transplantation must be checked medically on a case-by-case basis.

Tissue donation after death

Tissue donations usually come from the deceased. There are few living donation options. The prerequisites for post-mortem tissue donation are the determination of death according to the guidelines of the German Medical Association and the consent of the deceased or the consent of the relatives in the sense of the deceased. Furthermore, the deceased must be suitable as a donor from a medical point of view. Every organ donor can also donate tissue. However, like organ donation, tissue donation is not linked to brain death . Tissues can be donated up to three days after cardiac arrest , depending on the tissue . From a medical point of view, around 80 percent of all those who have died in hospitals are eligible for tissue donation. In Germany, the extended consent solution applies, i. H. consent to tissue donation can be given during B. be documented in an organ donation card. If there is no documented decision for a deceased person, the relatives must decide according to the presumed will of the deceased. If a tissue donation has been carried out, the relatives can say goodbye to the deceased in the manner they wish. After the removal, the corpse is reconstructed in a dignified manner, respecting ethics and piety. There is no need to fear disfiguring external changes in the deceased. After a cornea donation, a prosthesis or contact lens is inserted. The tissue removal carried out is not externally recognizable. The body can be laid out and buried as desired. Tissue grafts are typically not transferred directly to a recipient. They are specially prepared in a tissue bank. This process is called processing. During this treatment and processing process, the fabrics are extensively examined according to previously defined quality criteria. The tissue banks then store the tissues and hand them over to clinical users (the clinic or the surgeon) on request. The basics of the various manufacturing processes are regulated in detail in the drug and active ingredient manufacturing ordinance as well as in the guidelines of the German Medical Association and the professional associations.

procedure

A tissue donation usually consists of the following individual steps:

• Determination of death
• Clarification of the medical indication or contraindication
• Clarification of the will of the deceased
• Donor report to a tissue facility
• Tissue extraction
• dignified care of the deceased
• Serological screening (examination of blood / plasma) to rule out communicable infectious diseases, e.g. B. HIV
• Processing, d. hu a. Sterilization, preservation and packaging of the tissue donations in the tissue bank
• Conveying the tissues to a recipient and transplanting them
• upon request - feedback with thanks to the relatives of the donor

Contraindication

Certain diseases of the deceased lead to an exclusion from the tissue donation. In order to prevent the transmission of certain viruses to the transplant recipient, tissues from deceased persons with proven infections such as e.g. B. HIV , hepatitis B and hepatitis C excluded from transplantation.

Live tissue donation

The majority of tissue donations are post-mortem . Few tissues can be removed before death. The most common form of living donation is blood donation . However, tissue can also be used for femoral heads obtained during hip operations. Bone transplants are made from this in a bone bank. In heart transplants, some heart valves can be obtained from the patient's heart. Amnion donation is also a living donation. It will be taken from the donor as part of a planned caesarean delivery. Written consent from the patient is required for all living donations. The donor must be of legal age and capable of giving consent.

Legal regulations

Tissue law

In Germany, the Tissue Act was passed on July 20, 2007 . It leads to regulations on tissue donation and the like. a. in the Transplantation Act (TPG) and the Medicines Act (AMG). Tissue removal and preparation are regulated by the AMG. Legal questions about tissue donation such as information, obtaining consent and the prohibition of the tissue trade are anchored in the TPG. All institutions involved in tissue donation act strictly on this legal basis. They are controlled by federal and state authorities.

Advanced consent solution

The extended consent solution applies in Germany. It is anchored in the Transplantation Act in the version dated December 1, 1997. Accordingly, tissue from a dead person may only be removed if either the deceased has consented to a tissue donation during his lifetime or if the next of kin consent to the removal. If the deceased does not have a written declaration of tissue donation, the relatives are asked whether the deceased has commented on this topic during his lifetime. If you do not know the attitude of the deceased, you will be asked to decide in accordance with the presumed will of your relative. This must be documented in writing. The extended consent solution also applies in Switzerland. It is anchored in Article 8 of the Transplantation Act. In addition, the principle of uniqueness applies: If several organs or tissues are considered for a donation, consent should be obtained together. This avoids a double burden on relatives.

Priority of organ donation

It is stipulated by law that organ donation takes precedence over tissue removal. This means that an organ donation must not be impaired by a tissue removal. Since a tissue donation is also possible with organ donors, this is only permitted if a person appointed by the coordination office has documented that organ donation is not possible or that this is not impaired by the tissue removal.

Trade ban

The Transplantation Act ( § 17 TPG) has stipulated a trade ban for organs and tissues that are intended for transplantation. It is therefore forbidden to trade with them. In addition to the organs that are required to be mediated, this ban also includes conventional tissue transplants such as corneas, heart valves and blood vessels, because these are manufactured using non-industrial but well-known processes. However, medicinal products that have been manufactured from organs or tissues and require approval in accordance with Section 21 within the meaning of the Medicines Act are excluded from the regulation . The trade ban does not prohibit the reimbursement of expenses incurred as part of an organ or tissue donation. These are, for example, costs for removal, processing in a tissue bank or the transport of tissues.

statistics

Tissue donation

In 2010, the Federal Ministry of Health presented a report for the first time on the supply of the population with tissue and tissue preparations. In 2014 there was the second report from the Federal Ministry of Health. However, both do not contain any specific data on the tissues donated or transplanted in Germany. The information is still based on estimates. The German Society for Tissue Transplantation (DGFG) publishes annually the tissues donated and provided for transplantation within the framework of its network. However, these data only represent part of the tissue donations in Germany .

Tissue Transplant and Needs

Tissue transplantation is used today for a wide variety of clinical pictures when there is no other treatment option. It enables seriously ill people the way back to life and ends long phases of suffering. Patients can see again thanks to a donor cornea, are saved from death or amputation by a blood vessel transplant, regain their mobility after a bone donation or gain valuable years of life with a heart valve transplant. Tissue transplants are performed in numerous medical centers in Germany.

Corneas: Around 6,000 corneas are transplanted annually in Germany. Worldwide there are over 100,000 operations annually. Recipients are people whose cornea has changed pathologically or has been seriously injured. Patients who have been scarred by infections of the eye are also included. The trigger for this is often a herpes infection. Corneal diseases that require a transplant can be congenital or age-related. Changes to the cornea can also occur after surgery.

Amnion: The exact need for amnion grafts in ophthalmology is currently unknown. Today, however, it can largely be covered by living donations, as around 120 amniotic grafts can be obtained from a single placental donation. Around 3,000 transplants are currently performed nationwide.

Heart valves: In Germany, over 15,000 heart valve transplants are performed every year. This includes the grafting of mechanical and biological heart valve prostheses. The proportion of human heart valve transplants is unknown. Indications for a transplant are heart valve defects or diseases with severe cardiac dysfunction. Currently, donor heart valves are mainly used to replace infected valve prostheses, often in the context of emergency operations. In addition, they are mostly used in the field of heart valve defects in children.

Blood vessels: 50,000,000 operations on blood vessels are performed worldwide every year. The number of human tissue vascular grafts is unknown. However, their need is increasing. In Germany, an estimated 500 transplants are required each year. As with heart valves, the main indication is the use of infected plastic prostheses in the area of ​​the aorta and large body arteries. The transplant is often performed as an emergency operation.

Bones: Bone transplants are an essential therapy in spinal surgery and hip arthroplasty in Germany. More than 30,000 transplants of bone and connective tissue are carried out every year. The demand can largely be met.

Skin: The number of skin transplants performed in Germany is not known. However, their needs - especially in the event of fire disasters - are immense and are not met today. Skin grafts are used after severe burns, chronic ulcers, or operations with major skin loss. They are mainly used as a temporary solution for short-term covering of large wounds, since they are rejected by the patient's body without any special drug treatment.

history

The origins of tissue transplantation go back a long way in the past century. Even before organ transplantation was thought of, the Austrian ophthalmologist Eduard Zirm was able to successfully transplant the first human cornea as early as 1905 .

The topic in public

Although an estimated 52,000 tissue transplants are performed in Germany every year, the topic of tissue donation is little noticed by the public. Even ten years after the Tissue Act came into force in 2007, little is known about the requirements and options for tissue donation. The topic is usually mentioned in connection with organ donation and the joint so-called organ donation card .

Web links

• German Society for Tissue Transplantation (DGFG)

Individual evidence

1. ↑ Bone grafts are used for complex tissue defects, e.g. B. caused by replacement operations on artificial hip and knee joints, accidents or bone tumors. Skin grafts are used for large burns. Cell-free variants of skin grafts are u. a. Used to reconstruct the soft tissue after removal of tumors in the female breast or to close very large defects in the abdominal wall. German Society for Tissue Transplantation ( Memento of the original dated December 14, 2011 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. . Website of the German Society for Tissue Transplantation gGmbH. Retrieved October 27, 2011. 
2. ↑ Section 2, Paragraph 2 of the Transplantation Act.
3. ↑ German Society for Tissue Transplantation ( Memento of the original from December 14, 2011 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. . Website of the German Society for Tissue Transplantation gGmbH. Retrieved October 28, 2011.  
4. ↑ ^{a b c} § 3 and § 4 of the Transplantation Act .
5. ↑ § 8d of the Transplantation Act.
6. ↑ German Society for Tissue Transplantation . Website of the German Society for Tissue Transplantation gGmbH. Retrieved October 28, 2011.
7. ↑ German Medical Association - Scientific Advisory Board. '' Guidelines for running a bone bank (2001). '' In: '' Dtsch. Ärztebl 98 (15): A1011-1016 ''; German Medical Association - Scientific Advisory Board. '' Guidelines for running a corneal bank (2000). '' In: '' Dtsch. Ärztebl 97: 2122-2124 ''; Working group of German corneal banks of the German Ophthalmological Society. '' Working guidelines - good professional practice for corneal banks '', 2008.
8. ↑ German Society for Tissue Transplantation Website of the German Society for Tissue Transplantation gGmbH. Retrieved October 28, 2011.
9. ↑ German Society for Tissue Transplantation ( Memento of the original dated February 2, 2012 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Website of the German Society for Tissue Transplantation gGmbH. Retrieved October 28, 2011.  
10. ↑ German Society for Tissue Transplantation Website of the German Society for Tissue Transplantation gGmbH. Retrieved October 28, 2011.
11. ↑ § 8 of the Transplantation Act.
12. ↑ Law on Quality and Safety of Human Tissues and Cells, Tissue Act (Tissue Act) of July 20, 2007 ( Federal Law Gazette I, p. 1574 ); Valid from August 1, 2007.
13. ↑ Marco Andrea Frei: "The extended consent solution according to Art. 8 Transplantation Act", Zurich, Schulthess Verlag, 2012, ISBN 978-3-7255-6708-9
14. ↑ Section 4 (1) of the Transplantation Act.
15. ↑ Section 9 (2) and Section 11 (4) sentence 2 of the Transplantation Act.
16. ↑ § 21a Medicines Act v. July 19, 2011 ( Federal Law Gazette I p. 1398 ).
17. ↑ Section 17 (1) sentence 2 of the Transplantation Act.
18. ↑ Archive link ( Memento of the original from October 20, 2011 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Current report by the federal government on the situation of supplying the population with tissue and tissue preparations (2010).  
19. ↑ [1] Second report by the Federal Government on the situation of supplying the population with tissue and tissue preparations (2014).
20. ^ Zirm, E: A successful total keratoplasty. Albrecht Von Graefes Arch Klin Exp Opthalmol 1906; 64; 580-593.