ETHICAL CONSIDERATIONS AND FAQS REGARDING ANATOMICAL SPECIMENS AND RIMASYS SERVICES
Nomenclature: In professional circles, the nomenclature “anatomical specimens” is used instead of “body donations”, so this terminology is also used in this FAQs
Q: What is ananatomical specimen?
If during their lifetime, a person decides to voluntarily,and free of charge, provide their bodies for scientific purposes or for the training and continuous education of health care professionals, this is called a “body donation”. The body donations are anatomically processed after death and thus one speaks of an “anatomical specimen”.
Q: What is the origin of the anatomical specimen?
Our anatomical specimens come exclusively from certified donor programs of German anatomical institutes or from accredited organizations of the American Association of Tissue Banks in the USA. Obtaining the anatomical specimens is supported by transparent and comprehensive records of the donor's origin, medical history, biological data, cause of death, serology testing and (if originating from the USA) documents for import. The donors remain anonymous, the personal details not available and subject to the Data Protection Act.
Q: What are anatomical specimens used for?
The anatomical specimens may only be used for the purposes specified in the body donor contract. The basis for this is the body donor declaration between the body donor and the respective institute, signed during thelifetime of the donor as part of his last will. There may be minor differences between the contracts of different institutions, but all contracts are based on existing legal and ethical regulations. At RIMASYS GmbH and its subsidiaries, anatomical specimens are used for the research and development of better surgical techniques and implants and for the training of healthcare professionals. As a result, a higher quality of care for patients canbe achieved in the future.Additionally, the partnering tissue banks adapted the donor contract for the specifics of RIMASYSGmbH, so the donors are aware that bones might be broken for surgical education.
Q:How does an import workand why do anatomical specimens have to be imported from the USA at all?
The transportation of anatomical specimens takes place deep-frozen via air freight and is imported with clear documentation through customs clearance to Germany. German body-donor systemis in the hands of the individual anatomical institutes without an overarching governing or organizational organ. There are nooverarching institutes or authorities of all institutions located in Germany which regulate or standardize the donation system as a whole. As a result,almost every institute only accepts donations for its own use. This individual need is mainly based on the student training/anatomical preparation courses of medical students, but not for continuing education coursesof surgeons. Therefore, there is a need for additional anatomical specimens for research but also for better training and further education of assistant, specialist and senior physicians. In Germany, as an alternative sourceto the anatomical institutes, this additional training need is addressed by certified organizations like RIMASYS GmbH to maintainthe quality of care.
Q:Do the anatomical specimens pose a risk of infection?
Human anatomical specimens are classified as biological agents and are thus subject to the German Biological Agents Regulation(“BioStoffV”). The “BioStoffV”regulates the handlingof the specimens. The risk that biochemicals and human anatomical specimens pose for humans and the environment is classified in so-called “risk groups”. Anatomical specimens asused by RIMASYS GmbH are screened by the anatomical institutes for the infectious diseases by default. This coversHIV-1, HIV-2 and hepatitis B and C.Only specimens with non-reactive resultsare released. The serological reportsare enclosed with the donation documents and can be reviewed on request. Based on these tests and the fact that the anatomical specimens are stored for months at -20°C, the biological hazard potential is classified as low (risk group I-II)by the “BioStoffV”.
Q: How is a hygienic and respectful handling of human specimens ensured?
All employees of RIMASYS GmbH are instructed in the hygiene/handling of biological agents, as well as ethical behavior in dealing with human body donations and trained regularly. The hygiene regulations of RIMASYS GmbH and their implementation are based on the provisions of the Germany Biological Agents Regulation(“BioStoffV”) and the German Infection Protection Act (“IfSG”). The external individuals who come in contact with the anatomical specimens as instructors or course participants are usually medically trained specialist personnel who are experienced in handling biological agents and the required hygieneand respect. At all events, RIMASYS GmbH reserves the right to instruct all persons present regarding the applicable hygiene regulations and the respectful procedure with the anatomical specimens prior to the event.
Q: How does transportation of human specimens work?
Different laws and regulations apply to the transport of anatomical specimensdepending on the means of transport and duration of transport. RIMASYS GmbH follows the regulations of the International Air Transport Association (IATA) for all domestic andforeign transports, irrespective of means of transport and duration of transport. Among other things, these include the exact declaration, documentation and specification of the transport containers. The transport standards required by IATA include or even exceed federal or state regulations.
Q: What happens to the anatomical specimensafter they have been used?
Disposal of anatomical specimensis subject to the guidelines of the Federal / State Waste SpecialistGroup (“LAGA”). It guides that anatomical specimens, which include all amputates ofliving people as well as those of the deceased, are to be treated as "waste from health care facilities”. The disposal is carried out by specialized companies, the specimensare usually cremated / incinerated. Exempted from this rule are (complete) bodiesor parts considered as corpse. The definition of a corpse in Germany is subject to the burial laws of the federal states (“BestG”).Corpses must be cremated and buried in anurn. Subject to this regulation are all anatomical specimens, which are not to be regarded exclusively as a limb and/or its parts contain the torso or head. For ethical reasons, RIMASYS GmbH has decided to treat all anatomical specimens as a "corpse" and thus bring all to a burial.In case the customer of RIMASYS GmbH is responsible for the disposal of the specimens, proof of proper cremation / incineration is delivered to RIMASYS GmbH which is forwarded to the corresponding tissue bank.
Q: Is a company allowed to earnmoney by selling anatomical specimens?
No. Within Germany, the EU and in most of the states worldwide tradingcorpses and body parts including anatomical specimens is forbidden. RIMASYS GmbH does not trade anatomical specimens at any time. RIMASYS GmbH directly charges the specimen fees as occurred from tissue bank to its customers as pass-through-cost. RIMASYS GmbH generates revenues from the reimbursement of additional services, including the generation of realistic fractures in anatomical specimens. This service is a complex process based on several years of biological and biomechanical research. Comparably, RIMASY GmbH performs services like those, which are logistically and financially comparable to the work of a funeral home, pathologyor undertaker.
Q: How does RIMASYS GmbH generate lifelike fractures?
The generationof fractures in anatomical specimens is based on many years of scientific research and experience. Since 2011, the founders of RIMASYS GmbH have been engaged in the analysis of injury events, biomechanical modelling and generation of fractures. In order to realistically generate broken bones with in anatomical specimens, a comprehensive understanding of the accident analysis is required. The calculated biomechanical models are transferred to fracture simulators, proprietary machines of RIMASYS GmbH. The generation of the fractures happens semi-automatically and with constant verification of scientific parameters under the supervision of medical and biomechanical experts.