Карачич С., Шатаева Е. Биоэтические проблемы развития реабилитационной индустрии
Аннотация ◊ Одним из видов реабилитационных услуг является протезно-ортопедическая помощь. Появление на данном рынке крупных индустриальных компаний, производящих комплектующие изделия для оказания протезно-ортопедической помощи, привело к возникновению стандартов. Наличие стандартов — необходимое условие для развития любой индустрии, так как обеспечивается ее переход от производства штучных (индивидуальных) изделий к серийному и массовому производству. Однако именно индустриальный подход (его основная цель — экономическая выгода) противоречит основному принципу оказания протезно-ортопедической помощи — индивидуальному подходу. Определяющим при оказании современной протезно-ортопедической помощи становится не поиск оптимального решения для конкретного человека, а необходимость интерпретировать его конкретную ситуацию в рамках существующих стандартов. Человек рассматривается уже не как единое целое, а как набор элементов: руки, ноги, позвоночник и т. д.
Abstract ◊ Prosthetic and orthopedic assistance is one of the rehabilitation services. The appearance of big industrial companies, which produce complementary products for prosthetic and orthopedic help on this market, led to the establishment of standards. Standards are needed for the development within any industry, as long as they provide its transition from the production of pieceworks / individual products to serial and mass production. However, viz. the industrial approach (its main goal is the achievement of economic benefits), contradicts the basic principle of the rendering of prosthetic and orthopedic assistance — the individual approach. The search for an optimal decision for a particular person is not one of the main priorities for modern prosthetic and orthopedic help. It is necessary to interpret the person’s precise situation in the limits of current standards. The person is being considered not as a whole unity, but as a collection of elements: arms, legs, spine, etc.
Keywords: bioethics, bioethical problems, rehabilitation industry, prosthetic and orthopedic assistance.
The content of health care measures consists of medical rehabilitation measures as well as professional acts, which include orthopedic facilities and prosthetics. Their aim is to bring back human dignity to persons with disabilities, i.e. social integration, optimal health, independence and capability.
Disabled person has to learn how to fight against and make through disability and how to use an orthopedic facility properly from a therapist. On the other hand, therapist and surrounding people should learn from a disabled person how does that person feels about it, what are his or her goals and how does he or she use the facilities.
Technological medical progress is strong in the field of prosthetics as well. Digital people are all the way from robots and androids to cyborgs and bionics, who have been existing for a long time in the sphere of science fiction, but nowadays are becoming reality.
Furthermore, human mind evaluates as well and brings us into new and unknown spaces, in which ideas and new reality interlace and create new ideas.
Further progress, which will probably lead to new and important changes and understanding of practice in certain fields of prosthetics, is expected. The disparity between the possibility and real, useful application of medical prosthetics to medical care measures has been growing. There are some evaluations that the modern technological progress in medicine has decreased mortality by 30%, but on the other hand, it has led to the 60% increase of medical care costs, and only 10–30% of humankind have a significant and permanent income. Medical technology has been traditionally standardized ethically, i.e. its choice and application have been left to the decision of the doctrine of socially recognized experts and professional law of the skill called Lex Artis.
The contemporary science of medicine requires scientific verification, standardization and evaluation and it introduces different forms of organized social control (Jakšić, 1994).
The Agency for Quality and Accreditation in Health Care is a professional public institution whose role consists in health care quality and safety monitoring, implementation of voluntary process of health care certification on all levels as well as health care technology estimation.
The Agency suggests a plan and a program of measures for the following acts: insurance, improvement, promotion and monitoring of health care quality in Croatia (cf., Law of Health Care Quality, NN No. 107/07; National Strategy of Public Health Development 2006–2011; Law on the Protection of Patients' Rights, NN No. 169/04).
Do not forget that the technology is closely linked with the division ad structure of social power. Contemporary medical prosthetics is connected with the interests of producers and agents in the implementation of a certain technology as well. The power of rehabilitation industry and the industry of equipment is important and it spends a lot of money for the protection of its own interests and in the struggle for market share. With these funds science and health practice standards can be improved, but, on the other hand, social control can be corrupted. This can break the resistance of experts and create an expected professional and public opinion via advertising and strengthening of consumers’ mentality in the area of rehabilitation as well.
In the past few years a special kind of technological statement has been developed. The conclusions of these consensus conferences have been published. Now they are used as criteria for labour quality reviews. The cost effectiveness of a certain technology is usually reviewed with the use of special methods or by cost benefit analysis. It is very difficult to bring a decision with the criteria of importance for the solution of prior problems and with criteria of economy too. Concerning these two criteria, interests are divided. If the introduction of a new technology does not contribute to the resolution of a problem, then it is always unnecessary, inappropriate and expensive.
Assessment of Medical Technology
The assessment of a medical technology is a multidisciplinary, professional, impartial, objective process. It is grounded on the principles of evidence-based medicine, as well as on the transparent process for the assessment of clinical efficacy and safety, the economic analysis (e.g., the gold standard states’ analysis of cost effectiveness, cost-effectiveness analysis, cost-benefit analysis, and cost-utility analysis) of new or existing health technologies (drugs, medical devices, surgical procedures, diagnostic procedures, and other technologies in the field of prevention, diagnosis, treatment and rehabilitation), taking ethical, social, legal and organizational principles into account (cf., International Network of Agencies for Health Technology Assessment, URL; Kristensen, Sigmund, 2008).
Identical technology fits perfectly in one situation, but in another it is too expensive and unnecessary. Mistakes in rehabilitation industry are frequent. They can be the result of insufficient knowledge and subjective informing of an expert, advertising or fashion, but someone can also make a mistake because of his/her personal interests and a low professional morality.
For every new technology it is necessary to define an expected utility for national health care politics and an expected influence on the resources in the health care system. The reason is the fact that health care systems are very expensive, regardless of whether it was financed from private or public funds. The ordinary fact is that the health care system, together with pension system, is the one which consumes the biggest part of social wealth. Health care systems in contemporary societies are mostly socialized and make one of the main pillars in social countries. Cost pressures in health care are long-term and very dangerous, because of their connection with the increasing opportunities and expectations from health care providers (Zrinščak, 2007).
The logic of market economy and profits of medical clinical practice converts the same practice into a supermarket, which offers services and goods of various qualities. The crucial problem is the fact that the everyday clinical medical practice has become directly dependent on financial power centers. Besides, many national health care decision-makers (all kinds of industrial, commercial and financial companies, which produce, distribute and sell medicines, medical equipment and other sanitary facilities that are necessary for the discovering and treatment of illnesses) do not have any connections with humanistic and ethical demands in treatment and health preservation. All these companies are pathologically obsessed with illness (Matulić, 2005).
In the past ten years basic guidelines, which control us in our everyday work, have interfered not only with doctors’ clinical experience but with patients’ own mind (Gajski, 2009).
The need for production have increased and radically changed the way and the functioning of the entire orthopaedic industry. Prosthetic and orthopaedic industry has no way of making more individual devices but to use a modular system. The modules have serial or semi-manufactured parts of prostheses and orthoses, which are mutually compatible and can be combined and merged with binding elements — the adapters. Bearing prosthetic and orthotic parts corresponding to the shape of the body to which they apply are made individually by a plaster cast. This method allows a rapid production of supplies, simplifies their application and adaptation, and shortens the duration of treatment and rehabilitation. Orthopaedic devices issues are complex and require the collaboration of medicine, medical technology and health insurance. The patient is properly evaluated, and given an individually customized, professionally applied, as standard quality, aesthetically acceptable and functional tool, provided that such aid should be cheap and easily available for use and service. If it happens that a person loses one of the upper or lower extremities, and if this stump does not match the standard types of prostheses, we are increasingly in the situation when the person is subjected to repeated operations and additional amputations to make the stump fit standard measures.
Orthopaedic Technological Expectations
The prosthesis is not meeting the needs of the patient any more, but the patient is surgically treated in order to adapt to the nearest standard. There is a discussion of the new principles of limbs amputation — usually lower ones — so that these surgical procedures are meeting orthopaedic expectations. This means that amputation surgery in the world today must be designed to meet the requirements of prosthetics — the options that the patient allows prosthetics to dictate the manner in which to perform an amputation. It is a “conserving” surgery, which has become a matter of dispute among experts — due to technical advances should we change the traditional technique of operation? Creating of an individual prosthesis is significantly more expensive and the patient has to wait for it for much a longer time than if it is a case with standardized prosthesis. The idea to justify cost and benefit parameters is very much needed in respect that the sanctity of human life is a parameter by which one should defend the character and dignity of life. A person should never be a cost-parameter, because in this way the dignity of life as a basic principle of fairness is being called into question. The task of life sustaining is a dignified act of God, i.e. everything is subordinate to human being and the doctors should just fulfil this task of life maintaining in a manner worthy of the patient, and therefore the principle of rehabilitation industry should be subordinated to the person and not vice versa. An additional surgery procedure for one’s stump in order to approach the nearest standard is morally unacceptable. Also, it is an act that carries all the risks of operating procedures, which in its nature is based only on the material aspect and is contrary to human dignity and the values of life. A human being is reduced to a mere commodity, value. Though advertising machine seems to offer help, in fact, it does not help the human being and humanity completely. The person has become a “machine” that to some extent can be repaired but only up to certain limits (Malović, 2007). Recently there have been made universal prostheses and orthoses, which do not suit to individual needs of a patient and consequently cause additional biomechanical problems that can not be classified as iatrogenic diseases. In addition, it is not a surprise, the fact that a huge number of so-called cosmopolics medical professionals constantly work on creating new, but actually non-existing types of diseases in order to please so-called health care modernization or iatrogenic categorization (Beauchamp, Childress, 1994). The cultural paradigm of postmodern society is becoming more and more determined as material and profitable because the personal morality has been replaced with the morals of certain subsystem. The role of a patient has also been changed. It grew from paternalistic relationship into a partnership and dialogical relation “doctor — patient” (Matulić, 2005).
The Bioethical Aspects of Rehabilitation Industry
The changes in social relations have led to the changes in the understanding of the principles of medical ethics. Principles make good and do not harm anyone speaking about the harmony of natural laws and one’s own endeavor. However, the modern technological power of medicine has divided this one principle into two: 1. Make good; 2. Do no harm. So, it leaves pressure as a possibility of splitting them, and even of opposition between them.
The ethical principle, which requires an unconditional respect of human dignity, stays correct and binding forever without any regard to circumstances when a patient appears in front of a doctor as a free citizen and as an active subject in the process of treatment with all his/her rights and duties.
Today when everything is subordinated to technical efficiency on the one hand, and to profit on the other hand, medical practice is mostly under the attack of humanistic dimensions in every area of medicine, as well as medical rehabilitation.
Everyone has a right of certain life standards, which are necessary for health and prosperity of himself/herself and his/her family including the standards of rehabilitation industry that has to be in accordance with individual needs, but not with some universal standards that can disturb a right to achieve the highest level of health.
Since dilemma is an infallible part of all kinds of medical work, because doctor meets with a certain degree of uncertainty in numerous cases, and on the other hand medical workers have to be ready to react no matter what level of theoretical knowledge they have achieved. This is exactly the area of the activity of rehabilitation industry and technology, which impose their own rules set by profit objectives.
Ethical decision-making is a doctor’s obligation as well as a group’s and an individual’s responsibility, in general and certain cases, in dramatic and ordinary situations. Since all medical decisions have serious consequences, the optimal one is the one based on mutual consideration of the impact of real conditions, possible actions, probable consequences and own values. At first sight there maybe small omissions, trivial dishonesty, which can lead to serious mistakes, and this means that even small procedures has to be followed in the accordance with major principles. The right to achieve the highest possible level of health includes prostheses or orthoses made in accordance with individual needs as well.
In the past few years rehabilitation industry has been influential. It has been included into medical research and education, and partly in health care politics, medias and patients’ associations. Also, the same industry finances scientific investigations in the field that is not reliable but it produces wanted results, and some experts have become the integral part of the team of this industry.
Science is melted with technique. This is leading to the depersonalization and demoralization of clinical practice in which doctors are losers too (Heisenberg, 1997: 152, 156, 158).
Doctors are no longer able to obey the laws of medical science and its ethical principles, because they are lost in cost-effectiveness analysis, and patients are the victims of the wrong development of medical research. Both are becoming victims of technical rationalism, which is taking the first place instead of ethical standards.
More rapid development and the progress of medicine require much prompter studies of new developments. However, in some areas there are still no uniform attitudes and treatment protocols. The basic problem in medicine is still insufficient knowledge in this field and the lack of implementing guidelines related to prescribing, the doctor’s concern and evaluation of functional devices. Due to the advancement of technology, on the one hand, and the administration of unnecessary regulatory burdens, on the other hand, doctors, nurses and physiotherapists have to find time to review and assess clinical statuses and indications for the responsible use of tools. This leaves open the possibility of misuse and misinterpretation, which can be consistent with the interests and political goals of a profiteering group. There is a tendency to accept and encourage just what is an economic profit. If we look at it in the context of market principles, who will assure us that a party of interest who pays money is not going to order a high opinion of scientists to measure self-interest.
The observations of recent times have been increasingly emphasizing the issue of human rights with regard to the development of science and technology, the human rights resulting from the dignity of the human person, which is unique and inimitable, inalienable and untouchable. Dignity is not a measurable economic parameter. Still the door is open to abuse and manipulation of human beings in economic, political and ideological purposes. The person is worth as much as he/she is able to fill the requirements of the functions assigned to him/her [Luhmann’s terminology] (Luhmann, 1980: 28).
The principle that life is the greatest value and the biggest good (saint, unique and singular) has to be and to remain the ethical and humanistic demand, which is the basis of the respect of values and dignity of human being. There is a real danger that the technical principles will come before ethical ones. This is definitely non licet. The understanding of life quality should not fall into a vortex of economic calculations. The measuring of human dignity by cost-benefit and cost-effectiveness parameters is unacceptable.
Jakšić, Ž. i sur. (1994) Socijalna medicina. Zagreb : Medicinski Fakultet Sveučilišta u Zagrebu. ISBN 953-6255-01-4.
International Network of Agencies for Health Technology Assessment [Electronic resource] URL: http://www.inahta.net/ (retrieved on 5.06.2012).
Шатаева Елена Владимировна — доктор технических наук, директор научно-учебно-методического центра реабилитационно-оздоровительного назначения «Биотехнические системы и технологии» Института приборостроения и систем обеспечения безопасности Северо-Западного государственного заочного технического университета, г. Санкт-Петербург.
Shataeva Elena Vladimirovna, Doctor of Engineering, the director of the Scientific, Educational and Methodological Center for Rehabilitation and Health Improvement “Biotechnical Systems and Technologies” of the Institute of Professional Equipment and Safety Systems at North-West State Extramural Technical University (St. Petersburg City).