Biomedical Engineering controversial topics

Biomedical Engineering Society code of ethics

The BMES Code of Ethics, established in 2004, may also offer some insights into professional conduct.

BME is a learned profession that combines expertise and responsibilities in engineering, science, technology, and medicine. Since public health and welfare are paramount considerations in each of these areas, biomedical engineers must uphold those principles of ethical conduct embodied in this code in professional practice, research, patient care, and training. This code of ethics reflects voluntary standards of professional and personal practice recommended for biomedical engineers.

Biomedical Engineering Professional Obligations:

Biomedical Engineering Healthcare Obligations:

The BMES Code of Conduct suggests that patient privacy is the primary focus, although one could argue that the clinical engineering profession demands that both safe and effective healthcare is the primary concern. The safest place for a patient to be is not in a hospital; there is no risk of malpractice, ineffective treatments, or privacy breeches. However, the safest and most private person who is not in a hospital may also die because a lack of medical care can cause death. Clinical engineers must serve as part of the healthcare team that balances the safety of treatment with the efficacy of medical care.

6.3.1 An Overview of Natural Tissue Construction

Overall, natural tissue design is hierarchical: that is, a structure within a structure, like a nested set of eggs or the branches of a tree. The same structural motif is repeated at multiple length scales to endow the tissue with strength and efficiency of function. Biomimetic paradigms that have been derived from these basic structural and developmental biology concepts provide a rational starting point for the design and fabrication of biomaterials, especially for regenerative tissue-engineered medical devices.

1.3 WHAT IS BIOMEDICAL ENGINEERING

Many of the problems confronting health professionals today are of extreme importance to the engineer because they involve the fundamental aspects of device and systems analysis, design, and practical applicationall of which lie at the heart of processes that are fundamental to engineering practice. These medically relevant design problems can range from very complex large‐scale constructs, such as the design and implementation of automated clinical laboratories, multiphasic screening facilities [i.e., centers that permit many tests to be conducted], and hospital information systems, to the creation of relatively small and simple devices, such as recording electrodes and transducers that may be used to monitor the activity of specific physiological processes in either a research or clinical setting. They encompass the many complexities of remote monitoring and telemetry and include the requirements of emergency vehicles, operating rooms, and intensive care units.

The American health care system, therefore, encompasses many problems that represent challenges to certain members of the engineering profession called biomedical engineers. Since biomedical engineering involves applying the concepts, knowledge, and approaches of virtually all engineering disciplines [e.g., electrical, mechanical, and chemical engineering] to solve specific health care related problems, the opportunities for interaction between engineers and health care professionals are many and varied.

The term biomedical engineering appears to have the most comprehensive meaning. Biomedical engineers apply electrical, chemical, optical, mechanical, and other engineering principles to understand, modify, or control biological [i.e., human and animal] systems. Biomedical engineers working within a hospital or clinic are more properly called clinical engineers, but this theoretical distinction is not always observed in practice, and many professionals working within U.S. hospitals today continue to be called biomedical engineers.

The preceding list is not intended to be all‐inclusive. Many other applications use the talents and skills of the biomedical engineer. In fact, the list of biomedical engineers' activities depends on the medical environment in which they work. This is especially true for clinical engineers, biomedical engineers employed in hospitals or clinical settings. Clinical engineers are essentially responsible for all the high‐technology instruments and systems used in hospitals today; for the training of medical personnel in equipment safety; and for the design, selection, and use of technology to deliver safe and effective health care.

Engineers were first encouraged to enter the clinical scene during the late 1960s in response to concerns about the electrical safety of hospital patients. This safety scare reached its peak when consumer activists, most notably Ralph Nader, claimed that at the very least, 1,200 Americans are electrocuted annually during routine diagnostic and therapeutic procedures in hospitals. This concern was based primarily on the supposition that catheterized patients with a low‐resistance conducting pathway from outside the body into blood vessels near the heart could be electrocuted by voltage differences well below the normal level of sensation. Despite the lack of statistical evidence to substantiate these claims, this outcry served to raise the level of consciousness of health care professionals with respect to the safe use of medical devices.

In response to this concern, a new industryhospital electrical safetyarose almost overnight. Organizations such as the National Fire Protection Association [NFPA] wrote standards addressing electrical safety in hospitals. Electrical safety analyzer manufacturers and equipment safety consultants became eager to serve the needs of various hospitals that wanted to provide a safety fix, and some companies developed new products to ensure patient safety, particularly those specializing in power distribution systems [most notably isolation transformers]. To alleviate these fears, the Joint Commission on the Accreditation of Healthcare Organizations [then known as the Joint Commission on Accreditation of Hospitals] turned to NFPA codes as the standard for electrical safety and further specified that hospitals must inspect all equipment used on or near a patient for electrical safety at least every six months. To meet this new requirement hospital administrators considered a number of options, including: [1] paying medical device manufacturers to perform these electrical safety inspections, [2] contracting for the services of shared‐services organizations, or [3] providing these services with in‐house staff. When faced with this decision, most large hospitals opted for in‐house service and created whole departments to provide the technological support necessary to address these electrical safety concerns.

During the 1990s, the evaluation of clinical engineering as a profession continued with the establishment of the American College of Clinical Engineering [ACCE] and the Clinical Engineering Division within the International Federation of Medical and Biological Engineering [IFMBE].

Biomedical engineering is thus an interdisciplinary branch of engineering heavilybased both in engineering and in the life sciences. It ranges from theoretical, nonexperimental undertakings to state‐of‐the‐art applications. It can encompass research, development, implementation, and operation. Accordingly, like medical practice itself, it is unlikely that any single person can acquire expertise that encompasses the entire field. As a result, there has been an explosion of biomedical engineering specialists to cover this broad spectrum of activity. Yet, because of the interdisciplinary nature of this activity, there is considerable interplay and overlapping of interest and effort between them. For example, biomedical engineers engaged in the development of biosensors may interact with those interested in prosthetic devices to develop a means to detect and use the same bioelectric signal to power a prosthetic device. Those engaged in automating the clinical chemistry laboratory may collaborate with those developing expert systems to assist clinicians in making clinical decisions based on specific laboratory data. The possibilities are endless.

Perhaps a greater potential benefit occurring from the utilization of biomedical engineers is the identification of problems and needs of our present health care delivery system that can be solved using existing engineering technology and systems methodology. Consequently, the field of biomedical engineering offers hope in the continuing battle to provide high‐quality health care at a reasonable cost. If properly directed towards solving problems related to preventive medical approaches, ambulatory care services, and the like, biomedical engineers can provide the tools and techniques to make our health care system more effective and efficient.

2.14 The Role of the Biomedical Engineer in the FDA Process

On November 28, 1991, the Safe Medical Devices Act of 1990 [Public Law 101-629] went into effect. This regulation requires a wide range of health care institutions, including hospitals, ambulatory-surgical facilities, nursing homes, and outpatient treatment facilities, to report information that reasonably suggests the likelihood that the death, serious injury, or serious illness of a patient at that facility was caused or contributed to by a medical device. When a death is device-related, a report must be made directly to the FDA and to the manufacturer of the device. When a serious illness or injury is device-related, a report must be made to the manufacturer or to the FDA in cases where the manufacturer is not known. In addition, summaries of previously submitted reports must be submitted to the FDA on a semiannual basis. Prior to this regulation, such reporting was wholly voluntary. This new regulation was designed to enhance the FDA's ability to learn quickly about problems related to medical devices and supplements the medical device reporting [MDR] regulations promulgated in 1984. MDR regulations require that manufacturers and importers submit reports of device-related deaths and serious injuries to the FDA. The new law extends this requirement to users of medical devices along with manufacturers and importers. This act gives the FDA authority over device-user facilities.

The FDA regulations are ethically significant because by attempting to increase the FDA's awareness of medical device-related problems, it attempts to increase that agency's ability to protect the welfare of patients. The main controversy over the FDA's regulation policies is essentially utilitarian in nature. Skeptics of the law are dubious about its ability to provide the FDA with much useful information. They worry that much of the information generated by this new law will simply duplicate information already provided under MDR regulations. If this were the case, little or no benefit to patients would accrue from compliance with the regulation. Furthermore, these regulations, according to the skeptics, are likely to increase lawsuits filed against hospitals and manufacturers and will require device-user facilities to implement formal systems for reporting device-related problems and to provide personnel to operate those systems. This would, of course, add to the costs of health care and thereby exacerbate the problem of access to care, a situation that many believe to be of crisis proportions already. In short, the controversy over FDA policy centers upon the worry that its benefits to patients will be marginal and significantly outweighed by its costs.

1.6 Professional Status of Biomedical Engineering

Biomedical engineers are professionals, which are defined as an aggregate of people finding identity in sharing values and skills absorbed during a common course of intensive training. Whether individuals are professionals is determined by examining whether they have internalized certain given professional values. Furthermore, a professional is someone who has internalized professional values and is licensed on the basis of his or her technical competence. Professionals generally accept scientific standards in their work, restrict their work activities to areas in which they are technically competent, avoid emotional involvement, cultivate objectivity in their work, and put their clients' interests before their own.

The concept of a profession that is involved in the design, development, and management of medical technology encompasses three primary occupational models: science, business, and profession. Consider initially the contrast between science and profession. Science is seen as the pursuit of knowledge, its value hinging on providing evidence and communicating with colleagues. Profession, on the other hand, is viewed as providing a service to clients who have problems they cannot handle themselves. Scientists and professionals have in common the exercise of some knowledge, skill, or expertise. However, while scientists practice their skills and report their results to knowledgeable colleagues, professionals, such as lawyers, physicians, and engineers, serve lay clients. To protect both the professional and the client from the consequences of the layperson's lack of knowledge, the practice of the profession is often regulated through such formal institutions as state licensing. Both professionals and scientists must persuade their clients to accept their findings. Professionals endorse and follow a specific code of ethics to serve society. On the other hand, scientists move their colleagues to accept their findings through persuasion.

Consider, for example, the medical profession. Its members are trained in caring for the sick, with the primary goal of healing them. These professionals not only have a responsibility for the creation, development, and implementation of that tradition, but they are also expected to provide a service to the public, within limits, without regard to self-interest. To ensure proper service, the profession closely monitors the licensing and certification process. Thus, medical professionals themselves may be regarded as a mechanism of social control. However, this does not mean that other facets of society are not involved in exercising oversight and control of physicians in their practice of medicine.

A final attribute of professionals is that of integrity. Physicians tend to be both permissive and supportive in relationships with patients and yet are often confronted with moral dilemmas involving the desires of their patients and social interest. For example, how to honor the wishes of terminally ill patients while not facilitating the patients' deaths is a moral question that health professionals are forced to confront. A detailed discussion of the moral issues posed by medical technology is presented in Chapter 2.

One can determine the status of professionalization by noting the occurrence of six crucial events: the first training school, the first university school, the first local professional association, the first national professional association, the first state license law, and the first formal code of ethics. The early appearances of the training school and the university affiliation underscore the importance of the cultivation of a knowledge base. The strategic innovative role of the universities and early teachers lies in linking knowledge to practice and creating a rationale for exclusive jurisdiction. Those practitioners pushing for prescribed training then form a professional association. The association defines the tasks of the profession: raising the quality of recruits; redefining their function to permit the use of less technically skilled people to perform the more routine, less involved tasks; and managing internal and external conflicts. In the process, internal conflict may arise between those committed to previously established procedures and newcomers committed to change and innovation. At this stage, some form of professional regulation, such as licensing or certification, surfaces because of a belief that it will ensure minimum standards for the profession, enhance status, and protect the layperson in the process.

The last area of professional development is the establishment of a formal code of ethics, which usually includes rules to exclude the unqualified and unscrupulous practitioners, rules to reduce internal competition, and rules to protect clients and emphasize the ideal service to society. A code of ethics usually comes at the end of the professionalization process.

In biomedical engineering, all six critical steps have been clearly taken. The field of biomedical engineering, which originated as a professional group interested primarily in medical electronics in the late 1950s, has grown from a few scattered individuals to a very well-established organization. There are approximately 48 international societies throughout the world serving an increasingly expanding community of biomedical engineers. Today, the scope of biomedical engineering is enormously diverse. Over the years, many new disciplines such as tissue engineering, artificial intelligence, and so on, which were once considered alien to the field, are now an integral part of the profession.

Professional societies play a major role in bringing together members of this diverse community to share their knowledge and experience in pursuit of new technological applications that will improve the health and quality of life. Intersocietal cooperation and collaborations, at both the national and international levels, are more actively fostered today through professional organizations such as the Biomedical Engineering Society [BMES], the American Institute for Medical and Biological Engineering [AIMBE], Engineering in Medicine and Biology Society [EMBS], and the Institute of Electrical and Electronic Engineers [IEEE].

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