INTRODUCTION AND BACKGROUND
This article provides a background regarding the current regulation and training of intraoperative neuromonitoring (IONM) practitioners before employing the “four principles” approach of bioethics to frame the ethical concerns regarding the current gaps in the regulation of IONM. IONM is a medical procedure (1) used to assess the functional integrity of the peripheral and central nervous system. It affords real-time analysis of the nervous system, thus serving to warn and guide surgeons performing operations in which there is a high risk of neural injury. IONM requires that once the patient undergoing surgery has been anaesthetised, the IONM personnel place subdermal, intramuscular and occasionally internal needle electrodes into the patient, according to the specificities of the surgery. These electrodes both stimulate and record the electrical activity of the nervous system in order to obtain tracings on the IONM system. Feedback is then given to the surgeon after the IONM responses are analysed.(2)
Since there is no regulation or national guideline available regarding the provision of IONM services in South Africa, in effect any individual can provide this service. In practical terms, there are currently three popular “avenues” in South Africa by which IONM services are provided. First, spinal instrumentation companies may provide an IONM service to a surgeon who uses their spinal instrumentation. These implant companies provide this as a “value add” service. In these cases the IONM is provided by the sales representative of the spinal implant company. Many of these sales representatives have a background in an allied medical discipline, but many do not, and have had no formal training in neuro-anatomy, neuro-physiology and its clinical implementation with respect to IONM. The second “avenue” for the provision of IONM is through an independent company that provides the consumables and monitoring equipment along with a “technician” to perform the IONM. The companies providing IONM services gain an income by selling the consumables and renting out the IONM device that is used during the procedure. The technicians provided by these companies once again typically have a background in the allied health professions, and they may or may not have additional training in IONM, but no formal accreditation or training of these “technicians” is mandated. The third avenue by which IONM can be provided is that through a registered clinical technologist specialising in neurophysiology. The “regulations defining the scope of the profession of clinical technology” published under Government Notice R721 in Government Gazette 13137 of 5 April 1991 states that the responsibility of clinical technologists specialising in neurophysiology includes the “performance of electrophysiological [clinical neurophysiological] procedures, as well as tests on the brain, nervous system and muscular systems of the patient”.(3) Clinical technologists are registered with the Health Professionals Council of South Africa (HPCSA) and charge a professional fee for the provision of IONM services.
The HPCSA is a statutory regulator and serves as the primary regulatory body for health professionals in South Africa. Its objective is to promote the standards of professional education and training of health-care professionals in order to maintain excellent standards of professional and ethical practice.(4) In South Africa, however, IONM is not regulated by the HPCSA. Not having IONM regulated by the HPCSA or any other regulatory body, society or association affiliated to the HPCSA raises several ethical issues of concern.
This article employs the “four principles” of biomedical ethics to examine the practice of having non-regulated and, in many instances non-medical, personnel performing IONM. The “four principles” approach, or “principlism”, first described by Beauchamp and Childress, provides a simple, accessible and widely accepted approach to thinking about ethical issues in health care. The approach is based on four basic prima facie moral commitments – respect for autonomy, beneficence, non-maleficence and justice.(5)
RESPECT FOR AUTONOMY
Autonomy literally means self-rule or self-governance; it implies that one can freely act according to one's own chosen plans. The principle of respect for autonomy in medical ethics involves “respectful attitude” as well as “respectful action”. That is, it is to be acknowledged that an individual has the right to hold views, make thoughtful choices and take actions about his own life and health-care choices based on his values and beliefs.(6) An autonomous decision is made by understanding the consequences and circumstances of the decision, which is intentional and is free of external influences.
An important practical means of promoting autonomy in health care is the informed consent process. For informed consent to be valid it should (1) be voluntary, (2) include the disclosure of all possible complications, (3) be understood by the patient and (4) be obtained without coercion. The patient must be given the opportunity to make an informed decision about whether to have IONM performed after understanding the potential benefits and risks discussed later, and the person performing and interpreting the IONM should be responsible for gaining the aforementioned informed consent. A thorough understanding of neurophysiology and anatomy, along with its clinical application, is required to correctly convey the benefits, risks and expectations of IONM so that an autonomous choice can be made by the patient. If a person is not registered with the HPCSA, they may not perceive themselves as a “health-care professional” and hence may not feel responsible for being part of the informed consent process. At the extreme, patients may not even be informed that IONM will be performed on them during their surgical procedure. Only after the procedure the patient may discover that needle electrodes were placed into their body and IONM was performed.
In addition to informed consent, the concepts of “respect” and “dignity” are critical aspects of the concept of autonomy.(7) IONM is by its nature an invasive procedure. A patient may find it undignified and unrespectful for a non-health-care professional to place needle electrodes into their body, particularly in areas deemed “private” by the patient.
BENEFICENCE
Beneficence refers to the principle of acting in another's best interest. In medicine, beneficence relates to the duty of health-care providers to promote and protect the well-being of the patient and protect them from harm.(8)
Clinical knowledge is what ensures that health-care professionals make the best decisions for their patients. For a patient to benefit fully from IONM, it is imperative for the operator to have a complete understanding of the harms and benefits attached to each surgical procedure. A member of the IONM team should be part of the preoperative evaluation of the patient in order to identify which modalities need monitoring to achieve the maximum benefit of IONM. Armed with the clinical history and physical examination, the person performing IONM can create an individualised plan with the aim of maximizing benefit. Furthermore, the IONM team may need to review preoperative imaging and discuss the potential risks and possible changes in responses that may occur during the procedure.
These are all important aspects that can only be performed by an individual who has had a significant level of clinical training. Without proper training that should meet clearly defined national regulations and ideally be regulated by a society affiliated to the HPCSA, there is no guarantee that the IONM practitioner will have the capacity to examine a patient, as they may not be trained in history taking, clinical examination or clinical image interpretation. In such circumstances, IONM fails to fulfil the duty of beneficence.
NON-MALEFICENCE
The principle of non-maleficence asserts that one ought not to inflict evil, harm or “risk harm” on others.(8) IONM is generally viewed as a very attractive tool for surgeons, with the promise of making surgeries safer, with no inherent risk from the IONM itself. This, however, is not entirely true. Complications may arise from the physical act of monitoring, such as tongue lacerations, seizure provocation, electrical burns, allergic reactions to the materials and interference with other implantable devices such as pacemakers. More frequent and more concerning is the incorrect interpretation of IONM data. The intraoperative monitoring team needs to report a change in data to the surgeon in a timely manner. This implies that the correct modality must be used during IONM surgery, and that the IONM team is capturing the most important and useful information for that specific type of surgery. If any of these actions fail to occur, serious neurological injury can occur that would otherwise have been prevented.
The belief that operating with IONM makes surgery void of potential neurological injury is untrue. Numerous clinical trials (9–11) have shown that IONM does not necessarily prevent neurological injury and has the possibility to induce harm. Therefore, it is natural to assume that this field should be well regulated to maintain a high quality of practice with appropriately trained personnel. It is deeply problematic to risk the infliction of harm on a patient by a largely unregulated non-health-care professional.
JUSTICE
Justice refers to non-exploitation and reasonableness. It demands that treatment be fair, equitable and appropriate in light of what is owed and due to persons.(12) With respect to health care, Gillon (13) described three forms of justice, including (1) distributive justice which describes the fair distribution of scarce resources, (2) rights based justice which describes the respect for persons’ rights and (3) legal justice which pertains to respecting morally acceptable laws.
Distributive justice
In IONM the fair distribution of scarce resources is of importance. Clinical neurophysiology technologists who provide IONM are commonly based in the private health-care sector, having done most of their IONM training after completing their degree in clinical neurophysiology.(14) This has unfortunately left the public sector lacking in registered health professionals experienced in IONM. Very few clinical neurophysiologists are employed full time or otherwise by the public sector. This means that the burden of shortfalls in autonomy, beneficence, and non-maleficence, and thus the potential for consequent patient harm, are likely to fall unfairly on the already overburdened public health-care system.
Rights-based justice
Rights-based justice refers to adhering to person's fundamental rights. These rights may be natural or conventional.(13) Natural rights as a form of justice refer to respecting basic human rights, with a violation of these rights being immoral.(6) Conventional rights, which are based on society's views, are made up of the values of the persons that make up the society. In South Africa, basic human rights such as the right to access information are violated when a person performs IONM without fully disclosing to the patient their level of training and experience in the field of IONM.(15) Similarly, the right to dignity is undermined if invasive medical procedures are performed by non-health-care professionals and would contradict the societal acceptance of such a practice.(15)
Legal justice
Legal justice, as a form of justice regulated by laws and legislation, is also potentially undermined by the performance of IONM by a person who is not registered with the HPCSA. Laws and regulations make it possible for health-care professionals to be held responsible for negligence. If IONM practitioners are not required to register with the HPCSA, they are less susceptible to legal scrutiny and complaints via the HPCSA, since non-registration means they not answerable under the Health Professions Act.(16)
LIMITATIONS
A limitation of this manuscript is that given the relative novelty of IONM, there is little research on its use or regulation in the South African context. This means that in some cases, the authors have relied on personal experience to describe the status quo. This limitation is important as it highlights the reasoning behind the author's claims if they appear empirical.
CONCLUSIONS
When IONM is performed without due regard to ethical principles it is unreasonable and contravenes international standards.(1,17,18) The current practice of IONM in South Africa is not subject to any form of regulation. No national guidelines exist mandating a minimum level of training or experience in IONM in order to provide the service in an unsupervised manner. These guidelines need to be developed and sanctioned by a society or association with oversight from the HPCSA. In addition, independent providers of IONM should be governed as “health-care professionals” accountable to the HPCSA.
Authors’ contributions: J.D. Nel and C. Wareham were responsible for the conceptualisation of the manuscript. JD Nel gathered the data required for the manuscript. Jason J. Labuschagne, C. Lee and P. Chirwa provided critical feedback and helped shape the research, analysis and manuscript preparation and final submission.