The medico-legal and ethical considerations associated with intraoperative neurophysiological monitoring in the USA: overview and proposed guidelines for legal and risk management professionals

Abstract

Intraoperative neurophysiological monitoring, known by the acronym IONM, is a method for monitoring and recording the inner neurological activity of a patient undergoing surgery. When using conventional means of monitoring, neurological damage during surgery may go undetected. IONM prevents this by indicating what is going on within a patient, often in real time, enabling surgeons to change course during surgery. Although IONM offers benefits, its use should not be undertaken without regard to the legal and regulatory issues involved. These include contractual, malpractice, and products liability concerns. In the USA, where healthcare providers are seen as 'deep pockets', these issues must be approached with due care. Healthcare risk-management professionals should take precautions that ensure IONM use will be efficacious and utilised in a manner that minimises the risks inherent in the introduction of new technologies into heavily litigated fields. This paper provides professionals with legal strategies for accomplishing this task.

The investigation of Intraoperative Neurophysiological Monitoring and its Relevance to Neuroethics

“…In first place it must be understood that IONM is intended to protect nervous system during surgery [6]. Nevertheless this technique must be used with caution; one important aspect is that Neurosurgeons could try riskier surgical techniques trusting in Intraoperative Neurophysiological Monitoring protection [4]. Consequently there is one important thought: If bad Monitoring is going to be performed is better not to do it.…”

“…Furthermore there are minor adverse reactions like: dental and lingual injuries when performing MEP. In addition seizures and arrhythmias can occur due to electrical stimulation [4].…”

“…Most investigations have shown the utility of IONM for detection of neurological damage during surgery [13][14][15][16][17][18][19] so without discussion the mere fact of having a technique notifying what is wrong inside someone´s body deserves attention and rank. But despite of positive data in worldwide investigations, predictive power of long term post-surgical clinical state of patients has been questioned [4].…”

“…As a result of this same process Neurosurgery is highly sued because of bad practice [4]. It has to be considered that Neurosurgery is a complex specialty that works very close to sensitive and specialized neural structures.…”

“…Intraoperative Neurophysiological Monitoring (IONM) applies several Neurophysiological techniques during surgical intervention, evaluating nervous system results as normal or abnormal [1][2][3]. It has been stated that without application of IONM, neurosurgeons must rely in signals like respiratory rate, heart rate and blood pressure, which can bring late alerts concerning nervous system state during surgical intervention [4].…”