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Surgeons should determine standard of care for intraoperative neuromonitoring
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The use of intraoperative neuromonitoring during spine surgery is widely variable for different procedures, as well as in the parts of the United States in which it is used. Some spine surgeons use intraoperative neuromonitoring in all cases, even straightforward lumbar decompressions. Other surgeons only use it during high-risk deformity surgeries. In addition, some surgeons may not use it at all as they believe it is not predictive of injury and adds little to the safety of spine surgery.
As such, there is no medical standard of care that guides the use of intraoperative neuromonitoring (IOM) in spine surgery. This topic is addressed in greater depth in the Cover Story.
Standard of care
A recently developed spine surgery technique utilizes a minimally invasive surgery (MIS) access to perform a lateral lumbar interbody fusion (LLIF) and requires a specially designed tubular retractor and IOM system. The use of this specialized IOM system is marketed as a “must” to prevent neurological injury because the procedure requires a blinded approach through the iliopsoas muscle where the lumbar plexus resides. This technique has been taught to such an extent that most surgeons have accepted the use of IOM as part of the accepted safe technique to perform the LLIF and they feel that not using the specialized IOM system would prove below the standard of care. Today, this MIS LLIF technique is rarely, if ever, performed in the United States without the use of IOM.
The term “medical standard of care” is legal terminology used by attorneys in malpractice cases as a measuring stick to determine if a particular level of care was delivered based on the standards determined by surgeons. Standard of care is often defined as what other similarly trained and skilled health care providers with about the same amount of experience would do in a given situation. This includes both treatment decisions and how the surgical procedure is actually performed. In a situation where a company determines use of its specialized device is required for the safe performance of a surgical technique, the message invariably becomes the new medical standard of care for the procedure as all surgeons are taught in a similar fashion. Deviation from the standard would thus constitute medical malpractice should an unexpected neurological injury occur.
Experience guides treatment
Ultimately, spine surgeons should be the determinants of when IOM is used. For this MIS LLIF in question, the manufacturer initially made the determination that a specialized IOM device was required for the safe performance of the technique. This recommendation was not supported by any published comparative data or by a consensus of practicing surgeons. Because many surgeons are taught in a similar fashion, IOM ultimately became the new standard of care for MIS LLIF. Therefore, this medical standard of care, in effect, was developed by a device company and propagated through the surgeons trained by the company.
In general, when an outside entity determines a medical standard of care instead of practicing surgeons, it can create problems for surgeons who do not agree with the practice this standard of care supports. Medical standard of care should always be determined by practicing surgeons based on their personal experience or published research safety data. In the case of the MIS LLIF, the use of the recommended IOM system does not prevent all neurological injuries. Therefore, the surgeon who follows the company’s recommendations may develop a false sense of security.
Newer options for MIS LLIF surgical approaches have since been developed to diminish injury to the lumbar plexus. They involve staying completely out of the iliopsoas muscle from an oblique approach or shallow docking over the iliopsoas muscle first, and then directly visualizing and staying away from the lumbar plexus. However, because of the established medical standard of care surrounding the MIS LLIF situation, surgeons continue to use IOM with newer surgical approaches to practice defensive medicine rather than rely on sound clinical experience. Until the standard of care is changed, IOM will be a mandatory part of MIS LLIF despite its questionable effectiveness.
Established practice patterns
Established practice patterns are difficult to change as seen in the case of Solumedrol for acute spinal cord injury patients. Its use became a standard of care even though a number of contradictory research reports determined it was ineffective and likely led to more adverse events. Despite this, its use continued for years primarily due to a defensive medical practice posture. Similarly, it will take time until it is shown that the use of IOM does not lead to neurological protection in all MIS LLIF approaches and IOM should not be deemed the standard of care for MIS LLIF.
Experienced surgeons need to use sound judgment to establish opinions regarding the medical standard of care. The marketing department of a device manufacturer should never determine the standard of care. We would like to hear our readers’ thoughts on this topic and others addressed in Spine Surgery Today. Please send your comments to spine@healio.com.
- For more information:
- John C. Liu, MD, is the Chief Medical Editor, Neurosurgery for Spine Surgery Today. He can be reached at Spine Surgery Today, 6900 Grove Rd., Thorofare, NJ 08086; email: spine@healio.com.
Disclosure: Liu reports no relevant financial disclosures.