*Our clinical cases are drawn from the case report literature. The stories, names, and patient details are fictional, however the narratives are based on published patient cases that are available in the references. In this month’s clinical case, we look at the story of Annie *, a pregnant lady, who presented to the hospital with an implanted thoracic spinal cord stimulator (SCS). Her story reflects the blind spots that currently exist in standard healthcare procedures and protocols as biotech syndromes continue to emerge.
Annie, a 29 year old woman, presented herself to the hospital, 38-weeks pregnant and in active labour.
Annie’s medical history included asthma, diabetes, and chronic lower back and bilateral nerve pain resulting from a motorbike accident injury sustained years before. The latter was managed by an implanted spinal cord stimulator (SCS): a device that sends low levels of electricity directly into the spinal cord to relieve pain [1]. Following the implant, her chronic pain was effectively managed by the SCS; however, upon learning of Annie’s pregnancy, her pain specialist advised to turn off her SCS and prescribed non-opiate painkillers to manage her pain [1].
The hospital team prepared Annie for a C-section, as she had had two C-sections previously, and it appeared that no information regarding her SCS was relayed to the anaesthesia team. The presence of an implanted device has several potential implications for effective patient care, especially in emergency procedures such as C-sections [1].
The potential issues that emerge from an emergency procedure such as Annie’s stem from the structural blindspots that exist in a healthcare system in which medical devices proliferate across society without the adequate parallel training for healthcare professionals. Indeed, there exists a considerable information asymmetry between device manufacturers and clinicians when it comes to medical devices in general. When medical devices are designed, manufactured and implanted in isolation from medical professional environments, this leads to growing discrepancies between institutional knowledge and real-life applications of devices, including their potential negative consequences.
Figure 1: Patient's thoractic spinal Xray, showing the spinal stimulator in-situ, taken from the published case report of "Patel S, Das S, Stedman RB. Urgent cesarean section in a patient with a spinal cord stimulator: implications for surgery and anesthesia. Ochsner J. 2014 Spring;14(1):131-4. PMID: 24688346".
First of all, implanted devices may be open-loop or closed-loop systems, meaning that they either discharge doses/shocks with the input from the user (open-loop) or automatically and without the input of a user (closed-loop) [1-2]. Any change in device parameters may impact the observation and diagnosis of a patient’s symptoms. For instance, if the patient is experiencing back pain, it may be hard to establish whether it is caused by the patient being in active labour or by the device having potentially interacted with the body in such a way that it has triggered new symptoms.
In fact, healthcare professionals discussing Annie’s case in a ‘Emerging Digital Technologies’ workshop led by bleepDigital founder Dr Isabel Straw, noted that a lot of patients with implantables arrive at hospital without the device card or the manufacturer’s brochure [3]. Given the urgent nature of a patient’s condition and without key information at hand, including exact model, serial number or device type, it is difficult for clinicians to establish whether the device is functional and performing as intended.
In Annie’s case, she presented herself to the same hospital in which her SCS implantation operation had been performed, enabling the clinicians to access the relevant information to make informed and patient-safety first decisions. Furthermore, this allowed them to rule out possible foreign objects that may be in the way when administering anaesthesia in the spine. Thus, after discussion with the patient and the obstetric team, the team decided to proceed with Caesarean delivery under spinal anaesthesia because the benefits to the patient of neuraxial anaesthesia appeared to outweigh risks to the SCS. As a result, the hospital team was able to ensure a safe and healthy delivery of Annie’s baby.
Indeed, this clinical case scenario demonstrates that whilst implanted medical devices continue to proliferate amongst society, the understanding of how their presence in the body interacts amongst conflicting biological syndromes - particularly in extreme cases such as pregnancies - remains underdeveloped amongst healthcare professionals [1-3]. This is exacerbated by the existing discrepancy in information access between device manufacturers and clinicians, contributing to a concerning isolation of healthcare professionals amongst rapid technological advancements.
This chasm could lead to complex consequences for patients such as Annie, who’s positive outcome for her pregnancy was greatly influenced by the clinician’s team access to her SCS operation information. Without adequate training and improvements in collaboration between manufacturers and health care teams, Annie’s outcomes could become the exception rather than the rule.
*patient’s name has been anonymised
References
Patel S, Das S, Stedman RB. Urgent cesarean section in a patient with a spinal cord stimulator: implications for surgery and anesthesia. Ochsner J. 2014 Spring;14(1):131-4. PMID: 24688346; PMCID: PMC3963044.
Tessa A. Harland, Gregory Topp, Kevin Shao, Julie G. Pilitsis, Revision and Replacement of Spinal Cord Stimulator Paddle Leads, Neuromodulation: Technology at the Neural Interface, Volume 25, Issue 5, 2022, Pages 753-757, ISSN 1094-7159, https://doi.org/10.1016/j.neurom.2022.02.228
Brass, I., Straw, I., Mkwashi, A., Charles, I., Soares, A., Steer, C. (2023) Emerging Digital Technologies in Patient Care: Dealing with connected, intelligent medical device vulnerabilities and failures in the healthcare sector. Workshop Report. London: PETRAS National Centre of Excellence in IoT Systems Cybersecurity. DOI: 10.5281/zenodo.8011139
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