An Augmented Reality Device to Prevent Wrong-Level Spine Surgery

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Clear Guide Medical, Inc. Summary Wrong-level spine surgery has been classified as a “never event”, meaning an adverse event that is unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable. However, unlike other medical errors such as wrong side or wrong site surgeries which have been significantly reduced through the use of checklists and other protocol changes, wrong-level spine surgery numbers remain stubbornly high [Grimm-2014]. Since February 2009, CMS has not paid for any costs associated with wrong-site surgeries and many state and private insurers have followed suit [Wong-2014]. Moreover, the occurrence of wrong-level spine surgeries often results in legal action with significant financial awards to patients [Goodkin-2004], making it a costly error for both the physician and hospital. Although wrong site surgery occurs in all surgical specialties, the majority of cases have been recorded in orthopedic surgery [Ambe-2015]. Up to 50% of spine surgeons report having performed wrong-level surgery [Mody-2008] and Watts-2019 concluded “Wrong level surgery of the spine is a significant safety issue facing the field that continues to occur despite surgical teams following guidelines. As poor radiograph quality and interpretability were the most common root causes of these events, interventions aimed at optimizing image quality and accurate interpretation would be a logical first action.” This proposal aims to solve the wrong-level spine surgery problem by registering the patient’s back directly to the preoperative CT or MRI where image quality is not an issue, having the surgeon mark—on the MRI or CT screen—the entry point for surgery, and then projecting that point onto the patient’s back, an augmented reality innovation that can be seen by everyone in the OR. For the roughly 1 in 3000 patients who endures a wrong-level spine surgery [Mody-2008], eliminating the risk of wrong-level surgery can facilitate the decision to undergo spine surgery at all, and eliminate potentially life-changing complications. The public health implications of this proposal are fewer wrong-level spine surgeries which will benefit not only patients but also presumably reduce lawsuits against physicians and hospitals, thereby reducing insurance claims and thereby policy costs. Hospitals, too, can reduce costs by avoiding costly repeat/repair surgeries that are unreimbursed.