An Augmented Reality Device to Prevent Wrong-Level Spine Surgery

Clear Guide医疗公司 摘要 脊柱手术水平错误已被归类为“从未发生过的事件”，这意味着不良事件 明确(明显可识别和可测量)、严重(导致死亡或严重残疾)， 而且通常是可以预防的。然而，与其他医疗错误不同，例如错误的一侧或错误的位置 通过使用核对表和其他方案显著减少的手术 变化，错误水平的脊柱手术数量仍然居高不下[格林-2014]。自2月以来 2009年，CMS尚未支付与错误地点手术以及许多州和私人手术相关的任何费用 保险公司也纷纷效仿[Wong-2014]。此外，脊柱手术节段错位的发生往往 导致法律诉讼，并向患者提供巨额经济奖励[Goodkin-2004]，使其成为一项代价高昂的 医生和医院都犯了错误。 尽管在所有外科专科中都会发生错误的部位手术，但大多数病例都已被记录在案 整形外科[AMBE-2015]。高达50%的脊柱外科医生报告称手术水平错误 Surgery[Mody-2008]和Watts-2019得出的结论是：脊椎的错误节段手术是一个重要的安全性 尽管外科手术团队遵循了指导方针，但该领域面临的问题仍在继续发生。一贫如洗 射线照相质量和可判断性是这些事件、干预措施最常见的根本原因 旨在优化图像质量和准确解释将是合乎逻辑的第一步行动。这 该提案旨在通过直接注册患者的背部来解决脊柱手术的错位问题 对于图像质量不成问题的术前CT或MRI，让外科医生标记 MRI或CT屏幕-手术的切入点，然后将该点投影到患者的背部， 手术室里每个人都能看到的增强现实创新。 对于每3000名接受错误水平脊柱手术的患者中约有1人[Mody-2008]，消除了 错误水平手术的风险可以帮助做出接受脊柱手术的决定，并消除 可能会改变人生的并发症。 这项提议对公众健康的影响是减少错误节段的脊柱手术，这将使 不仅是病人，而且可能还会减少针对医生和医院的诉讼，从而 减少保险索赔，从而降低保单成本。医院也可以通过避免昂贵的费用来降低成本 重复/修复未报销的手术。

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.