Facilitating the Safe Diffusion of Surgical Innovations

Patients, surgeons, and hospitals express concern regarding how to introduce surgical innovations safely and effectively into clinical practice.1 Currently, physicians lack evidence-based strategies for acquiring new surgical skills in practice.2 Hospitals similarly lack practical guidance for authorizing physicians to use new procedural skills for patient care. The challenges involved with hospital credentialing and privileging for new procedures are compounded by pressure-inducing expectations of patients, healthcare administrators, and device manufacturers for physicians to be on the cutting edge of technology. How best to enable physicians to incorporate innovations efficiently into clinical practice while ensuring patient safety remains an untapped area for surgical quality improvement and clinical advancement. Assigning responsibility for this task is complex but has become more clear in recent years. Prior court rulings articulate that the medico-legal responsibility for suboptimal patient outcomes with new technology first lies with physicians and their hospitals but that industry also shares this liability.1,3 These precedents offer several routes to emphasize a focus of patient safety when introducing surgical innovations into practice. This article highlights novel strategies that may assist surgeons and hospitals in addressing the challenges associated with incorporating emerging procedures and technology with safe patient care. Peer coaching by experienced surgeons has been proposed to assist with safe surgical skill acquisition in practice.4,5 Hospital credentialing committees may better utilize expert surgeons as proctors for less-experienced surgeons who apply for privileges to perform new procedures. Furthermore, opportunities exist in leveraging industry's financial incentives with surgeons’ drive for clinical advancements. The strategies described in this article offer ways to ensure procedural competency to benefit and protect patients when surgical innovations enter practice. SURGEON–SURGEON OPPORTUNITIES Presently, practicing surgeons are faced with significant challenges when deciding to learn and use new procedures and technologies. While residency programs provide an educational environment that supports the longitudinal learning of surgical knowledge and skills, this atmosphere fades in professional practice. Additionally, further training requires time and financial resources that may deter surgeons from attaining the experience and expertise needed to implement new procedural skills. One way to improve the process for training surgeons to use new technology properly may be through surgical coaching. Coaching continues to gain traction due to its potential for improving surgical performance during postresidency practice.4,6 A surgical coach may be a peer or an expert in the field who mentors and empowers using a partnership mentality and effective communication skills. Greenberg et al4 describe that coaching can target improvements in surgeons’ technical, cognitive, and interpersonal skills. The evidence demonstrates that surgeons at various stages in their career may be amenable to a coaching intervention.5,7 In 1 example, surgeons—who ranged in experience from chief resident to a senior surgeon with over 30 years in practice—were coached by an expert surgeon and observed valuable gains in technical abilities, decision-making, and teaching strategies.5 While important considerations such as a coach's ethical duty to individual surgeons and their patients have yet to be explored, surgical coaching may play a meaningful role for surgeons seeking to acquire new procedural skills safely. Despite many surgeons’ nature to strive continually to improve patient care, the best mechanisms for training surgeons to use new procedures and technology are unknown. The current literature is scarce on existing and preferred methods of learning for practicing surgeons; however, the most commonly chosen methods for adopting new procedures are not necessarily the most effective.2 Many surgeons would prefer focused time with a more experienced surgeon observer,2 similar to how residencies and fellowships are designed. Although mini-fellowships of months-long duration are often impractical for surgeons with busy clinical practices, shorter repeating visits with expert surgeons may be a reasonable option to explore in the future. In the attempt to provide safer and cost-effective care for patients, hospitals might consider financially supporting surgeons who seek to utilize the expertise of their surgical colleagues as a strategy for acquiring new procedural skills. HOSPITAL–SURGEON OPPORTUNITIES After surgeons determine that a new technology will benefit their patients, undergo training, and feel sufficiently trained to request privileges at an institution, the hospital is charged with deciding whether to grant the privileges. For more complex innovations, the Society of Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines recommend that a hospital's privileging process includes proctoring in addition to documentation of adequate credentials and experience.8,9 Instances where proctoring was underutilized previously have led to patient injury and malpractice claims of negligent credentialing against hospitals.1 In the context of introducing new surgical techniques into practice, a proctor is a surgeon with recognized expertise who functions on behalf of the hospital solely as an observer and evaluator. Proctoring differs from coaching in that a proctor reports back to the hospital's credentialing committee; in contrast, a coach works in partnership with the individual surgeon to improve their skills and is not a part of the credentialing committee. Though they fundamentally serve different roles, a proctor's role in the credentialing and privileging process could be complemented by a surgical coach. A proctor's feedback would inform a credentialing committee if a surgeon was not currently ready to receive privileges for a new procedure. The proctor may delineate steps that surgeon must take to become eligible for those privileges. Subsequently, a surgical coach might use that evaluation to help a surgeon improve their skill and become privilege-ready for patient care. Proctoring and coaching strategies can strengthen the process of hospital privileging and improve patient safety when introducing novel procedures or surgical technology. INDUSTRY–SURGEON OPPORTUNITIES As the production source of many surgical innovations, technological companies are increasingly familiar with medico-legal consequences when the innovation is not applied safely in practice.1 Uniquely, their financial investment in the rapid diffusion of new surgical technology is an opportunity for collaboration with surgeons and professional societies to ensure that the process happens safely and efficiently. Previously, companies would host physicians for 1 to 2 days of hands-on training with a new surgical device and then promote its frequent use in the operating room on patients.1 Although companies subsequently have avoided recommending specific criteria for necessary training following the aforementioned legal rulings,3 it could be argued that it is in companies’ economic interest to facilitate surgeons’ safe adoption of their technologies. When aligned with conscientious partners focused on maximizing patient benefit, collaboration with industry could help promote the diffusion of innovative technology in a safe manner for surgical patients. Formal partnerships with professional surgical organizations would mitigate the inherent conflict of interest that industry carries by focusing on the patient as the highest priority when introducing new surgical technology. At Ariadne Labs, we have initiated collaborations with industry to improve patient safety practices with surgical innovations. For example, we have partnered with Johnson & Johnson to focus on trainings that emphasize both technical aspects of using a new surgical device and nontechnical aspects such as communication, teamwork, and decision-making with the new device. This partnership strategy has been piloted using a “device briefing tool” to introduce a new tissue-sealing device to surgical teams in Thailand (manuscript under review). Another example pertains to device companies that recruit surgeons to train on their simulators. Here, surgical groups could leverage new partnerships to employ more rigorous training regimens to ensure patient safety with new surgical devices. Furthermore, novel industry technologies that enable video review of intraoperative performance may be used by surgeons and hospitals to assess their performance, make practical changes to improve performance, and enhance patient outcomes with surgery.10,11 Industry's economic motivations and surgeons’ drive to provide innovative patient care offer an underutilized route for collaboration for ensuring the safe diffusion of surgical innovations. We must acknowledge that improving strategies to introduce innovative procedures cannot be realized without careful planning and buy-in from all stakeholders. Surgeons—in rural, community, private, and academic practices—feel the pressures and understand current limitations in their ability to acquire new procedural skills after residency or fellowship. Furthermore, discussing with patients the risks involved with new surgical procedures presents a significant challenge for surgeons. When comprehensive knowledge of risks is limited, as is often the case with complex innovations, patients’ vulnerability increases. Honest, open discussions between surgeons and patients will be needed to honor the informed consent process. Beyond physicians, companies and hospitals often also share medico-legal liability when newly acquired skills result in poor outcomes for patients. In this practice environment, professional specialty organizations and state medical societies may benefit from collaborating to establish credentialing guidelines and from working with industry to provide financial and structural support for practicing surgeons in pursuit of safely using innovative technology. While challenges are inevitable, collaboration from stakeholders at all levels will be essential to ensure the safe, effective, and responsible introduction of new procedures and technology. This discussion presents potential routes for surgeons, hospitals, and professional organizations to take when safely incorporating surgical innovations into clinical practice. Despite the extrinsic pressures to quickly implement new procedures and technologies, healthcare providers are ultimately responsible for ensuring patient safety and delivering high-quality care. Surgical coaching, proctoring, and collaboration with industry are promising frontiers for strengthening surgeons’ professional development while simultaneously benefitting patient care. While new barriers may emerge as current ones are addressed, these novel approaches to implementing surgical innovations may lead to better, safer care for patients.