Risk Management Tools & Resources

 


Surgical Black Box: Benefits, Barriers, and Risks

Surgical Black Box: Benefits, Barriers, and Risks

Laura M. Cascella, MA, CPHRM

Healthcare technology is quickly advancing and offers many promising prospects for improving patient care and reducing safety risks. One advancement that may prove highly consequential is the surgical, or operating room (OR), black box — a technology that seeks to improve surgical safety and outcomes.

Surgery is a well-known area of risk in healthcare, and MedPro claims data consistently show that the top malpractice allegation category across all cases is surgical treatment.1 This isn’t surprising given the intrinsic nature of the OR setting, which is “a dynamic, complex, interprofessional, and multidisciplinary environment, where many potential factors . . . can interfere with and affect the intraoperative procedure and performance, and thus patient safety.”2

However, many of the adverse events that occur during surgery are considered preventable,3 which highlights the need to develop strategies and tools — such as black box technology — to address safety issues.

The surgical black box is a system of microphones, sensors, and cameras that integrates into the OR setting and captures data related to environment, performance, communication, equipment, patient factors, and more.4 Much like an airplane black box that provides critical flight data, the surgical black box provides crucial information about what transpires in the OR setting. But unlike the airplane technology, the surgical black box isn’t meant to just provide retrospective details; rather, its purpose is to proactively identify safety hazards and inefficiencies so organizations and surgical teams can effectively remediate them.5

Although adoption of this technology is still in its infancy, it appears poised to dramatically reshape surgical care and safety. Numerous studies and articles describe a range of potential black box benefits, including the ability to:

  • Capture and aggregate valuable data points that provide insight into the numerous factors affecting intraoperative care
  • Eliminate recall bias and improve the accuracy of important details that affect surgical risk and patient safety
  • Identify variations, inefficiencies, and potentially dangerous workarounds in surgical care
  • Determine factors that negatively affect the surgical environment (e.g., alarms and interruptions)
  • Monitor and improve compliance with safety protocols (e.g., use of checklists and timeouts)
  • Evaluate various aspects of teamwork, such as communication and leadership style
  • Provide valuable information to improve technical skills and enhance training and education
  • Increase staff satisfaction and reduce burnout (secondary to addressing other identified issues, such as distractions, scheduling problems, and poor communication)6

Like any health technology, however, the surgical black box isn’t without barriers and risks. Below are three main challenges associated with this technology as well as potential risk strategies to help overcome them.

Implementation

Implementing new technology in healthcare settings requires careful consideration and planning to avoid stress, frustrations, a chaotic environment, and potential safety issues. A well-designed change management process can help organizations prepare to adopt surgical black box technology and assess readiness at the organizational and staff levels.

Strategies that can assist with implementation include the following:

  • Conduct a change readiness assessment to identify areas of strength and weakness for adopting the technology, including overall strategy, goals, cost, technology infrastructure, resources, etc.
  • Procure leadership buy-in and support for implementing the technology, and seek multidisciplinary champions to help facilitate adoption.
  • Make sure plans are in place to provide clear and transparent communication with surgical team members and other stakeholders (e.g., administrators, information technology [IT] staff, and risk managers). Communication should occur from the initial planning stages throughout the implementation process and beyond.
  • Determine whether and how the new technology might affect workflow processes in the OR, and seek input from surgical team members on developing workflow policies that align with both their needs and the realities of the technology.
  • Develop a strategy for engaging patients and patient advocates in the implementation process, including creating tailored communications, soliciting feedback, and addressing important concerns.7

Provider and Staff Reluctance

Changes to processes and technology are difficult even in carefully planned and well-managed situations. Resistance to change is a natural human response, and various factors may trigger it.

With regard to introducing surgical black box technology, surgical team members and others may have general concerns about loss of control and change, or they may have concerns that are specific to the nature of the technology — such as worries about privacy, legal implications, fears of scrutiny, and more.

Strategies that can assist with addressing reluctance include the following:

  • Offer training and education on the technology prior to, during, and after implementation to help acclimate providers and staff, identify concerns, and recognize potential issues.
  • Make sure training and education address more than just logistical and technological aspects. Training also should take into account legal and ethical concerns.
  • Clearly communicate how the organization plans to use the data from the surgical black box, including how it will be handled and secured.
  • Work toward creating an overall culture of psychological safety in which errors, near misses, workarounds, and inefficiencies are viewed as learning opportunities rather than personal failures or shortcomings.
  • Assure team members that the purpose of the data is to improve quality, safety, and efficiency, not to create a punitive environment or assign blame.
  • Stay current on evolving legal implications related to the technology, and provide transparent communication to stakeholders. Instill confidence that the organization is mindful of these issues and monitoring with diligence.8

Privacy/Security

Privacy and security are paramount concerns with all types of emerging healthcare technologies, including the surgical black box. Surgical team members and patients might have significant concerns about being recorded and the outcome of audio and video recordings. They, as well as others, also might feel apprehensive about how the system is secured and how information is maintained.

Strategies that can assist with addressing privacy/security issues include the following:

  • Determine the privacy features of the system, such as the ability to blur images and de-identify voices, and clearly communicate to stakeholders how the organization plans to use those features.
  • Work with technical and cybersecurity staff to assess privacy and security risks and implement safeguards at all points of risk exposure.
  • Develop written policies related to data governance and maintenance. As part of these policies, determine how long the organization will maintain data, who is responsible for data maintenance, and when/how audio and video recordings will be deleted.
  • Consider using signage outside and inside the OR setting to indicate the presence of the surgical black box and to provide notification of when recording is in progress. Incorporate verbal acknowledgment of the technology as part of surgical team timeouts and briefings.
  • Determine whether your organization plans to make patients aware of the presence of the surgical black box; doing so may depend on how the technology is used (e.g., for research studies or quality improvement). Consult experts as needed to ensure (a) compliance with privacy and informed consent laws, (b) protection of quality data, and (c) consideration of ethical aspects.
  • If patients will be made aware of the surgical black box, educate them about the purpose of the technology and its safety benefits. Explain how the technology works, what it records, how the organization will use the data, who will have access to the data, privacy/security safeguards, and data-retention timeframes.9

In Summary

Improving surgical care is an enduring and pressing issue in modern medicine, and — like other issues — might be amenable to technological solutions. The surgical black box is a ground-breaking advancement that holds promise for revolutionizing surgery and improving quality, safety, efficiency, and more.

Healthcare organizations that want to incorporate this technology should consider potential barriers and risks, such as concerns related to implementation; provider, staff, and patient hesitancy; and privacy/security. Careful planning, assessment, communication, education, and training can help organizations effectively manage change and minimize upheaval when integrating surgical black boxes and other technologies into clinical care.

Resources

For articles and news related to surgical black box technology, see the following resources:

Endnotes

1 MedPro Group cases, closed 2013–2024.

2 Møller, K. E., Sørensen, J. L., Topperzer, M. K., Koerner, C., Ottesen, B., Rosendahl, M., . . . Strandbygaard, J. (2023). Implementation of an innovative technology called the OR Black Box: A feasibility study. Surgical Innovation, 30(1), 64–72. doi: https://doi.org/10.1177/15533506221106258

3 Boet, S., Etherington, C., Lam, S., Lê, M., Proulx, L., Britton, M., Kenna, J., . . . Singh, S. (2021). Implementation of the Operating Room Black Box Research Program at the Ottawa Hospital through patient, clinical, and organizational engagement: Case study. Journal of Medical Internet Research, 23(3), e15443. doi: https://doi.org/10.2196/15443

4 Blum, K. (2022, November 15). Black boxes in the operating room could improve teamwork, patient safety. Association of Health Care Journalists. Retrieved from https://healthjournalism.org/blog/2022/11/black-boxes-in-the-operating-room-could-improve-teamwork-patient-safety/

5 Bai, N. (2022, September 28). ‘Black boxes’ in Stanford Hospital operating rooms aid training and safety. Stanford Medicine News Center. Retrieved from https://med.stanford.edu/news/all-news/2022/09/black-box-surgery.html

6 Ibid., Peregrin, T. (2023, July 10). Black box technology shines light on improving OR safety, efficiency. American College of Surgeons Bulletin, 108(7). Retrieved from www.facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2023/july-2023-volume-108-issue-7/black-box-technology-shines-light-on-improving-or-safety-efficiency/

7 Boet, et al., Implementation of the Operating Room Black Box Research Program at the Ottawa Hospital through patient, clinical, and organizational engagement: Case study; Møller, et al., Implementation of an innovative technology called the OR Black Box: A feasibility study.

8 Ibid; Hawn, M. (2023, October 3). Why every operating room needs a black box. Association of American Medical Colleges. Retrieved from https://www.aamc.org/news/why-every-operating-room-needs-black-box; Bajaj, S. (2024, June 7). This AI-powered “black box” could make surgery safer. MIT Technology Review. Retrieved from www.technologyreview.com/2024/06/07/1093338/surgical-safety-technologies-ai-black-box-surgery-operating-room

9 Boet, et al., Implementation of the Operating Room Black Box Research Program at the Ottawa Hospital through patient, clinical, and organizational engagement: Case study; Peregrin, Black box technology shines light on improving OR safety, efficiency; Walsh, R., Kearns, E. C., Moynihan, A., Gerke, S., Duffourc, M., Compagnucci, M. C. . . . Cahill, R. A. (2023). Ethical perspectives on surgical video recording for patients, surgeons and society: Systematic review. BJS Open, 7(3), zrad063. doi: https://doi.org/10.1093/bjsopen/zrad063; Dalen, A. S. H. M., Legemaate, J., Schlack, W. S., Legemate, D. A., & Schijven, M. P. (2019). Legal perspectives on black box recording devices in the operating environment. British Journal of Surgery, 106(11), 1433–1441. doi: https://doi.org/10.1002/bjs.11198; Saver, C. (2019, May 17). Artificial intelligence makes surgical ‘black box’ smarter. OR Manager. Retrieved from www.ormanager.com/artificial-intelligence-makes-surgical-black-box-smarter/

Legal Disclaimers