Coming soon to an operating room near you …

What do the oil industry, the aviation industry, and surgery have in common?  They are all industries where errors can have catastrophic results.[1] One way they differ is that the oil and aviation industries have developed risk analysis and management strategies based on detailed data collection to identify hazards before accidents occur.  In contrast, surgical teams generally rely on self-reported data, incident reports and patient charts when evaluating adverse outcomes.  This kind of analysis, however, is limited by faulty memories, low participation and a lack of objective data. To address these shortcomings, and improve the surgical team’s ability to learn from previous mishaps, an operating room black box has been developed by researchers at St. Michael’s Hospital in Toronto, to continuously capture several sources of intra-operative data.[2]  

These operating room black boxes can continuously gather information from audio recording devices, video cameras placed in the room or on surgical instruments, as well as medical sensors and devices.[3] They can even record noise levels and the temperature of the operating room.[4]   The recordings and data from the black box can identify performance issues – technical things that can go wrong during a surgery – as well as less tangible factors such as distractions, communication and team dynamics that can all lead to errors. 

To date, this black box technology has been installed in four hospitals in Ontario and eight hospitals in the US and Europe and is producing data that has the potential to make surgeries safer.  In an ongoing collaborative research study, all of this data will be analyzed by experts at the International Centre for Surgical Safety in Toronto, with the ultimate goal of developing strategies to reduce preventable errors in the operating room.

We have all heard of the use of flight cockpit black boxes to understand what happened during a plane crash. Aviation black boxes are only analyzed in the case of an air accident, but the developers of operating room black boxes hope this data will be evaluated routinely to help improve training, quality and patient safety.

Results after one year

Recently, researchers have reviewed operating room black box data collected over one year at St. Michael’s Hospital in Toronto. The data from 132 laparoscopic operations was analyzed to determine the rate of distractions, errors, and injuries.  The results of this analysis provide some surprising insights into what goes on in an operating room.

It has long been recognized that distractions in the operating room may be associated with decreased patient safety. These distractions can be as simple as the opening of a door.  The operating room black box data indicated that door openings occurred an average of 42 times per surgery which averaged 94 minutes in length. Machine alarms also contributed significantly to distractions, occurring an average of 67 times in each surgery.  Other sources of distraction included absent or malfunctioning devices in 33% of the cases, and the presence of irrelevant conversation in 26% of the cases. Added together, distractions occurred an average of once every 40 seconds.

Pointing out that airline pilots function within a “sterile cockpit” rule that prohibits unnecessary conversation during critical takeoff and landing periods, the research team hopes to identify critical steps in surgical procedures where there is no room for conversations that are not related to the patient.

What about errors and events?  The researchers noted that errors did happen during every procedure but very few led to adverse events.  “Errors” were generally defined as a deviation from the correct procedure and “events” were defined as injuries caused by healthcare providers that have potential to cause patient harm. The data revealed that there was an average of 20 “errors” per case and an average of 8 “events” per case, with bleeding being the most common event.  Many of these events were corrected during the same operation. 

Improving patient care

Surgery is considered to be a high-risk activity, and these researchers believe it requires the same risk analysis approach used by the airline industry. They are committed to the principles of openness, transparency and accountability, and hope the results from this study will inform the development of policies to improve patient safety in the operating room.

If this technology is adopted beyond the research stage, many questions will arise.  Will you, as a patient, get to choose to have your data collected or not?  Will you have any control over how the recordings and data from your surgery are used?  Will this information become part of your medical record? Will you have access to the recordings and data?  Not surprisingly, efforts are underway by some agencies to frame the collection of this data as a quality assurance activity and protect it from being used in legal proceedings.[5] Some authors cite concerns that loss of these protections would compromise the ability to use this data to improve patient and system safety.[6]

Efforts to improve patient safety in the operating room are important and necessary.  Having said that, as a patient you have the right to know what happened during your operation, especially if something went wrong.  Operating room black boxes have the potential to meet multiple objectives, provided that carefully considered policies are in place to ensure appropriate access and use of this information.







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Brenda Osmond


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