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Shining a glaring light on surgery: technology that records every move aims to improve safety

Faulkner Hospital is trying out a system called the “OR Black Box,” which collects data to pinpoint missteps during operations.

The operating room has long functioned in secrecy, a sanctum where a team works in quiet synchrony to cut open and, hopefully, repair an unconscious patient’s body. Those who do the work rarely talk about it with others and often can’t remember exactly what happened, making it hard to assess what went wrong, or what went right, or whether anything could have been done better.

But now an AI-powered technology may put an end to the mystery, by recording what goes on in the OR in the finest detail — every move each person makes, every word uttered, every instrument used, every shift in the patient’s vital signs, more than a half-million data points from each OR over the course of each day.

The technology is called the OR Black Box, although it involves no box, black or otherwise. The name is intended to evoke the “black box” airlines use to track everything that happens in the cockpit.

More than two dozen hospitals in the United States and Canada have installed the system — a set of wide-angle video cameras that stream to sophisticated software — in some of their operating rooms. In mid-November, Brigham & Women’s Faulkner Hospital in Jamaica Plain began piloting the system in two of its 16 operating rooms, to see if it would make sense for wider adoption in the Mass General Brigham hospital group.

For some, the technology is disturbing, an intrusion into a heretofore private space; its data, they fear, could be used against medical professionals in court. For its fans, the OR Black Box is a powerful and essential tool, with the potential to make surgery safer and more efficient.

“It’s providing this treasure trove of data. It’s giving us vast new insights into the quality of procedures and the quality of performance,” said Dr. Jeff Salvon-Harman, vice president of safety at the Institute for Healthcare Improvement, a Boston-based nonprofit focused on improving outcomes in health care around the world.

All the information is immediately de-identified — faces blurred, bodies distorted — so no one can tell who was there, and all recordings are erased after 30 days. The data are aggregated into a monthly report that shows how often a surgical team performs every step called for in the hospital’s standards.

Patients who end up in a Black Box-equipped operating room won’t be able to watch a video of their procedure; even their surgeon doesn’t get a copy of it. The recordings are analyzed to identify patterns, what Salvon-Harman calls “all those minor events that can add up.”

The intention is never to point a finger at an individual, said Dr. Douglas S. Smink, Faulkner’s chief of surgery. “It’s about the system, and the team,” he said. “Any one human could make a mistake. That doesn’t mean they’re a bad person, or they did poorly. … We want to identify common behaviors in our system, so that we can all benefit.”

The Black Box zeroes in on the undramatic day-by-day minutiae. Faulkner surgeons plan to use it to see how often the team carries out every component of the pre-anesthesia “time-out,” such as stating the patient’s name, date of birth, the procedure, and so forth. “You would hope it would be 100 percent,” Smink said. “It’s not.” Finding out what’s being skipped will inform staff training.

“That’s where you have the most impact on safety — if you can get your teams to do the same, safe things every time,” Smink said.

For example, after Duke Health in North Carolina adopted the Black Box four years ago, the device detected that the staff was not following the precise steps needed to prepare the patients’ skin before incision, said Dr. Christopher Mantyh, professor of surgery and vice chair of clinical operations at the Duke University School of Medicine.

“It’s the simple things that we thought we were doing well,” Mantyh said. “We looked at it – ‘yeah, we’re not doing this right.’” So the hospital bought lunch for the OR staff and re-trained them.

Potentially, adhering to such protocols could mean fewer surgical-site infections. But data answering the critical question — whether the Black Box reduces surgical complications — are not yet available.

And many OR workers bristle at the idea of being watched so closely.

The staff at the Faulkner has not warmed to the new system, according to Janet Donovan, an operating room nurse at Faulkner and secretary of theMassachusetts Nurses Association’s bargaining committee. Donovan said thatnurses and others who work in the operating room uniformly object to the OR Black Box. They are concerned about patient privacy, liability, and whether the data could be used in disciplinary actions.

Donovan is not convinced by the hospital’s promise to protect identities. With the system running in only two ORs, and often the same staff working in both, it would not be hard to figure out who did what, she said.

In addition, nurses worry that the recordings could be subpoenaed in a malpractice case. The recordings are supposed to be erased after 30 days, she said, but couldn’t a judge order the hospital to preserve them? “Living in the age of technology, we all know that nothing that is recorded ever truly goes away,” Donovan wrote in a letter to Smink that she said had 50 signatories objecting to the technology.

But the hospital is not giving staff the option of declining to work in a Black Box-equipped room. Smink said the Brigham is moving slowly and thoughtfully: Mass GeneralBrigham officials have been discussing the technology for three years and started it in just the one hospital.

“The operating room has traditionally been a secretive place where we’re notopen to sharing things that happen there,” Smink said.

He understands the idea of being recorded is “uncomfortable.”

“But it’s in our best interest,” he said.

The consent forms that patients sign before surgery already ask permission forvideo or recording, but the Faulkner does not seek a separate consent for use ofthe Black Box. The hospital tells patients about the Black Box during the preoperative assessment, and a sign on the door states that video and audio recording is taking place.

The hospital’s lawyers and malpractice insurers have studied the question of liability and are not concerned, according to Smink. The company behind the Black Box says its data so far have never been drawn into a court case and will be protected from legal discovery because it’s part of the peer review process, which allows for private evaluation of physicians’ work.

But Andrew Meyer, a Boston malpractice lawyer, said he would definitely attempt to obtain Black Box recordings if they were relevant to a malpractice case, and he believes he might succeed. “It’s a sad state of affairs,” he added, “that they want everyone to be anonymous because they want their mistakes hidden. … Secrecy only leads to further misconduct.”

Salvon-Harman, the quality improvement expert, said that part of the purpose of the Black Box is accountability, and that aspect does contain “some significant risks, if it’s being co-opted to judge performance … or to start pulling that data into the court of law.”

In aviation — an industry patient safety proponents have long sought to emulate — safety depends on workers feeling free to report mistakes or problems without fearing punishment. Ideally the same holds true in health care, but the legal protections are not as firm, Salvon-Harman said. “There is this opportunity for the legal system to attempt to override those protections, which could be very undermining,” he said.

Still, Salvon-Harman added, “We have to recognize that being a professional means we would be comfortable with shared visibility into the practice of our craft. We should be able to stand up to that scrutiny.”

The scrutiny is important because “our perception of how we do things is very different from reality,” said Dr. Teodor Grantcharov, the inventor of the Black Box. It’s not unusual for members of a surgical team to report that everything went perfectly, while the data show all kinds of flaws, he said.

For example, it’s been well-established that fewer complications occur when the surgical team performs every item on a “surgical safety checklist,” such as confirming the patient’s identity and the surgical site, and taking a “time-out” at critical junctures. Such checklists are now required by accreditation agencies. Many hospitals report that they perform the checklist nearly 100 percent of the time. But a closer look reveals, Grantcharov said, that as few as 40 percent have checked off every box on the list.

The OR Black Box can pick up all that information, and pinpoint where improvements can be made.

First introduced in 2014 and revised in 2020, the OR Black Box springs from Grantcharov’s lifelong effort to standardize and improve surgical practice. Working on his PhD in Copenhagen two and a half decades ago, he detected great variability in skill from one surgeon to another, and even from one operation to another by the same surgeon. Personal factors such as fatigue, as well as whether the team works well together and the number of distractions, can all contribute to the variability, he said.

“I made it my life’s goal to study all these factors,” and determine which can be modified, he said.

Grantcharov eventually moved to Toronto, where he became a professor of surgery at the University of Toronto and founded Surgical Safety Technologies, the company behind the OR Black Box. In 2022, he took a position as professor of surgery at Stanford University and associate chief quality officer for innovation and safety at Stanford Healthcare. That year Stanford Hospital became the first on the West Coast to adopt the OR Black Box.

Duke Health, which has had the Black Box in two ORs for four years, is sufficiently pleased with the results to add five more this year — four in ORs and one in the trauma bay, said Mantyh. Despite worries about liability in the beginning, he said, “People came on board very very quickly. I haven’t heard any negativity.”

“You’re learning from your mistakes,” Mantyh said. “The flip side of it is you’re learning from your successes.”

Much of the most valuable information doesn’t involve the surgery itself, but logistics such as whether the OR is ready on time and all the equipment is in the room, but not more equipment than needed. The system can potentially save money by reducing surgical complications and increasing efficiency in managing the OR, such as shortening the time between surgeries.

Is it worth the cost? Grantcharov declined to give a price for the OR Black Box, saying that the company “uses a proprietary pricing algorithm” that takes into account such factors as the number and type of rooms where it will be used. In addition to the installation costs, hospitals pay a fee for the data analysis that Surgical Safety Technology performs.

“It’s not the price that’s the barrier. The barrier is culture,” Grantcharov said. “The operating room is one of the most secretive environments in modern society and changing that is not easy.” Boston Children’s Hospital also has an OR Black Box, installed several months

ago, but it’s not being used on patients. Instead, doctors are test-driving the technology in the simulated operating room, where surgeons go to brush up, a “wonderful place to give people exposure [to the technology] in a professionally low-risk environment,” said Dr. Peter H. Weinstock, executive program director of the hospital’s simulation center.

Weinstock is part of a consortium of Boston-area surgeons who are exploring the possibility of adopting the Black Box at their institutions. He recently returned from a meeting of doctors and hospital administrators using or contemplating the Black Box, held by Surgical Safety Technologies in Palm Beach. There he sensed widespread enthusiasm.

“The opportunity to get real quantitative data that will be relatively easy to obtain — that’s a game-changer,” Weinstock said.

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