Newly developed surgical ‘black box’ is similar to airplane device used to analyze data after crash

An adverse event investigation typically must rely on a mix of people’s imperfect memories and incomplete data. However, there is growing interest in using systems during surgery that record a wealth of information — not just videotape, but data from the devices used in the operation and other information such as the correct timeout procedure.

Proponents say such a system would be akin to the “black box” recordings that crash investigators use after an airplane disaster, which provide valuable information about what happened when people’s memories are unavailable or insufficient. However, such recordings also pose important questions for healthcare managers about patient safety, privacy, and the potential use of the information in malpractice litigation.

A system developed by Teodor Grantcharov, MD, PhD, FACS, professor of surgery at the University of Toronto and the Canada research chair in simulation and surgical safety, is gaining attention as the most advanced model so far, and the one most likely to be available for general use soon. Grantcharov is a surgeon specializing in advanced minimally invasive surgeries at St. Michael’s Hospital in Toronto, which has been using the recording system for more than a year.

Since April 2014, Grantcharov has recorded all of his procedures with the unit, which is about the size of a box of tissues or a thick book and looks like any other electronic unit used in laparoscopy.

It records almost everything that goes on in the OR, such as video from the laparoscopic camera, hundreds of data points from around the OR, physiologic details of the patient, conversations between members of the surgical team, temperature and decibel levels in the room, and a gallery view of the operating theater.

SAFETY ADVOCATES PUSH IT

The drive for surgical black boxes comes mostly from patient advocacy groups rather than the healthcare community.

In 2005, members of the American Medical Association adopted a policy that encouraged recording during clinical care for educational purposes, but the policy mostly addressed patient privacy and emphasized that patients must consent to the recording.

State legislators more recently have pushed for recording systems. There is a bill in the Wisconsin legislature that would require cameras in every operating room in the state. The bill is known as the “Julie Ayer Rubenzer Law” for a Wisconsin woman who died after she was given excessive amounts of propofol during a breast augmentation procedure. Her brother Wade Ayer founded the National Organization for Medical Malpractice Victims and helped draft the bill. The legislation has been assigned to the Assembly Committee on Health.

In Massachusetts, a bill was introduced in recent years that would require hospitals to allow recording by a licensed videographer, at the patient’s expense.

The system designed by Grantcharov is intended to improve patient safety by helping surgeons improve their performance, not to generate evidence for use in litigation, he says.

As the system is used at St. Michaels, the data from a procedure are analyzed within 48 hours, and then the video and audio files are destroyed. The other data are retained for 30 days so that they can be used in documenting the 30-day outcome of patients. After 30 days, the data are de-identified and anonymized.

“We use the data on a system level and also to provide feedback to individuals,” Grantcharov says. “The information on a single procedure is not useful for us. We use the data to identify trends and deficiencies within our hospital, but we don’t use it to blame and shame people or in court.”

When the black box was introduced at St. Michael’s, Grantcharov was the only one using it, and it was available in just one OR. Over time, the system was adopted by more surgeons and made available in more ORs. After the successful trial at St. Michaels, the system is being introduced for beta testing at other hospitals in Canada, the United States, and South America.

In a pilot project involving 54 procedures, surgeons reviewing data from the black box found adverse events in 38 of the cases, and 75% of the problems were not noticed at the time by the surgical team.

SURGENS SKEPTICAL

Grantcharov acknowledges that surgeons and managers will be wary of creating such a detailed record of the procedure that might be used against them in court.

After he presented research from his use of the system at the 2015 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), the question-and-answer session included attendee surgeons who voiced concerns that a black box would be weaponized by plaintiffs’ attorneys.

Grantcharov points out, however, that the Healthcare Quality Improvement Act (HQIA) protects data collected for peer review and quality improvement from discovery. That protection is justified when the system is intended to improve performance, he says, not to augment the patient record. Additionally, the information would not be available to attorneys if it were destroyed and/or anonymized after a short period, as is done at St. Michael’s. However, Grantcharov says that even if the data did make its way to the courtroom, he believes it would be beneficial to the hospital and the surgical team in a malpractice case.

“The data would most often work to their favor in proving what did and did not happen,” he says. “We did not design it with the courts in mind, but I think more documentation in surgery will lower malpractice claims by improving team performance in surgery.”

COURT USE IS POSSIBLE

Though the HQIA protects information generated as part of a formal peer review process from use in litigation, that protection is not ironclad, says M. Daria Niewenhous, JD, an attorney with the law firm of Mintz Levin in Boston. Efforts to keep such information out of the courtroom often are challenged, Niewenhous says.

Increased data collection would help with the increasing pressure from payers and governmental authorities who are looking for ways to measure quality, she says, but managers should proceed carefully.

“This could be a useful tool, but safeguards must be put into place to ensure the confidentiality of patient information and to control how such information is used,” Niewenhous says. “The black box data has a place as a training tool and may well result in better-trained surgeons and clinicians. Care must be taken to de-identify information used, much as how medical school and other training programs de-identify X-rays shown in lectures.”

CHALLENGING QUESTIONS

Niewenhous notes that with more widespread use, the information could become a part of the patient’s medical record and therefore no longer under peer review or other protections. Also, some of the state legislation that is pending or under consideration would require that the recordings be made a part of the patient record.

“There are challenging questions to be addressed. For example, should a patient or his/her legal representative have the right to watch the video and, if so, under what circumstances?” Niewenhous says. “We are becoming more used to having our activities recorded and, with technology readily available to enable patients to view the information, will patients call for the option to have their procedures recorded?”

Ensure that the legal and ethical issues surrounding use of these black boxes and the use, storage, and retention of the information they collect are addressed before their use becomes more popular, Niewenhous says. Too often, she says, policies and procedures have to catch up to technology that is already in use.

Grantcharov urges healthcare leaders not to let the legal concerns overshadow the potential for improving patient safety.

“We as healthcare providers need to be aware of our deficiencies and be able to improve them, and I have no doubt in my mind that this is a tool that can help in that regard,” he says. “Once we have shown this in a multi-center trial, we hope that this will lead to a change in the way we practice surgery and a change in the way we critically reflect on our performance.”