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Published On: Mon, Oct 13th, 2014

Will a surgical ‘black box’ create more malpractice suits?

A team of Canadian researchers are working to adapt black box aviation technology to monitor surgeries. The team, led by surgeon Teodor Grantcharov, believe the device will help improve patient outcomes by providing surgeons with real time analysis and feedback data on the progress of an operation. According to Grantcharov, approximately 20 errors occur per surgery though these are rarely recognized.

Surgical instruments Image/defenseimagery.mil.

Surgical instruments
Image/defenseimagery.mil.

The system his team is developing uses cameras and microphones to monitor the movements, conversations and environment of the operating staff, as well as patient data such as heart rate and blood pressure. The software is then capable of synthesizing information on cutting and stitching quality, the care and handling of organs, and physician-staff communication in real time.

Grantcharov, a surgeon at St. Michael’s Hospital and professor at the University of Toronto, believes that once surgeons complete their medical training and being practicing professionally, “nobody watches us, nobody coaches us, and nobody provides feedback”. The pressure for surgeons to appear perfect, Grantcharov believes, harms the medical community. “Changing the culture starts with admitting or being transparent about our deficiencies.”

This desire to acknowledge human error and reconstruct events to learn from them inspired Grantcharov to begin working on the black box two years ago. This has since led to partnerships with Air Canada, Google Glass, and a pilot program in place at St Michael’s since April. Patients have been excited and willing to participate in the project and preliminary data demonstrates the tremendous impact that minor inconveniences in the operating room can make on the outcome of an operation.

However, some surgeons have responded with concerns that the system may be used against physicians in malpractice suits. In some jurisdictions there are legal protections on the data used to improve performance in hospitals but legality varies drastically from state to state. The Healthcare Quality Improvement Act has a blanket prohibition for information that hospitals use for peer review and self-regulation. This unintentionally infers that data from recorded surgeries that isn’t used for review purposes would be admissible.

Surgeon Chethan Sathya wrote that allowing the use of data from a black box for anything other than internal review would “open the floodgates to a new wave of malpractice concerns”. Alternatively, the concern posed by the American College of Surgeons is that use of the device would have a negative psychological effect on physicians and staff in the hospital room.

By contrast, the New York University School of Law as well as the American Board of Professional Liability, have both expressed strong support for Grantcharov’s device. The mutual opinion is that keeping data hidden from patients and their representatives fosters distrust amongst the public for professional health services. Malpractice suits, in their opinion, exist to give agency to patients suffering from the results of medical negligence.

The black box is currently entering testing phase in Denmark, South Africa and the Northeastern United States. According to Sathya, if the technology comes to the United States, integration will be quick as the black box isn’t classified as a medical device and won’t require approval by the FDA.

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