Every aircraft in the world has one; a black box that records sounds, registers incidents and stores data in case something goes wrong. And to help prevent the same mistake from being made again.
Together with international experts, researchers at Rigshospitalet are testing whether having a black box in an operating room is a good idea. The aim of the study is to see whether a black box designed specifically for operating rooms (the OR Black Box®) can increase patient safety and reduce unnecessary disruptions in operating rooms.
A whole new approach to improving working procedures and patient safety
At the forefront of the project is a project group from the Juliane Marie Centre at Rigshospitalet, headed by Prof. Jette Led Sørensen, and with project manager Jeanett Strandbygaard. They explain that the project is ground-breaking, both technologically and in relation to patient safety and learning in operating rooms:
“Today, we primarily learn from isolated retrospective analyses of incidents in the operating room. With the OR Black Box®, we’ll have a completely new type of real-time big data from operating rooms with data about the operation itself, data from devices and data on disruptions and interruptions in the room, which can be linked to the anonymous interactions of staff during surgery,” explains Jeanett Strandbygaard.
“This huge amount of data, that’s anonymised by the black box, will help us understand linkages, identify trends, and gain a new understanding of causal relationships in operating rooms. We hope that this project can help reduce complications during operations and create optimal conditions in the room; both for patients and staff,” emphasises Jeanett Strandbygaard.
The black box has been installed in a gynaecological and obstetric operating room at Rigshospitalet and Consultant Surgeon Mikkel Rosendahl from the Department of Gynaecology was one of the first to operate with the black box in the room.
He is excited about the project and sees many opportunities in relation to optimising and improving working procedures:
“I think that having the black box in the operating room has several unique advantages: Firstly, we can map out life in the operating room. By using the algorithms, we can identify inappropriate working procedures, unnecessary disturbances or, at worst, elements that that exacerbate or cause serious incidents.
Secondly, we can identify working procedures that need to be improved. If we’re always waiting for the surgeon, orderly, anaesthesiologist or some other person, then we can make adjustments and optimise the process to everyone’s benefit.
There’s something very unique about recording every operation, anonymising data and storing it for a period. This means that if a complication arises, we can go back and watch the “film” and possibly identify the cause. It’s a unique opportunity to make a targeted effort to minimise the chance of it happening again,” stresses Mikkel Rosendahl.
The operating room has a very special need for learning. The operating room is a complex and high-risk area. Research shows that approximately 40-55% of all medical complications occur there. Research also shows that a normal operation can have disruptions as often as every 40 seconds. The many disruptions are not necessarily a problem, but the OR Black Box® will allow researchers to study this in a whole new way - without focusing on specific people. Jeanett Strandbygaard, an obstetrician and gynaecologist at Rigshospitalet, is often in the operating room, and she explains:
“In the operating room, we’re used to navigating an environment with disturbances such as phone calls and decisions regarding other acute patients; and it works. However, perhaps we can do better and work more safely, for both patients and staff, if we can adjust the ‘disruption culture’ based on the findings we can gather from the OR Black Box®,” she says.
Innovation in the health services
The OR Black Box® project is part of preparations for the new BørneRiget, the Capital Region of Denmark’s new hospital for children, young people and women in childbirth, and the project is also part of Rigshospitalet’s innovation and big data strategy to support clinical decisions.
Merete Lange, head of the Juliane Marie Centre and project director of BørneRiget, explains:
“It’s a crucial project for the way we view safety in the operating room and it will place Rigshospitalet at the forefront of surgical and anaesthesiological innovation and safety.
I believe that the black box project can contribute new knowledge that will renew and develop the way we work in the Danish healthcare sector. I also see the project’s potential to cast new light on working environment problems and equipment issues in operating rooms.
Data from the black box can provide us with unique knowledge to make improvements for both patients and staff, and we look forward to getting started.
I’m impressed by the way staff have welcomed the project, which could feel a bit like Big Brother. The common goal of increasing patient safety means that many consent to taking part in the project and display their willingness to be innovative,” says Merete Lange.
An advanced black box, especially designed for the operating room
The OR Black Box® being tested collects large amounts of data from the operating room: sounds, interactions between staff, data on temperature in the room, noise levels, disruptions, phone calls and other forms of interactions and activities in the room. This is all recorded via four cameras and two microphones attached to the ceiling of the operating room.
Data on the patient’s surgery (pulse, blood pressure and the operation itself) is automatically registered by the black box. In this way, data can be combined, making it possible to see the whole picture, rather than separate pieces.
The big data collected is be anonymised and encrypted and then placed in a database from which researchers can examine and analyse events and correlations, for example between disturbances in the room, interruptions and complications during surgery.
Data collection is in collaboration with international hospital organisations from Holland, Canada, the US, and others. Thus, the joint volume of data can be used to develop future algorithms to aid surgical decision-making in operating rooms, thereby ensuring the highest possible quality surgery. For more information, visit www.surgicalsafety.com
Learning at organisational level - not personal
It is important for the researchers to emphasise that the objective is not to identify human error or to point fingers at anyone, but rather to look at the operating room and what happens there, as a whole. Focus is on organisational contexts that may need adjustment.
No recordings without consent
Both patients and all staff involved must consent to participating in the project before the black box is turned on. All video footage and recordings are encrypted and anonymised so people are not identifiable and the original recordings are deleted after 30 days. The project has been approved by the National Committee on Health Research Ethics and Videnscenter for Datasikkerhed (knowledge centre for data security).
The OR Black Box® being tested at Rigshospitalet was developed by the project’s cooperation partner from St. Michael’s Hospital in Toronto, Canada, headed by Prof. Teodor Grantcharov, in collaboration with Air Canada and the University of Toronto.
St. Michael's Hospital has been using the OR Black Box® in operating rooms for a number of years, and they launched an international cooperation and network on the Black Box, which Rigshospitalet has joined.
300 operations analysed each year
The first OR Black Box® is being tested in a gynaecological operating room at the Department of Anaesthesiology at the Juliane Marie Centre. The goal is to disseminate the concept and black box to other operating rooms and high-risk areas at Rigshospitalet, as well as other hospitals in Denmark.
Researchers at Rigshospitalet hope to be able to analyse data from about 300 operations a year during the project.
50 test operations completed without issue
Photo: picture from an operation at Rigshospitalet, recorded by the OR Black Box®
At the time of writing, 50 operations have been carried out in the operating room containing the black box, and surgeons, nurses and others present in the room have welcomed the project and have not expressed any discomfort or issues with operating while the black box is recording.
"I was only conscious of it for the first five minutes, then I just carried on as usual. You don’t notice it, as the camera and microphones are silent and don’t move”.
Birgitte Kjærsgaard Jensen, operating room nurse, Rigshospitalet
“It doesn’t feel like anything has changed in the operating room, so I don’t think about the fact that there’s an OR Black Box® in the room. I think it’s a great idea and that it’ll benefit both patients and staff,”
Marianne Sand Flindt, anaesthesiologist nurse, Rigshospitalet
Patients have also welcomed the project. All patients consented to participate, says the project group.
The research project, which is expected to be completed in 2023, is titled “Implementation of the OR Black Box in a gynaecologic operation room: a data-driven paradigm shift in the operation room’.
For more information, contact
The OR Black Box® project is support by funding from
- The Erik and Susanna Olesen Charitable Foundation
- The Simon Fougner Hartmann Family Foundation
- The Juliane Marie Centre, Rigshospitalet
Rigshospitalet is the first hospital in Scandinavia to begin using the OR Black Box® system in the operating room. The technology was developed by Surgical Safety Technologies Inc (SST).
Read more about the black box used at Rigshospitalet at rigshospitalet.dk/orblackbox