Anne van Dalen

250 I Summary and General Discussion SUMMARY This thesis describes the implementation process of a video- and medical data recorder in the operating room (OR), named the OR Black Box. This system was used as a data- driven surgical safety and quality improvement initiative by using the outcome report for post-operative structured team debriefing. Part I: Implementation of the OR Black Box in the operating room The OR Black Box ® (ORBB) is implemented in one OR at our academic medical centre. As is often the case with relatively new technology, clear legal guidelines and methods on how to use such a system were lacking. In Chapter 1 the privacy law concerns, medicolegal considerations and universal legal requirements regarding the use of a video- and medical data recorder (MDR) were reviewed. Regardless of the national differences in legislation, the general privacy principles are quite clear on how to implement such a quality improvement system. It is important to ensure clear consensus and openness between participants and researchers about the methods and purpose of the MDR. When the MDR is used as a quality improvement tool, the patient is not the object of the study itself, which means that written informed consent, does not necessarily have to be obtained. An opt-out option is sufficient, with their decision clearly noted in the medical record. The MDR outcome data can therefore never become part of the patient’s medical record. Staff, including medical students, are asked formally, to volunteer to work with the MDR. An official informed consent stating the purpose of the data recordings, where the data recordings are analysed, what the expected benefits for the participants are, and how the data are stored securely, is obtained. Following the general privacy principles, the safety and personal privacy of the staff and patients is protected, when using the privacy-by-design principles and ensuring full transparency of the methods used. To this end, the patient’s personal identifiers are stripped from the file as soon as possible (deidentification), faces of the staff are scrambled and voices are altered, and the data is kept safe and secure. The outcome report is anonymised and the original data is deleted as soon as the report is generated. Only the outcome report is presented to the team, and hence used for quality