College - Author 1
College of Engineering
Department - Author 1
Biomedical Engineering Department
Degree Name - Author 1
BS in Biomedical Engineering
College - Author 2
College of Engineering
Department - Author 2
Biomedical Engineering Department
Degree - Author 2
BS in Biomedical Engineering
College - Author 3
College of Engineering
Department - Author 3
Biomedical Engineering Department
Degree - Author 3
BS in Biomedical Engineering
Date
3-2025
Primary Advisor
Christopher Heylman, College of Engineering, Biomedical Engineering Department
Additional Advisors
Robert Turbow, College of Engineering, Biomedical Engineering
Abstract/Summary
The Operating Room Forcing Function system aims to address the persistent issue of wrong-site, wrong-procedure, and wrong-patient errors (WSPEs) in surgical settings. WSPEs are largely caused by circumvention of the timeout procedure (a planned pause before incision to stop and confirm crucial details of the procedure to be performed known as ‘The Universal Protocol’). The goal set forth by our sponsor, Dr. Robert Turbow, is to develop a lock-out mechanism that requires a timeout to be performed by all appropriate personnel before an operation can begin.
Hospitals are extremely complex systems with competing values, productivity pressures, fast paced work, tight-coupled systems, non-linear interactions, and a punitive culture which can all make room for short cuts and noncompliance. These pressures, along with poor human factors consideration in hospital and device design, allow for circumvention of safety protocols and in some cases, catastrophic failure.
Initial investigation of the problem highlighted that the system needed to be intuitive to learn, provide some sort of visual/audible feedback, and provide multiple levels of verification while still allowing for a total system override in case of emergencies. After defining the problem and key customer requirements, multiple design concepts were created and evaluated in their functionality and ability to address the issue at hand. To create a system that exceeds the Universal Protocol in reliability, we planned to implement a multi-layered design that ensures/forces compliance with the timeout procedure while remaining efficient and unobstructive to normal surgical workflow with a special emphasis on human factors engineering. Interviews with operating room staff and observation of live timeout procedures provided information and feedback throughout the course of the design process.
A final concept was selected, and a prototype system was created. The design proposed in this report entails an audio playback of the timeout protocol where each piece of information must be individually addressed and confirmed. The system includes a set of pedals that operating room staff members must use to simultaneously signal their agreement with each set of information. Only once all information has been confirmed and the timeout checklist is complete, the system switches power on to an external component (Bovie machine, unlocking sharps container, overhead lights, etc.) to provide the lock out functionality. This system ensures that all members are present and attentive during the timeout procedure and that surgery cannot begin until all members are in anonymous agreement of all procedural information.
Tests were performed to ensure the design provided all the desired functionality and met customer requirements initially defined. These tests yielded reliable device functionality, positive user feedback and satisfaction, and indications for reducing the risk of WSPEs and enhancing overall patient safety.
URL: https://digitalcommons.calpoly.edu/bmedsp/200