Dynamic control assignment and automated risk assessment for external control interfaces in the operating room based on ISO IEEE 11073 SDC

Abstract

Surgical procedures require a variety of medical devices, each bearing an ever-increasing number of settings and functions. Most devices are placed in the unsterile area of the operating room. Therefore, the surgeon and other sterile staff members are not able to interact with the device interfaces. Surgeons often rely on so-called ‘yell-and-click communication’ to have a setting changed, which is error-prone, slow and moreover leads to process interruptions for the involved OR personnel. Suitable control devices, like a foot switch or a sterile user interface, can allow sterile staff members direct access to certain device functions. In a networked operating room, such control devices could exist for any controllable value or operation. Due to spatial limitations in the OR, it is desired to use as few physical control devices as possible. To control a large variety of parameters, these control devices' associated functionality could be re-assigned during a surgical procedure. The manufacturer-independent communication standard ISO IEEE 11073 SDC is tailored for medical device control in the operating room and makes such a re-assignable control interface technically feasible.However, each control association must be assessed with regard to its usability and risk management. For example, a critical control target must never be controlled by an element which is too coarse for the intended task. Therefore, it is a key requirement to develop a software model for control devices and a mechanism to allow or deny a proposed mapping desired by the user based on safety and usability criteria.In the present work, we outline a system to describe and categorize input devices (control elements such as buttons, knobs and foot switches) and controllable counterparts (Targets) typically found in the surgical context. Great attention is given to the means necessary to safely control critical parameters. We assess the current descriptive capabilities of SDC and propose necessary additions to create more comprehensible software models of the control devices. Finally, we present a new convention for medical device modeling which could be used to propose or prohibit unsafe or unintended mappings in a user interface for configuring control devices in the operating room.

Keywords: medical device control, human, machine interface, operating room network, configurable external control, automated risk assessment

DOI: 10.54941/ahfe1003943