Article intro - Taxonomy for Medical Robots

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"Abstract—When establishing common standards to represent a knowledge domain, it is most important to agree on the fundamental definitions and core concepts. Within robotics, this has been challenging, since the structure, control and application domains of robots have changed fundamentally in the past two decades, and standardized concepts and definitions and only catching up slowly to these. A particularly interesting area is of the medical robots, which is an outlier in the robotic world,  since medical robots almost always require close human contact, and not necessarily in a collaborative form. Establishing sound and lasting definitions will assist the maturing of the domain.     

I.     medical robot definitions

According to the IEEE 1872 standard, a robot is an agentive device in a broad sense, purposed to act in the physical, world in order to accomplish one or more tasks. In some cases, the actions of a robot might be subordinated to actions of other agents, such as software agents (bots) or humans. A robot is composed of suitable mechanical and electronic parts.  In the industry, more commonly the ISO 8373:2015 standard’s definition is taken for a robot, a programmed, actuated mechanism with a degree of autonomy, moving within its environment, to perform intended tasks.
Medical robots are robots with medical intended use, thus their manufacturer is supposed to clearly indicate if their application falls under the medical domain, and therefore the system should be considered a medical device. At that point, it falls under the strict regulations of the European Medical Device Regulation (MDR), or of the US Food and Drug Administration (FDA) requiring appropriate safety and reliability. Until very recently, there has been no international standard for medical robots [1], therefore many manufacturers wanted to avoid confusion with their medical device product and the traditional industrial robots by simply not calling their system a robot [2].  Nevertheless, standardization is paramount in the medical domain, since that is believed to be the best way to increase safety systematically.

II.     Surgical and rehabilitation robotics

A.   ISO/IEC domains
In the past eight years, a joint working group of robotic experts was addressing the problem of lacking taxonomy in the medical robotics domain, and the first ISO/IEC joint particular standard for surgical/rehabilitation robots is due in late 2018 [3,4]. These provide a guideline for practical degree of safety for surgical/rehabilitation robots, defining the basic types of robots and tools, and identifying integrated components. The newly introduced definitions (establishing a new taxonomy):
·   Robotically Assisted Surgical Equipment (RASE): Medical Electrical Equipment that incorporates Programmable Electrical Medical System (PEMS) actuated mechanism intended to facilitate the placement or manipulation of Robotic Surgical Instrument
·   Robotically Assisted Surgical System (RASS): Medical Electrical System that incorporates PEMS actuated mechanism intended to facilitate the placement or manipulation of Robotic Surgical Instrument
·   Robotic Surgical Instrument: invasive device with applied part, intended to be manipulated by RASE to perform tasks in surgery
·   Rehabilitation, Assessment, Compensation and Alleviation robot (RACA robot): medical robot intended by its manu-facturer to perform rehabilitation, assessment, compensation or alleviation comprising an actuated applied part.
B.   IEEE initiatives
Parallel to ISO/IEC, the IEEE has also been looking into establishing the taxonomy of medico-surgical robotics. In 2012, a working group was established within the Robotics and Automation Society (RAS) to develop a new ontology standard under IEEE 1872, but it was later dissolved. Earlier this year, EMB (co-sponsored by RAS) started a new working group: IEEE P2730 Standard for Classification, Terminologies, and Definitions of Medical Robots, which is supposed to deliver new results within three years.   

III.     Application of the definitions

The community strongly believes that standardized taxonomies should facilitate not only R&D, but also the technology transfer and safety regulations of the field. A common set of core definitions should be agreed and respected to allow the construction of more complex ontologies for the medical robotics domain."

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