CHAPTER 3 AT A GLANCE:
SYSTEMS INTEGRATION & TECHNICAL STANDARDS

Overview

There are wide ranges of medical devices used in today’s operating rooms (ORs). However, many devices do not or cannot communicate among each other. A standard interface for interoperability among these technologies is therefore needed if simpler and seamless integration is to be achieved today and in the future. A platform comprising clinically connected devices that operate via plug and play standardization was the ultimate goal defined by this Working Group as desirable for the Operating Room of the Future (ORF).

Clinical Needs

This Working Group identified two critical steps for achieving systems integration and standards:

Technical Requirements

A plug and play platform must be developed. Such a platform is believed to be key for communications and control of multiple devices used in the OR. Standards that need to be included in this configuration were identified, including features pertaining to bandwidth, speed, and synchronization capabilities of the configured devices.

Research Priorities

This Working Group identified four priority areas for research. Among the most important:

The full report of this Working Group appears below:

CHAPTER 3:
SYSTEMS INTEGRATION AND TECHNICAL STANDARDS

…THE REPORT OF WORKING GROUP 2

PARTICIPANTS Julian Goldman, MD, Massachusetts General Hospital (Clinical Leader) Ramin Shahidi, PhD, Stanford University (Technical Leader) Michael Brown, General Electric Global Research Richard Bucholz, MD, St. Louis University Laurence Clarke, PhD, National Cancer Institute Jeff Collman, PhD, Georgetown University Gilbert Devey, BS, Georgetown University Tony Epifane, Karl Storz Endoscopy Michael Evans, Stryker Endoscopy Peter Kazanzides, PhD, Johns Hopkins University Walter Lambiotte, Stryker Communications Dave Lieberman, Olympus Surgical William MacNeil, MS, Johns Hopkins University Sohan Ranjan, MS, Georgetown University

3.1 OVERVIEW: THE NEED FOR AN INTRAOPERATIVE AND INTEGRATED SYSTEMS PLATFORM

There are wide ranges of medical devices used in today’s operating rooms (ORs). However, almost all of these devices operate independently or are incapable of communicating with other devices or technologies. Significant improvements in operating room efficiency and quality might be achieved by the design and implementation of an intraoperative and integrated systems platform.

A standard interface for interoperability is needed for all technologies used in the OR if simpler and seamless integration is to be achieved. However, the integration should be driven not by what components and technology matches are possible but by what makes sense clinically. In terms of integrating surgical equipment, what makes sense is taking a broader approach than just dealing with surgical information. The approach must integrate and incorporate the “physiological datastream”– that is, the anesthesia record, medical administration, and other information that is specific to the OR and patient activity.

This Working Group devoted significant time to identifying the building blocks that are needed to clinically and technically generate system platforms for multipurpose OR suites. A platform comprising clinically connected devices (operating via plug and play standardization) was the end goal desired for the Operating Room of the Future (ORF).

3.2 CLINICAL NEEDS: ISSUES IN DEVELOPING INTEGRATED OPERATING ROOM SYSTEMS AND TECHNICAL STANDARDS

At least two significant steps were identified as critical for building new, more useable systems for the OR. These are:

1. Defining information that is mandatory in the OR. Laying the groundwork for building an integrated and standardized system for the OR requires, first of all, determining what information is needed for clinical decision-making. Clinical requirements must be defined and articulated by surgeons and associated personnel and then conveyed to engineers and industry developers. This information will eventually need to be integrated into OR information systems and made readily available to OR clinicians.

These definitions of OR requirements must encompass not only the information and tools that are required in the OR but must also include and synthesize existing procedural protocols. There are currently varying types of protocols used in the OR. Clinical requirements (once identified) will define and generate the needed standards that represent a single, global protocol. Achieving this global protocol is the goal for attaining effective and measurable work in the OR.

2. Generating a systems platform for a multipurpose OR suite. A building block approach to defining clinical requirements and standards is needed from which to generate systems platforms for a multipurpose OR suite. Four key areas that must be addressed in standards development are as follows: imaging, visualization, control of devices, and communications. In addition, the platforms must facilitate reconfigurability that is needed for different procedures and for accommodating different surgeons’ needs and tastes.

The building blocks of the OR informational system also have to continually define engineering requirements and so enable the system to meet platform standards for an application-specific, protocol-based workflow. There have to be multi-level device integration and high bandwidth data communications when required.

Too much technology?

An issue that arose during this Working Group’s discussion was: Is there too much technology in today’s OR to allow for clinical efficiencies? A need for surgical operation-specific procedural maps was voiced, as was the need for technology (and `modular technology, should needs change) that ought to be in the OR on a given day for achieving clinical efficiency. Ideally, each OR would be physically standardized to facilitate performing particular procedures and be physically mapped according to placement of tools and task-specific people.

Figure 3: Operating Room of the Future at Massachusetts General Hospital
(courtesy of the Center for Integration of Medicine and Innovative Technology (CIMIT))

Planning for each procedure’s requirements (and following specific, usual surgical routines) will indicate specific technology platforms that are needed for some procedures, not always for others. This standardized inventory is, as one group member noted, an extremely critical foundation from which to begin “before you start filling your room with standards of seven other different technologies.” A goal may well be a requirement to design multipurpose, easily reconfigurable ORs. It was believed, however, that hospital administrators and hospital efficiency experts would not support separate ORs for each specialty. Standardization will occur only after the room is defined by the procedures (whichever operation is taking place).

Improved use of technology and current OR clinical requirements demand that planners:

3.3 TECHNICAL REQUIREMENTS: STANDARDS AND TOOLS FOR IMPROVED OPERATING ROOM PROCESS INTEGRATION

The technology for creating standards or standardized interfaces among devices in today’s OR needs to be identified. These systems must satisfy clinical requirements, and they must address what clinicians say they need in the OR.

At the outset, a plug and play system for developing this interface appears to be key for communication and control between multiple devices. Identifying requirements for this platform is essential. Specifically, devices that need to work together have to be identified as do their requirements for operation (e.g., in terms of bandwidth, speed, and synchronization).

Each device’s range of capabilities has to be included in this configuration as well. Capabilities to transmit the status of its completed tasks to a designated location or via a built-in, real-time confirmation mechanism have to be included. Other features of the platform include authorization mechanisms for each device’s use, and configurations that allow for only specified access to its capabilities by some designated users.

In addition, devices of the same type must be assigned to a specific class. The class must be understood as having specific capabilities and standards. For instance, insuffulators as a class have many capabilities, but some have all capabilities and others only have a few of these. Surgeons in the OR need to know about the particular capabilities of the insuffulator on hand so as to plan their work accordingly.

Although the need for building an improved platform is great and immediate, this Working Group agreed on the need for performing “historical due diligence” of device-related standards that have failed to date. Investigating these standards and why they did not succeed is a task that should be undertaken. The successes of certain other standards, such as HL7, USB, and DICOM, also need to be included in the ongoing research on workable system integration and standards for the ORF.

3.4 RESEARCH PRIORITIES

At least four research areas were identified as priorities by this Working Group including: