Surgeons long have relied on imaging studies to inform the plan for a procedure, yet the two disciplines traditionally have remained separate. The advent of image-guided procedures like cardiac catheterization and neuroangiography began blurring the lines between imaging and surgery.
Cath and angio procedures are invasive, involve anesthesia and require prep and recovery areas similar to surgery. Are these rooms imaging rooms or operating rooms (ORs)? The trend is for an even greater integration of the two disciplines.
Smart ORs fall into two categories: ORs utilizing intra-operative computed tomography (CT) or magnetic resonance imaging (MRI) that provide images near real-time, typically used in conjunction with neurosurgery, spinal and orthopedic procedures; and hybrid ORs that combine the real-time fluoroscopy of an interventional lab with the equipment and capabilities of a surgical suite.
The hybrid OR is a concept becoming well-recognized, although the definition is less than clear. Every hybrid OR is unique; literally, no two are alike. Each is designed to incorporate the imaging and surgical technologies required for a range of both minimally invasive and open procedures on high-risk patients.
Surgery and imaging partnership
During the 1980s, the development of the laparoscopic surgical scope ushered in the era of minimally invasive surgery. Optical scopes quickly were replaced by videoscopes, which could be displayed on a monitor for improved viewing by the entire surgical team.
Today, minimally invasive scope-based surgery accounts for the vast majority of procedures. Many of these procedures are performed on an outpatient basis, leading the way to shorter stays, quicker turn-around of facilities, faster recoveries, reduced infection rates, improved patient safety and improved outcomes.
As digital imaging became the industry standard, picture archiving and communication system (PACS) workstations were placed in the OR for viewing images during the procedure and interfaced with integrated, surgical video systems, allowing images to be shown on any of a number of displays located in or viewable from the surgical field.
Multiple displays, suspended on arms extending from hubs supporting the surgical lights and booms, have become the norm in OR design. These displays can be positioned for ease of viewing by both the surgeon and supporting team. Indeed, positioning of displays and selection of images to be viewed on each has become a standard part of procedure setup.
More recently, large-screen displays, frequently in the 42- to 56-inch range, routinely are placed around the OR to be easily viewable during the specific procedures planned for the room. Large-screen displays can provide an expanded view of images, thus showing finer detail not easily detectable by the eye on the smaller boom-suspended displays. An example of large-screen display application is the brain lab concept. This incorporates intraoperative image capture with an entire wall of displays placed opposite the surgeon's position on which freshly captured images can be displayed to assist with the procedure.
Today, these larger displays are finding their way onto the ceiling-mounted C-arm rails, thereby becoming an integral part of the imaging system itself and driven by split-screen technology capable of customizing the display for each procedure to show as many as 21 different views simultaneously on a single screen. Several manufacturers now offer a rail-mounted, 56-inch display, which provides more viewing surface than the four to eight individual smaller screens regarded as the standard just a few years ago.
The valuable clinical enhancement, supported by intraoperative imaging of any modality, is immediacy: the ability to view the procedure site live, view the procedure itself and view the resulting procedural progress real-time. Just as real-time interventional imaging provides guidance during a cardiac and neurological catheterization procedure, interoperative MRI systems provide surgical guidance, showing the progress in tumor removal or ablation.
CAVE (Cave Automated Virtual Environment) technology, typically placed in a room adjacent to or nearby the OR, provides the surgical team with a large 3-D image of the surgical site and the ability to rotate and finely position the image for a clearer view, thus enhancing visualization of the planned entry and procedure strategy. In the future, health facilities professionals should expect to see more use of 3-D display technology and possibly holography, in the OR itself.
As real-time imaging supports enhanced manual manipulation of surgical tools, incorporation of the remotely controlled surgical tools forms an integrated viewing and operating system. Examples would include surgical robotics providing views into surgical sites and facilitating manipulation of microsurgical instruments from a nearby video console.
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| Hands-on technology project management is required during construction to manage the many disparate vendors and technologies of a hybrid operating room. |
Physical preparation
What are the challenges of planning, designing and building smart or hybrid ORs? And how are the planning, design and construction disciplines changing to address advancing OR technologies?
Clearly, one of the first considerations is space. It's a valid assumption that most, if not all, operating rooms in the future will encompass some imaging and image display capabilities. The benefits are too great to ignore and the added cost is becoming increasingly insignificant, especially in consideration of the improved outcomes.
Whereas a typical OR in the past might occupy 450 to 650 square feet, a hybrid OR or image-guided procedure room can easily top 1,200 square feet, once space is provided to support all of the necessary technologies within the procedure room itself, plus nearby equipment and control rooms. Even if rooms initially are planned as traditional ORs, inclusion of nearby soft space that at first can serve as offices or storage rooms allows facilities to hedge their bets that needs for advanced technologies will arise.
The sheer amount of technology required to fully equip a hybrid OR is immense. For example, a hybrid OR may require a single-plane, ceiling-mounted C-arm; a complete hemodynamic monitoring system; a contrast injector; anesthesia, perfusion and equipment booms; surgical lights; and an integrated surgical audio-video system. In addition to these fixed elements are other items often associated with an operating room: physiological monitor, slush machine, patient warmer, medication and supply storage units and a resuscitation cart — in addition to the charting, PACS and video integration workstations required to manage and record the procedure. Place this room in a university setting and wideband connectivity must be added to support remote viewing for education or consultation.
The total number of systems, technologies and equipment items in these rooms can easily top 100 — with almost as many vendors and sources. Clearly, these rooms require a great deal of planning and a highly integrated design process. Hands-on technology project management is required during construction to ensure the many disparate vendors and technologies are coordinated in accordance with the project schedule, and that their systems are properly installed, integrated, configured, tested and commissioned to provide true interoperability on the day of occupancy.
Planning challenges
Hybrid ORs present perhaps the greatest planning challenge. Each is unique, specifically designed and equipped to support the procedures envisioned by the practitioners who will occupy the room. The complement of procedures performed and technologies required can vary widely between rooms.
Given the high degree of specialty for which each room is designed, maintaining the traditional division of responsibilities between medical equipment planning, low-voltage design and information technology (IT) integration is ludicrous. The lines between these disciplines have become extremely blurred in recent years as medical equipment has become computerized, contributing the vast majority of information utilized in procedures — information that is communicated through the low-voltage infrastructure and IT network and captured in the patient's medical record.
Planning and design requires a team comprising design professionals with clinical experience working in both departments as well as experience planning and building multiple imaging and surgery projects, and a team conversant in both the current and upcoming technologies, plus the latest clinical methods.
Additionally, the team must have current experience integrating the multiple technologies encountered in the hybrid OR of today. This means not just in IT infrastructure, but integrating PACS, surgical video, electronic medical records, physiological monitoring, hemodynamic monitoring, electrophysiology, 3-D mapping, radio frequency ablation and the many other specialized technologies frequently found only in these rooms.
Experience also is required in planning and implementing the many physical attributes of an OR, including surgical tables, surgical lights, equipment and anesthesia booms, documentation stations, automated dispensing systems for medications and supplies, anesthesia machines and so forth.
Once all of the primary technology vendors are chosen and have prepared their preliminary site-specific drawings, a roundtable coordination session is required. This session ensures that all responsibilities are understood, equipment conflicts are resolved, rough-in and power requirements are captured and coordinated, connectivity needs are identified and understood, interface points are known, information formats and software interface needs are understood, and any middleware requirements are defined and assigned.
In addition to the OR, the control and imaging equipment rooms must be coordinated to ensure that physical space is allotted for the many workstations, monitors, keyboards, control devices and related central processing units and uninterruptible power supply units; power and connectivity points are correctly placed; and access is allowed for future maintenance and upgrades. Moreover, a clear understanding must be reached with clinicians regarding room survivability during a power or network outage.
The project schedule should be reviewed and updated with each vendor's site readiness requirements and installation timelines added. A series of follow-up coordination meetings may be held following the first coordination meeting to confirm responsibilities and schedule. The project schedule also should include coordination of in-service education and applications training for all of the new equipment.
Involvement of the architecture and engineering team, general contractor, primary subcontractors, and owner's IT team in these meetings is a necessity as many of the technologies have space considerations, require utility connections and connect through the IT network.
One of the most important elements of success for a hybrid OR project is managing the technology procurement process and schedule. Although there is a tendency to delay technology selection, bidding strategies can be employed to ensure the most current product is delivered and installed without causing construction delays or change orders, and without sacrificing access to state-of-the-art products.
A procurement schedule must be established early on, perhaps even before commencement of construction, identifying procurement start dates, procurement process, selection and order processing timelines as well as delivery, installation, testing and commissioning dates for every item — all coordinated with contractor on-site dates and key industry conferences that might affect product selection.
For a hybrid OR project to be successful, integrated technology planning, design and management must occur through a team with clinical planning capability, including multiple project hands-on operational experience in both imaging and surgery, and a thorough understanding of all medical and IT technologies — all working with a uniform goal, from earliest conceptual planning through project completion. Proactive on-site management and coordination of technology procurement, delivery, installation, integration and commissioning coordinated with construction and the construction schedule are highly demanding, but are an absolute necessity to avoid costly schedule delays and change orders.
A team approach
Coordination and communication are key, along with recognition that every project team member must be involved from start to finish. Hybrid ORs are so complex, involve so many technologies and so many disciplines that a simple definition of responsibilities just can't work. Neither health care organizations nor contractors can complete their work without the other. Traditional divisions simply don't apply.
A hybrid OR project requires a team that includes the designers, builders, vendors, support staff, physicians, clinicians, IT and clinical engineering. All have a stake in a successful completion.
Terry Miller is executive vice president at GBA, a health care technology consulting firm based in Franklin, Tenn., a frequent speaker and author, and a member of the Healthcare Guidelines Revision Committee for the 2014 edition of the Facility Guidelines Institute's Guidelines for Design and Construction of Health Care Facilities. He can be reached at terry.miller@gbainc.com.
| Sidebar - Converting a conventional OR into a hybrid model in record time |
| The goal was challenging — renovate an existing operating room (OR) into an integrated hybrid OR — and the three-month project schedule was unheard of. But in the area surrounding this 200-bed acute care hospital, 50 to 75 percent of the population is older than 45 years and many very ill patients were forced to travel out of state to undergo the only option available to them — a transcatheter aortic valve replacement. While the design team was being assembled, work began on preliminary layouts to convert space from the existing OR, a perfusion room and an office into a new 920-square-foot hybrid OR. The design team then short-listed medical equipment vendors and made out-of-state site visits so they could see the equipment in operation and talk to the staff and clinicians who were using it. Final selections were made following the site visits. Another challenge was to find a construction team that could meet the timeline of the project and the installation of complex equipment including a ceiling-mounted, single-plane interventional/angiographic imaging system; hemodynamic monitoring system; anesthesia and perfusion booms; surgical lights; and the OR integration system. The room also would require lead shielding, which is not a requirement for a typical OR. To sustain revenue and avoid lag time between the demolition and rebuild, the existing OR couldn't be demolished until vendors could confirm delivery of their equipment to the site. This had vendors scrambling to manufacture equipment and assemble their installation and training teams. Every member of the team played an important role in meeting the accelerated timeline. The architects attended site visits and created light/boom placement alternatives for testing visualization. Department directors engaged staff in decisions. Physicians gave final approval of equipment and placement. The medical equipment consultant coordinated with the vendors, keeping everyone informed and working with the supply chain to ensure that purchase orders were issued to meet the schedule. And the construction crews worked 24/7. Ultimately, the schedule was met and, most importantly, the need in the community was satisfied. The new hybrid has been in operation only a few months, but surgeons already have performed several successful procedures possible only in a hybrid OR. By Lynne Ingle, R.N., CNOR, project manager at GBA, Franklin, Tenn. |