Walk into a modern hybrid operating room today and you will be surrounded with state-of-the-art equipment. The technologies ranging from the imaging systems to integration solutions have improved by leaps and bounds over the past few years. But a fully equipped hybrid OR comes with a hefty price tag that typically only the large teaching hospitals could afford. And such rooms were reserved exclusively for cardiac and vascular procedures because of the influx of transcatheter aortic valve replacement (TAVR) technology.
However, now the rooms are used for a greater diversity of procedures including neurological, pediatric and orthopedic surgery and can pay for themselves even at smaller hospitals. Those smaller facilities have been taking on hybrid OR projects recently in order to stay competitive and retain their patient bases.
Greater diversity has also spurred manufacturers to develop solutions to actually fit all the technology into the space. While challenging to implement, careful planning of how and where the various technologies will fit into the space has become incredibly important. In some cases the drive to create the most efficient space has even resulted in vendors joining together to deliver the best solutions for customers.
Utilization is the name of the game
The shift away from only cardiac and vascular procedures toward a more diverse mix including orthopedic, pediatric and neurological procedures is part of a growing trend, according to Tom Watson, clinical analyst at MD Buyline. The number of patients qualifying for cardiac and vascular procedures is currently modest due to some of the FDA’s TAVR device restrictions.
Many of the trans-catheter procedures are currently limited to patients who cannot undergo traditional open-heart valve replacement because they fall into the high or extreme risk category.
In order for a hospital to have the room pay for itself, the shift needed to happen. “If you invest in a hybrid OR and you spend close to $5 million by the time it’s finished, you need that room to be utilized between five to seven days a week,” says David Browne, senior group marketing manager at MAQUET Medical Systems USA. “It’s not enough to simply do a few different procedures a week.”
Now that CMS is bundling payments, it’s more important than ever to bring as many medical professionals into the same room as possible, according to Sudhir Kulkarni, segment director of hybrid OR at Siemens Healthcare.
The same imaging equipment can be used for any procedure, but the secret to making it a multi-discipline room lies in the room layout. The ceiling must be outfitted with the proper surgical lights and a surgical table must be installed that can easily transform from a supine to a bench position and anything in-between.
MAQUET and Trumpf Medical offer certified surgical tables with all the functionality required for an OR environment that can be integrated with the imaging systems. Philips Healthcare, Siemens and Toshiba America Medical Systems can all be paired with Maquet’s MAGNUS tables.
The MAGNUS table systems have removable and interchangeable table tops for a range of different surgical procedures. It can be moved into lithotomy, lateral, knee-chest, prone and supine positions for a range of procedures including gynecological, spinal and neurological surgery.
Trumpf, which was acquired by Hill-Rom in August, offers the TruSystem 7500 surgical table, which can be integrated with Siemens’ Artis zeego. The integrated solution can be used for neurosurgery, urology, trauma surgery, orthopedic surgery, abdominal surgery and thoracic surgery.
But bringing all of those procedures into one room brings its share of challenges. “If all of these multiple disciplines are going to be working in that room, then they need space to bring in all of that equipment,” says Kulkarni. He has noticed that in order to accommodate all of the equipment, the rooms have started to become bigger over the past couple of years.
The technology follows suit
When GE Healthcare designed its Discovery IGS 730 and 740, which received FDA approvals in 2011 and 2014 respectively, it kept the idea of a multi-discipline hybrid OR at the forefront. “We already had that understanding about the market going forward baked into the design of the product,” says Miranda Rasenberg, global interventional marketing manager at GE.
The IGS 730 and 740 are both mobile laser-guided angiography systems and the only difference is the detector sizes. The 730 has a 30 by 30 centimeter detector, which is an ideal field-of-view size for cardiology and vascular applications. The 740 has a 40 by 40 centimeter square panel, which is a comfortable size for abdominal procedures. Their mobile design sets them apart from systems like Siemens’ floor-mounted Artis zeego and Philips Healthcare’s ceilingmounted Allura Xper system.
Traditionally, GE only had a floor-based product platform but when it noticed the hybrid OR trend coming down the pipeline, the company started to think about what would most satisfy the needs of the surgeons and hospitals, learned that the main clinical criteria and customer needs were really about the capability for gantry back out and sterility,” says Rasenberg.
If a surgeon is performing a very complicated minimally invasive procedure and open surgery is suddenly required, they must be able to move the gantry out of the way immediately. If the system is mobile it makes that process much easier.
GE also took note that for each type of procedure, the surgeon approaches the patient from a different angle — for a cardiac case, the surgeon would be on the left side of the patient, but in a vascular case the surgeon would be on the right side. A mobile system can be helpful in handling those different types of procedural approaches.
Ever since the IGS 730 and 740 hit the market, GE has noticed that many of the smaller hospitals have taken an interest in the technology. “These hospitals would not be able to financially sustain having a high-end hybrid OR dedicated to just one department or one procedure,” says Rasenberg. “They would be looking for synergies between different departments to optimize the return on investment.”
Keeping track of dose
In 1992, the Center for Devices and Radiological Health and the FDA received reports of potential patient radiation injuries as a result of fluoroscopic X-ray exams. In early 1994, mandatory radiation dose requirements under the Safe Medical Devices Act of 1990 provided information that proved that the dose associated with the X-ray systems were causing harm to the patients.
Now, millions of fluoroscopically guided procedures are performed on an annual basis and many organizations including Accreditation for Cardiovascular Excellence are recommending and even requiring hospitals to monitor and record patient radiation dose. In response, many of the new fluoroscopy systems on the market have build-in radiation reporting and managing capabilities.
In March, Toshiba launched its Dose Tracking System (DTS) for its Infinix cardiovascular X-ray systems. It displays a real-time 3-D model of the patients with color-coded radiation dose so the physician can change the distribution throughout the procedure. Once the dose reaches the yellow zone at 1.5 Gy, the physician is alerted to move the X-ray beam. When the procedure is finished, the system generates a dose report, which lists the peak skin dose and displays a colorcoded 3-D patient model.
Toshiba announced enhancements to DTS in early November including new patient head models that allow the system to provide peak skin dose estimates for neurovascular procedures. It also features frontal and lateral bi-plane coverage, which is optimal for neurovascular and congenital cardiology cases.
Smaller hospitals step up to the plate
The large teaching hospitals have been touting their flashy, high-tech equipment and cutting-edge procedures for years and it hasn’t gone unnoticed by smaller facilities who have stepped up their game as well. “They’re not willing to just stand by and let their patient base erode and be pulled away,” says MD Buyline’s Watson.
The smaller hospitals are starting to take on hybrid OR projects, but without all of the bells and whistles of a high-end solution. Both the hospitals and the vendors have determined that having all of the premier features is not necessarily required. All of the high-end imaging systems on the market are outfitted with advanced software solutions but MD Buyline has noticed that there has recently been more of an interest in systems without all of those bells and whistles.
“I think some of the tier two hospitals may be going in and dipping their toes into the water without jumping out all the way to start with,” says Watson. “They are not just automatically going out and buying everything they possibly could ever want or need to be a hybrid solution.”
There are primarily two different types of hybrid ORs — one is primarily focused on imaging with the ability to do some surgical work and the other is a true hybrid OR that can be switched to almost any type of surgical application.
That is largely dictated by the type of table technology the hospital deploys. The imaging systems come with an imaging table that has some surgical capabilities, but not all of the functions that are required for every procedure.
But about 90 to 95 percent of the recent deals involve a traditional imaging/OR table opposed to a full-fledged surgical table, according to MD Buyline. The surgical table adds an additional $200,000 or more to the total cost of the system and most facilities are not willing to make that kind of investment.
Integrating all of the pieces
With all of the new technology flooding into the hybrid OR, managing workflow is becoming increasingly complex. That creates a great need for integrated ORs that feature a basic automation system and sometimes more advanced integrations including telemedicine and real-time information systems.
Many hospitals deploy one of the automation packages that manufacturers offer in order to link all of the OR equipment to one central device. It enables the surgeon to operate the equipment through voice commands or a remote control panel.
Most of those systems also offer some level of teleconferencing capabilities. Telemedicine is a growing area, but it’s generally the bigger hospitals most interested in it right now, according to Maquet’s Browne. The large teaching hospitals are going so far as to stream live procedures in lecture halls to educate their students.
The real-time information systems provide the surgeons with access to PACS images, EMRs and lab reports while performing high-level procedures such as open heart surgery, tumor removal or neurosurgery. That enables the surgeon, radiologist and pathologist to communicate efficiently without all having to be present in the surgical suite.
Is it worth the investment?
While OR integration has its benefits, whether those benefits are worth the pricey investment is not clear. According to MD Buyline figures, automation packages range between $20,000 and $50,000, telemedicine solutions can cost as little as $30,000 or as much as $400,000 depending on whether two-way communication is added and real-time information systems can range from $20,000 to $500,000, also depending on two-way communication.
MD Buyline has noticed that some of the prices have come down, but whether or not the buy makes sense even at the lower price point is still in question. Regardless, the level of integration that a hospital deploys should be determined by its size and what it actually needs.
A small hospital with one hybrid OR may not need high-end telemedicine and realtime information systems. “That’s probably a little bit of overkill for most of those hospitals,” says James Laskaris, emerging technology analyst at MD Buyline. “You have to think of where you can best target your money.”
But when a hospital does make the decision to purchase a full range of integration solutions, it’s imperative that those solutions work together seamlessly with the imaging equipment, surgical lights and booms. “There are so many different vendors that are working together that sometimes it can make it very difficult to get setup and work through all the issues,” says Katie Regan, clinical publication manager at MD Buyline.
In order to ensure that all of the technologies work together properly, some of the imaging vendors have been partnering with the integration system vendors. In November, Philips announced a partnership with Image Stream Medical (ISM) to integrate its imaging system with ISM’s audio and visual integration solution.
On the hospitals’ side, they must choose what vendors they want to work in the initial planning and strategy session in order to make the process smoother. The room has to be logistically designed so that there is adequate movement around the table for the imaging system, without the lights and monitors getting in the way. “They realized that you can’t take the two solutions and push them together and expect it to work well,” says MD Buyline’s Watson.
Now that more hospitals are taking on hybrid OR projects, these are the challenges that are naturally cropping up. The surgeons must learn a plethora of new procedures, the rooms must expand to accommodate all of the new equipment and vendors must find a way to make that equipment work well together. But as the technology to train the surgeons refines and the imaging, integration, table, light and boom vendors team up, the challenges start to iron out.
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DOTmed Registered OR Suite - February 2015 Companies
Names in boldface are Premium Listings.
Joe Kruizenga, Northbay Networks
Kathy Juarez, Sound Imaging
Angie Tom, Didage Sales Company
Thomas Green, Paragon Service
Kevin Berger, IMRIS
Brent Juillerat, Supply4GI
Alison Fortin, Global Inventory Management
Gregory Wallace, H&S MEDICAL
Michael katz, E.M.J Equipment LLC
Scott Scholl, Medical Inventory Control
Tracy Cunningham, Endo Technologies, Inc.
Shannon Moore, STAT Biomedical, Inc.
Jerry Kauffman, Medical Equipment Corporation