Despite concerted efforts to improve safety and efficiency in operating rooms, a host of issues still remain. A harmonic scalpel will fall off the sterile operating field, a surgeon who is struggling to put on their gown will be assisted (and touched) by a nonsterile team member and an electrocautery pen will produce smoke that could be dangerous to those in the OR.
While each of these issues may seem relatively small, each can affect the safety of patients and staff members and hinder efficiency.
Becker's Hospital Review recently spoke with Mark McBride, MD, an orthopedic surgeon with more than 20 years of OR experience, who is also a co-founder and the CEO of Operating Room Innovations (ORI). ORI's mission is to design innovative operating room solutions to enhance safety, outcomes and business performance. Dr. McBride recounted some of the safety-related issues he has seen in ORs and described innovative solutions that ORI is developing to address these issues.
A team with extensive OR experience and a troubleshooting mindset
Having worked in ORs for more than two decades, Dr. McBride found himself frequently noticing if something appeared unsafe or inefficient. At times he would offer suggestions or ideas, but he reflected, "I often found it difficult to get the attention needed to get these things solved."
While working at a hospital in San Diego, Dr. McBride began brainstorming solutions with another orthopedic surgeon, Joseph Jankiewicz, MD, who had even more experience than Dr. McBride. In addition, the two surgeons would exchange ideas with two highly experienced OR scrub technicians, Ruel Salvaldor and Alex Duy Bui.
"We all have this troubleshooting, problem-solving mindset," Dr. McBride said. "We all recognized problems in the operating room, and we wanted to develop solutions." Collectively, this team of four decided that the best path forward would be to start a company to create innovative solutions and bring these solutions to ORs across the United States. "The focus of the company," said Dr. McBride, "is safety, efficiency and value through innovation."
ORI's first product solved a common OR challenge
The first challenge this team identified involved the recognition that surgical tools, such as harmonic scalpels, can fall outside of the sterile operating field or onto the patient. When this occurs, it can lead to potential infections, burns, delays and unplanned costs. (At the hospital where Dr. McBride and the others worked, two harmonic scalpels had fallen outside of the operative field in one week, eliciting a negative response from administrators asking, "How could this happen?")
The technicians on the team had an idea for a solution to safely hold surgical tools or tubing in place during a procedure that could prevent these sterile items from falling outside of the sterile field. This idea led to the designing and patenting of ORI's DropStop® Securing Kit.
DropStop allows the surgical team to safely secure surgical tools in the operative field. Dr. McBride explained that this solution makes it easy to access the tools, without being cumbersome. He said, "We wanted to make it easy to access the surgical tools. You can position DropStop anywhere [in the surgical field] that works for the individual's workflow." Dr. McBride added, "Having these tools reliably secure, right in the center of the surgical field, where they're safe from contamination, was another goal we wanted to achieve."
Benefits from being able to secure these tools and prevent drops of expensive, sterile surgical devices include improved safety, optimized workflow and reduced cost. Also, DropStop allows for customization in that it can be placed anywhere on the surgical field, drape or surgical gown. That way members of the surgical team can safely access the tools they need when they need them.
A specific example of how DropStop can be used in the OR involves electrocautery pens, which are often used by surgeons during procedures. These pens are extremely hot and if dropped on a patient can cause burns. An adaptation of DropStop is to secure the pen's plastic holster in the operative field area, right in the surgeon's field of view. Dr. McBride described this application as a win/win — DropStop prevents the pen from being dropped, improves patient safety and improves the surgeon's workflow. "It secures right in the operative field area . . . their workflow is improved, and the surgeons really like it," Dr. McBride said.
ORI has worked to improve the safety of donning gowns
Surgeons are well aware that the seemingly simple task of donning a gown is neither simple nor safe. Historically, when getting ready, a surgeon has needed a hand putting on their gown, requiring assistance from a nurse, anesthesiologist or technician — who may not be sterile and who has their own responsibilities to prepare all for surgery. As Dr. McBride said, "Everyone recognizes that having a nonsterile assistant help don the gown is not ideal."
In addition, even when donned correctly, gowns have not been completely sterile because they have not provided complete coverage of the surgeon's back. In the current OR environment, not being completely covered is problematic. "There's no longer just one sterile field," Dr. McBride said. "There are numerous sterile fields. It's impossible to be compliant with the mandate that you never turn your back to the sterile field because you're surrounded by it."
To solve both of these problems, the team at ORI worked to create a gown that completely covered the surgeon's back, which a surgeon could put on alone, without any assistance. The result was the development of the SoloFit® Hoodless Toga. SoloFit provides 360-degree coverage, which reduces the chances of breaking sterility, and can be donned by a surgeon without any assistance. Consistent with ORI's mission, this innovation improves safety and efficiency.
The initial response to both DropStop and SoloFit has been overwhelmingly positive. Dr. McBride said, "Those who work in operating rooms really like the idea that people who work in the operating room for a living are solving problems where there hadn't been solutions."
ORI expands its product offerings
Building on DropStop and SoloFit, ORI saw a need and an opportunity to develop a specialty drape. As Dr. McBride explained, a company had developed a positioning device with an arm that could make doing hip replacement surgery easier, reduce the load on assistants and possibly eliminate the need for an extra assistant. Surgeons liked the concept but were hesitant to adopt it because they didn't see a way to safely drape the device to eliminate concerns about contamination.
ORI looked at this problem and came up with a drape solution that allows surgical teams to work with this new device. This drape enhances safety for the patient and staff by maximizing coverage and protection from contamination. Dr. McBride explained that this innovation "completely changed the surgeon's perception of this device and eliminated concern about how to drape it."
ORI has also been focused on addressing the problem of surgical smoke in the OR, which may be harmful for people to inhale. The concern about surgical smoke has led several states to pass legislation requiring smoke evacuation devices where electrocautery devices are being used.
While there are smoke evacuation devices on the market, in Dr. McBride's experience these devices are cumbersome, difficult to work with and obstruct the surgeon's view. ORI's team realized that by adapting and customizing the DropStop technology, it was possible to provide a smoke evacuation device that freed up the surgeon's hands, didn't obstruct their view and could be positioned in different places during the workflow of the case. ORI tested this solution — named SmokeStop — with several orthopedic surgeons who saw it as a great solution.
"This is another way of leveraging the DropStop technology to improve the experience for the people who work in the operating room," Dr. McBride said. "DropStop reduces the risk of infection for patients, but things like SmokeStop are more geared toward improving safety for the operating room personnel."
COVID-19 has elevated the focus on OR safety
Within hospitals, the COVID-19 pandemic has affected virtually every aspect of operations. While the emphasis on safety in the OR was already high, it has been further elevated.
In particular, Dr. McBride has seen two OR trends related to the pandemic. First, because patients have been reluctant to go to hospitals, it has accelerated the shift to ambulatory surgery centers for many procedures, especially hips and knees. In ASCs' smaller ORs, Dr. McBride remarked, "Products like SoloFit are even more imperative to make sure the environment is safe for the patient."
The other trend is even greater emphasis on preventing viral airborne viruses by focusing on the OR environment. This trend has accelerated a project that ORI is working on that is focused on designing a new climate control system for the surgical team.
Conclusion
There remain issues within ORs that can affect patient and staff safety, workflow, efficiency and cost. Operating Room Innovations is leveraging the real-world experience of surgeons and technicians to design practical solutions to these problems. Dr. McBride summarized, "We want to continue to drive improvements in safety, efficiency and value through innovation."