In many perioperative environments, OR nurses and staff manually handle and transport patient specimens to pathologists. Not only does this involve staff exposure to toxic formalin solution, but it can also introduce unintended variabilities into the integrity of the specimen. At Periop Leader Week, we saw in person a powerful solution to this issue from Milestone Medical called UltraSAFE. We recently spoke with Michelle Bell, Milestone Medical’s Chief Scientific Officer, about this existential problem and her company’s innovative approach to solving it.
Periop Leader Network (PLN): For those who aren’t familiar with Milestone Medical, would you briefly introduce the company and explain its commitment to improving safety and efficiency in healthcare?
Michelle Bell, Chief Scientific Officer, Milestone Medical: Milestone Medical was born out of the desire to improve patient care across the board. We started as an analytical chemistry company, and our owner saw a real gap in how patient samples were handled in the pathology laboratory. Out of that came Milestone Medical. Over the years, we have become known as a company that really emphasizes safety for the patient as well as the users, and we took on the role of trying to create a safer environment for everyone.
PLN: What inspired Milestone to develop UltraSAFE, and what challenges with traditional formalin handling was the system designed to address?
Ms. Bell: Formalin is a Class 1 carcinogen. As such, there are very specific regulations that monitor how much exposure users and staff have to that particular chemical. In addition, our company recognized a gap in how formalin was administered onto patient samples, and we wanted to develop a piece of equipment that could engineer out that risk to perioperative employees.
PLN: With increasing attention on occupational safety and formalin exposure, how can UltraSAFE help hospitals strengthen their safety protocols and prepare for regulatory inspections?
Ms. Bell: Regulatory inspections always look at your handling practices. That involves looking at how you monitor staff safety, how you monitor administration of formalin, and the environment in which formalin is being administered. If you’re not meeting any of those requirements, it can lead to a deficiency for your facility that will require addressing.
There’s also a big focus on the risk of spills and spill containment. Thought processes are changing around how to manage those properly, and in so doing, it is creating a need to be able to engineer in practices that actually eliminate or mitigate that risk. Eliminating the risk is of course going to be the top of your safety pyramid; that will always be best practice. But in reality, when handling patient specimens, there’s a critical time between when the tissue sample is taken out of the patient, and when it is actually put into formalin. That timing can really impact and cause issues with the quality of the downstream test results for the patient. It’s not always feasible to remove formalin completely from the facility, and in those cases, UltraSAFE really engineers in the practice of keeping the users safe while also ensuring the sample is properly handled.
PLN: Formalin has been used in healthcare for decades. Why does it continue to pose a significant occupational health risk, particularly for perioperative nurses and OR personnel?
Ms. Bell: Although formalin has been used in healthcare for decades, its widespread use does not make it safe. Formaldehyde, the active chemical in formalin, is a known human carcinogen and can cause respiratory irritation, skin sensitization, and other serious health concerns. Perioperative nurses and OR personnel face particular risks because traditional specimen-handling practices often involve manually pouring formalin into open containers, creating opportunities for harmful vapor exposure, spills, and direct contact. Repeated exposure, even at low levels, raises concerns about long-term health effects, making safer formalin-handling practices essential to protecting healthcare workers.
PLN: What are some of the hidden costs and consequences of formalin exposure that hospital administrators may overlook when evaluating their current specimen handling procedures?
Ms. Bell: That’s a really great question that we get asked quite often. It’s important to look at several things. First, you really want to look at the cost for a spill if and when it does occur, because there is a human element to this. It’s not if the failure will occur; it’s when. So, what is that cost? There’s cost in the time of the staff for reporting the incident. There’s cost in the resources to contain that spill. There’s cost in potentially losing time in that area where it has to be shut down during the cleanup process. There are hidden costs as well. When a staff member is exposed to formalin at a high level, it’s possible that they wind up with respiratory issues, with problems with their nasal sinuses. Down the line, if they’re exposed over and over again, there are illnesses that are completely tied back to that formalin exposure that can be a risk for your staff as well.
PLN: Beyond protecting healthcare personnel, how does UltraSAFE simplify specimen handling and improve daily workflow efficiency in the OR?
Ms. Bell: Current workflow processes require nurses and nurse assistants and OR staff to make daily judgments on how much formalin is the right amount for these specimens: “Did I put enough on that specimen?” “Do I have the right size container for that specimen?” UltraSAFE takes away some of that guesswork. UltraSAFE is designed to create a system where the amount of formalin is based on the weight of the specimen, so you are always getting the appropriate ratio of fixative to specimen. That’s one of the big talking points between your OR and your pathology lab, so it can really improve that relationship by making sure that the specimen is covered with the right amount of fixative.
UltraSAFE also produces a record of that fixation. One really critical point is fixation time. All nurses are aware they’re supposed to put that on the record or on the container. But again, there’s a human element to that, so if that’s forgotten, UltraSAFE already has all of that information stored and on the label. When it prints out that label, it gives you the amount of fixative that was applied, as well as the time and the operator. It gives you really good traceability for that specimen to make sure all of those points are handled properly.
PLN: Why is standardizing the amount of formalin used for specimen fixation important, and how does UltraSAFE help eliminate inconsistencies between operators?
Ms. Bell: The ratio of fixative to sample is really critical to ensure we get a proper fixation for the specimen. From all my time spent in a laboratory, I really understand what that means because I see the downstream results. Nurses need to understand that they must make sure that for the entire sample—from the outside all the way into the center of that specimen, regardless of how large it is—all of those cells are properly fixed, not just the ones on the outside. Making sure we have the right amount of formalin in relationship to the size of the specimen is crucial for the patient’s diagnosis.
We also need to make sure that we’re obtaining an accurate record of the time the specimen went into formalin because we have all learned in the laboratory over the last several years that the time between the specimen being removed from the patient and placed into the fixative is critical to success for a lot of the downstream testing. That time needs to be kept to a minimum so that we’re maintaining as much of that molecular and structural detail as we can for the results that will come later from the laboratory.
PLN: How can implementing UltraSAFE improve collaboration and standardization between the OR and the pathology laboratory?
Ms. Bell: I think there’s always a little bit of a disconnect between the departments, and not for anything purposeful. It’s just that we’re both very busy departments. So, if we can find ways to better communicate our needs to each other, there’s always value in that. The fact that UltraSAFE takes some of that guesswork out for your nurses, and creates a solid record for that patient that the laboratory can refer back to, lends value to creating a better atmosphere of collaboration between the OR and the pathology lab.
PLN: When considering the costs associated with formalin exposure, how can investing in UltraSAFE provide long-term operational and financial benefits for healthcare facilities?
Ms. Bell: There are several places where it will provide value. Cost avoidance is a really big one. You are avoiding the cost of a potential spill at any point and losing that staff time and OR time. There are cost savings on the health of your staff, keeping them safe and healthy. There’s also value in providing a safe work environment from a staff retention standpoint. If you’re really demonstrating as an organization that you take the safety of your employees seriously, it shows them that you value each of them as an individual. I think you’re always going to see an improvement in retention rates when organizations treat their employees that way.
PLN: What would you say to an OR director or a hospital executive who recognizes the risks of formalin exposure but is hesitant to change their current specimen-handling process?
Ms. Bell: Change management is always a really difficult task. First, find your champion for this particular instrument. Next, identify early adopters who are really committed to that process. Often you’ll find them in health and safety, and also in the laboratory. If you can all work together to come up with a plan that really demonstrates how this will improve patient outcomes, it’s a really powerful statement. We are always here to help with any of that process. We can assist with educating any of your stakeholders on the values that our instrument provides, as well as the best practices.
Learn more about Milestone Medical and UltraSAFE.
