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How to Eliminate Operators’ Exposure to Formalin in the Operating Theatres

How to Eliminate Operators’ Exposure to Formalin in the Operating Theatres


Formalin is now officially classified as a Class 1 carcinogenic substance for humans by the EU. Employers have the duty to minimize operator’s exposure to this substance by reducing or substituting it with non or less dangerous alternatives. If substitution isn’t possible, employers are asked to limit operator exposure with the use of closed system and monitor formalin’s effects on the user’s body. In response to this concern, Milestone has developed UltraSAFE, an automatic formalin dispending system for buckets in the OR, which supports the concept of zero formalin exposure preventing any direct contact with formalin.

Safety in Sample Collection

Mr. Ralf Lieberz shared the experience of his OR staff with UltraSAFE. Over the last two years the staff (about 60 people in 15 operating theatres) has been enhancing the safety of the sample collection by incorporating in their process the use of UltraSAFE. In Germany, like in other major countries, the exposure limit to formalin is determined by law. In the event of excessively high exposure, danger areas must be marked, access restrictions must be implemented, technical protective measures must be taken, databases for each employee must be maintained and documentation of every working day and occupational healthcare is required. Traditionally, the OR staff has been accustomed to manually filling buckets or bags with formalin, thereby consistently exposing operators to toxic fumes. Additionally, this manual process lacked the precision needed to measure the correct amount of formalin for each sample, posing a risk of compromising the fixation process.
Ralf Lieberz Process, Risk and Quality Manager at Helios Universitätsklinikum Wuppertal
“Here in Wuppertal, we have about 60 people in the surgery and they are very happy with this system”
Mr. Lieberz reports how the use of the automated formalin dispenser, UltraSAFE, enables formalin dispensing in a closed environment, preventing any toxic contact, and streamlining the filling process to achieve greater standardization and comfort. An additional level of safety is ensured by the built-in charcoal and HEPA filters of UltraSAFE and the capability to be connected to the existing ventilation line.

Optimal Fixation Conditions

It’s no secret that the accurate identification of biomarkers in immunohistochemistry or molecular biology requires an optimal pre-analytical step, and it all begins inside the Operating Room. The gold standard for fixation is the 4% buffered formalin solution, that allows a pH range between 6.8 and 7.2, similar to water.
Fixation is a crucial step because it significantly affects the morphology of the cells, thereby impacting the final analysis results. Mr. Ralf Lieberz provided us with an example of this. As shown in the first image, cells that underwent an improper fixation process (due to reasons such as an incorrect amount of formalin or improper fixation duration) lack contrast, exhibit altered cellular morphology and display numerous artifacts. Conversely, in the second image, the same sample treated with a correct fixation process demonstrates good cellular morphology and satisfying HE staining.
lymphnode with a germinal center stained with HE, treated with an improper fixation

Lymphnode with a germinal center stained with HE, treated with an improper fixation

The same tissue as shown in image (A), handled with an optimal fixation procedure

The same tissue as shown in the previous image, handled with an optimal fixation procedure.


Mr. Lieberz describes how the UltraSAFE unit has been successfully implemented in the laboratory routine of Helios Universitätsklinikum Wuppertal.
“There’s totally no exposure of formalin outside the box of UltraSAFE. Our staff likes the system because it is very simple, small and easy to use and clean”
He highlights not only the important aspect of ensuring the operator’s safety, but also emphasizes the efficacy in executing an optimal fixation process, specifically tailored to prioritize and enhance patient safety.

Want to know more?

Watch our educational Webinar “How to Eliminate Operators’ Exposure to Formalin in the Operating Theatres”
Our guest Speaker, Mr. Lieberz, talks about the challenges they faced in reducing formalin exposure at Helios University Hospital Wuppertal, and shares his feedback about the innovative UltraSAFE automatic formalin dispensing system.

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