Background

Formaldehyde is one of the most common methods for preserving tissue samples. Formaldehyde was in 2011 designated as a carcinogen, and since 2015 the use of formaldehyde has been prohibited unless exhaust ventilation systems such as fume cupboards have been installed. This means that fume cupboards must be available at all sites, creating a complex sample handling and workflow. In addition, the transfer itself has been problematic and sometimes caused a need for tissue replacements. Waste management also constitutes a challenge for the individual departments as disposal of the residual formaldehyde takes place on site.

Overall, the performance of tissue sampling is an overlooked area as it constitutes a minor activity of a department with an annual average of 141,000 samples in the Region of Southern Denmark. 68% of these are performed in hospitals and 32% in the primary sector. The amount of tissue samples increases by about 10% per year, and that makes work efficiency and quality control even more compelling.

There is, therefore, a need for an innovative technology that can improve the quality of execution of tissue samples and the work conditions for health workers. Safe-Biopsy is such an innovative technology solution that comes in the form of an advanced and intuitively usable plastic cylinder prefilled with formaldehyde.

When the tissue sample is placed in the cylinder, it is covered by the formaldehyde. When removed from the cylinder, the tissue sample is freed from the formaldehyde that is kept inside the cylinder. This means that staff will never get in touch with the toxic fluid, and the tissue sample will only be exposed to a minimum of oxygen which might otherwise initiate putrefaction and render the sample useless.

Purpose/Vision

There is a need for a managerial and clinical evaluation of Safe-Biosy's applicability in connection with the development of a fully functional prototype. Therefore, Safe-Biopsy will be tested in practice at Odense University Hospital (OUH), where the prototype will be tested clinically and scientifically to optimise patient and staff safety. It will initially be tested at the departments of Gynaecology Obstetrics, Dermatology and Oncology.

There is a need for inspiration and cooperation partners in the fields of user-driven innovation, clinical matters and health economics. Therefore, detailed investigations will be launched including descriptions and documentation of existing workflows regarding selecting, handling and preserving tissue samples. The findings will be compared with the results to be obtained by introducing Safe-Biopsy. The regulatory aspects of validation and verification to get the CE marking are already in place.

The overall goal is to develop a fully functional Safe-Biopsy for commercial launch in close collaboration with Patient@home, and a subsequent full implementation within the primary and secondary healthcare sectors of the Region of Southern Denmark.

Expected Results

The expectations are that Safe-Biopsy will

• streamline workflows
• fit into existing workflows
• provide "one-step workflows"
• preserve tissue samples optimally
• minimise the number of times staff have to repeat the sampling process
• centralise all waste management in the Department of Pathology (including formaldehyde)
• prevent that healthcare professionals are exposed to formaldehyde
• eliminate the need for fume cupboards/exhaust ventilation systems in outpatient clinics, wards and operating theaters
• lead to intuitive use of technology
• lead to optimal ID security by using wireless ID-tagging and time and location data
• be ready for implementation in other hospitals.

Read more about the project HERE (in Danish)