Combimark
It is globally accepted best practice that all radiographic images must display a correct anatomical side marker to ensure R/L fidelity. These radiographic markers are the most frequently handled objects in the radiology department. The same markers are used with every patient, and are kept in the radiographer’s pockets when not utilised, and are never or rarely cleaned. Issues include:
- Radiographers R and L, touch marker, touch patient.
- Risk of blind spot infection
- Some radiographers do not use their markers – lose them or can’t put finger on them and rely on retrospectively digitally marking sites when uploading images, which is not best practice.
Disposable markers are available but they are expensive and some contain materials unsuited to use in healthcare settings such as latex.
Consultant Radiologist OLCH, Dr Aisling Snow saw an opportunity to develop a competitively priced disposable marker made from more appropriate biodegradable materials. Dr Snow partnered with her sister Fiona Snow, an industrial designer, to form Combimark, an Enterprise Ireland HPSU and TCD spin out that produces SideSafe disposable x ray markers. These markers are the first that are sustainably disposable and are ground-breaking in medical device design being 100 per cent plastic-free and made with a low-intensity manufacturing process
Study scope
The primary aim of the Combimark/Health Innovation Hub Ireland usability study was to collect end-user – radiographers – feedback on the markers. The feedback would inform final product design prior to market launch. The study comprised of two sites, with two stages in Study site 1 – Our Ladies Children’s Hospital (OLCH) and one in Study Site 2 -St James’ Hospital.
- Study site 1 team:
Radiographer Services Manager
Stage 1: 13 radiographers
Stage 2: 9 radiographers
- Study site 1 current practice: Lead markers and digital markers.
Study site 2 team:
Radiographer Services Manager
Eight radiographers
- Study site 2 current practice: Lead markers and digital markers.
HIHI recommendations
SideSafe markers have four clear clinical benefits:
- Cleanliness: current reusable markers have been found to be contaminated (80 per cent) and rarely if ever cleaned (92 per cent). One SideSafe marker for one patient eliminates any opportunity for the spread of infection via X-ray markers.
- Accessibility: Reusable markers are underused, with reliance often on digital X-ray marking, which is not recommended best practice. This can actually lead to errors in image reporting. SideSafe makers can be docked in portable X-rays, are clean and safe to take into ICU, and will always be present in the X-ray room ensuring markers are within reach of radiologists
- Device Regulations 2020: CE marked Sidesafe meets all of the necessary EU Medical Device Regulations 2020, compared with the unregulated legacy product.
- Cost benefit: Infection control and the treatment of hospital-acquired infections bears a significant cost on hospitals and serious risks for patient health. SideSafe protects hospitals from the costs associated with managing infection spread by side markers, and the cost associated with decontamination of reusable markers. In a large Irish hospital more than 100,000 radiographs are taken each year – this is up to 100,000 opportunities for infection to spread via current reusable markers and 100,000 chances for a side safety error to be made if a marker isn’t used.
Market potential
Based on this report HIHI recommends that Combimark’s SideSafe markers should be considered as a standard of care in radiology. The market potential for the product – a world first in its field as a sustainably disposable device is significant, considering the direction of global healthcare waste disposal. SideSafe markers are sustainably disposable as it is 100 per cent plastic-free and made with a low-intensity manufacturing process. Once disposed of, SideSafe markers completely decompose.
More than 2.4 billion X-rays are performed worldwide each year, with 200 million performed in the United States alone. Disposables are appropriate in numerous clinical settings but sustainability is becoming an issue with new guidelines being issued. It is a challenge to produce disposables sustainably to meet growing needs and this is a key Combimark market focus.
Combimark feedback
Benefit to using HIHI:
- HIHI allowed Aisling as a clinician to be a step removed from organising the usability test in both sites, which had the benefit of avoiding any sense of obligation on the radiography services managers and on the radiographers involved.
- HIHI provided a structure and defined workflow for engagement with clinical teams.
- HIHI facilitated the collection and collation of data.
- HIHI provided contacts and introductions to other entrepreneurs and people of relevance in clinical sites, as well as facilitating media engagement.