Poster - 30: Use of a Hazard-Risk Analysis for development of a new eye immobilization tool for treatment of choroidal melanoma

Purpose: Our treatment for choroidal melanoma utilizes the GTC frame. The patient looks at a small LED to stabilize target position. The LED is attached to a metal arm attached to the GTC frame. A camera on the arm allows therapists to monitor patient compliance. To move to mask-based immobilization we need a new LED/camera attachment mechanism. We used a Hazard-Risk Analysis (HRA) to guide the design of the new tool. Method: A pre-clinical model was built with input from therapy and machine shop personnel. It consisted of an aluminum frame placed in aluminum guide posts attached to the couch top. Further development was guided by the Department of Defense Standard Practice - System Safety hazard risk analysis technique. Results: An Orfit mask was selected because it allowed access to indexes on the couch top which assist with setup reproducibility. The first HRA table was created considering mechanical failure modes of the device. Discussions with operators and manufacturers identified other failure modes and solutions. HRA directed the design towards a safe clinical device. Conclusion: A new immobilization tool has been designed using hazard-risk analysis which resulted in an easier-to-use and safer tool compared to the initial design. The remaining risks are all low probability events and not dissimilar from those currently faced with the GTC setup. Given the gains in ease of use for therapists and patients as well as the lower costs for the hospital, we will implement this new tool.