There is great news about 3D printed surgical manuals: An advanced surgical planning tool has been approved by FDA for use at VA facilities. It speeds up the pre-surgery process.
In order to fill the gap left by the removal of a tumor, jaw reconstruction often involves bone grafts from other parts of the body. This technique is effective but requires a lot of planning and precision during surgery.
Design and planning software has advanced, and 3D-printed surgical guide technology has allowed for a more advanced approach.
New tools allow surgeons to better plan their approach and produce surgical guides in order to carry out the plan in the OR. This creates a patient-centric approach that saves time and money and improves patient outcomes.
Advanced surgical planning tool
VA physicians are required to obtain outside surgical planning services and 3D printed surgical guides. Because this process can take several weeks, it’s frequently not pursued as Veterans may require rapid treatment.
VA Ventures and VHA Office of Advanced Manufacturing have made it possible to bring this service in house.
Oromaxillofacial Advanced Surgical Planning System (OMF ASP), uses medical imaging such as CT scans to create surgical plans that guide the procedure. The system can create digital and physical patient-specific designs. This includes surgical plans, guides models, templates, models, and models. These designs can be used to plan and perform surgeries.
Recent approval by the Food and Drug Administration (FDA) has given OMF ASP System permission. This allows VA surgeons to have access to the system planning services, anatomical models and templates, as well as surgical guides, in-house.
VHA’s first Class II medical device clearance is with OMF ASP System. This system was both developed and manufactured by VHA. This category covers 43% of medical devices. It includes a variety of devices such as powered wheelchairs, and pregnancy test kits. This is the first case of a hospital system receiving FDA clearance for a 3D-printed Class II medical device.
Veteran will feel safer in the System
The system gives surgical teams the opportunity to customize and optimize their approach before they perform surgery. This helps to reduce the time required for adjustment during surgery. It also makes it safer for patients.
The system is made in-house. This allows Veterans to receive faster treatment, which can be critical for certain tumors. It also improves post-surgery results.
OMF ASP provides additional tools that allow for a customized surgical approach to each patient. The OMF ASP System also allows for greater surgical precision due to the level of detail that is aligned with the intricate details of the face.
Significant cost savings
A significant benefit is the possibility of cost savings. While Advanced Surgical Planning services and surgical guide products often cost $5,000 or more, there is a potential for a savings of $2,000 – $3,000 per service.
OMF ASP System is limited to hospital release starting in fall 2022. It will gradually increase in national availability within VHA by 2023.
OAM has now developed this third product for medical devices. OAM produces it in-house to serve VHA patients and their clinicians. In March 2021, the GioStent had been produced in-house by a Veteran in critical need. The Thermal Fuse Cover was also released in January 2022 and was ready for use.