Worldwide, an estimated 18 million people die annually due to lack of or inadequate safe surgical care. Yet in austere settings, providing safe surgery is challenging: 1) nonsterile facilities result in high patient infection rates of 15% and above 2) bodily fluid splashes breach the limited personal protective equipment to infect surgical providers, with the chronic epidemic of 85,000 annual provider infections, highlighted by the Ebola crisis, and 3) surgical capacity relies on burdensome supply chains while teams must be as agile as possible.
The old paradigm of safe surgery was to protect entire rooms, which inspired bulky operating facilities in buildings, tents, trailers, trucks, and semi-portable ventilation systems, which all are hard to transport to austere settings, expensive to run and maintain, and rely on electrical grids or large generators.
SurgiBox shrinks the sterility problem for surgery down from the size of the operating room to the size of the patient. SurgiBox offers excellent protection of patients against surgical site infections and simultaneously offers protection of providers by forming a barrier against splashes of patient’s bodily fluids, while it is ultra-portable, rapidly deployable, low-cost, requires minimal maintenance and of minimal environmental footprint.
SurgiBox consists of a clear sterile drape with antimicrobial adhesive, cut-through bottom. The drape is inflated into a bubble over the incision site with air processed through the battery powered environmental control system. Providers operate through arm ports and materials move in and out via material ports. The system is optimized and tested for the most common surgical and ob/gyn procedures and is designed to be easily incorporated into existing workflows. It will be distributed as fully self-contained, ready-to-use kits suitable for limited spaces, such as backpacks.
SurgiBox is a three-part product, leveraging well-established manufacturing norms but incorporating some cutting-edge innovations. The patient-contacting enclosure is manufactured in much the same way as and with comparable production costs to other surgical gowns and drapes. The environmental control system is manufactured as a filter cartridge-blower assembly that connects via tubing to the enclosure. The included batteries are modified off-the-shelf ones that can be charged via almost any local source, from car batteries to laptops to outlets. Production cost for the reusable portion is orders of magnitude lower than for operating room ventilation systems, whether full-size or semi-portable ones. We expect that the device will be able to be manufactured to consistently high quality to comply with US FDA General Controls and similar regulations.
It is expected to see first use in military, humanitarian, and disaster-relief settings, where we are already actively engaging with defense and nongovernmental entities. The centralization of medical consumable stockpiles helps to make this a feasible early market worth millions of dollars. From there, SurgiBox will help to increase safety of ambulatory as well as complex procedures in higher and middle income countries. Ultimately, with effective enough economy of scale and widespread enough acceptance, SurgiBox will reach anywhere safe surgery is needed.