Surgery, by definition, involves violating the body's primary defense against infection. Traversing the skin, whether with a scalpel or a needle, always introduces microorganisms into the patient - the only question is what organisms and how many.
Multiple steps are employed to minimize the risk of surgical site infections (SSI). For example:
The surgical site is prepped with agents that reduce skin flora.
All instruments employed during surgery, e.g., the scalpel, are sterilized.
All implants, electrodes, etc., are sterilized.
The surgeon and all staff gowns with sterile gowns and gloves.
The operating room is thoroughly cleaned after every surgery.
Airflow in the OR is controlled.
Personnel allowed into the OR is kept to a minimum.
USDA.gov describes sterilization as: "a process that destroys or eliminates all forms of microbial life, including spores. Disinfection methods can involve the use of physical (e.g., heat or ultraviolet light) or chemical (e.g., disinfectants) processes to reduce, inactivate, or destroy pathogenic microorganisms."
Despite these efforts, the frequency of SSIs remains at about 2%. Why? The reason is that absolute sterility is not possible even with all of the interventions described above.
Noguchi et al. found that airborne microorganisms can induce infections and that the duration of a surgical procedure is directly proportional to the frequency of SSIs.
Laminar air flow systems can reduce the risk of infection by moving air away from the patient. This suggests that microorganisms can become airborne in the operating room. Therefore, every effort must be made to reduce the "bacterial and fungal load" on all non-sterile objects in the operating room. The anesthesia cart, electrosurgery generators, and foot pedals are three examples.
The BiPAD device is sterilized and has a shelf life of five years.
Foot pedals cannot be sterilized; they are on the floor and not covered. Moreover, they are not waterproof and cannot be cleaned thoroughly.
Moreover, introducing microorganisms into the air within the operating room is associated with activities involving those non-sterile devices. For example, foot pedals are often handled without gloves, and positioning the bipolar forceps foot pedal often involves staff crawling under the operating table during surgery.
Noguchi et al. noted: "A high number of dispersed airborne particles were observed when unfolding the drape and surgical gown. Since the drape and surgical gown were initially sterile, the particles from them are considered bacteria-free. However, airborne particles can act as vectors for transmitting bacteria after coming in contact with unsterile areas (e.g. skin, walls, or floor) . Particles settled on an unsterile floor can be easily dispersed by air eddies generated from opening doors and foot traffic. A recent study noted a trend towards lower SSI rates in hospitals with decreased operating room staff turnover . Thus, it is preferable that the actions such as unfolding a drape and surgical gown should be carried out away from the operating and instrument Tables."
Foot pedals and other non-sterile equipment contribute to the introduction of microorganisms into the air in the operating room during surgery. The less these items are handled and the fewer such non-sterile items in the OR, the lower the likelihood of surgical site infections. BiPAD can reduce risk of SSIs.
Noguchi, C., Koseki, H., Horiuchi, H., Yonekura, A., Tomita, M., Higuchi, T., Sunagawa, S., & Osaki, M. (2016). Factors contributing to airborne particle dispersal in the operating room. BMC Surgery, 17. https://doi.org/10.1186/s12893-017-0275-1