Gentherm Medical has developed ThermAffyx, a Patient Safety System that combines patient warming and secure positioning for robot-assisted surgery. The company said the design addresses the limited operating-room space available during robotic procedures and does not require forced-air warming equipment.
The system was launched at this year’s Association of periOperative Registered Nurses Global Surgical Conference. According to Gentherm, medical professionals reported that nearly all of their robotics patients were hypothermic, highlighting the challenge of maintaining normal body temperature during these procedures.
ThermAffyx is intended to address two issues that can overlap in robotic surgery: maintaining normothermia and limiting unintended patient movement. Patients are often placed in Trendelenburg, with the body tilted head-down to provide access to the pelvis and lower abdomen. They may remain in that position while robotic systems are docked and used.
This positioning can increase pressure and shear forces, potentially contributing to pressure injuries, nerve-related complications and patient shifting. Conventional care typically uses a securement pad together with forced-air warming. However, robotic equipment can occupy the space needed for over-body warming, while under-body warming can conflict with the securement pads used to position the patient.
Gentherm described ThermAffyx as a pressure-redistributing underbody foam pad with integrated warming technology. Its safety sensors do not require direct contact with the patient, and the heating zone allows an adult patient to be positioned in different locations while receiving active warming. The system has been tested with patients weighing up to 297 lb. (134.7 kg).
The company said ThermAffyx operates from standard hospital electrical outlets. Gentherm also said it designed and verified the system against applicable industry standards and FDA guidance covering compatibility with electrocautery, diathermy, defibrillation, RFID, wireless power transfer and 5G devices. It cautioned that residual risks remain when external equipment is used outside the manufacturer’s control or labeling.
Gentherm said commercialization is already under way, with trials taking place across the U.S. and adoption reported among both new customers and existing Gentherm accounts. The company said the product received Class II indications for maintaining normothermia and securement, following discussions with the FDA through a Q-Submission and subsequent design, testing and usability work.
Nurses and anesthesiologists contributed to the design through focus groups and hands-on usability studies. Gentherm said the system adds an incremental technology cost below most capital-budget thresholds, while its potential value lies in reducing complications associated with hypothermia, patient movement and pressure-related injuries.
ThermAffyx is available through Gentherm’s U.S. contract sales team. Although it was developed particularly for minimally invasive and robotic-assisted gynecological, urological and general surgery procedures requiring tilted positioning, Gentherm said its design may also support temperature management in orthopedic, cardiovascular, colorectal and plastic surgery cases.
Sources: The Robot Report.