Further bacteriological evaluation of the TOUL mobile system delivering ultra-clean air over surgical patients and instruments.

Two mobile TOUL-400 units (types 1 and 2) that produce an exponential ultra-clean air flow (EUA) via a mobile screen were evaluated (maximum height from floor to centre of screen: type 1, 1.4m; type 2, 1.6m). Bacterial deposition rates were lowered by >60% (P=0.001) over a table area of 1.7 m (length)x1.0m (width) with the TOUL-400 type 1 unit, and the mean air count at 1.0m from the screen was reduced from 23 to 1.6 colony-forming units (CFU)/m3 in experiments in a room with six air changes/h (ACH). The corresponding reductions were two- to three-fold greater in an operating room (OR) with 16 ACH due to higher bacterial contamination levels in the control experiments. The dramatic but localized reduction of the deposition rate recorded on one 14-cm settle plate (>2376-fold at 0.8m from the screen in the OR) apparently reflected the focus of the EUA. The impact of the TOUL-400 unit was underestimated by almost 100-fold by the air counts of bacteria recorded in parallel at the same sampling point (26.5-fold reduction). During sham coronary angiography and sham hip arthroplasty performed in a room with six ACH, ultra-clean air (<10 CFU/m3) was obtained over the incision area with the TOUL-400 type 2 unit when the EUA was undisturbed (maximum screen-wound distance 1.7 m). In actual coronary angiography (room with six ACH, screen-wound distance 2.0-2.3m) and various surgical procedures in the OR (screen-wound distance 1.4-1.8m), ultra-clean air was obtained at the wound in three of 18 instances, characterized by undisturbed air flow and a maximum distance of 1.8 m. The newly developed TOUL-300 surgical instrument table (1.3-1.7 x 0.6m), equipped at one end with the same EUA unit as the TOUL-400 unit, was evaluated for a room with six ACH and an OR with 16 ACH. It yielded ultra-clean air at 0.8m (1.9 CFU/m3, 96% reduction, P=0.01) and reduced the deposition rate by >60% over most of the table surface. Simplified positioning of the screen or a longer reach, plus a mechanism for precise focusing of the air flow on to the wound area would increase the clinical utility of the TOUL EUA system.