The COVID-19 pandemic has increased awareness of perioperative aerosolization hazards. Powered air-purifying respirators (PAPRs) provide increased and more consistent protection than surgical masks and other respirators (N95/FFP2–3) , and have been used empirically in healthcare settings. However, there is a lack of independent evaluation of their appropriateness for surgery, especially in the context of multidisciplinary team interaction. Following satisfactory preclinical, graded user assessment , a clinical study (IRB: AEROSOLVE 1/378/2172) was performed for this purpose using a PAPR system (VersafloTM TR-300; 3M, St Paul, MN, USA) with lightweight full-hood (S-433S).
First, as mandated by local infection control requirements in advance of clinical trialling, the microbiological safety and local airflow impact of the PAPR in the operating room environment was assessed. Settling plate testing was carried out at 10 key operating room positions (including operating table and instrument trolley); team members, wearing either a PAPR or surgical mask, performed predefined particulate-generating actions and simulated surgery (laparoscopic cholecystectomy). Results were compared with those obtained in an empty theatre. Smoke studies evaluated operating room airflow impact around the PAPR–user during baseline and forced expiration with and without concomitant surgical masking. Both studies confirmed PAPR usage compatibility within the acceptable limits for safe surgery, and that surgical masks need not be worn in addition to the PAPR sets.