Bacterial Contamination of Propofol in the Operating Theatre

Abstract

There have been several reports of propofol becoming extrinsically contaminated with bacteria. These reports have usually related to infusions or delays in administration after the ampoule has been opened. This observational study was performed to examine bacterial contamination of propofol during usual practice in the operating theatres of a single large hospital group. One hundred samples of propofol were collected and cultured. Samples were taken immediately after administration in cases where the delay between opening the ampoule and administration was at least 15 minutes. The samples were classified according to whether the propofol was kept in the ampoule or a syringe after opening the ampoule and whether the intended use was for a single patient or multiple patients. The time between opening the ampoule and administration was recorded. There were three positive bacterial cultures. These samples all came from ampoules used for more than one patient, without the later dose (doses) being drawn into a syringe at the time the ampoule was opened. This common clinical practice, especially in paediatric anaesthesia, does not comply with the manufacturer's recommendations. The clinical significance of the bacterial contamination detected is not clear. It is recommended that propofol should be handled in an aseptic fashion and measures taken to minimize the risk of bacterial contamination.

Safety and efficacy of remimazolam besylate in patients undergoing colonoscopy: A multicentre, single-blind, randomized, controlled, phase Ⅲ trial

“…Propofol can affect the cardiovascular system and cause oxygen desaturation, such that the involvement of an anesthesiologist is recommended for the care of every patient undergoing propofol anesthesia ( Wesolowski et al, 2016 ). In addition, propofol may cause pain on injection ( Dedic et al, 2010 ; Euasobhon et al, 2016 ), exhibit nonlinear kinetics ( Wesolowski et al, 2016 ), and some formulations carry the risk of bacterial contamination ( McHugh and Roper, 1995 ; Soong, 1999 ). Midazolam, the first water-soluble benzodiazepine drug, has been widely used in sedation and induction of general anesthesia ( Reves et al, 1985 ).…”

Propofol EDTA and Reduced Incidence of Infection

“…Several studies have examined contamination of propofol without EDTA durin� clinical use [6][7][8] .…”

“…Soon� studied the incidence of �acterial contamination of propofol without EDTA durin� usual practice in the operatin� theatres of a sin�le lar�e hospital �roup and investi�ated whether there was any relationship �etween contamination and the practice of multi-dosin� 6 . One hundred samples of propofol were collected from the remnants of syrin�es and ampoules immediately after propofol administration.…”

“…They recommended that propofol should �e handled in an aseptic fashion and drawn up into a syrin�e immediately after openin�. They o�served that propofol infusions contained no preservative or antimicro�ial a�ent 6 . The contamination incidence in this study 6 was 4.�%, in accord with a previous study, which found a 6.3% incidence of �acterial contamination of propofol 7 .…”

Pharmaceutics for the anaesthetist

“…However, as usage of the drug increased, reports of bacterial contamination of propofol emulsion also started to appear, with the suggestion that some cases of postoperative infection might have been due to the injection of contaminated product [84–86]. The concern that the preservative‐free product could easily be contaminated through handling [87, 88] led the original patent holders, AstraZeneca, to reformulate the preparation. Antimicrobial studies demonstrated that EDTA at a concentration of 0.005% successfully retards microbial growth and has no adverse effects on the physicochemical stability of the product [89].…”