Microbiological Testing of Scopeguard Endoscope Sheaths
Abstract
To show that the Scopeguard Endoscope Sheath is an effective protective barrier and is impermeable to a bacterial challenge of Brevundimonas diminuta. This organism has been chosen as it is a small microorganism of approximately 0.2μm in diameter which will give the best challenge to the test items. This strain is a laboratory standard microorganism.
The sponsor has requested that the samples are tested using the FDA guidelines (Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as protective Barriers) (8.1) as a guide.
Five Scopeguard Endoscope Sheaths from three batches will be aseptically filled with a volume of Tryptone Soya Broth and sealed and then placed vertically into a broth containing a suspension of Brevundimonas diminuta for 24 hours at 36±1°C. After 24 hours the Scopeguard Endoscope Sheaths will be removed from the suspension and incubated vertically for a further 14 days at 36±1°C. Concurrent positive controls for each of the three batches will be run. These will consist of two Scopeguard Endoscope Sheaths filled with Tryptone Soya Broth and small pin prick holes pierced into them. The positive controls will be incubated with the test samples for 24 hours at 36±1°C in the broth containing a suspension of Brevundimonas diminuta and then incubated vertically for up to a further 14 days at 36±1°C until growth is seen.
Two negative controls for each batch will be run with two filled Scopeguard Endoscope Sheaths incubated concurrently not in the suspension of Brevundimonas diminuta for a total of 15 days at 36±1°C. Two Scopeguard Endoscope Sheaths from three batches will be filled with a volume of Tryptone Soya Broth inoculated with approximately 100cfu of Brevundimonas diminuta and incubated for up to 5 days at 36±1°C as a fertility control to show that a low level Brevundimonas diminuta is able to grow in the Scopeguard Endoscope Sheaths.
The following files are available for download
Efficacy of Scopeguard Endoscopic sheath to bacterial challenge as a protective barrier (application/pdf / 738 KB)
