In the wake of multiple outbreaks of superbugs linked to contaminated duodenoscopes, the FDA recommended changes to procedures used to reprocess endoscopes after each use and ordered medical personnel to be more rigorous in employing those procedures. Though the duodenoscope is a more complex instrument than other endoscopes, they all require strict disinfection procedures.
To help medical personnel quickly and easily determine if a flexible endoscope has been properly disinfected and stored, Healthmark Industries Co. offers the NOW! Test. This simple and rapid test can check for Gram-negative bacteria in 12 hours, helping to ensure that a scope is safe to use on the next patient.
Endoscopes are notoriously difficult to clean and sterilize—they can even retain organisms from the final rinse water. And, though flushing with alcohol and instrument-grade air are intended to dry even the tiniest internal channels, these methods can fail as well.
According to Healthmark, numerous studies confirm that Gram-negative bacteria such as Pseudomonas, Klebsiella, Serratia, Legionella and Salmonella are likely to remain behind in an improperly reprocessed scope. Typically, a medical facility would test a stored scope by taking a sample and culturing it, which can take as long as 48 hours.
The NOW! Test utilizes a unique enzyme detection method employing an easy-to-read fluorometer that can read telltale fluorescence in a liquid sample.
The kit includes the fluorometer, a bottle of reagent that reacts with Gram-negative bacteria (< 10 CFU, or colony-forming unit), a resealable plastic sample collection bag, a cuvette with sterile growth media, a pipette and a prepackaged vial of sterile water.
Scopes are tested after being reprocessed. The technician places the sample bag around the end of the scope’s flexible insertion tube, flushes the supplied vial of 5 ml of sterile water, followed by an air flush with a 30 cc syringe. The sample is collected in the plastic bag.
Using a pipette, the tech draws 0.5 ml of the flushed solution and puts it into a cuvette, which is then sealed. The cuvette is next placed in the block incubator for a minimum of 12 hours. At the end of that period, the tech adds the reagent to the sample, seals the cuvette, inverts it four times and inserts the cuvette into the fluorometer. The results are ready in 10 minutes. If the fluorometer reads below 300 nm (or nanometer), Gram-negative bacteria down to 10 CFU was not detected. If greater than 300 nm, further steps—including reprocessing and further testing—need to be taken.
Watch a video demonstrating the process here.