Research Lab Develops Cost-effective Test to Detect Presence of CRE on Reprocessed Duodenoscopes

Microchem Laboratory, an established, EPA/FDA GLP-compliant contract testing laboratory founded in 1988, announces testing support to hospitals interested in culture surveillance of duodenoscopes, in response to CDC guidance and recent outbreaks of CRE.

According to the Centers for Disease Control and Prevention (CDC), “...until there is further evidence that duodenoscopes can be consistently reprocessed in a manner that eliminates contamination of the duodenoscope and prevents transmission of pathogens, the role for post-reprocessing microbiologic surveillance remains.”

Endoscopes enable the procedure known as endoscopic retrograde cholangiopancreatography (ERCP), involving passing a small tube down the patient’s throat for assessing and treating conditions such as cancer, gallstones and other digestive ailments.

According to Dr. Benjamin Tanner, president of Microchem, “Several infection control practitioners have contacted us in recent weeks, struggling to find support labs for duodenoscope surveillance.”

Microchem Laboratory is one of the few laboratories in the United States qualified and prepared to help hospitals comply with the CDC interim duodenoscope surveillance protocol and the CDC interim duodenoscope sampling method.”

Tanner adds,  “More than 500,000 ERCPs are performed each year in the United States to clear bile ducts, remove cancers, etc., so the net benefit of the procedure is overwhelming despite existing infection risks. Still, CRE, lurking on properly cleaned and reprocessed endoscopes, may kill up to half of infected patients, thus we are pleased to offer an affordable solution to allow hospitals to study and ultimately enable this life-saving procedure. Perhaps Microchem's testing support will prevent affected hospitals from having to reprocess duodenoscopes using costly and slow ethylene oxide sterilization.”

Microchem scientists have refined the CDC method to include a critical control missing from the CDC sampling protocol and anticipate processing more than 500 samples for a large, affected hospital.

Microchem’s website describes its duodenoscope testing services at: http://microchemlab.com/test/cdc-duodenoscope-surveillance-sampling Briefly, Microchem provides the materials and training to hospital endoscopy staff, who use a refined, simplified procedure to flush the endoscope.  Samples are then sent to the lab for next-day analysis. In the event of contamination, hospital staff is notified promptly.

Tanner served on an expert panel at a special meeting of the American Gastroenterological Association in San Francisco on March 21, 2015, convened in response to a CRE outbreak stemming from contaminated duodenoscopes and attended by endoscope manufacturers Fuji and Pentax, representatives from the Food and Drug Administration (FDA), and representatives from the CDC.

He notes, “To address the issue, manufacturers should partner with independent laboratories to sample endoscopes - especially complex endoscopes with elevator channels -  for the presence of bacteria over time in ‘real-life’ use.  If there is a problem, then companies can work to simplify endoscope design, refine reprocessing procedures, or develop high-level disinfectants that more readily penetrate biofilm.”

Microchem Laboratory is a contract testing laboratory built to serve industry with a wide array of testing services. The lab specializes in testing of disinfectants (including high-level disinfectants), sanitizers, antimicrobial objects, antimicrobial devices, and sanitizers.

Microchem was founded in 1988 by Dr. Norman Miner and is now operated by Tanner. The lab is staffed by a capable, friendly group of scientists, microbiologists and chemists who understand clients need fairly-priced testing services, done accurately and reported quickly. The laboratory has been audited nearly half-a-dozen times by federal agencies including EPA and FDA.  It is compliant with current Good Laboratory Practice regulations. Clients are always welcome to visit and audit the laboratory. Call 512-580-1342 or visit www.microchemlab.com.

Source: Microchem Laboratory