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# New CDRH Tool for ’Scope Reprocessing Assurance
- URL: https://www.fdaweb.com/new-cdrh-tool-for-scope-reprocessing-assurance/
- Published: 2020-01-09T12:00:00.000Z
- Updated: 2026-09-14T15:58:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145810

CDRH scientists and engineers have developed a new tool to help hospitals determine how clean an endoscope is after it has been reprocessed. The effort is being led by the Center’s Biofilms Research Group and the Office of Science and Engineering Laboratories. Studies at hospitals are underway to confirm the tool’s effectiveness, FDA officials said during a [1/9 Webcast](https://www.fda.gov/science-research/fda-grand-rounds/quality-control-stopping-infections-they-happen-through-safer-endoscope-reprocessing-01092020?utm%5Fcampaign=2020-01-08%20Endoscope%20Reprocessing%3A%20Join%20Us%20Tomorrow%20for%20a%20Webcast&utm%5Fmedium=email&utm%5Fsource=Eloqua#event-information).  

Bacterial contamination mitigation for reprocessed medical devices is top concern at FDA, especially with endoscopes and their use in 75 million endoscopic procedures annually. “An ongoing challenge related to endoscope use has been antibiotic-resistant bacterial infection outbreaks,” the agency says. “Research has shown that biofilm can build up inside endoscopes over time, making current cleaning and disinfection procedures less effective.”

FDA developed the inexpensive tool to detect and quantify microcontamination amounts, much lower than anything currently commercially available. The agency calls its approach FDA QC-ER, or “FDA Quicker” because the device provides fast results and helps hospitals maintain the quality control of their endoscope reprocessing, the FDA officials said.

The tool uses protein detection for determining reprocessing quality control, CDRH research electrical engineer **Anant Agrawal** told the Webcast. To examine the disinfection on the most challenging part of endoscopes, the distal end, the tool uses extractionless quantitative protein detection, and to examine endoscope channel lengths the tool uses a two-phase flow extraction-based quantitative protein and microbe detection, he said.

A three-hospital study is underway to obtain quantitative information on protein amounts on and in endoscopes during various stages in the cleaning process, among other objectives, Agrawal said. Once the study is complete, FDA intends to publish the results. He said that the agency also intends to develop a point-of-reprocessing polymerase chain reaction molecular test for microorganism detection in real time. “We also want to do a deeper analytical dive into our data to see if we can improve our method or improve reprocessing itself,” he said.

In the future, Agrawal said that because the tool’s technology was developed in-house, licensing and commercialization is being looked at to make it widely available. The technology will also be looked at for use with other reprocessed devices, he added.