With dozens of patients infected with CRE using tainted endoscopes, hospitals are spending money to ensure these instruments are safe to use in accordance with FDA guidelines. The device in question is the duoendoscope used in a procedure done hundreds of thousands of times each year. The design of these devices makes them extremely difficult to clean and reprocess.
New Guidelines for Cleaning
As a result of design issues, patients are getting infected with carbapenem-resistant Enterobacteriaceae – bacteria with a close to 50 percent mortality rate. Outbreaks in major cities such as Chicago, Seattle and Los Angles have left a number of people dead. Interim reprocessing and surveillance protocols are in place to prevent further risks to patients. They include culturing the devices to rule out cross-contamination concerns.
John Vargo, MD, MPH of the Cleveland Clinic stated that centers that do any endoscopy are investigating the quality of their reprocessing and instituting their own surveillance programs to improve patient safety.
Other experts, such as Ji Young Bang, MD, of Indiana University, question whether the guidelines go far enough. The protocols do not specify how frequently hospitals should do the culturing. This leaves it open to the administration to interpret the rules based on budgetary concerns.
How Hospitals are Reprocessing Scopes
Many hospitals around the country have instituted additional procedures to clean the scopes and reduce the risks of cross-contamination. The Maine Medical Center is using a “flush and flex” process for all scopes that are elevator-equipped. This means they apply alcohol to the components of the reprocessed scope prior to using it on the patient. Moving the various parts of the devices allows for an additional disinfection immediately before the tool is put into service.
At the Indiana University medical center where Ji Young Bang works, they simply doubled the manufacturer’s cleaning instructions. Every device goes through the process twice before culturing. Of the 592 cultures done on 62 different scopes, they found 59 cases of contamination with five of them containing pathogenic organisms. All the contamination was located in the elevator mechanism, which is the source of the deadly outbreaks, as well.
The Federal Food and Drug Administration agrees the current designs are unsafe despite the extra precautions. Until a better product is available, however; hospitals need to use the current generation of scopes and maintain rigorous sterilization procedures. The manufacturer’s guidelines call for scrubbing of the elevator section with a special brush, then using a liquid or gaseous sterilizer.
Hospitals will need to manage whatever cost is involved to clean the instruments, too. Researchers with the University of Pennsylvania reported that the culturing program alone amounts to around 21,000 dollars a year and that was just for 19 individual scopes. Facilities with bigger inventories will have to pay more.
Plans to change the design of these scopes are underway. The goal is to make them simpler and crevice-free. Scopes that require the elevator mechanism will have a detachable tip that allows for easy and more efficient cleaning, as well. The next generation of endoscopes is not expected to be complete for a couple of years.