New Disposable Endoscopes Receive FDA Approval

In early 2016, the United States Senate released a report detailing an investigation that delved into how the faulty design of the medical scopes used in most US hospitals was linked to numerous superbug infections. In a move toward increasing equipment safety, medical device makers are now offering new disposable scopes to eliminate one source of these deadly bacteria.

While the number of healthcare-associated infections in US hospitals has declined over the last five years, patients continue to be at risk for acquiring new infections during hospitalization. The overprescribing of antibiotics along with lacking adherence to best hand hygiene practices by healthcare workers are two main factors that continue to contribute to the ongoing problem of nosocomial infections. Approximately 721,800 healthcare-associated infections occurred in US hospitals in 2011, and nearly 75,000 of those infected died during their hospitalizations that year; of those infections, an estimated 123,100 caused gastrointestinal illness.

In recent years, investigations have revealed that certain medical scopes are one source of hospital-acquired gastrointestinal infections. A 2015 report from the US Food and Drug Administration (FDA) found that the use of a type of gastrointestinal scope, called a duodenoscope, was linked to infections from multidrug-resistant bacteria in some hospital patients. Doctors use duodenoscopes, flexible tubes equipped with lights and cameras, to examine the small intestine by guiding the scopes through a patient’s mouth, throat, and stomach. More than 500,000 of these procedures occur in the US each year, and duodenoscopes must be properly cleaned and sterilized after each use to eliminate any bacteria.

“Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” though, noted the FDA when explaining how the design flaw of these devices makes them difficult to thoroughly disinfect. “However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”

The use of these duodenoscopes were linked to superbug outbreaks around the world, including a cluster of carbapenem-resistant Enterobacteriaceae cases in Los Angeles, triggering an examination into the use of these devices throughout the healthcare industry. In response, the Centers for Disease Control and Prevention (CDC) issued surveillance protocols for the healthcare industry on how to identify contaminated duodenoscopes and prevent additional infection outbreaks.

Now, in an effort to eliminate the potential for medical scope-transmitted infections, the FDA recently approved two new endoscopes designed for one-time use. One of the newly-approved devices, from the Germany-based company invendo medical GmbH, offers a sterile option to address the challenges of cleaning and reprocessing. “Our revolutionary technology uniquely addresses the significant challenges associated with the cleaning and disinfecting of traditional reusable endoscopes by providing an ergonomically advanced endoscope that offers both sterility and single use,” said the company’s Chief Executive Officer, Timo Hercegfi, in a recent press release. The FDA noted that disposable endoscopes are to be used for a single procedure in one patient, and are not to be sterilized or reprocessed for reuse.