Flexible endoscopes are used every day to diagnose and treat serious medical conditions. But lawsuits and regulatory investigations have raised troubling questions about whether some reusable endoscopes, including Olympus duodenoscopes and bronchoscopes, can be adequately disinfected between patients.
The concern is especially serious because these devices may transmit multidrug-resistant organisms (MDROs), potentially causing life-threatening infections.
Duodenoscopes and bronchoscopes contain tiny channels, components, and internal surfaces that can be extremely difficult to clean. If bacteria or other microorganisms remain inside the device, they can potentially be transferred to another patient during a subsequent procedure.
The FDA has acknowledged that infections associated with duodenoscopes have occurred even when hospitals followed the manufacturer’s reprocessing instructions. The agency has investigated contamination and infection reports involving Olympus duodenoscopes and has required manufacturers to conduct additional post-market surveillance.
That raises an important question:
What happens when a hospital does everything it is instructed to do, but the medical device itself cannot be reliably cleaned?
That is a central issue in litigation involving reusable endoscopes.
A contaminated endoscope can potentially transmit organisms such as carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococcus (VRE). These infections can be extremely difficult to treat.
Patients who contract these organisms may suffer:
FDA records have included reports of suspected patient-to-patient transmission of multidrug-resistant organisms involving Olympus scopes, including situations in which the devices were reportedly reprocessed according to manufacturer instructions.
Product liability lawsuits involving reusable Olympus endoscopes allege, among other things, that certain devices were defectively designed, making them difficult or impossible to adequately clean and disinfect.
Plaintiffs have also alleged that manufacturers:
These are allegations, and each case must be evaluated based on its individual facts and medical evidence.
If you or a loved one developed a serious or unusual infection after an ERCP, bronchoscopy, or another procedure involving a reusable endoscope, it may be worth investigating whether a contaminated medical device played a role.
Important evidence may include:
If a defective medical device caused you or a loved one to suffer a serious infection, the manufacturer, not the patient, may be responsible for the consequences.
At Galfand Berger LLP, our personal injury attorneys investigate cases involving defective medical products and serious injuries. We can work with medical professionals and other experts to determine what happened, whether a defective device may have contributed to an infection, and who may be legally responsible.
If you developed a serious infection after a procedure involving an Olympus duodenoscope, bronchoscope, or another reusable endoscope, contact Galfand Berger LLP for a free consultation. Call 800-222-USWA (8792) or complete our online form. You may have a limited amount of time to pursue a claim. Don’t wait to investigate your rights. We have offices in Philadelphia and Reading, PA, and serve clients across PA and NJ.
At Galfand Berger, our personal injury attorneys have been pursuing justice for injured victims throughout Pennsylvania and New Jersey for nearly 80 years.
