- FDA said Thursday it is investigating more than 450 reports of contamination and patient infection linked to reprocessed urological endoscopes over the past four years, including three deaths that occurred outside the United States.
- Devices from Olympus and Karl Storz were cited in medical device adverse event reports (MDRs) that identified the manufacturers. Olympus submitted the three reports disclosing patient deaths from bacterial infection after procedures using the endoscopes. A spokesperson said the company is cooperating and working with FDA and device users to minimize risk.
- FDA has been monitoring infections associated with reprocessed duodenoscopes, a specialized form of endoscope, since the Centers for Disease Control and Prevention first alerted the agency to a potential association between the devices and drug-resistant bacteria in 2013. Because the problems reported with urological endoscopes and duodenoscopes could apply to similar devices, the agency said it is now reviewing information on other types of endoscopes as well.
With its warning of risks associated with urological endoscopes, FDA's focus expands to a second category of endoscopic devices that are used in multiple patients and disinfected between procedures. Its earlier concerns about contaminated duodenoscopes, which also have been linked to patient deaths, led the agency to recommend that hospitals transition to newer versions of the devices that can be reprocessed more effectively or that eliminate the need for reprocessing.
FDA is "very concerned" about the three deaths from bacterial infection tied to urological endoscopes, Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement. The devices are used in diagnostic and therapeutic procedures in the urinary tract.
“Olympus fully supports the FDA recommendations and appreciates the agency’s recognition that the risk of infection related to the use of reusable urological endoscopes is low," Stephanie Sherry, vice president of corporate communications said in a statement provided to MedTech Dive.
"Still, we recognize the seriousness of reported infections, and we are committed to providing the support, training, and education needed to facilitate user compliance with reprocessing instructions.”
Some of the adverse event reports, received from Jan. 1, 2017, through Feb. 20, point to inadequate reprocessing, but FDA is also assessing device design and labeling instructions for cleaning the products in its investigation of potential causes of contamination, Shuren said.
The agency believes the risk of infection from the devices is low, based on available data, and has not concluded that a particular manufacturer or brand carries a higher risk than others. FDA is advising healthcare providers to carefully follow manufacturers' instructions for reprocessing urological endoscopes and their components, avoid using devices that have failed a leak test or are damaged, schedule routine inspection and maintenance as well as discuss with patients the risks involved in procedures performed with the devices.
The increased scrutiny of urological endoscopes follows a series of actions the regulator has taken over the past several years aimed at improving duodenoscope safety, culminating in a recommendation that hospitals transition away from the conventional devices with fixed components and adopt products with disposable parts or that are fully disposable.
Duodenoscopes are threaded through the throat and into the top of the small intestine to diagnose and treat problems in the pancreas and bile ducts.
When duodenoscope manufacturers Fujifilm, Olympus and Pentax failed to meet timetables for completing post-market studies of the reprocessed devices ordered by FDA in 2015, the agency issued warning letters to bring them into compliance.
Preliminary data from the studies released in 2018 and 2019 indicated elevated contamination levels persisted with the products, but analyses did not determine a cause. A 2019 FDA advisory panel attempting to get at the root of the problem put a spotlight on workplace challenges for duodenoscope reprocessors that complicated the cleaning process for the devices, including inadequate training and lengthy instructions.
One company that stands to benefit from a shift to single-use endoscopes is Boston Scientific, which won FDA 510(k) clearance in late 2019 for the first fully disposable duodenoscope. Disruption from the coronavirus pandemic delayed the launch of the device, called Exalt D, but the company said in September that demand was picking up.
Another device maker eyeing the single-use duodenoscope market is Cook Medical, which signed a global distribution agreement for Ambu's disposable device in 2019. The Danish medtech gained FDA clearance for its single-use duodenoscope in July.
Olympus, Pentax and Fujifilm each hold clearances for disposable endcap duodenoscopes, and GI Scientific is authorized to market a shield that can be attached to a reusable duodenoscope to reduce contamination during procedures.
This story has been updated to note that Olympus holds a clearance for disposable endcap duodenoscopes.