As transmitted infections continue to plague notoriously difficult-to-clean reusable endoscopes, the FDA has cleared two new single-use, disposable devices, allowing providers to skip the decontamination process altogether.
The first is a portable cystoscope from UroViu, designed to help inspect the bladder via the urethra and perform interventional procedures.
The Uro-G is the third device from the company to receive an agency clearance, following the Uro-V and Uro-N diagnostic and injection-capable cannulas, all of which connect to a reusable video display and handle. The off-the-shelf Uro-G is equipped with a fully deflectable, flexible tip, designed for outpatient diagnostic procedures.
The clearance comes on the heels of the FDA’s announced investigation into reports of infections from reusable urological devices, such as cystoscopes and ureteroscopes used to access the bladder and kidneys.
RELATED: FDA cites potential infection risks with reusable urological endoscopes
This includes three deaths from associated patient-to-patient infections outside the U.S., in addition to more than 450 reports describing contamination issues and potentially drug-resistant bugs, the agency said in April.
The FDA has also been tracking issues with larger, gastrointestinal endoscopes for several years. During that time, the agency issued warning letters and required manufacturers to perform postmarket safety studies, before ultimately urging the industry to move away from durable, reusable designs in favor of fully disposable or modular devices.
RELATED: Olympus rolls out first single-use bronchoscopes following Veran acquisition
To that end, the FDA’s second recent clearance was granted to EndoFresh for its disposable digestive endoscopy system. The China-based company’s device includes a camera system plus single-use attachments for an upper GI endoscope and a colonoscope.
Both EndoFresh and UroViu pitched their devices as cost-effective alternatives to traditionally reusable devices, allowing providers to save on repairs and capital investments in specially designed disinfecting equipment.
In addition, the two companies also highlighted their devices’ portability, allowing procedures to be performed in multiple settings ranging from the intensive care unit to outpatient clinics.
RELATED: Too tough to clean: FDA urges industry transition to disposable duodenoscopes
The larger players in the endoscope market, such as Olympus and Boston Scientific, have also been pursuing easier-to-clean and disposable devices, including the latter’s single-use LithoVue ureteroscope and the FDA’s first fully disposable duodenoscope, the EXALT Model D.
Meanwhile, after receiving a green light last year for its duodenoscope with a disposable end cap—allowing greater access to clean the device’s intricate moving parts and its many nooks and crannies that can harbor pathogens—Olympus has begun rolling out its first single-use bronchoscopes, following its $340 million acquisition last December of the respiratory-focused Veran Medical Technologies.