Posted on January 28, 2016 by Cogentix Medical

The FDA, Bronchoscopes and ICU Safety

A small but growing problem

SuperbugsBetween 2010 and 2015, the FDA received a total of 109 Medical Device Reports (MDRs) that mentioned infections or device contamination associated with reprocessed flexible bronchoscopes. While this isn’t a significant number when considering the number of bronchoscopy procedures performed in the U.S. each year, 50 of these MDRs —almost half — occurred in 2014. Such a number suggests a significant uptick of incidents, and therefore an increased risk, of using bronchoscopes.

On September 17, 2015, in response to the rising number of infections and device contaminations, the FDA Released a Safety Communication on the Reprocessing of Bronchoscopes. The FDA identified bronchoscopes as being part of a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed. The FDA is proactively investigating these devices to determine whether additional steps should be taken to ensure patient safety and reduce the likelihood of contamination.

Common risk factors

As part of that investigation, the FDA studied the commonalities in the MDRs regarding infections associated with flexible bronchoscopes and found these two recurring factors 1) Failure to meticulously follow manufacturer instructions for reprocessing and 2) Continued use of devices despite integrity, maintenance and mechanical issues.

Evidence shows that reprocessing conventional bronchoscopes is becoming more difficult, and conventional bronchoscopes are resulting in greater numbers of cross-contamination incidents among patients. The FDA report highlights how this is a growing concern for providers and patients alike.

The good news is that using the PrimeSight Bronchoscope with EndoSheath Protective Barrier minimizes all the risk factors mentioned above, from improper cleaning to device integrity. The following is a list of the risk factors identified by the FDA and how the PrimeSight system mitigates safety risks. 

FDA-Identified Issues with Reprocessing of Conventional Endoscope

Solution: The EndoSheath Protective Barrier

Lack of pre-cleaning, which typically includes surface wiping and channel flushing to prevent drying of blood, tissue and other biological debris, at the point of use.

The EndoSheath barrier is designed to prevent tissue or biological debris from coming in contact with endoscope during the procedure (at point of use).

Failure to perform a thorough manual cleaning before using high-level disinfection (HLD) or sterilization.

Using the EndoSheath barrier prevents gross contamination and therefore simplifies cleaning process and alleviates the potential for material to remain after cleaning.

Failure to flush or brush channels.

No internal endoscope channel.  All channels are brand new and sterile for each case.

Use of expired detergent or high-level disinfectant.

Reprocessing is simplified and HLD is not utilized.

Insufficient flushing, rinsing and/or drying after HLD.

Flushing is not required and HLD is not utilized.

FDA-Identified Issues with Conventional Endoscope Design

Solution: The Unique Design of PrimeSight Endoscopes

Persistent device channel kinks or bends.

No internal endoscope channel.  All channels are brand new and sterile for each case.

Channel wall scratches, divots, or crevices.

No internal endoscope channel.  All channels are brand new and sterile for each case.

Holes, cracks, or other imperfections in the distal end.

The EndoSheath barrier isolates the endoscope, including the distal end, from patient contact and minimizes the potential for material to be contained in any endoscope imperfections.

Use of repaired or refurbished devices with out-of-specification parts.

To utilize PrimeSight endoscopes with the EndoSheath Protective Barrier, all specifications must comply with manufacturer’s standards for proper fit and size.

Use of devices despite residual material in the instrument or suction channels.

No internal endoscope channel.  All channels are brand new and sterile for each case.

As you can see, the PrimeSight system is designed to eliminate the common risk factors or make them extraordinarily unlikely. And, it’s working; of all the FDA reported patient infections, none were from PrimeSight Bronchoscopes using the EndoSheath Protective Barrier.

Further indication of the effectiveness came in the 2015 ANSI/AAMI National Standards on Flexible and Semi-Rigid Endoscope Reprocessing, which references endoscope sheaths, such as the EndoSheath product, as an effective microbial barrier.

An efficient solution

EndoSheath streamlines and simplifies reprocessing, making it both a highly efficient and cost-effective approach to a potentially dangerous problem. In addition, scopes can be reprocessed in about than 10 minutes. This is a time-savings of about 30 minutes compared to conventional scopes, a critical factor during nights, weekends and holidays when support staff time is at a premium.

PrimeSight offers an opportunity for ICUs across America to adopt high-quality bronchoscopy technology while addressing some of the high-risk concerns associated with conventional scopes. To learn more about PrimeSight Bronchoscopy with the EndoSheath Protective Barrier, visit for professional insights and reports regarding how your ICU can be safe and more efficient.

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