Will FDA Guidance Help Stem Endoscope Lawsuits Going Forward?

Washington, DCThis past year has been rife with reports of infections linked to endoscopes and / or duodenoscopes; devices used for diagnostic endoscopic procedures which are intended to be cleaned and re-used. However, many an endoscope lawsuit over the past year have asserted that such devices are either not cleaned and disinfected properly, or feature design flaws that suggest a thorough disinfection is practically impossible.

Infections are transferred from one patient to another when such devices are not properly disinfected between procedures. Numerous outbreaks at hospitals have been traced to endoscopes and duodenoscopes, with some individual hospitals chastised by the US Food and Drug Administration (FDA) for failure to report deaths from infections linked to the medical devices.

As 2016 comes to a close, the medical community is hoping for improvements in the year to come, aided by a recent release by the FDA of recommendations designed to combat cross-contamination from endoscopes.

Whether the recommendations will succeed in mitigating cases of infection and cross-contamination sufficient to stem an endoscopic infection lawsuit remains to be seen.

According to a release by the Association for the Advancement of Medical Instrumentation (AAMI 11/30/16) the federal regulator has issued guidance for medical device manufacturers intended to minimize cross-contamination from valves and accessories used with flexible gastrointestinal endoscopes.

The FDA recommendations and guidance, in part, address the potential for contamination from backflow to water bottles via irrigation channels that don’t feature a backflow-prevention mechanism. Contamination returned to the water bottle via backflow can foster cross-contamination should the same water bottle be deployed for use with another patient, unless the bottle and related components are properly disinfected or discarded altogether.

Labelling would inform medical professionals as to whether, or not equipment is reusable.

Another strategy in the fight against the kind of cross-contamination that has led to many surgical infection lawsuits, is the use of an ATP bioluminescence test. Reuters Health Medical News (11/24/16) reported last month that Adenosine triphosphate (ATP) bioluminescence has the potential to detect microbial residue in endoscopes, and when used in association with retraining of medical staff could help minimize the risk of spreading infections via the endoscopes and duodenoscopes.

A study authored by Dr. Subhas Banerjee and colleagues at Stanford University School of Medicine and published online last month in Gastrointestinal Endoscopy (11/03/16) noted that cleaning and reprocessing of flexible endoscopes involves several steps, with the manual cleaning component possibly presenting as most prone to error.

ATP bioluminescence testing can identify microbial and biological residue in endoscopes, the researchers note, and is “practical, rapid and low-cost,” the study authors said.

ATP bioluminescence testing could also be performed on duodenoscopes before patient use, they add, to confirm adequate decontamination.

Whether, or not such measures will be adopted and thereby save a would-be plaintiff from filing an endoscope negligence lawsuit in the year to come, remains to be seen.