How Will Recent FDA Guidance On Endoscope Reprocessing Impact Hospitals?

With all the recent outbreaks related to flexible endoscope usage, proper cleaning of scopes continues to be top of mind for hospitals and patients. The FDA has recently released guidance on mitigating the risk from cross-contamination of scopes, which can be found here.

Whether or not this guidance will help reduce the likelihood of a hospital having cross-contamination issues remains to be seen. This article found at LawyersandSettlements.com by Gordon Gibb discusses the recent FDA guidance as well as other recent recommendations from AAMI and Stanford University School of Medicine.

“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…

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.”

Read the entire article here…

Hospitals must continue to update their processes to minimize the risks of infection from flexible endoscope usage. Recent guidance from the FDA, AAMI and Stanford shed new light on the subject. Hospital employees must be vigilant to implement and follow these best practices as they come out, and revise processes that may subject their patients to risks. These will be areas to focus on in 2017.