Reprocessed Urological Endoscopes – Scopes for their Use

Dear All,

We still think of using Reprocessed Urological endoscopes and on April 1st 2021 FDA has come out with release ‘on Infections associated with Reprocessed Urological endoscopes. This release is of considerable importance for all of us and is indeed an eye opener of sorts.

The US Food and Drug Administration (FDA) is warning healthcare providers about the risk for potentially life-threatening infections associated with reprocessed endoscopes used for viewing the urinary tract, including cystoscopes, cystouerthroscopes, and ureteroscopes.

The federal agency is investigating more than 450 medical device reports, including three reports of deaths, received between January 1, 2017, and February 20, 2021, that describe post-procedure infections and other possible contamination problems associated with the reprocessing or cleaning and sterilization of the devices.

Manufacturer Olympus Corporation submitted three reports of deaths attributed to a bacterial infection. In two of those reports, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed that the bacteria that caused the infection was present in the forceps/irrigation plug. The FDA said the third victim's death involved a cystoscope that did not pass a leak test. It's not known to what degree the reported infections or patient comorbidities played a part in the patient deaths.

In addition to following reprocessing instructions, the recommendations include not using a device that has failed a leak test, developing schedules for routine device inspection and maintenance.

https://www.fda.gov/medical-devices/letters-health-care-providers/infections-associated-reprocessed-urological-endoscopes-letter-health-care-providers?utm_medium=email&utm_source=govdelivery

Almost all of us use Endoscopes for our daily procedures. What is the policy that is followed by us in this respect? Is it possible for us to avoid reprocessed equipments?

With warm Regards,

Venu

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