April 19, 2021

Volume XI, Number 109

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April 16, 2021

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Food and Drug Administration (FDA) Discover Infections Linked to Reusable Urological Endoscopes

According to recent reports, the FDA is investigating cases where patients have died due to contamination issues with medical devices. Specifically, the infections are apparently stemming from “the patient-to-patient transfer of pathogens from devices used to view and access the urinary tract, bladder, and kidneys, including cystoscopes, ureteroscopes, and cystourethroscopes.”

With regard to the latest death reports, two out of three were associated with a tool or accessory used with the endoscope. The irrigation accessory plug that controls water flow and enables the endoscope to access its working channel was the source of the infectious bacteria. The third report involved another indication of damage to the medical device, a cystoscope that did not pass a leak test.

Unfortunately, the FDA has received over 400 reports of these post-procedure infections from January 2017 to February 2021. As investigations continue with these reports and medical devices, the FDA wants to keep updating the public and health care providers as often as possible to “ensur[e] the safety of reprocessed medical devices used in multiple patients.”

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COPYRIGHT © 2021, STARK & STARKNational Law Review, Volume XI, Number 96
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About this Author

Jeff Krawitz, Casualty Litigator, Stark and Stark Law firm
Shareholder

Jeff Krawitz is a Shareholder and member of Stark & Stark’s Accident & Personal Injury Group and concentrates his practice in casualty litigation focusing on complex injury, coverage issues and bad faith claims. He also has, and continues to, litigate claims arising from motor vehicle and transportation accidents, many of which involve catastrophic damages. His practice also includes the representation of litigants in professional liability claims including those involving medical negligence. Mr. Krawitz has extensive experience in both state and federal courts...

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