FDA investigates the reports of infections associated with reprocessed urological endoscope

The FDA puts its best foot forward to ensure safety in regard to reprocessed medical devices. The FDA is actively engaged to help understand the risk and the causes associated with endoscopic procedures.

Endoscopic Superbugs infections 

Doctors use an endoscope to look inside the patient’s body to screen for disease and in some cases treat existing conditions. Endoscopic devices consist of light video cameras attached to long thin plastic tubes. Certain endoscopes come under scrutiny for potentially spreading the carbapenem-resistant Enterobacteria - a potentially deadly antibiotic resistant infection even when proper disinfection procedures are followed. 

According to FDA, duodenoscopes, a type of endoscope used for endoscopic retrograde cholangiopancreatography (ERCP) procedures to examine the GIT system especially the pancreatic and bile ducts are designed in a way that may prevent the full cleaning and disinfection. If you have come across anyone who has unexplained illness after an endoscopic procedure, there are higher chances of infection. 

Sterilizing endoscopic devices are important 

Sterilizing the duodenoscopes between the uses requires hospital personnel to pay detailed attention to it. It is important for the safety of the patients to sterilize and disinfect the endoscopic medical devices and instruments regularly after each use. A multi-step process and detailed thorough cleaning and disinfection is a must to eliminate the risk and reduce the risk of transmitting serious infections. These infections can cause life-threatening conditions between the uses. The Center for Disease Control and Prevention (CDC) has reported the potential link between the multidrug-resistant bacterial infections in patients who have undergone endoscopic procedures with the reprocessed medical devices or instruments. 

FDA announcements regarding the Reprocessed endoscopic devices

The FDA announced that it is investigating numerous medical devices causing patient infection and other possible contamination issues due to the reuse. The reprocessed urological endoscopic devices like cystoscope, ureteroscope, and cystourethroscopy devices which are needed to view the urinary tract and system have higher chances of spreading infection among the patients exposed to endoscopy.

Reprocessing of the medical devices involves both cleaning, disinfection, and sterilization of the devices and instruments before reuse. Medical devices are supposed to improve your care and not put you at risk of potentially fatal infection. If anyone has contracted the infection due to the endoscopic procedure, it is important to bring it to light. Proper guidance must be given to the hospital personnel to take further action to prevent these types of infection which can spread through the contamination of medical devices. 

FDA action incase of reprocessing of medical devices 

From Jan 1 2017 to Feb 20, 2021, the FDA received over 450 Medical Devices Reprocessed describing post-procedure patient infections or other possible contamination issues associated with reprocessing these devices. Many medical device companies were cited in the FDA's reports. The FDA is continuing to investigate these reports, but the FDA has not concluded any specific manufacturer or brand of devices to be associated with a higher risk of contamination. 

The letter to health care providers, hospitals, and medical professionals on April 1, 2021, provides recommendations of reprocessing and using the devices as per the instructions laid by the FDA. It is important to discuss and know the potential risk and benefits associated with the procedures involving reprocessed urological endoscopes with patients. 

Tags : #FDA #medicaldevices #endoscope #bacterialinfection #medicircle #myhealth

Related Stories

Loading Please wait...


Trending Now

Worldwide EndoMarch, Endo Run to raise mass awareness on Endometriosis!February 21, 2024
Uptick In Respiratory, and Cardiac Problems Due To Poor Air Quality In DelhiFebruary 21, 2024
Evidence shows risks associated with energy drinks in childrenFebruary 21, 2024
iHub-Data at IT-Hyderabad announces collaborative initiative with technical institutions for AI/ML training programsFebruary 20, 2024
Viatris Receives Global Minimized Risk of Antimicrobial Resistance Certification, Advancing its Commitment to Responsible Antibiotic ProductionFebruary 20, 2024
“Kusum Ka Biyaah” Indian Hindi film based on a true story releasing on 1st March 2024February 19, 2024
Introducing Moscow's Pioneering Initiative: An Open Dataset for AI-driven Brain Disease Detection"February 19, 2024
ICPA Health Products Introduces Coolora Spray - A Rapid Relief Solution For Oral & Throat DiscomfortFebruary 19, 2024
Section 43B of the Income Tax demystifiedFebruary 16, 2024
Nutricircle Introduces Health Supplements My45NutrientsTM to Enhance Overall Well-beingFebruary 16, 2024
YFLO organised a session “Design Your Story” to inspire young FICCI Ladies to design their own compelling storiesFebruary 15, 2024
149 experts call to find all TB to stop TBFebruary 15, 2024
ICPA Welcomes Global Leader In Periodontal Aesthetics - Prof Giovanni Zucchelli On His Inaugural Visit To IndiaFebruary 14, 2024
Fast Fashion and Sustainability are not friends and do not go well with each other: Namrata Joshipura, one of India’s most celebrated Fashion designers February 14, 2024
YFLO to organise a session Design Your StoryFebruary 14, 2024
Starkey Launches Genesis AI Hearing Aids in India, Pioneering a New Era in Hearing HealthFebruary 14, 2024
Indian Institute of Heritage and University of Birmingham announce strategic partnershipFebruary 14, 2024
Siddharth Anand’s Fighter emerges as the first hit of 2024February 13, 2024
India’s 26 years old youth’s Adventurous Atal Yatra to Celebrate Silver Jubilee of the Golden Quadrilateral beginsFebruary 13, 2024
Vitafoods India 2024 - Exploring Nutraceutical FrontiersFebruary 13, 2024