March 09, 2015
The number of patients exposed to multidrug-resistant organisms within healthcare and hospital environments continues to rise. Many of these infections have been associated with inadequate hand-sanitizing; however, infections including Carbapenem-resistant Enterobacteriaceae (CRE) have been associated with medical devices (e.g. ventilators, urinary, and intravenous catheters). Recently, the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in California had recent outbreaks of CRE due to contaminated endoscopes. After further investigation, the organism was harbored in the elevator channel of the TJF-Q180V endoscopes, which was difficult to sanitize. The company modified this portion of the scope and resubmitted to the U.S. Food and Drug Administration (FDA) for approval. The company has submitted data indicating that they were unable to sanitize the device to remove 99.9999% of all microbes, the FDA standard.1
A spokesperson for the FDA stated that the company associated in the CRE infection outbreak never obtained permission to sell the device and never asked for clearance to put it on the market (the endoscope has been on the market for at least three years). In addition, the manufacturerof the endoscope did not think it needed permission to sell the device.1 Finally, the FDA spokesperson also stated “since more than 500,000 procedures are done every year in the U.S., the risk of bacterial transmission is very, very low. We believe the benefits outweigh the risks,” thus devices continue to stay in the U.S. market.1
Although I applaud the FDA for working with endoscope companies to ensure a safe device for future testing, I am very concerned about a few issues about the FDA. How does a device make it into the U.S. market and be used for 3 years without FDA oversight? How does a medical company simply say they “did not think they needed FDA permission to sell the device”? How do you allow a company to continue to sell and use endoscopes with mechanical flaws causing CRE transmission? Although the risk of bacterial transmission is low, tell that to the families of the seven patients who died or the number of other patients who have been infected with CRE due to duodenoscopic procedures. In addition, the Centers for Disease Control and Prevention provides facilities with a CRE toolkit including summary of prevention strategies for acute and long-term care facilities that includes core measures that are not very helpful and are very vague including “minimizing use of invasive devices”.
Should the FDA be held to a higher standard? Should the FDA hold companies to a greater measure of accountability for safety? How confident are you that a family member receiving an endoscopic procedure will not be infected with CRE? For patients receiving these procedures, should a process be in place ensuring that the device meets an infectious disease sterility standard? I welcome comments on this issue.
Michael J. Cawley, PharmD, RRT, CPFT, FCCM, is a Professor of Clinical Pharmacy at the Philadelphia College of Pharmacy, University of the Sciences. He has greater than 25 years of experience practicing in the areas of medical, surgical, trauma, and burn intensive care as both a critical care clinical pharmacist and registered respiratory therapist.
1. Cohen E. Deadly superbug-related scopes sold without FDA approval. CNN. www.cnn.com. 2015 Mar 5.
2. Centers of Disease Control and Prevention. 2012 CRE Toolkit – Guidance for Control of Carbapenem-resistant Enterobacteriaceae (CRE). www.cdc.gov. Accessed March 9, 2015.