UCLA, CREA, and FDA

By Emily Largent

Before law school, I worked as a nurse at Ronald Reagan UCLA Medical Center.  The work was interesting, as was the news.  I was there when the Los Angeles Times published an investigation revealing that Japanese gang figures received liver transplants at UCLA and when the Times reported on UCLA employees illegally viewing medical records of celebrities.

This week, UCLA made headlines once again when officials announced that nearly 180 patients may have been exposed to a potentially deadly superbug from contaminated duodenoscopes.  Seven UCLA patients–two of whom died–were infected with carbapenem-resistant Enterobacteriaceae (CRE) after a procedure known as endoscopic retrograde cholangiopancreatography (ERCP).  CRE are a family of germs that are difficult to treat because they have high levels of antibiotic resistance, and CRE can lead to death in up to 50% of patients who become infected.

This problem is not unique to UCLA.  The University of Pittsburgh Medical Center had a duodenoscope-related outbreak in 2012. Last month, Virginia Mason Medical Center in Seattle acknowledged that 32 patients were sickened by contaminated endoscopes from 2012 to 2014.  Eleven of those patients died.  From January 2013 to December 2014, the FDA received 75 Medical Device Reports (MDRs) related to possible microbial transmission from duodenoscopes.

The FDA issued a safety communication yesterday, February 19th, which warned doctors that the complex design of duodenoscopes may impede effective reprocessing.  Reprocessing is a multi-step process to clean and disinfect or sterilize reusable devices.  The FDA noted that multi-drug resistant infections have been associated with reprocessed duodenoscopes “even when manufacturer reprocessing instructions are followed correctly.” (UCLA stated that its scopes had been sterilized in line with the manufacturer’s standards.)  Nevertheless, the FDA urged medical providers to carefully follow manufacturers’ cleaning instructions and talk to patients about the benefits and risks of undergoing procedures involving duodenoscopes.

Some have argued that this did not go far enough.  What other options are available to the FDA?

Should the FDA order manufacturers to stop distributing or recall the duodenoscopes?  They are used in more than half a million procedures each year in the United Staes to drain fluids from blocked pancreatic and biliary ducts.  Duodenoscopes are considered less invasive and less risky than surgery, and they have been credited with saving lives through early detection and treatment.  The FDA has stated that “the continued availability of these devices is in the best interest of public health.”

In 2011, the FDA issued draft guidance entitled “Processing/Reprocessing Medical Devices in Health Care Settings.”  The FDA could finalize this guidance and provide clinicians with best practices for reusable medical devices.  Senator Patty Murray (D-WA) called for this on February 4, after Virginia Mason reported infections.  This is the approach I favor, as patients will continue to get sick unless regulators give hospitals better guidance (or the duodenoscopes are redesigned).

Emily Largent

Emily Largent

Emily Largent is an Assistant Professor of Medical Ethics and Health Policy at the Perelman School of Medicine. She also teaches at the University of Pennsylvania LawSchool. Her research examines ethical and regulatory issues arising in human subjects research and when integration of clinical research is integrated with clinical care; she has a particular focus on Alzheimer’s disease research. Emily received her PhD in Health Policy (Ethics) from Harvard and her JD from Harvard Law School. Prior to that, she received her BS in Nursing from the University of Pennsylvania School of Nursing and completed a fellowship in the Department of Bioethics at the National Institutes of Health.

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