FDA Warns About Commonly Used Medical Scope
Required

Recent “Superbug” Infections Related to Commonly Used Medical Scope

The FDA recently issued an urgent Safety Communication to healthcare providers and patients alike warning that a commonly used medical scope may not be able to be cleaned completely between patient uses because of its complicated design. Seven people are ill, and 2 died, at Ronald Reagan UCLA Medical Center, and four more patients sickened at Cedars-Sinai Medical Center, after becoming infected with an antibiotic-resistant superbug known as CRE following a common procedure using a duodenoscope. Over half a million patients in the United States each year undergo procedures using duodenoscopes which are flexible, lighted tubes placed into a patient’s mouth and threaded down the GI tract into the top of the small intestine, known as the duodenum, for biopsies and treatment of multiple gastroenterological conditions.

The new FDA safety communication advises hospitals and doctors that the complex design of the duodenoscope may prevent it from being completely cleaned through re-processing, a multi-step cleaning and disinfecting process for medical devices that are used more than once, on more than one patient. Reusable medical scopes that cannot be thoroughly cleaned may allow transmission of infection between patients.

Between January 2013 and December 2014, 75 reports involving 135 patients claimed possible infection and exposure to CRE, a bacteria present in the “gut”, after procedures using a duodenoscope. The FDA is working with hospitals, doctors, the device manufacturers and the CDC to raise awareness of the problems associated with completely cleaning the devices even if all manufacturers’ recommendations are followed, and to change the way the scopes are cleaned to help reduce possible infection and exposure rates.

Despite problems with the cleaning process, the FDA decided to keep duodenoscopes on the market because the vast majority of patients are greatly helped by use of the device, and the risk is low for infection.

The FDA has issued recommendations for both healthcare providers and patients regarding procedures using a duodenoscope.

Healthcare providers must:

  • Give thorough, detailed information to patients about the risks and benefits of using a duodenoscope;
  • Advise what potential complications or problems to look for indicating infection; and
  • Immediately notify the device manufacturer and FDA if they suspect an infection was caused because of the failure of the reprocessing cleaning process.

Before giving consent, patients should:

  • Ask lots of questions;
  • Know all the risks and benefits involved with the use of duodenoscopes;
  • Follow up immediately with the doctor if fever, pain, nausea, severe chest pain or any other signs of problems or infection develop; and
  • Report any side effects to the FDA at fda.gov/MedWatch/report.

The FDA is also issuing further guidelines to scope manufacturers requiring that they show they are improving the methods for cleaning the reusable scopes and provide documentation about how well the cleaning process is working.

Five lawsuits have been filed against the maker of the duodenoscopes in question, Olympus Corp. of the Americas, which has been sued for wrongful death, negligence, and fraud.

In this day and age of transparency, it is unconscionable that there is no law requiring hospitals to educate their patients about the risks of being exposed to potentially deadly superbugs. “We believe that these kinds of secret networks are the fundamental reason that we have 440,000 people die from preventable infection or medical errors every year,” explained Lisa McGiffert, director of the Safe Patient Project. Although federal law requires reporting of two other deadly superbugs, MRSA and C. diff, there are no such requirements with CRE and we support the call for mandatory nationwide reporting of all superbug infections and outbreaks to help prevent the spread of dangerous antibiotic-resistant infections and to promote public safety.