Congressman Ted W. Lieu (D-CA) has introduced two pieces of legislation after a yearlong investigation that he requested by the House Committee on Oversight and Government Reform found significant gaps in existing law that contributed to a nationwide problem of superbug outbreaks due to tainted duodenoscopes.
The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, a new congressional investigation shows. As many as 350 patients at 41 medical facilities in the United States and worldwide were infected or exposed to tainted gastrointestinal scopes from Jan. 1, 2010, to Oct. 31, 2015, according to the Food and Drug Administration (FDA). (For more information, see the Los Angeles Times story at http://bit.ly/1pkPvb5.)
In 2015, at the UCLA Medical Center in Los Angeles, hundreds of patients were exposed to the antibiotic-resistant bacteria (or superbug) Carbapenem-resistant enterobacteriaceae (CRE), due to tainted duodenoscopes in a routine medical procedure, and the Los Angeles Times reported three patients died related to CRE-infected duodenoscopes. (For more information on that topic, see the following story: “FDA says to inform patients about risk of endoscopy linked to CRE infections,” Same-Day Surgery, April 2015, at http://bit.ly/1VvCxBv.)
Shortly afterward, another outbreak, also from CRE-tainted duodenoscopes, occurred at Los Angeles-based Cedars-Sinai Medical Center. These are two of several outbreaks that have occurred across the country. One of the causes of the outbreaks was the difficulty in cleaning the devices and a lack of scientifically verified reprocessing guidance, according to Lieu.
“Patients and hospitals deserve to know that the medical devices being used on patients can be properly cleaned and are designed effectively,” said Lieu in a released statement. “Patients should not be worried that undergoing a routine medical procedure could lead to them becoming infected with a deadly superbug.”
These two pieces of legislation are:
-
The DEVICE Act (Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency).This legislation requires device manufacturers to notify the FDA whenever they change the design or cleaning instructions of their devices. The bill also requires manufacturers to notify FDA whenever safety warnings are issued in foreign countries related to the design and cleaning of devices. Finally, the bill requires FDA to further regulate tests of medical devices to determine whether bacteria are present.
-
The Preventing Superbugs and Protecting Patients Act. This legislation requires that the reprocessing instructions for medical devices be scientifically validated. This step ensures that the cleaning instructions for medical devices work. This is the House companion bill to a Senate bill, which Sen. Patty Murray (D-WA) introduced.
