REP. TED LIEU INTRODUCES TWO NEW BILLS TO HELP PREVENT SUPERBUG OUTBREAKS

April 15, 2016
Press Release

FOR IMMEDIATE RELEASE

Washington - Today, Congressman Ted W. Lieu (D | Los Angeles County) introduced two pieces of legislation after a yearlong investigation 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.

Upon introduction of his legislation, Rep. Lieu made the following statement:

“Antibiotic-resistant bacteria are a major threat to public health.  I am proud to introduce these pieces of legislation today in response to the numerous superbug outbreaks happening in hospitals across the nation.  Patients and hospitals deserve to know that the medical devices being used on patients can be properly cleaned and are designed effectively.  Patients should not be worried that undergoing a routine medical procedure could lead to them becoming infected with a deadly superbug.  What happened to the patients and families at UCLA Medical Center and hospitals across the country should not happen again.

“I am deeply grateful to the Oversight and Government Reform Committee for making this issue a top priority.  This legislation is a result of their yearlong investigation into the many superbug outbreaks caused by tainted duodenoscopes across the country.  I am also grateful to FDA for cooperating fully with my office and the Oversight Committee.  Through diligent hard work and investigation, the Committee has identified many of the causes and solutions needed to protect patients from future superbug outbreaks.”

Rep. Lieu’s New Superbug Legislation

The DEVICE Act (Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency)

This legislation further increases patient safety by requiring device manufacturers to notify Federal Drug Administration (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.

Upon introduction of The DEVICE Act, Rep. Elijah Cummings, Ranking Member, House Oversight and Government Reform Committee, made the following statement:

“Congressman Lieu has been steadfast in addressing this critical public health issue on behalf of his constituents and the nation. His leadership is a strong example of elected officials identifying problems and implementing solutions that the will help improve the lives of the American people.”

***

The Preventing Superbugs and Protecting Patients Act

This legislation improves safety for patients undergoing medical procedures by requiring that the reprocessing instructions for medical devices be scientifically validated.  This ensures that the cleaning instructions for medical devices actually work.  Furthermore, this is the House companion bill to the Senate bill, which, last month, Senator Patty Murray (D-WA), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, introduced.   Rep. Peter Roskam (R-IL) also introduced The Preventing Superbugs and Protecting Patients Act in the House along with Mr. Lieu.

Upon House introduction of The Preventing Superbugs and Protecting Patients Act, Senator Murray made the following statement:

“Patients should be able to trust that the medical devices used in their treatment are safe and effective, but as we saw in my home state of Washington, our medical device monitoring system too often falls short.  I’m proud to be working with Representative Lieu on legislation that would provide the FDA with additional tools to review and ensure the safety of medical devices like duodenoscopes, and I’m committed to continued work to improve our medical device monitoring system and protect patients and families in Washington state and across the country.”

Legislation Background

Last year, at the UCLA Medical Center, 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.  Shortly afterwards, another outbreak also from CRE tainted duodenoscopes occurred at Cedars-Senai Medical Center.  These are two of several outbreaks which 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 guidances.

###