REP. LIEU REINTRODUCES THE DEVICE ACT OF 2017

February 3, 2017
Press Release

FOR IMMEDIATE RELEASE

Washington – Today, Congressman Ted W. Lieu (D | Los Angeles County) issued the following statement upon reintroduction of his legislation to combat the spread of antibiotic-resistant bacteria (superbug) outbreaks in hospitals due to tainted medical devices. H.R. 872, the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency (DEVICE) Act of 2017 increases patient safety by requiring device manufactures to notify the 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.

“Antibiotic-resistant bacteria continues to be a major threat to public health. I am proud to reintroduce the DEVICE Act in response to superbug outbreaks occurring in hospitals across this nation. As we look to improve the health and safety of consumers and patients, especially those who are undergoing routine medical procedures with medical scopes, it’s important we do all that we can to prevent superbug outbreaks.”

MR. LIEU’S EFFORTS TO COMBAT THE SPREAD OF ANTIBIOTIC-RESISTANT SUPERBUGS

  • In 2015, in response to news of superbug infections and deaths occurring at Cedars-Sinai Medical Center in Los Angeles and at the Ronald Regan UCLA Medical Center, Mr. Lieu called for a Congressional hearing to examine the outbreaks.
  • Mr. Lieu sought answers from the Olympus Corporation of Americas, makers of the duodenoscopes that transmitted the deadly CRE bacteria to patients during a routine medical procedure. In the letter, he asked Olympus Corp. how they planned to prevent superbug outbreaks linked to contaminated medical scopes and about the effectiveness of their cleaning instructions.
  • Mr. Lieu also sent letters to government agencies, including a letter to FDA Commissioner Margaret Hamburg seeking further information and ideas on how to best prevent fatal outbreaks of antibiotic resistant bacteria and a letter to the SEC Chair Mary Jo White to investigate Olympus for fraud and violations of U.S. securities laws.
  • In August 2016, Mr. Lieu sent a letter to Secretary John Kerry urging the State Department to request that Japanese authorities investigate and prosecute Olympus for civil or criminal misconduct in their mishandling of antibiotic-resistant bacteria infections caused by their medical devices.
  • After a yearlong investigation that Mr. Lieu requested, 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. This led to Mr. Lieu introducing two pieces of legislation, H.R. 4965, the Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency (DEVICE) Act and H.R. 4966, the Preventing Superbugs and Protecting Patients Act.
  • On February 4, 2016, Senator Patty Murray (D-WA) introduced the Senate companion bill to Mr. Lieu’s H.R. 4966. It was included in Section 3059 of the 21st Century Cures Act, which was signed into law by President Barack Obama on December 13, 2016.

THE TEXT OF H.R 872 CAN BE FOUND HERE

H.R. 872 is supported by the American Public Health Association, Consumer's Union, MRSA Survivors Network, Society of Infectious Disease Pharmacists, Infectious Disease Society of America, and the American Gastroenterological Association

Original cosponsors include Representatives Judy Chu (D-CA), Elijah Cummings (D-MD), Eleanor Holmes Norton (D-DC), Gwen Moore (D-WI), Louise M. Slaughter (D-NY)

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