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."