A California lawmaker recently introduced legislation aimed to curb infections
due to tainted duodenoscopes. Congressman Ted W. Lieu introduced the two
bills after the House Committee on Oversight and Government Reform concluded
that regulatory gaps contributed to the recent outbreaks.
As previously discussed on our
San Diego Injury Blog, the inability to thoroughly sterilize the specialty endoscopes was linked
to a drug-resistant “superbug” that claimed the lives of three
California patients earlier this year. All of the infected patients underwent
endoscopy procedures at UCLA’s Ronald Reagan Medical Center. An
internal investigation linked the outbreak of Carbapenem-resistant Enterobacteriaceae
(CRE) to a contaminated duodenoscope.
Rep. Lieu proposed two bills. The DEVICE Act (Disclosure; and Encouragement
of Verification, Innovation, Cleaning, and Efficiency) aims to increase
patient safety by requiring device manufacturers to notify the U.S. Food
and Drug Administration (FDA) whenever they change the design or cleaning
instructions of their devices. The bill also requires manufacturers to
notify the FDA whenever safety warnings are issued in foreign countries
related to the design and cleaning of devices. In addition, the proposed
measure requires the FDA to
further regulate tests of medical devices to determine whether bacteria are present.
The second bill, the Preventing Superbugs and Protecting Patients Act,
is a companion bill to legislation previously introduced in the Senate
that would establish requirements for reusable medical devices relating
to cleaning instructions and validation data. The bill would specifically
require device makers to submit proposed labeling, including instructions
for use, as part of a pre-market 510(k) submission to the FDA. In addition,
manufacturers would be required to submit validated data regarding cleaning,
disinfection, and sterilization.
In announcing the legislation,
Rep. Lieu stated:
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.
We are closely tracking the proposed bills and will provide updates as
they become available.
If you or someone you care about has suffered serious harm due to a dangerous
or defective medical scope, don’t hesitate to contact
a San Diego injury lawyer at the Law Offices of Robert Vaage for a free
consultation. Our legal team has successfully represented clients against
manufacturers and distributors of medical devices for more than 30 years.