The U.S. Food and Drug Administration (FDA) recently ordered the three
leading manufacturers of duodenoscopes to complete post-market surveillance
studies regarding how the devices are cleaned. The agency is seeking to
determine how well new reprocessing instructions are working in the “real
world” and whether additional measures are needed to lower the risk
“These studies will provide critical information about the effectiveness
of current reprocessing instructions and practices that may provide additional
information to inform the FDA’s actions to protect the public health
and help reduce the risk of infections,” the
FDA said in a statement.
Duodenoscopes must undergo a multi-step cleaning and disinfection procedure
called reprocessing so the medical devices can be reused between patients.
If the complex procedure is not performed properly, the medical devices
can transmit infections, including those that are resistant to antibiotics.
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. In total, nearly 180 patients were
The FDA previously issued warning letters to the three manufacturers. The
letters highlight a range of violations committed by the medical device
makers, including the failure to report infections tied to the scopes.
In its most recent order, the FDA directed the manufacturers to determine:
- Are user materials, such as user manuals, brochures and quick reference
guides included in the manufacturers’ duodenoscope labeling and
instructions for use, sufficient to ensure user adherence to the manufacturers’
- After use of the manufacturer’s validated reprocessing instructions,
what percentage of clinically used duodenoscopes remain contaminated with
- For devices that remain contaminated after use of the manufacturers’
labeled reprocessing instructions, what factors contribute to microbial
contamination and what steps are necessary to adequately decontaminate
The manufacturers must submit plans for the studies to the FDA within 30 days.
If you or someone you care about has suffered serious harm due to a contaminated
or otherwise defective medical device, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation.