As San Diego product liability lawyers, we are cautiously optimistic about
a new duodenoscope that features a disposable cap. The new design is intended
to improve access for cleaning and reduce the potential for device contamination.
Superbug Infections Tied to Tainted Scopes
As we have previously discussed on this San Diego Injury Blog, contaminated
duodenoscopes have been linked to at least 25 different outbreaks of antibiotic-resistant
infections and sickened at least 250 patients worldwide. In California,
three patients died. An internal investigation linked the outbreak of
Carbapenem-resistant Enterobacteriaceae (CRE) to a contaminated duodenoscope.
In total, nearly 180 patients were potentially exposed.
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.
In its investigation into the contaminated duodenoscopes, the U.S. Food
and Drug Administration (FDA) issued warning letters to the three leading
scope manufacturers. The letters highlight a range of
violations committed by the medical product manufacturers, including the failure to report infections tied to the scopes. The agency
also ordered the duodenoscope makers to complete post-market surveillance
studies regarding how the devices are cleaned.
FDA Claims Scope Design Will Improve Patient Safety
The FDA recently announced a new scope that is designed to be easier to
clean. The Pentax ED34-i10T model duodenoscope features a cap that can
be changed between patients.
Earlier this year, the FDA issued a
Safety Communication alerting health care providers about a design issue with an earlier version
of the Pentax duodenoscope, the ED-3490TK. It highlighted the potential
for cracks and gaps to develop in the adhesive that seals the duodenoscope’s
distal cap onto the scope, which could allow fluids and tissue to leak
into the scope.
“We believe the new disposable distal cap represents a major step
toward lowering the risk of future infections associated with these devices,”
Dr. William Maisel, the acting director of the FDA’s Office of Device
said in a statement. “We encourage companies to continue to pursue innovations that
will help reduce the risk to patients.”
Of course, it is unclear how much the new scope will reduce the infection
risk to patients. While the tip of the device may be easier to sanitize,
harmful bacteria can also be found in other parts of the scope. In addition,
the majority of scopes used by hospitals still feature the design linked
to the outbreak of antibiotic-resistant infections.
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.