Recent media reports have focused on a drug-resistant "superbug"
that has infected and killed patients exposed to contaminated endoscopes
in California. According to Bloomberg, the same type of
medical devices - and the same superbug - contaminated 70 patients and killed 15 patients
in Florida six years ago.
According to the Florida Department of Health, patients at two hospitals
in Highlands County were exposed to the superbug, called CRE, after procedures
using devices called duodenoscopes in 2008 and 2009,
Bloomberg reports. Although officials say the cases were reported to federal regulators,
the U.S. Food and Drug Administration (FDA) has no record of the report.
The FDA was notified of two cases of CRE linked to unclean duodenoscopes
at a Tampa hospital in 2012, according to agency spokesperson Leslie Wooldridge.
A 2013 paper published in the
American Journal of Infection Control also reported cases of CRE in contaminated endoscopes in Tampa, Bloomberg states.
FDA Warns About Medical Device Contamination
In February, the FDA issued a
safety communication saying that the complex design of the endoscopes can make them difficult
to clean - even when following the manufacturer's specifications.
For example, some parts of the devices may have small crevices that cleaning
tools cannot adequately reach. This means that bodily fluids or other
organic materials from prior procedures may be transmitted to the next
patient who has an operation with that same device.
In March, the agency went on to issue
new regulations for the sterilization of reusable medical devices, including testing protocols
for manufacturers and six criteria that should be addressed in the cleaning
instructions for users.
Additionally, companies in the process of designing reusable devices must
provide proof that they can be cleaned effectively before receiving FDA
approval, according to the new rules.
Duodenoscopes are used in roughly 500,000 procedures per year in the U.S.
to treat potentially life-threatening conditions in the pancreas and bile
ducts. Between January 2013 and December 2014, the FDA received reports
of 135 patients who may have been infected from the scopes.
However, the risk of contamination of duodenoscopes has been known in the
medical community and by the FDA for years. Although the agency did issue
warnings about potential negative outcomes, it did not pull them from
the market because the agency believed the life-saving benefits outweighed
the risk of infection, which an official says is low.
In May, the FDA is
convening a panel to discuss the transmission of infections via duodenoscopes in the U.S.
and to develop recommendations to reduce infection risk and improve sterilization
Superbug Lawsuits Are Underway
As reports of CRE deaths linked to duodenoscopes come to light, so do legal
claims. A Washington woman has filed a wrongful death claim against a
hospital and medical device manufacturer after her husband contracted
the superbug from an allegedly contaminated scope, according to news reports.
In California, two claimants are suing Olympus Corp., one maker of duodenoscopes,
for failing to update the cleaning instructions for its scopes after a
If you or someone you love had a procedure involving a duodenoscope or
other reusable medical device, and you suspect the product was defective
or used negligently,
contact The Maher Law Firm. Our attorneys are experienced in handling both
medical malpractice and
product liability cases.