The U.S. Food and Drug Administration (FDA) recently issued a warning about
a new class of medical devices that is prone to contamination and may
pose risks to patients. According to the FDA, it is currently investigating
infections linked to flexible bronchoscopes.
As we have
previously discussed on this blog, the inability to thoroughly sterilize specialty endoscopes known as duodenoscopes
was linked to a drug-resistant “superbug” that claimed the
lives of three California patients in 2013. While the FDA stated that
the risk of infection from bronchoscopes “appears to be lower”
than the risk posed by duodenoscopes, at least 14 patients have been infected
with the same deadly bacteria.
Approximately 500,000 bronchoscopy procedures are performed in the United
States each year. The reusable scope is a thin, lighted tube that is threaded
through the nose or the mouth to allow a physician to examine a patient’s
throat, larynx, trachea, and lower airways. After each procedure, the
scope must be reprocessed, a multi-step process that is supposed to clean
and sanitize the device.
As part of its ongoing, comprehensive investigation into infections associated
with reprocessed reusable medical devices, the FDA is examining 109 reports
received from January 2010 to June 2015 concerning infections or device
contamination related to bronchoscopes. In some cases, the FDA found “persistent
device contamination despite following the manufacturer's reprocessing
instructions.” However, in other situations, it found that hospitals
failed to meticulously follow manufacturer instructions for reprocessing
and/or continued to use the devices despite integrity, maintenance and
To lower the risk of a serious infection, the
FDA warned healthcare providers to strictly adhere to the manufacturer’s reprocessing instructions
and specifically not to skip steps. The agency also reminded facilities
to immediately stop using any bronchoscope that fails a leak test or shows
visible signs of damage, such as loose parts, damaged channel walls, kinks
or bends in tubing, or holes.
The FDA also advises that patients undergoing bronchoscopy procedures should
ask their doctors what to expect following the procedure and when to seek
medical attention. The FDA alert states that symptoms such as fever, pain,
nausea and vomiting may be a sign of a more serious problem.
If you or someone you love has suffered serious harm due to a contaminated
or otherwise defective medical device, don’t hesitate to contact
a San Diego product liability attorney at the Law Offices of Robert Vaage
for a free consultation.