In recent days, an antibiotic-resistant “superbug” known as CRE killed two people and infected five others at UCLA’s Ronald Reagan Medical Center; an estimated 179 more patients may have been exposed from October to January after undergoing a procedure called an endoscopic retrograde cholangiopancreatography.
Authorities suspect the deadly germs were transmitted by inadequately sterilized medical scopes used in the procedure, known as duodenoscopes, which are difficult to clean because of their complex design.
Medical device industry critics say poor design makes some tools impossible to clean. Researchers at the University of Michigan Health System cut this surgical suction in half, and found the device packed with debris.
But
an investigation we did in 2012, revealed that the problem of dirty
instruments is national in scope, and defies easy solutions. We detailed how
contaminated medical instruments have been showing up in hospitals and
outpatient surgery centers with alarming regularity. In 2009, the Department of
Veterans Affairs admitted that 10,737 veterans in Florida, Tennessee and
Georgia were given endoscopies or colonoscopies since 2002 with endoscopes that
may have been inadequately cleaned. Investigation of a 2008 hepatitis C outbreak
that sickened at least six people in Las Vegas revealed that an outpatient
surgery center was improperly cleaning endoscopes and reusing biopsy forceps
designed for a single use.
Medical instruments are often cleaned and disinfected between patients in units housed in hospital basements, which are stocked with high-tech machines including automated device washers. University of Michigan Health System
At
a little-noticed 2011 Food and Drug Administration workshop on the problem,
some critics put the blame on poor or overly-complex design of instruments.
Decades ago, medical instruments were almost exclusively made of steel and
glass, and many resembled the tools used by butchers or auto mechanics.
Cleaning those tools was easy, and sterilization required little more than a
heavy shot of steam.
The
growth of minimally invasive surgeries in the 1990s, however, brought flexible
endoscopes that are passed through tiny incisions to see inside patients.
Instruments became smaller, more specialized and complicated, with moving
parts, tiny holes and long, narrow, hard-to-clean channels running the length
of the implements.
At
the FDA workshop, experts pointed to the proliferation of complex instruments,
but also cited inadequate testing by manufacturers and the struggle faced by
poorly-paid hospital employees who clean and sterilize devices in between
procedures, often under pressure from nurses and surgeons who need the devices
quickly for the next procedure.
Researchers at the Unviersity of Michigan
Health System examined the insides of 350 surgery-ready suction tips, a tool
surgeons use to suction away blood and fluid. All of them contained blood,
bone, tissue. University of Michigan Health System
In
a letter sent this week, a California lawmaker is calling on Congress to
investigate what the FDA and device makers are doing to prevent more
infections, according to the Los Angeles Times. In his letter, U.S. Rep. Ted
Lieu told the House Committee on Oversight and Government Reform that disease
outbreaks linked to dirty instruments “have national security ramifications.” Lieu
told the Times that a recent FDA safety alert issued in response to the UCLA
problems provides no assurances that more outbreaks could be prevented.
“While federal agencies such as the Centers for Disease Control and Prevention are combating superbugs,” Lieu said, “the current recommended sterilization procedures would continue to result in superbug outbreaks and deaths.”
Read
full investigation “Filthy surgical instruments: The hidden threat in
America’s operation rooms.”
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