Microbiology, 2021

550 13 • Control of Microbial Growth
hospitals or health-care workers be held liable if they have strictly followed a flawed procedure? Should
manufacturers be held liable—and perhaps be driven out of business—if their lifesaving equipment fails or
is found defective? What is the government’s role in ensuring that use and maintenance of medical
equipment and protocols are fail-safe?
Protocols for cleaning or sterilizing medical equipment are often developed by government agencies like
the FDA, and other groups, like the AOAC, a nonprofit scientific organization that establishes many
protocols for standard use globally. These procedures and protocols are then adopted by medical device
and equipment manufacturers. Ultimately, the end-users (hospitals and their staff) are responsible for
following these procedures and can be held liable if a breach occurs and patients become ill from
improperly cleaned equipment.
Unfortunately, protocols are not infallible, and sometimes it takes negative outcomes to reveal their flaws.
In 2008, the FDA had approved a disinfection protocol for endoscopes, using glutaraldehyde (at a lower
concentration when mixed with phenol), o-phthalaldehyde, hydrogen peroxide, peracetic acid, and a mix of
hydrogen peroxide with peracetic acid. However, subsequent CRE outbreaks from endoscope use showed
that this protocol alone was inadequate.
As a result of CRE outbreaks, hospitals, manufacturers, and the FDA are investigating solutions. Many
hospitals are instituting more rigorous cleaning procedures than those mandated by the FDA.
Manufacturers are looking for ways to redesign duodenoscopes to minimize hard-to-reach crevices where
bacteria can escape disinfectants, and the FDA is updating its protocols. In February 2015, the FDA added
new recommendations for careful hand cleaning of the duodenoscope elevator mechanism (the location
where microbes are most likely to escape disinfection), and issued more careful documentation about
quality control of disinfection protocols (Figure 13.34).
There is no guarantee that new procedures, protocols, or equipment will completely eliminate the risk for
infection associated with endoscopes. Yet these devices are used successfully in 500,000–650,000
procedures annually in the United States, many of them lifesaving. At what point do the risks outweigh the
benefits of these devices, and who should be held responsible when negative outcomes occur?
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