What is the government’s role in ensuring that use and maintenance of medical equipment and protocols are fail-safe?

Who Is Responsible?
Carbapenem-resistant Enterobacteriaceae infections due to contaminated endoscopes have become a high-profile problem in recent years. Several CRE outbreaks have been traced to endoscopes, including a case at Ronald Reagan UCLA Medical Center in early 2015 in which 179 patients may have been exposed to a contaminated endoscope. Seven of the patients developed infections, and two later died. Several lawsuits have been filed against Olympus, the manufacturer of the endoscopes. Some claim that Olympus did not obtain FDA approval for design changes that may have led to contamination, and others claim that the manufacturer knowingly withheld information from hospitals concerning defects in the endoscopes.
Lawsuits like these raise difficult-to-answer questions about liability. Invasive procedures are inherently risky, but negative outcomes can be minimized by strict adherence to established protocols. Who is responsible, however, when negative outcomes occur due to flawed protocols or faulty equipment? Can 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?