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Surgical Instrument Sterilization Crisis: Instruments That Can’t Be Autoclaved

Technologically advanced medical instruments save countless lives each year, helping millions of patients avoid the risks that come with open surgery. But the same advanced mechanisms that make these instruments so versatile and effective can also make advanced surgical instrument sterilization devilishly hard.

According to a recent New York Times article, over the last several years duodenoscopes (used to diagnose and treat diseases of the pancreas, bile duct, and gallbladder) have sickened hundreds of patients—often infecting them with “superbug” bacteria that cannot be treated with even the most powerful classes of antibiotics. Such superbug infections have extremely high mortality rates. For example, in just a single U.S. city over a single two-year period, more than 30 patients were infected with antibiotic-resistant strains of bacteria carried on duodenoscopes (even though the scopes had been cleaned and inspected according to manufacturer recommendations and existing FDA guidelines). Roughly a third of those patients died from their infections. And these weren’t even particularly deadly antibiotic-resistant bacteria: Other common strains have mortality rates as high as 50 percent.

The Scope of the Surgical Instrument Sterilization Crisis is Still Unknown

More than half a million Americans undergo duodenoscope procedures each year. Owing to the delicate and complex construction of these devices, they cannot be exposed to steam heat (“the gold standard for cleaning and sterilization”). In fact, steam heat can microscopically damage the instruments in such a way that it increases the likelihood of viable pathogens surviving cleaning attempts. And this isn’t limited to one single device; it’s an issue with all types of endoscopes, and the bulk of other technologically advanced surgical instruments.

As an alternative to steam-heat, the manufacturers specify alternate surgical instrument sterilization procedures. These hand-cleaning methods include hundreds of individual steps and inspections. Nonetheless, recent tests found that one in 20 duodenoscopes cleaned according to manufacturer-recommended non-steam surgical instrument sterilization protocols retained potentially deadly microbes. This was 10 times worse than manufacturers and the FDA had anticipated.

Four years ago the FDA asked manufacturers to attempt to comprehensively assess the risk of cross-contamination posed by their endoscopes. As of this summer, most manufacturers had only completed about half of this assessment. Some weren’t more than 15 percent complete.