Hidden danger: dirty medical tools
For more than a decade, doctors at Detroit Medical Center lodged complaints about surgical instruments. Some were dirty or broken, they said. Others were missing altogether. Now both the CMS and the state of Michigan are investigating the claims, which were aired in a newspaper account late last month.
No matter what investigators find at DMC, unclean surgical instruments and other medical devices are nothing new. The reasons include the difficulty of cleaning some tools, the training and labor conditions of employees tasked with cleaning them and a lack of data and transparency that obscures links between infections and dirty medical instruments.
Jahan Azizi, a retired clinical engineer for risk management at the University of Michigan who is an expert on cleaning medical instruments, said few studies have evaluated the scope of the problem. “If you do not know something exists, you cannot fix it,” Azizi said.
The alleged lapses at DMC, a division of Dallas-based Tenet Healthcare Corp., surfaced only after the Detroit News obtained and reviewed 200 pages of emails and documents. After the story broke, CEO Joseph Mullany wrote in an internal memo that the organization was not aware of any surgical-site infections related to its central sterile-processing services.
Dr. Kenneth Kizer, a professor at the University of California at Davis School of Medicine and former CEO of the National Quality Forum, said it can be hard to pin down the source of an infection acquired during an invasive procedure. And because the role of contaminated instruments is “underappreciated,” he said, they’re not the first
The FDA’s most recent guidance urges manufacturers to make devices easy to clean and disinfect.
place people look.
The task of ensuring medical devices are properly reprocessed (cleaned, disinfected and sterilized for further use) is divided among a wide array of parties. Infection control professionals, government agencies, industry groups and professional societies have established various guidelines. Manufacturers are responsible for following those guidelines when they develop cleaning instructions, Deborah Kotz, a Food and Drug Administration spokeswoman, said in an email.
By federal regulation, reusable medical devices must have labeling that includes those instructions, all of which the FDA examines as part of its regulatory review for those devices, Kotz said. For some devices, the FDA also evaluates the manufacturer’s validation of those instructions.
The FDA’s most recent guidance urges manufacturers to make devices easy to clean and disinfect. It also recommends that reprocessing take into account human factors, such as “actions requiring substantial dexterity or strength, good visual acuity, or familiarity with uncommon practices.” Reprocessing instructions, it says, should be “understandable” and “written in simple language to the greatest extent possible.”
In spite of the regulations and standards, medical devices are increasingly “impossible to clean,” said Azizi, the retired clinical engineer. Devices used for minimally invasive surgery are incredibly complex, and ease of cleaning is not a priority when they’re being designed, he added.
The consequences can be devastating. Duodenoscopes transmitted a deadly antibiotic-resistant bacteria to more than 300 patients between 2010 and 2015 at 41 hospitals, according to the FDA. The design of these flexible tubes, which go down the throat, through the stomach and into the small intestines, allow the device to retain the bacteria after standard cleaning.
Such challenges also raise questions about the employees who do the cleaning.
Reprocessing “would appear to require, or might benefit from, additional training and a level of detail that wasn’t required before, just because the technology has changed so much,” Kizer said.
Central service technicians, who decontaminate, clean, process, sterilize, store and assemble medical devices, are key players in reprocessing. According to the Bureau of Labor Statistics, the nation’s roughly 50,000 medical equipment preparers on average earned about $35,000 in 2015.
“I would question whether the wages and the training standards of these workers have kept up with the technology that they’re being asked to ensure the safety of,” Kizer said.