Here There and Everywhere

Shortly after his initial surgery in 2009, the 63-year-old began experiencing severe pain and discomfort around the site of his scar, which had turned bright red and was oozing thick fluid. Doctors reopened him up to determine the problem — and found that an infection had eaten away part of the bone and set loose the screws and sutures they had placed just weeks earlier.

A Hidden Danger in the OR

Harrison’s case, unfortunately, was not an isolated one. Within days, at least six other joint surgery patients at Methodist developed similarly serious infections, leading to a temporary shutdown of the hospital’s operating rooms while officials from the U.S. Centers for Disease Control and Prevention (CDC) probed for a cause.

They found what they were looking for, and then some, in two commonly used surgical tools: an arthroscopic shaver and an inflow/outflow cannula. Both contained human tissue and bone, despite having been thoroughly cleaned after every procedure — a discovery that suggested the problem might be bigger than just one hospital in Texas.

In fact, according to a new report by investigative journalist Joe Eaton of the Center for Public Integrity, a nonprofit that focuses on ethics and accountability, dirty medical devices are a widespread and potentially deadly threat to your health. In 2008, Eaton notes, a hepatitis C outbreak in Las Vegas revealed that a local outpatient surgery center was working with contaminated tools, some of which were intended for only single use anyway. This, in turn, led to an inspection of 1,500 other such centers — and the finding that 28 percent of them had “infection control deficiencies related to equipment cleaning and sterilization.”

But that’s not even the worst of it. In 2009, the Department of Veterans Affairs admitted that improperly cleaned endoscopes had been used on more than 10,000 vets, some of whom later tested positive for HIV or hepatitis. It’s difficult to know for sure how many of those infections (if any) resulted from the dirty instruments, but experts say the risk is higher than most people realize.

“The cases we hear about,” CDC medical officer Melissa Schaefer, MD, told Eaton, “are only the tip of the iceberg.”

Whose Fault Is It, Anyway?

It would be easy to blame hospitals for this potentially deadly danger (and in some cases, we should), but Eaton says the problem is more complicated than it looks.

For one thing, research shows that sterilization instructions from manufacturers are often not up to industry standards. In a study presented last summer at a workshop for the Food and Drug Administration (FDA), scientists at the University of Michigan Health System ran a tiny video camera inside 350 “surgery-ready” suction tips and found that every one contained traces of blood, bone, tissue, and rust. Even more disturbing, however, was the fact that all but seven still contained debris after the team put the tools through the recommended cleaning and disinfection processes.

“I don’t know who approved this or who made this a reusable item, but this is not a reusable or cleanable item,” said lead researcher Jahan Azizi, a risk management clinical engineer at the University of Michigan, referring to one of the suction tips. Azizi blames the proliferation of dirty instruments on poor product design and manufacturing — but experts say there are many other factors to consider as well.

Among them, Eaton reports, is that as tools become more specialized and intricate, so too do their cleaning needs. There are added parts to sterilize, smaller channels to unclog, different materials to wield — you can’t just blast everything with a heavy shot of hot steam and move on.

“Cleaning was once a basic factory job,” said Joe Lewelling, vice-president of standards development at the Association for the Advancement of Medical Instrumentation. “Now it’s very complex. It takes a lot of steps. It’s more like a laboratory process.”

That process needs to be regulated, industry vets say — but by whom?

The Need for Action

According to Eaton, most sterilization of surgical instruments takes place in hospital basements, where underpaid employees work in less-than-ideal conditions to keep equipment in rotation, sometimes cleaning as many as 40,000 tools a day. Technicians are under a vast amount of pressure to do their jobs both quickly and well, which leads to high staff turnover and a frenetic atmosphere that lends itself to mistakes.

Mary Olivera, director of sterilization at a New York City medical facility and past president of the New York State Association of Central Service Professionals, thinks these issues could be addressed if central sterile techs were required to be certified to work in medical facilities. (Currently, only New Jersey mandates professional certification in the field.)

“The people who do your nails, they have to take an infection control course before they can apply for a license,” Olivera told Eaton. “Same with a dog groomer. Yet the people who deal with lifesaving equipment, they are required to have zero education.”

Olivera is among a group of people who have been pushing for legislation to regulate sterilization workers, but as she and her colleagues are finding out, change is easier said than done.

In July of 2009, after the CDC’s Methodist investigation, the FDA launched a safety review of arthroscopic shavers. Findings from the review have not been made public, but insiders say the results are “scary” and show serious potential for patient harm. Years later, however, the agency still has not taken any additional action to address the problem, save an alert on its Web site encouraging facilities to assess the effectiveness of their cleaning procedures.

“These are important products that have been used for decades with little evidence of risk to public health as a result of reprocessing,” FDA spokeswoman Karen Riley said by way of explanation. “In 2010, there were 2.1 million arthroscopic procedures of the knee performed and yet total adverse events from all causes was one percent. This does not merit withdrawal of a valuable device.”

John Harrison might disagree. Nearly three years after going under the knife for a “routine” operation, he can’t even raise his right arm to scratch an itch on his head. And the damage isn’t just physical.