Feb. 22, 2012 at 7:28 AM ET
By Stacey Naggiar and Kerri Zimmer
When John Harrison checked into a Texas hospital in 2009 for rotator cuff surgery, he thought that after a six-week recovery period, he’d be as good as new. But two weeks after the operation, the 63 year-old was experiencing severe discomfort and swelling in his shoulder and knew something was terribly wrong.
During an emergency visit to the hospital, doctors told him that he had been infected during surgery with a deadly bacteria called P. aeruginosa. And Harrison wasn’t the only one -- six other patients who had undergone surgery at the same hospital had contracted potentially lethal infections as well.
The hospital, along with the Centers for Disease Control and Prevention, launched an investigation and closed operating rooms for two weeks. Surgery was cancelled while they searched for clues and they found some, in something called an arthroscopic shaver. Somehow potentially deadly bacteria had survived the sterilization process and infected Harrison’s shoulder.
And the problem isn’t isolated. Other investigations in hospitals across the country have revealed the use of other dirty surgical instruments, such as endoscopes used for colonoscopies, have led to infection outbreaks.
Investigative reporter Joe Eaton of the Center for Public Integrity, a Washington, D.C., nonprofit that focuses on ethics and public service, tackled the issue head on. As a result of the CPI investigation, NBC News Chief Medical Editor Dr. Nancy Snyderman took a closer look at the wide range of instruments used during surgical procedures and the care with which they are handled. Who is in charge of cleaning the instruments? How are they sterilized? And how is the process regulated?
What NBC found suggests that the handling of the increasingly high-tech instruments can be a weak link in hospitals’ patient safety net.
Trust in the System
Every time surgeons enter the operating room, they and a team of skilled technicians, follow a very specific protocol. They check everything from electrical outlets to oxygen tanks, and double check the basics too, like confirming patient identity. Still, mistakes are made and infections occur -- sometimes because of factors out of the surgeon’s control.
The team in the operating room consists of trained specialists who undergo years of schooling for their respective professions. They have degrees. They are licensed. But the technicians responsible for sterilizing the tools used in procedures are actually not technicians at all.
In the Basement
The departments responsible for cleaning and reassembling surgical instruments -- usually known as “sterile processing” -- are frequently found in hospital basements and sometimes staffed by underpaid hourly laborers. These workers can be a forgotten and neglected part of the team involved in a surgical procedure. As the CPI report indicates, the sterilization workers say they feel more like they’re doing an unrecognized service, with pressure from nurses and surgical staff to make the process as fast as possible. The faster the instruments make it into the operating rooms, the more patients are moving through the surgical suites. But what may seem like a push for efficiency can backfire, with disastrous consequences.
New Jersey is the only state that requires hospital sterilization workers to undergo training.
Sharon Greene-Golden, head of “sterile processing” at Bon Secours Mary Immaculate Hospital in Virginia, points out that this is a job that must be done by skilled and certified technicians. She thinks of her team as the unseen patient advocates and says, “It is a job that cannot be given to robots because the robot doesn’t have the critical thinking to say this is still dirty.” At Bon Secours, Greene-Golden has made her sterile processing department state of the art, a model for what should be happening across the country.
New research finds that too often, surgical tools are leaving the basements still contaminated with hidden blood, tissue and other debris from previous surgeries. Risk management clinical engineer Jahan Azizi at the University of Michigan ran a video camera through 350 suction instruments and found that all of them contained some kind of debris after they had been sterilized according to protocol. His results were presented to the Food and Drug Administration at meetings this past year.
According to a statement the FDA gave NBC News, “Hospitals are reminded to carefully clean and sterilize reusable medical devices. A patient’s risk of acquiring an infection from a reprocessed medical device is very low.” But requirements for reprocessing medical devices largely consist of such reminders. Although the FDA requires device manufacturers to provide cleaning instructions they don’t require hospitals to report dirty surgical instruments that find their way into operating rooms. And, only 25 states are required to report surgical site infections.
The CPI’s Eaton says that part of the problem is the increasing numbers of minimally invasive surgeries has spurred development of smaller, more complex instruments made from materials like tungsten, plastic and other polymers – not just steel and glass. Experts have pointed out that these new tools are harder to clean and require more detailed instructions from the manufacturers. The FDA requires surgical instrument manufacturers to provide cleaning instructions for each tool. But with rapid advances in surgical procedures over the past few decades some say these cleaning instructions have failed to keep up with the changing landscape of the industry.
“Theoretically, if a device is truly impossible to clean, it should never end up on the marketplace,” said Eaton.
Moreover, the testing of these reprocessing procedures are conducted in laboratories, not in the real world. This helps explain Azizi’s results in which 100 percent of suction tools he looked at were contaminated.
In a statement to NBC, the Advanced Medical Technology Association (AdvaMed) responded that proper reprocessing of reusable medical devices is a shared responsibility between the FDA, device manufacturers, health care facilities and physicians.
“The medical technology industry is committed to providing patients with safe and effective medical devices and diagnostics," according to the AdvaMed statement. "Reprocessing of reusable medical devices is done in accordance with strict FDA requirements to ensure their safe and effective use. FDA requires manufacturers to provide health care facilities and physicians detailed instructions for the cleaning and sterilization of reusable medical devices. And manufacturers are required to validate that these instructions will result in clean, sterile devices."
Some experts say the system is flawed and what’s needed is tighter regulation from the government, manufacturers and hospitals -- as well as better communication. In the meantime, patients like Harrison are left with debilitating and lifelong repercussions. What was supposed to be a surgery that would improve his life has led to seven other surgeries. He now lives in constant pain, without the full use of his arm. Harrison says, “It’s changed my life …every aspect of it.”