February 23rd 2012
It seemed simple enough at the time. In 2009, John Harrison, a 63-year-old oil industry sales manager in Mission, Texas, had surgery to repair the rotator cuff in his right shoulder, a routine procedure that usually requires at most a single night’s stay in the hospital, followed by physical therapy. For Harrison, however, there was nothing routine about the ordeal that ensued. In the weeks following the surgery, his scar turned bright red, hot to the touch, and oozed thick fluid that looked “like butter squeezed from a bag.” Alarmed, Harrison’s wife Laura called The Methodist Hospital in Houston, where the surgery was performed. The doctor urged Harrison to immediately make the seven-hour drive back to Houston for an emergency checkup. That night, surgeons opened up Harrison’s shoulder and found that infection had eaten away part of his shoulder bone and rotator cuff. Screws and metal hardware surgeons placed in his shoulder had pulled loose. Sutures had come undone. Surgeons cleaned out Harrison’s shoulder, installed two drains and gave him antibiotics to battle the infection.
When Harrison awoke from that surgery, he imagined his nightmare was over. But in reality, it had just begun. Since then, what began as a simple operation has turned into a lengthy struggle that left him for months at a time dependent on hired nurses, unable to dress himself, take a shower, or work, and afraid for his life. “I’m a pretty tough guy, being in the oil patch,” said Harrison, a soft-spoken man who tends to understate the severity of his ordeal. But the pain “felt like someone hit your shoulder with a baseball bat with a razor blade attached to it.”
Harrison at first blamed himself, thinking he had not taken proper care of his surgical wound. The truth was much worse: Harrison was one of at least seven joint surgery patients at Methodist who acquired dangerous infections during a two-week period. The outbreak led Methodist to close operating rooms and cancel knee and shoulder surgeries while hospital and Centers for Disease Control and Prevention (CDC) investigators searched for the cause. They found two likely sources in unlikely, yet terrifying, spots—deep inside a hand-held power tool called an arthroscopic shaver, which surgeons use to shave away bone and tissue during surgery, and inside a long narrow metal tube called an inflow/outflow cannula, which is used to irrigate and suction the surgical site. During the Methodist investigation, the hospital inspected surgical tools with a tiny video camera to make sure places impossible to see with the naked eye were clean. They were not. Inside the cannulas and arthroscopic shavers, the video camera made startling finds. Human tissue and bone were stuck in both devices. The camera also discovered a bristle from a cleaning brush in an arthroscopic shaver. Further investigation revealed that Methodist had not cleaned the cannulas with brushes, as manufacturer instructions require. Instead, the hospital ran tap water through the instruments.
The case of the dirty arthroscopic shavers, however, was even more frightening. According to accounts by Methodist staff and a government infection control researcher, the hospital followed the cleaning instructions provided by Stryker, the Kalamazoo, Mich. manufacturer of the shavers used on all the infected patients. The instruments had been properly cleaned, but they were still dirty. That set off alarms that would travel through the larger medical community. Dr. Pritish Tosh, a former investigator at the Centers for Disease Control and Prevention Epidemic Intelligence Service, blames the Methodist infections on those dirty devices. “Evidence from the investigation suggests the Methodist infection outbreak was most likely caused by retained tissue…,” Tosh wrote in a paper published in 2011 in the journal Infection Control and Hospital Epidemiology. The bacteria that caused the infections were “likely introduced into the case patients’ joint spaces” by dirty instruments or fluid that passed through them.
Investigators say hospital-acquired infections are notoriously difficult to track to their sources, but Tosh’s account is likely the only explanation Harrison is going to get for why he endured seven follow-up surgeries, but still cannot raise his arm when he wakes up in the morning. “I’m angry,” said Harrison. “This is 2.5 years. I should be at the time of my life where I need to enjoy it a little bit.” In 2011, Harrison filed a lawsuit against Stryker and Methodist. Early this year, Harrison settled with Methodist for an undisclosed amount. His case against Stryker has been moved to federal court. Harrison’s attorney, Carl Shaw, declined to comment on the lawsuit. Stryker also declined to comment, but paperwork the company filed in court denies Harrison’s claims, arguing among several defenses that the firm’s arthroscopic shavers “conformed with the prevailing standard and customs of the state-of-the-art of the industry.”
A Larger Problem
Was the Methodist case a fluke? Hardly. Filthy, dangerous medical implements have been showing up in hospitals and outpatient surgery centers with alarming regularity. In 2009, the Department of Veterans Affairs admitted that 10,737 veterans in Florida, Tennessee and Georgia were given endoscopies or colonoscopies between 2002 and 2009 with endoscopes that may have been improperly cleaned. Some of those patients later tested positive for HIV, hepatitis C, or hepatitis B. Several lawsuits filed against the VA by veterans are currently working their way through the courts, and attorneys expect many others to follow. Investigation of a 2008 hepatitis C outbreak that sickened at least six people in Las Vegas revealed that an outpatient surgery center was improperly cleaning endoscopes and reusing biopsy forceps designed for a single use. Following that outbreak, a Centers for Medicare and Medicaid Services (CMS) pilot program inspected 1500 outpatient surgery centers and cited 28 percent for infection control deficiencies related to equipment cleaning and sterilization.
Last summer, the Food and Drug Administration (FDA), which regulates medical devices, held a little-noticed workshop to address concerns regarding dirty devices. Over two days, manufacturers, hospital representatives, and officials from the CDC and FDA described the challenges of thoroughly cleaning complex but reusable medical devices between procedures. Jahan Azizi, a risk management clinical engineer at the University of Michigan Health System, presented the most ominous data and conclusions to the crowd of around 200 government and industry insiders. “This is unfortunately after lunch, and I apologize for that if you have a weak stomach,” Azizi said, as he described how his team ran a tiny surgical video camera inside 350 surgery-ready suction tips (a common tool surgeons use to suction blood and fluids). All of the suctions tips, Azizi said, contained blood, bone, tissue, even rust.
But what Azizi found next was even more troubling. After discovering the debris, Azizi’s team ran the 350 suction tips through the manufacturer’s recommended cleaning and disinfection processes and reexamined them. All but seven of the suction tips still contained debris. The problem, Azizi claimed, was a design flaw that caused debris to clog out of reach of cleaning brushes. “I don’t know who approved this or who made this a reusable item, but this is not a reusable or cleanable item,” Azizi said about a particular suction tip, adding that when he cut the tip open, “a handful of stuff came out.” Azizi said he chose suction tips because they are included in almost every tray of instruments surgeons use, but that the lesson is far reaching. “There are a lot of them that are difficult or impossible to clean,” Azizi said.
A critic of the device manufacturing industry, Azizi blames poor manufacturer design for the difficulty of cleaning devices, but experts say bad design is but one of a litany of reasons why dirty instruments are being used on patients. At the FDA workshop, experts pointed to several other reasons, including the proliferation of highly complex surgical instruments, inadequate device testing by manufacturers, and the struggle faced by poorly-paid hospital employees who clean and sterilize devices between procedures, often under pressure from nurses and surgeons who need the devices quickly for the next operation.
It is difficult to know exactly how often dirty instruments are to blame for the infections that plague hospitals, since bacteria can hide anywhere, from a doctor’s unwashed hands to a nurse’s dirty scrubs. But experts say it happens far more often than generally understood. “The cases we hear about,” said Dr. Melissa Schaefer, a CDC medical officer, “are only the tip of the iceberg.”
From Hand Scalpels to Robots, High-Tech Creates New Cleaning Challenges
Decades ago, medical instruments were almost exclusively made of steel and glass, and many looked like the tools used by a butcher or an auto mechanic. Cleaning these tools was simple, and sterilization required little more than a heavy shot of steam. The tremendous growth of minimally invasive surgeries in the 1990s, however, brought flexible endoscopes that are passed through tiny incisions to see inside patients. Instruments became smaller, more specialized and complex, with moving parts, tiny holes, and long narrow channels running the length of the implements. Manufacturers turned to materials like tungsten, plastic, and other polymers. Progress continues. As surgeons begin to rely on robotics, devices are becoming even more elaborate.
Intricate modern instruments revolutionized surgery, but they have proven difficult to clean. Those tiny internal channels become clogged with unseen tissue and blood. Steam sterilization melts and destroys some modern devices. Instruments made of materials like rubber may not heat all the way through, as many metals do, creating sterilization challenges. “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.”
Theoretically, if a device is truly impossible to clean, it should never end up on hospital shelves. The FDA, as part of its medical device clearance process, requires device manufacturers to verify that their cleaning instructions are effective. Few in the industry, however, believe the regulation works. Instead of testing their tools in the real world of hospitals, industry veterans say, manufacturers usually hire independent labs to evaluate their cleaning instructions under perfect conditions. “If the lab can do the test, the lab has done their job for the manufacturer,” Trabue Bryans, a vice president and general manager of the lab company WuXi App Tec, said at an October meeting of the Association for the Advancement of Medical Instrumentation at the FDA. “We have all the time in the world.” Stryker, the manufacturer of the arthroscopic shavers used in the Methodist infection cases, declined to say whether it tested its reprocessing instructions in hospitals.
In hospitals, the struggle to clean and sterilize surgical implements usually takes place in the basement, in hot, humid, “central sterile processing” units where employees, some making as little as $8.50 an-hour, work in fast-paced conditions to keep equipment in rotation. Technicians are responsible for cleaning and sterilizing a vast range of instruments, from the tiniest forceps to intricate modern power tools. At the largest hospitals, as many as 40,000 devices pass through every day. Charles Hancock, an independent medical device sterilization consultant in New York who has worked in the industry since the 1960s, said some central sterile departments are clean and efficient, while others are dirty and overcrowded with a “dungeon mentality.” Most, he said, are somewhere in the middle.
While instruments are often cleaned and sent back to surgery rapidly—perhaps too rapidly—Hancock said they also sometimes sit around for hours, or days, before they are cleaned, which allows blood and tissue to dry and harden. If a device is improperly cleaned prior to sterilization, the process can bake the blood and tissue on the instrument. With devices in rotation for years, or even decades, Hancock said the number of dirty devices currently in hospital supplies is likely massive. But even in the best of conditions, many surgical tools are tough to clean. “Sometimes we have to beat the instrument on the table to loosen up the bone,” said Sharon Greene-Golden, a central sterile processing manager at Bon Secours Mary Immaculate Hospital in Newport News, Va., and president-elect of the International Association of Healthcare Central Service Materiel Management (IAHCSMM), which advocates for the central sterile industry.“Labor and delivery sends trays that look like they have been to a massacre,” Greene-Golden said. “You get instruments that are covered in blood and amniotic fluid. They stink. Everything is terrible about them.”
Dressed in gowns, face shields, and rubber gloves, workers treat every instrument “as if the case had Ebola,” Greene-Golden said. But hospitals across the country have a limited number of tools and frequently pressure central sterile processing units to clean them as fast as possible in order to keep patients moving through profitable surgery suites. Since techs are the low man on the totem pole, it’s hard to push back against nurses and surgical staff. Worst of all, central sterile techs say doctors and nurses rarely acknowledge their role in successful surgeries. Except when an important person or a doctor’s family member is on the table, that is. “They call and say, ‘Dr. Jones’s wife is having surgery,’” Green-Golden said. “You didn’t call when I was having surgery. You didn’t call when my momma was having surgery.”
The fast pace, low prestige, and low pay leads to high staff turnover, sometimes for fast food or retail jobs. For those who stay, there is resentment. Candace Alston, 36, worked as a central sterile processing technician for ten years, at two different Virginia hospitals. While many others rotated through the basement, working a month or two before finding other jobs, Alston stayed. The gore got to her at first, Alston said, but she soon got used to it. “I enjoyed the work. I enjoyed the job,” she said. Alston finally quit her job in August to study business administration online. The problem was compensation, Alston said, which had increased to $12 an hour, up from $8.50 when she started a decade earlier. “It’s demanding. You have people’s lives in your hands,” she said. “We have a lot of responsibility but not the pay.”
Robert Tremblay, a 27-year-old tech at a Boston hospital, said the job is frantic, especially in decontamination, the first step of device reprocessing, which he likens to “cleaning the dishes before you put them in the dishwasher.” But cleaning medical instruments is much more complex and tedious, Tremblay said, requiring special brushes to remove blood, bone and tissue from the nooks, crevices and channels. Skip one step, and the device is dirty. Does it happen? “All the time,” Tremblay said. As Tremblay worked at the decontamination sink a few months ago, he cut his finger with a dirty dental pick, and had to be tested for HIV. Most central sterile workers have a similar story. Still Tremblay, who has a biology degree and is working toward a nursing degree, said jobs in the field are plentiful and it’s “better than working at Dunkin’ Donuts.”
If these secrets of central sterile processing are unknown to patients, they are equally mysterious to the doctors who use the equipment. Speaking at the FDA summit last summer, Dr. Daniel Schwartz, a chief medical officer at CMS, said that when he was in private urology practice, he assumed the tools he used were safe. Later, at CMS, Schwartz said he learned about “bio-burden, soil, design issues, and instruments that made it difficult to impossible to clean” and began to worry. “And my guess is most physicians would feel the same way if they heard some of the things that we're talking about today,” he said.
Central sterile techs play a key role in making sure clean devices make it to surgery suites, yet only New Jersey requires techs to be certified, despite a recent push by IAHCSMM and state organizations. “The people who do your nails, they have to take an infection control course before they can apply for a license,” said Mary Olivera, the director of sterilization at a New York City medical facility and past president of the New York State Association of Central Service Professionals. “Same with a dog groomer. Yet the people who deal with lifesaving equipment, they are required to have zero education.”
Earlier this month, New York State Assemblyman Harry Bronson (D-Rochester) and Sen. Mark Grisanti (R-Buffalo) introduced bills that would require professional certification for central sterile workers. Since 2007, Olivera and others have unsuccessfully pushed bills in the New York state legislature that would mandate licensure or certification. Jo Colacci, government affairs director at IAHCSMM, said hospital employee unions opposed previous bills proposing mandates.
FDA 'Safety Review' Reveals Problems, then Vanishes
The fact that arthroscopic shavers retain tissue between patients is no surprise to Danny Tipei, the owner of Inex Surgical, a large surgical repair company outside Chicago that repairs broken arthroscopic shavers for hospitals and surgical centers. Tipei said it’s common for his technicians to take apart a shaver and find it clogged with flesh or bone. “It looks like dried fruit, like skin from an apple that you leave for four or five days outside,” Tipei said. “It will be all dried out and twisted. We have tiny forceps that we use to remove it.”
At The Methodist Hospital, however, the infection outbreak and dirty shavers set off government alarms. Maureen Disbot, vice president of quality at Methodist, said the hospital brought in Stryker representatives and showed them how the device was retaining tissue, even after it was cleaned according to instructions. “We actually invited the manufacturer here when we started uncovering our findings, to make sure our interpretations are correct,” Disbot said. After consulting with Stryker, Disbot said the hospital was confident that it followed the manufacturer’s cleaning instructions. The problem, she said, was not the hospital’s cleaning method. Stryker declined to comment on Disbot’s account, but documents it filed in Harrison’s case say any damages resulted from acts or omissions by third parties.
After discovering the dirty instruments, Methodist informed the FDA, which in July of 2009 launched a safety review of arthroscopic shavers. But more than 2.5 years later, the FDA has done little to solve the problem, despite review findings that experts alternatively call “gross” and “scary.” According to FDA spokeswoman Karen Riley, the agency, as part of the safety review, asked arthroscopic shaver manufacturers to study how well their shavers were being cleaned at health care institutions. The FDA declined to make public what the manufacturers found, claiming the information is proprietary. But according to industry insider accounts, the findings showed serious potential for patient harm.
Nigel Wilkinson, senior vice president of regulatory affairs and quality at Massachusetts-based manufacturer Smith & Nephew, which manufactures shavers, presented his company’s findings at the FDA workshop this summer. Wilkinson said Smith & Nephew inspected 72 shavers at eight hospitals and surgery centers, and that all but three of the devices contained “residuals” after cleaning by hospital staff. Wilkinson said none of the technicians at the medical facilities followed the company’s 11-step instructions, which order imprecise tasks including “scrub interfaces several times using a twisting action if possible.” In a telephone interview, Wilkinson said the investigation showed that many technicians are not properly trained and do not have adequate access to manufacturer instructions. The company did not, however, investigate whether or not tissue remained even after technicians perfectly followed the company’s instructions. Asked if he thought the company’s shavers currently on the market are clean, he paused. “I would hope so,” he said. “But we’ve got thousands in the marketplace. I could not say what is going on with all of them.”
Azizi, at the University of Michigan Health System, said in addition to surgical suction tips, his team also inspected 15 arthroscopic shavers. He found biological material and other debris in all of them. Stryker declined to release the results of the arthroscopic shaver study it performed at the request of the FDA, but Rodney Parker, senior manager of clinical sciences at the firm, said the company’s results were similar to Smith and Nephew’s. Despite the Methodist case, Parker said he isn’t worried about the device being a major cause of infections, since it has been on the market for decades. Asked about the dirty devices manufacturers found during the FDA safety review, he said he didn’t know who is to blame. “Is it the cleaning that did it or is it the design that did it? I don’t know,” Parker said. “Can we do a better job at education? Yeah.”
Stryker spokeswoman Tamara Cutler declined to comment further on the issues of cleanliness with the company’s arthroscopic shavers, but forwarded this email message: “As a global medical device company, we work with many regulatory agencies, including the FDA, to ensure our products and practices meet all quality and safety standards.”
In October 2009, five months after the infection outbreak at Methodist, Stryker issued clarified cleaning instructions for their arthroscopic shavers. The process included ten steps, the final one recommending cleaning staff use a digital scope to visually inspect the insides of the handpiece. “If visible soil remains, repeat steps 1–9, focusing on areas that have soil remaining.”
Since the infections, Disbot said Methodist technicians inspect the interior of every shaver with a tiny video camera to make sure it is clean before it is used. “We regret that our patients had this experience,” Disbot said, “but we have done everything and we have now fixed the problem. That’s what we stand on.” But Disbot admits it’s questionable whether or not the lessons learned at a large academic hospital have trickled down to smaller hospitals. “I can’t say that a rural hospital in Michigan knows about Methodist’s work,” she said.
Despite the Methodist infections and the alarming FDA safety review findings, the agency has ordered no system-wide mandatory check of arthroscopic shavers. No products have been recalled. The FDA posted an alert on its website encouraging facilities that use the shavers to evaluate the adequacy of their cleaning procedures, and file a voluntary report to the agency if they find shavers retaining tissue between users. The agency said it has received no further reports of shavers retaining tissue. Manufacturers, including Stryker, also sent warnings to their customers. Asked why the agency has not done more in the face of evidence on dirty devices, Riley at the FDA said “these are important products that have been used for decades with little evidence of risk to public health as a result of reprocessing.” Further, Riley wrote that “in 2010, there were 2.1 million arthroscopic procedures of the knee performed and yet total adverse events from all causes was 1 percent. This does not merit withdrawal of a valuable device.”
Charles Hancock, the New York private sterilization consultant, claimed Riley’s numbers are meaningless. It’s well-known in the industry, Hancock said, that hospitals frown on staff reporting all but the most obvious and severe adverse events because it draws scrutiny. “No one disputes that,” Hancock. “Those numbers are irrelevant.” The true number, he said, is likely much higher. Workers in sterile processing units are also agree that dirty devices are a widespread problem. Asked if dirty devices are regularly making their way into surgical suites at some hospitals, Lesa Jackson, a supervisor of sterile processing at St. Luke’s Episcopal Hospital in Houston, said she has no doubt. “Oh yes,” she said. “Yes. Yes.”
Riley at the FDA said the safety review of arthroscopic shavers has been folded into a larger effort to ensure that all medical devices are correctly reprocessed. So far, that effort has resulted in draft agency guidance released last summer suggesting manufactureres develop more robust reprocessing instructions appropriate for the real world hospital environment. The draft also suggests changes to pre-market device testing criteria. The draft guidance, if and when it becomes final (a FDA spokeswoman said it is unclear when the final rules will be released) will serve as a guide for device manufacturers as they seek FDA clearance for new devices. But the guidance, which the draft points out “does not establish legally enforceable responsibilities,” would have little or no effect on the thousands of devices already being used by surgeons, including the arthroscopic shaver used on John Harrison.
More than 2.5 years after his initial surgery, Harrison’s shoulder looks like it has been hit by shrapnel. He can’t scratch his head. He can’t cast a fishing lure. He may face additional surgeries to bring his range of motion back to what it was before he first went under the knife, a prospect he finds terrifying. Most of all, he regrets putting his wife, Laura, through the struggle. Harrison said he was delirious on that journey back to the hospital after his initial surgery. Laura drove and talked to him to keep him awake. He was “out of it” for much of the next year, and his caregiving fell to her. And it was Laura who first learned from doctors about just how much danger Harrison was in. Soon after his second surgery, Harrison wanted to leave the hospital and go home, and did not understand why he couldn’t. That’s when Laura told him what he was facing. “She says, ‘John, we’re not trying to make you better. We’re trying to save your life,’” Harrison recalls. “I took my IV with me, went into the bathroom, and had a good cry.”