The Center for Public Integrity published a report last year that exposed filthy surgical instruments as a serious threat to patients' health. The importance of the topic was illustrated with the story of John Harrison, a 63-year-old Texas man who underwent a routine rotator cuff surgery and ended up with a life-threatening infection, chronic pain, seven follow-up surgeries and limited range of motion. The two likely sources? An arthroscopic shaver and an inflow/outflow cannula, a tool used to irrigate and suction the surgical site, which was clogged with human tissue and bone.
Harrison was not alone. He was one of at least seven joint-surgery patients at the Methodist Hospital in Houston who came down with infections within a two-week period. That led the hospital and the Centers for Disease Control and Prevention to investigate the outbreak. They found the hospital was not cleaning the cannulas per the manufacturer's instructions, but instead, running tap water through them. Additionally, the arthroscopic shavers had been cleaned properly but were still dirty.
The story is representative of a widespread problem across hospitals in America. A VA hospital in Florida reported in 2009 that it may have exposed almost 11,000 veterans to infection from endoscopes that may not have been properly cleaned between 2002 and 2009. Additionally, a medical device researcher presented these findings at a 2011 Food and Drug Administration (FDA) summit: By running a tiny video camera through 350 surgery-ready suction tips, the team found that all contained blood, bone, tissue and rust. The team then sterilized them per the manufacturers' instructions and still found debris in nearly all of them.
Jahan Azizi, a risk management clinical engineer at the University of Michigan Health System, found that standard suction tips, even after following a manufacturer’s recommended cleaning and disinfection process, contain debris. Azizi claimed a design flaw in regular Yankauer suction tips caused debris to clog out of reach of cleaning brushes. In short, the poor design of some tools makes them impossible to clean. This is further illustrated in the photo below. When Azizi’s team cut open and viewed a suction tip as a cross-section, they found blood, bone, tissue or rust debris still left inside the surgical device.
Over the years, medical advances in minimally invasive surgeries required smaller, more specialized and complex surgical tools. As such, manufacturers turned to flexible materials such as tungsten, plastic, polymers and rubber to produce the intricate modern instruments to handle these new surgeries. Unfortunately, these new surgical tools are difficult to clean, as the tiny internal channels become clogged with debris, and the old method of steam sterilization can melt or destroy the device.
Other factors that plague hospital sterile processing departments or central sterile processing units include:
- Large volume of devices that need to be cleaned. If they are left to sit, the blood and tissue can dry and harden. Oftentimes, the sterilization process will further bake the debris into the device
- Manufacturers testing sterilization techniques in labs under perfect conditions, versus hospitals
- Sterile processing technicians feel pressure to clean devices quickly for the next operation. - Often, the SPD staff faces high turnover rates, poor compensation and no formal certification or licensing
Clearly, changes need to be made to prevent surgical site infection and increase liability for hospitals and manufacturers down the road. Infections are of huge concern among sterile processing teams right now, especially due to the new crop of superbugs. As a result, healthcare facilities are turning more often to disposable surgical tools, such like SurgiMark's Via-Guard suction tips, to protect patients from infection. SurgiMark designed its vascular suction tip in response to the need for a disposable suction device that can be used in minimally invasive surgeries that require detailed suction and adjustable intensity.