The Link Between Deep Organ Surgical Site Infections (SSIs), Bio-Burden, Waterborne Pathogens and Laparoscopic Instruments
“The Centers for Disease Control and Prevention (CDC) reports that hospital acquired infections (HAI’s) cause 99,000-plus patients to die of the total 2 million patients per year that contract these infections. This mortality figure is more than the combined total number of deaths attributed to AIDS, breast cancer and motor vehicle accidents” (Thomas L. Kovach, Infection Control Today, June 2005). Surgical infections account for approximately one-third of all HAI’s. A large percentage of all surgical procedures done in the U.S. are done laparoscopically. Any and all steps taken to reduce the risk of a surgical infection caused by a laparoscopic instrument contaminated by bio-burden and/or waterborne pathogens will have an immediate impact on reducing the risk of an HAI and improve patient outcomes.
The first rule every clinician and reprocessing employee is taught when it comes to sterile reprocessing is “If it’s not clean, it can’t be sterile.” The following articles identify the link between deep organ surgical infections (SSIs), residual bio-burden, waterborne pathogens and reusable laparoscopic instruments. More importantly, these articles document how to reduce the risk of a deep organ SSI caused by instruments that are difficult, if not impossible to clean.
In the April 2001 AORN Journal, Romona Conner states, “Decontamination is the first and most important step in the sterilization process. Inadequate cleaning of organic debris may result in retained organisms and make the sterilization process ineffective.”
In the June 2002 issue of Infection Control Today, Kelly M. Pyrek states, “Inadequate cleaning has the potential to allow for residual bioburden to be sequestered in bodily fluids that may be contaminated with gram-negative bacteria. You can sterilize it but you may fail to destroy microbial endotoxins that are heat-stable. So cleaning is an absolutely crucial step before any terminal disinfection or sterilization process.”
So how “absolutely crucial” is it to remove all residual bio-burden and microorganisms from inside the lumen of a laparoscopic instrument before the sterilization process? In the Center for Disease Control’s (CDC) report “Guideline for the Prevention of Surgical Site Infection, 1999”, on page 253, the authors state, “Microbial contamination of the surgical site is a necessary precursor of SSI. Microorganisms may contain or produce toxins and other substances that increase their ability to invade a host, produce damage within the host, or survive on or in host tissue. One of the most common causes of multiple system organ failure in modern surgical care is intra-abdominal infection.”
The CDC report goes on to document the fact that, “Among surgical patients, SSI’s were the most common nosocomial infection, accounting for 38% of all such infections. Of these SSI’s, two thirds were confined to the incision, and one third involved organs or spaces accessed during the operation. When surgical patients with nosocomial SSI died, 77% of the deaths were reported to be related to the infection, and the majority (93%) were serious infections involving organs or spaces accessed during the operation.”
During a laparoscopic procedure, nothing comes in contact with the “organs or spaces accessed during the operation” more frequently than reusable laparoscopic instruments. In her article, Infection Control Challenges With Laparoscopic Instruments, Ann Hewitt, RN, BSN, MM, states, “Reusable laparoscopic instruments that are not (or cannot be) properly cleaned and sterilized are a major cause of deep organ SSIs. The CDC notes ‘Inadequate sterilization of surgical instruments has resulted in SSI outbreaks’ and cites articles in Anesthesiology, MMWR and Journal of Hospital Infections in asserting this claim.” (Infection Control Today, November 2002).
Hewitt goes on to point out in the article “Due to the design of internal lumens and channels in many laparoscopic instruments, it is impossible to access the entire surface area that needs cleaning. Squared off corners, dead spaces and rough edges all provide nooks and crannies for the deposit of tissue, blood, mucous or other bio-burden. Devices that you know are damaged, corroded, bent or constructed with inaccessible surfaces (i.e., no flush ports) that come into contact with patient tissue should not be used on patients.”
In her article “Care of Endoscopic Instrumentation” (Infection Control Today, February 2001) Eileen Young states, “The initial and most important step of reprocessing is thorough cleaning to remove gross soil, including microorganisms (bio-burden), which allows the disinfectant or sterilizing agents to work effectively. Organic materials may inactivate these agents or present a barrier that prevents disinfectants from reaching all surfaces of an instrument.”
Natalie Lind, CRCST, CCSMC, ACE, pointed out in her article “Reprocessing Specialty Instruments” (Infection Control Today, June 2000) that, “Improperly processed instruments pose a significant threat to patient outcomes. Failure to process instruments correctly can lead to nosocomial infections. Ideally, reprocessing considerations should be addressed before an instrument is selected and purchased. Part of the overall purchase decision should be the instrument’s cleaning and sterilization validation.”
When it comes to “an instrument’s cleaning and sterilization validation”, Linda Clement, a consultant in sterile processing for STERIS Corporation warns, “Be sure the vendor understands you are asking for more than just cleaning instructions. You must have the independent laboratory verification that those instructions actually work for cleaning the instrument.” (Infection Control Today, November 2002).
Dennis Maki, MD, head of the Infectious Diseases Department at the University of Wisconsin Medical School, emphasizes, “When sales representatives make claims about how well their product works, ask to see their documentation – clinicals, independent laboratory testing, etc. If the manufacturer can’t document its claims, why would you use that product with your patients?”(Infection Control Challenges With Laparoscopic Instruments, Hewitt).
The pressure on healthcare organizations to reduce their patients’ risk of an SSI has never been greater. The Joint Commission on the Accreditation of Healthcare Organizations’ (JCAHO) revised their standards beginning in January 2005 to help reduce the more than two million hospital acquired infections (HAI’s) that occur annually in the United States. As part of that effort, during their audits, JCAHO is asking healthcare organizations to document measures and actions that they are taking to reduce their patients’ risk of contracting an SSI.
In the CDC’s Guideline for Prevention of Surgical Site Infection, the authors state, “An SSI prevention measure can be defined as an action or set of actions intentionally taken to reduce the risk of an SSI. Many such techniques are directed at reducing opportunities for microbial contamination of the patient’s tissues or sterile surgical instruments.”
The first action that can be taken immediately by a healthcare organization to reduce the risk of a deep organ SSI caused by a contaminated laparoscopic instrument is to stop using any laparoscopic instrument that does not have a flush port. The second action that can be taken immediately was suggested by Ann Hewitt in her article, “If the facility has instruments where no documentation can be provided (presumably because it was never done), the facility should give serious consideration to replacing those instruments. The ICP can support the OR and CS departments by exploring the moral and financial liability issues associated with using instruments where clean ability can not be documented.”
Another action that can be taken by a healthcare organization is to switch exclusively to single-use, disposable laparoscopic instruments for every procedure. While expensive, the use of disposable laparoscopic instruments will ensure a clean, sterile, moisture free instrument for every patient and it will significantly reduce the risk of a deep organ SSI caused by a contaminated instrument that is difficult, if not impossible to clean.
As an alternative to the expense of disposable instruments, a healthcare organization can switch to reusable laparoscopic instruments that have been independently documented to remove bio-burden from inside the lumen, ensure 100% bacteria kill during the sterilization cycle, and be 100% free of residual moisture after emerging from the sterilizer (so as to eliminate the risk of waterborne pathogens colonizing inside of the lumen of the instrument).
What is the risk of an SSI being caused by waterborne pathogens colonizing in the moisture that remains trapped inside the lumen of a laparoscopic instrument after the sterilization cycle? “The most common misconception in healthcare settings is that waterborne pathogens are not major contributors to HAI’s,” says Joseph S. Cervia, MD, professor of Clinical Medicine and Pediatrics at the Albert Einstein College of Medicine in New York (Infection Control Today, June, 2005). Dr. Cervia goes on to point out, “modes of transmission for waterborne infections may include contact from an improperly reprocessed medical device.”
Removing moisture (and the risk of contamination caused by waterborne pathogens) from the internal lumen of the Clean Port(TM) laparoscopic instrument is easily achieved with the patented “Venturi” technology inside of every lumen. On every run of Nelson Laboratories’ “Sterilization Validation” testing, there was no moisture remaining in the lumen of any of the Clean Port laparoscopic instruments. By eliminating the moisture on every reprocessing cycle, Clean Port instruments eliminate the risk of an SSI caused by waterborne pathogens that can colonize in the residual moisture that remains inside of conventional laparoscopic instruments (including instruments that have to be disassembled during reprocessing that are re-assembled before the sterilization cycle).
Another action that can be taken immediately to reduce the risk of an SSI caused by a contaminated laparoscopic instrument is to reduce the practice of flash sterilization. All to frequently, instruments that are flash sterilized have not been properly cleaned and decontaminated (If it’s not clean, it can’t be sterile). In the CDC’s report they point out, “However, flash sterilization is not intended to be used for either reasons of convenience or as an alternative to purchasing additional instrument sets or to save time. Inadequate sterilization of surgical instruments has resulted in SSI outbreaks.”
Kelly M. Pyrek states in her article “Nooks and Crannies: The Breeding Grounds for Bacteria” (Infection Control Today, June 2002) that “One strong argument to be made for streamlined instruments and devices is the time required for decontaminating and cleaning them. With the nursing shortage, hospital staffs are stressed and stretched, and we need to simplify cleaning tasks.” The internal lumen of the patented Clean Port line of laparoscopic instruments is “streamlined” to “simplify the cleaning task” and remove infectious bio-burden with a simple flush (as documented by Nelson Laboratories). More importantly, with their one-piece construction, Clean Port instruments are easier and faster to clean and decontaminate as compared to time consuming, complex, labor intensive instruments that have to be disassembled during reprocessing that can trap waterborne pathogens after the sterilization cycle.
How can residual bio-burden trapped inside the lumen of a conventional lapaparoscopic instrument cause a deep organ SSI? Residual bio-burden accumulates on the operating rod and inside the throat of the lumen. During a surgical case, as the surgeon opens and closes the jaws (causing the operating rod to rub against the throat of the lumen), some of the residual bio-burden can break loose from the operating rod and/or lumen and be deposited in the patient’s deep organ cavity. As this dead, “sterile” bio-burden begins to decompose in the patient’s deep-organ cavity, it can release endotoxins, which can in turn stimulate cytokine production.
The CDC’s report on surgical infections states, “Many gram-negative bacteria produce endotoxins, which stimulates cytokine production. In turn, cytokines can trigger the systemic inflammatory response syndrome that sometimes leads to multiple system organ failure. One of the most common causes of multiple system organ failure in modern surgical care is intra-abdominal infection.”
When it comes to deep organ SSI’s, having dead, “sterile” bio-burden deposited from a laparoscopic instrument into a patient’s deep-organ cavity during a surgical case creates the potential risk of a deep organ SSI. What is an even greater risk is when the accumulated bio-burden and/or waterborne pathogens inside the lumen of the laparoscopic instrument survives the sterilization cycle and instantaneously begins to colonize inside the patient’s deep-organ cavity. According to CDC data, “When surgical patients with nosocomial SSI died, 77 percent of the deaths were reported to be related to the infection and the majority (93 percent) were serious infections involving organs and spaces accessed during the operation.”