By Ann Hewitt
The tragic deaths in late 2001 of two patients who developed fatal pneumonia after being examined with a contaminated bronchoscope underscore once again the critical importance of proper cleaning and terminal processing of instruments. Infection control practitioners have been emphasizing the importance of thorough cleaning of instruments and devices almost as long as they've been telling us to wash our hands. Unfortunately, the need to put both those ideas into practice remains as pressing as ever.
A July 2002 investigation by The Chicago Tribune notes, "(Hospital acquired infections) kill more people each year than car accidents, fires and drowning combined."1 These infections are a significant factor in both morbidity and mortality in the hospital, and surgical site infections (SSIs) are an important component of all nosocomial infections. After reviewing data the Centers for Disease Control and Prevention (CDC) collects in its National Nosocomial Infections Surveillance system (NNIS), the CDC stated, "SSIs are the third most frequently reported nosocomial infection."2
Surgical site infections are particularly troublesome because "...one third involved organs and spaces accessed during the operation. 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."3
According to data from the NNIS system, the distribution of pathogens isolated from SSIs has remained stubbornly consistent. This fact is especially disturbing in light of the CDC's observation that, "Advances in infection control practices include improved operating room ventilation, sterilization methods, and barriers, surgical techniques, and availability of antimicrobial prophylaxis. Despite these activities, SSIs remain a substantial cause of morbidity and mortality among hospitalized patients."4
Reusable laparoscopic instruments that are not (or cannot be) properly cleaned and sterilized are a major cause of these deep-organ SSIs. The CDC notes in its Guideline for Prevention of SSI that, "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.5
There are more causes of SSIs than just contaminated instruments, of course. Patients bring with them characteristics that make them more susceptible to development of a surgical infection; there is nothing the diligent practitioner can do to change the fact that a patient is elderly or diabetic, or has a history of steroid use or has abused tobacco. Routine practices in the hospital, such as the once-ubiquitous shaving of the surgical area or an antiseptic preoperative shower site on the night before the operation, can contribute to or reduce the incidence of SSI.
CAUSES AND COSTS OF SSI
Nonetheless, instrument processing is a significant risk factor that is under the control of the hospital, and it is one which has the potential for a significant impact on the prevention of surgical site infections.
Ramona Conner noted in the April 2001 AORN Journal, "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."6
She continued, "If an improperly cleaned instrument is placed on the sterile field, the sterile field should be considered contaminated, and appropriate steps to correct the problem should be taken. The unsterile instrument and other instruments that may have come in contact with it should be removed from the sterile field. Proper decontamination and removal of all possible biomaterial is the most important step in the sterilization process. High bioburden inhibits the sterilization process, and sterility cannot be guaranteed. The old principal of 'when in doubt, throw it out' should be applied."7
The financial imperative is also compelling: the cost to a facility of caring for a patient who has become more ill due to the facility's negligence was estimated in 1999 to be more than $3,000. The cost of a deep-organ infection is obviously higher. In addition to the direct costs attributable to SSIs, 41 percent of patients who suffered them were readmitted to the hospital within 30 days of discharge, vs. only 7 percent of patients without an SSI. "When the second hospitalization was included, the total excess hospitalization and direct costs attributable to SSI were 12 days and $5,038, respectively."8 That amount is exclusive of any monetary damages that might be recovered if the patient (or his surviving family) brings suit. It has been estimated that if a hospital with an annual surgical volume of 10,000 procedures were able to reduce its incidence of SSIs by 50 percent, it would save approximately $450,000 per year.9
ISSUES CONTRIBUTING TO IMPROPER CLEANING
It's a fact of life that many operating rooms, gastroenterology labs and sterile processing departments are understaffed and underequipped. Even when the absolute number of FTEs appears to be appropriate, there may be a deficiency in knowledge or experience that creates obstacles to getting instruments processed for reuse in a timely way. Laparoscopic instruments present a particular challenge because their long, narrow shafts are especially difficult, if not impossible, to clean, even when the staff is knowledgeable and not crunched for time. Stephanie Cook, RN, the transplant team surgical coordinator at Vanderbilt University Medical Center, emphasizes, "The surgical team needs to take ownership of the instruments in their care -- making sure to clean them of gross soil as soon as they come off the surgical field."
Even when the instrument processing system is well designed and well run, hazards present themselves. Linda Clement, a consultant in sterile processing for STERIS Corporation, says, "One of the most frustrating and challenging issues confronting sterile processing staff is the continuing struggle to clean and sterilize complicated medical devices, especially laparoscopic instruments. Although medical device manufacturers have made much progress in bringing new and improved medical devices to market, the focus has been function during surgical procedures; other considerations are often neglected in the product development and design phase. The simple fact of the matter is that if a device is difficult to clean or sterilize, sterile processing technicians are routinely placed in the position to do what they can and hope for the best. Unfortunately, this type of processing leap-of-faith can adversely affect patient care."
In any facility, the challenges include:
It is an article of faith that proper handling of instruments after surgery can contribute to the successful cleaning and sterilization of these instruments. A brief summary of the proper steps would include these points:
"Removing gross soil from narrow channels and lumens is difficult."10 Indeed, devices with lumens present a special challenge due to their inherent structure. Because laparoscopic forceps, graspers and dissectors have complex jaw assemblies and long, narrow shafts, they have a demonstrated propensity for trapping infectious bioburden and debris.
The positive pressure of the CO2 in the insufflated abdomen may cause blood or other contaminated fluid to flow up into these areas.11 If you use modular instruments, taking them apart to clean must be done carefully and cleaning must be meticulous. One-piece instruments must be designed to be easily flushed to remove all bioburden.
TRAINING IS CRITICAL
Patients and the hospital community are ill-served if the people handling the instruments have not been properly trained. Surgical instruments are expensive, complex and delicate. Managing the process from end of surgery to "patient ready" involves more than just telling a new employee where the enzymatic cleaner is kept, or how to load the instruments in the sterilizer.
There are several ways for a healthcare worker (HCW) to become proficient in reprocessing of instruments, including laparoscopic devices. One highly regarded avenue is via the Purdue University Central Service Technical Training Correspondence Course. In this course, a student will cover disciplines related to healthcare (anatomy, microbiology), instrument care (instrumentation, infection control, packaging and sterilization) and department processes (inventory and equipment management, warehousing, distribution, and even human relationship management).
The International Association of Healthcare Central Service Materiel Management (IAHCSMM) works closely with Purdue in the development of this course and administers the certification process following completion. Additionally, IAHCSMM offers an alternative path to certification. IAHCSMM's alternative is appealing to the experienced instrument reprocessing professional who has learned on the job. It is based on hours of documented experience in activities such as case cart management; packaging technique, instrument set and tray assembly; instrument cleaning, decontamination and sterilization; linen management; and proper decontamination attire.
As implied above, the most common ways the HCW learns about instrument handling and reprocessing is the old-fashioned way: on-the-job training. A documented protocol for teaching, combined with a knowledgeable and accessible on-site trainer, is certainly an acceptable way to learn the mechanics of decontaminating, cleaning, sterilizing and managing inventory.
To achieve success with this method, there needs to be a process in place, a qualified instructor, a collegial and supportive atmosphere and an adequate level of interest and ability on the part of the HCW. Financial pressures on the sterile processing department and the operating room, as well as underfunding of the infection control department, may preclude the success of on the job training as a methodology. Too often, administration may not recognize that a certain level of skill and experience is necessary to handle these complex instruments; that dedicated staff is most likely to do the most professional job possible; and that paying for these qualities is an investment, rather than a cost. If the people processing instruments are not equipped to deal with the challenges, they should not be entrusted with this important job.
INSTRUMENT DESIGN MAKES A DIFFERENCE
Regardless of the level of skill and commitment exhibited by the HCW reprocessing the device, however, there exists the potential for patient calamity. 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, rough edges and even scratches resulting from too-vigorous brushing all provide nooks and crannies for the deposit of tissue, blood, mucus or other bio-burden.
David J. Weber, MD, an epidemiologist at the University of North Carolina, has noted that instrument design complicates the cleaning process, due to configurations that include narrow lumens, mated surfaces, sharp angles, occluded dead-ends, absorbent materials and rough or pitted surfaces.12
How best to address this challenge? A good place to start is to consider the instruments your facility currently owns. Devices that you know are damaged, corroded, bent or constructed with inaccessible surfaces which come into contact with patient tissue should not be used on patients. Next, review your policies and procedures and measure them against two things: 1) the guidelines set forth by the Association of periOperative Registered Nurses (AORN), Association for Professionals in Infection Control and Epidemiology (APIC) and CDC on reprocessing of instruments; and 2) the processes that are actually occurring in your facility. If your policies are not up to standard, you should update them using the guidelines as a model. If your policies are up-to-snuff but your staff is not consistently following them, you need to assess the reason(s). Has staff been adequately trained? Do they have the proper tools to meet the policies? Are they held accountable for their work? Develop a plan of action to address the specific deficiency, such as retraining on problem areas, acquiring the correct cleaning equipment, incorporating accountability into performance reviews, etc.
With instruments that have passed your initial assessment for viability, evaluate the ease with which they can be cleaned. Modular instruments that must be disassembled may contribute to deviations from your cleaning policies because they are delicate and difficult to reassemble properly. Spend some time with the people who are charged with the actual cleaning and determine whether they have problems with two key components of preparing instruments for sterilizing: creating friction against surfaces and flushing fluid through channels to dislodge debris. In manual cleaning, the friction would come from brushing, which would remove organic matter from the surfaces accessed by the brush. If a machine such as an ultrasonic cleaner or a washer-disinfector is used, the "friction" results from a physical process such as ultrasonic waves or agitation from steam. In manual and mechanical cleaning, the intent is to remove as much bioburden as possible from the instrument surfaces.
Despite any concern about the potential for scratches that can result from aggressive brush use, the practitioner should keep in mind that static contact of the cleaning solution to the instrument is much less effective, particularly in the long, narrow lumens found in laparoscopic instruments. Mechanical action is imperative in order to prepare the instrument for sterilization. Buying instruments made of high-grade stainless steel will eliminate the problem of scratches.
Where does this leave the practitioner who wants to support the best cleaning and sterilizing practices?
The ICP should request data from all manufacturers of laparoscopic and endoscopic equipment in the facility (both flexible and rigid) verifying cleanability -- i.e., documentation that an independent laboratory has performed the testing that proves the device can actually be cleaned of bioburden, preparing it for sterilization. Dennis Maki, MD, head of the infectious diseases department at the University of Wisconsin Medical School, emphasizes, "When sales representatives makes 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?" 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 SP departments by exploring the moral and financial liability issues associated with using instruments where cleanability can not be documented.
Of course, when the time comes to buy new instruments, the same recommendation applies. No endoscopic device that presents a risk of nosocomial infection should be brought into the facility. Demand to see documentation that the manufacturer has used an independent laboratory to validate that the device can be cleaned. (Remember, if it isn't clean, it can't be sterilized.) Linda Clement warns, "Be sure the vendor understands you are asking for more than just cleaning instructions. You must have the independent verification that those instructions actually work for cleaning the instrument."
At the same time, you need confirmation that the instruments you're evaluating are durable, reliable, easy to work with and will give you a good return on your investment. Talk with other facilities to learn their experiences concerning durability and OR satisfaction with the instruments you are considering. Find out what the SP department has to say about the ease of disassembly and reassembly (or if they have switched to one-piece design wherever they can), their overall impression of ease of handling, whether instruments stand up to the rigors of cleaning. Instruments that could cause deep-organ SSIs are no bargain, and neither are instruments you have to replace frequently.
Internally, demand accountability. It is critical that staff members who have some responsibility for cleaning instruments are knowledgeable, capable and have the time to dedicate to reprocessing properly. The ICP should work with OR and CS management as a team to develop a plan to create improvement as needed. There are numerous articles on the subject of process improvement -- the facility may even have a quality improvement team that would be able to advise. Additionally, there are outside consultants whose work focuses exclusively on improving instrument management and processes.
There is a difference between "doing things right" and "doing the right thing." If your facility's instruments have design flaws, the healthcare team may follow all proper handling and reprocessing procedures; that is, they may be "doing things right" and still be using contaminated instruments. Doing the right thing means your team will take every available step to prevent the infection of a vulnerable patient, including eliminating undocumented, non-cleanable instruments. The potential to reduce surgical site infections lies within your power. Make sure you've done all you can to avoid a tragic outcome related to an unclean device in your facility.
Ann Hewitt is with Caduceus Consulting of Winnetka, Il.