Designed to Kill?

Over the past few decades laparoscopic surgery has taken on an ever-evolving role in the vast realm of surgical procedures. Laparoscopic surgery is praised for its ability to reduce the effects of surgical trauma, lower morbidity and mortality, and achieve faster recovery times. However, healthcare workers must take into consideration the risks that may occur.

The number and breadth of laparoscopic procedures has increased steadily since the late 1980s. In 1999, it was estimated that each year more than 2 million patients underwent laparoscopic procedures in the U.S. Those numbers have continually climbed. For example, according to a Food and Drug Administration (FDA) report, estimates of the number of trocars used in the U.S. have seen a steady increase from more than 3 million in 1994 to nearly 4.8 million in 2000; and the numbers were projected to rise to 6.2 million in 2004.¹ According to Gaylyne Marshall, RN, CNOR, clinical education specialist for STERIS Corp., the three common problems that patients experience from laparoscopic procedures are infection, pain, and bowel perforation.

According to an Institute for Healthcare Improvement (IHI) article, data suggests that surgical site infections (SSIs) occur in 2 percent to 5 percent of all surgeries and that rates climb as high as 20 percent an estimated 780,000 operations.² The Centers for Disease Control and Prevention (CDC)s Guideline for Prevention of Surgical Site Infection, 1999, reports that based on National Nosocomial Infectious Surveillance (NNIS) system reports, one-third of the SSIs reported involved organs or spaces accessed during the operation 93 percent of which were fatal.

The NNIS data cited in the CDC study clearly documents the life-threatening risk of a deep organ SSI, asserts Jim Schneiter, a medical device designer. Accordingly, any and all steps taken by healthcare facilities to reduce the risk of deep organ SSIs caused by a conventional laparoscopic instrument will have a significant impact on the 100,000 Lives Campaign, he offers.

Schneiter, who has spent 32 years in the healthcare industry the last 20 of which designing implantable medical devices to reduce complications and improve patient outcomes has been an advocate for investigating laparoscopicrelated SSIs for six years. He suggests the internal design of reusable laparoscopic instruments plays a significant role to the occurrence of these deep organ infections.

Over the entire time we have been doing laparoscopic procedures, the rate of deep organ surgical infections has remained constant in this country, he asserts. Over the last 10 years, hospitals have spent billions to reduce the rate of surgical infections and yet, the rate has not decreased. Even more frustrating is the fact that it is the same pathogens that are causing these infections, and this is after weve quadrupled the number of surgical patients who receive antibiotics prophylactically.

Most hospitals over the last five or six years have moved to the use of disposable trocars for their lap procedures. We have controlled all of the environmental elements outside of the patients abdominal cavity. Despite all of these activities, deep organ surgical infections remain a major cause of morbidity and mortality among surgical laparoscopic patients.

Schneiter continues, Given everything that has been tried in the operating room (OR) environment, it is now time to focus on the one device that goes from one patients deep organ cavity to another patients deep organ cavity the reusable laparoscopic instrument. When you consider the fact that most ORs use disposable trocars, it becomes impossible to ignore the role that reusable laparoscopic instruments play in causing deep organ surgical infections.

What other device can be the conduit for the transmission of pathogens into the deep organ cavity during a laparoscopic procedure?

One German study investigated whether reprocessed single-use devices (SUDs) used in laparoscopic surgery pose an increased infectious risk to patients.³ Cleanability testing was conducted on contaminated devices, and residual bioburden testing was carried out to establish the efficacy of disinfection and sterilization.

During the first stage of the study, all devices remained contaminated after cleaning, but were effectively disinfected. The researchers also noted that sterilization could not eliminate the microorganisms completely. X-ray photoelectron spectroscopy (XPS) was used to quantify contamination elements on the materials tested and found contamination on both the outside and inside of all devices. Of the tested SUDs, 40 percent remained unsterile following resterilization.

Instruments are used in a pressurized area during laparoscopic procedures. This pressurization can drive debris and liquid contaminates up into the instruments internal lumen,4 making cleaning problematic and allowing microorganisms to survive the sterilization process. They have many components, notes Marshall. Manual cleaning could be compromised and reassembly could be incorrect or incomplete, and this could lead to compromised disinfection or sterilization processes. If they are not properly cleaned and processed, bioburden can accumulate in the cracks and crevices.

Schneiter began his studies of laparoscopic instruments after his friend went in for a laparoscopic procedure and ended up spending two months in the hospital due to a deep organ surgical infection. I started getting lap instruments from hospitals and I would literally grind off the side walls of these instruments so that I could visualize what was inside of them, he says. I was surprised at the number of lap instruments that had been reprocessed yet contained a significant amount of bioburden trapped inside of the lumen and on the operating rod. It became clear to me that the design of the internal lumen of these instruments prevented the effective flushing and removal of bioburden.

Ultimately, to effect change, Schneiter designed the Clear Flush® Laparoscopic Instrument and licensed the technology to BOSS Instruments Ltd. The Clear Flush design facilitates a more effective cleaning and sterilizing process because in Schneiters design, the nooks and crannies that accumulate and retain bioburden inside of conventional laparoscopic instruments are eliminated.

The instrument design also removes residual moisture after reprocessing, according to independent laboratory testing conducted at Nelson Laboratories Inc., utilizing the Association for the Advancement of Medical Instrumentation (AAMI) standards. This design improvement eliminates the opportunity for waterborne pathogens to colonize inside the lumen after the sterilization process.

Marshall says there currently are no federal requirements for laparoscopic instruments to undergo laboratory testing for cleaning efficacy.

It is time for a wake up call for the industry when it comes to evaluating conventional laparoscopic instruments, Schneiter concludes. Healthcare facilities must start to demand from their laparoscopic instrument suppliers cleaning and sterilization documentation that has been validated by an independent testing laboratory utilizing AAMIs protocol. 

References

1. Janie Fuller, et. Al. Laparoscopic Trocar Injuries: A report from a U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Systematic Technology Assessment of Medical Products (STAMP) Committee. Nov. 7, 2003.

2. Institute for Healthcare Improvement. The Steps to Safer Surgery. 
www.ihi.org/IHI/Topics/PatientSafety/SurgicalSiteInfections/Improvement-Stories/TheStepstoSaferSurgery.htm.  

3. Roth K, et. Al. Specific hygiene issues relating to reprocessing and reuse of single-use devices for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1091-7. Epub 2002 Apr 9.

4. STERIS Corp. The care and handling of rigid endoscopes: A Clinical Education Study Guide. Study Guide # 008.